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Novartis

Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).[1]It is one of the largest pharmaceutical companies in the world.

Novartis AG
Headquarters in Basel
TypePublic (Aktiengesellschaft)
ISINCH0012005267
IndustryPharmaceuticals
Predecessors
  • Ciba-Geigy
  • Sandoz (via merger)
Founded
  • March 1996; 26 years ago (1996-03)
  • (from merger)
Founders
  • Johann Rudolf
  • Alexander Clavel
Headquarters
Area served
Worldwide
Key people
Vasant Narasimhan (CEO)[2]
ProductsPharmaceutical drugs, generic drugs, over-the-counter drugs, vaccines, diagnostics, contact lenses, animal health (list...)
Revenue US$51.63 billion (2021)[3]
US$11.69 billion (2021)[3]
US$24.02 billion (2021)[3]
Total assets US$131.79 billion (2021)[3]
Total equity US$67.82 billion (2021)[3]
Number of employees
110,000 (2021)[3]
Websitewww.novartis.com

Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren; sold to GlaxoSmithKline in 2015 deal), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), cyclosporine (Neoral/Sandimmune), letrozole (Femara), methylphenidate (Ritalin; production ceased 2020), terbinafine (Lamisil), deferasirox (Exjade), and others.

In March 1996, the companies Ciba-Geigy and Sandoz merged to form Novartis; the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. Other Ciba-Geigy and Sandoz businesses were sold, or, like Ciba Specialty Chemicals, spun off as independent companies. The Sandoz brand disappeared for three years, but was revived in 2003 when Novartis consolidated its generic drugs businesses into a single subsidiary and named it Sandoz. Novartis divested its agrochemical and genetically modified crops business in 2000 with the spinout of Syngenta in partnership with AstraZeneca, which also divested its agrochemical business.

Novartis is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA),[4] the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA),[5] and the Pharmaceutical Research and Manufacturers of America (PhRMA).[6]

Corporate structure

Shareholders of Novartis by country of origin as of 2019.[7]

  Switzerland (42.38%)
  United Kingdom (26.15%)
  United States (25.41%)
  Others (6.06%)

Novartis AG is a publicly traded Swiss holding company that operates through the Novartis Group. Novartis AG owns, directly or indirectly, all companies worldwide that operate as subsidiaries of the Novartis Group.[8]

Novartis's businesses are divided into three operating divisions: Innovative Medicines, Sandoz (generics) and Alcon (eyecare).[9] In April 2019, Novartis spun off Alcon into a separate company.[10] In August 2022, Novartis announced plans to spin off Sandoz as part of restructuring.[11] The Innovative Medicines division comprises two business units: Novartis Pharmaceuticals and Novartis Oncology.[12]: 150 [13] Novartis operates directly through subsidiaries, each of which fall under one of the divisions, and that Novartis categorizes as fulfilling one or more of the following functions: Holding/Finance, Sales, Production, and Research[8][12]: 251–253 

Novartis AG also held 33.3 percent of the shares of Roche until 2022, however it did not exercise control over Roche.[14] Novartis also has two significant license agreements with Genentech, a Roche subsidiary.[15] One agreement is for Lucentis; the other is for Xolair.[12]: 239 [better source needed]

In 2014, Novartis established a center in Hyderabad, India, in order to offshore several of its R&D, clinical development, medical writing and administrative functions.[16] The center supports the drug major's operations in the pharmaceuticals (Novartis), eye care (Alcon) and generic drugs segments (Sandoz).[17]

Place in its market segments

Novartis is the world's second-largest pharmaceutical company by market cap in 2019.[18]

  • Alcon: At the time Novartis bought Alcon, they had annual sales of $6.5 billion and a net income of $2 billion.[19] In April 2019, Novartis completed the spin-off of Alcon as a separate commercial entity.[20]
  • Sandoz: As of 2013, Sandoz has been recognized as the world's second-largest generic drug company.[citation needed] Sandoz' biosimilars lead its field, getting the first biosimilar approvals in the EU.[21][22] In 2018, Sandoz reported US$9.9 billion in net sales.[23] In August 2022, Novartis announced plans to spin off Sandoz by second half of 2023.[11]
  • Vaccines and Diagnostics Division: In 2013, Novartis announced it was considering selling the vaccines and diagnostics division off.[24] This sale was completed in late 2015, and the division was integrated into CSL's BioCSL operation, with the combined entity trading as Seqirus.[25][26] In 2018, Novartis sold its consumer healthcare joint venture vaccines division to GlaxoSmithKline for US$13.0 billion.[27]
  • Consumer: Novartis is not a leader in the over-the-counter or animal health segments; its leading OTC brands are Excedrin and Theraflu, but sales have been slowed by problems at its key US manufacturing plant.[28]

In 2018, Novartis ranked second on the Access to Medicine Index,[29]: 88  which "ranks companies on how readily they make their products available to the world's poor."[30][31]

Finance

For the fiscal year 2020, Novartis reported earnings of US$8.072 billion, with an annual revenue of US$49.898 billion, an increase of 2.51 percent over the previous fiscal cycle. Novartis shares traded at over $84.38 per share, and its market capitalization was valued at $190.3B as of September 16, 2020.[32]

Year Revenue
in mil. USD$
Net income
in mil. USD$
Price per Share
in USD$
Employees
2005 29,753 6,130 32.03
2006 35,105 7,175 36.99
2007 38,947 11,946 37.10
2008 42,584 8,195 35.44
2009 45,103 8,400 31.98
2010 51,561 9,794 39.41
2011 59,375 8,940 44.42
2012 51,971 9,270 46.50
2013 52,716 9,175 61.40 135,696
2014 53,634 10,210 76.50 133,413
2015 50,387 17,783 86.92 122,966
2016 49,436 6,712 71.10 122,985
2017 50,135 7,703 77.33 126,457
2018 46,099 12,614 91.13 129,924
2019 48,677 11,732 88.14 103,914
2020 49,898 8,072 84.38 110,000
2021 51,626 24,018 87.47 110,000

History

Novartis was created in March 1996 from the merger of Ciba-Geigy and Sandoz Laboratories, both Swiss companies. [33]

Ciba-Geigy

Ciba-Geigy was formed in 1970 by the merger of J. R. Geigy Ltd (founded in Basel in 1857) and CIBA (founded in Basel in 1859).[33]

Ciba began in 1859, when Alexander Clavel (1805–1873) took up the production of fuchsine in his factory for silk-dyeing works in Basel. By 1873, he sold his dye factory to the company Bindschedler and Busch. In 1884, Bindschedler and Busch was transformed into a joint-stock company named "Gesellschaft für Chemische Industrie Basel" (Company for Chemical Industry Basel). The acronym, CIBA, was adopted as the company's name in 1945.[34]

The foundation for Geigy was established in 1857, when Johann Rudolf Geigy-Merian (1830–1917) and Johann Muller-Pack acquired a site in Basel, where they built a dyewood mill and a dye extraction plant. Two years later, they began the production of synthetic fuchsine.[35] In 1901, they formed the public limited company Geigy, and the name of the company was changed to J. R. Geigy Ltd in 1914.[36]

CIBA and Geigy merged in 1970 to form Ciba‑Geigy Ltd. /ˌsbə ˈɡɡi/.[37]

Mid-1990s controversy

In the mid-1990s, state and federal health and environmental agencies identified an increased incidence of childhood cancers in Toms River, New Jersey, from the 1970–1995 period. Multiple investigations by state and federal environmental and health agencies indicated that the likely source of the increased cancer risk was contamination from Toms River Chemical Plant (then operated by Ciba-Geigy), which had been in operation since 1952. The area was designated a United States Environmental Protection Agency Superfund site in 1983 after an underground plume of toxic chemicals was identified. The following year, a discharge pipe was shut down after a sinkhole at the corner of Bay Avenue and Vaughn Avenue revealed that it had been leaking. The plant ceased operation in 1996. A follow-up study from the 1996–2000 period indicated that while there were more cancer cases than expected, rates had significantly fallen and the difference was statistically insignificant compared to normal statewide cancer rates. Since 1996, the Toms River water system has been subject to the most stringent water testing in New Jersey and is considered safe for consumption. Dan Fagin's Toms River: A Story of Science and Salvation, the 2014 Pulitzer Prize winning book, examined the issue of industrial pollution at the site in detail.

Sandoz

 
The Sandoz brand exists today as a subsidiary of Novartis.

Sandoz is the generic drugs division of Novartis. Before the 1996 merger with Ciba-Geigy to form Novartis, Sandoz Pharmaceuticals (Sandoz AG) was a pharmaceutical company headquartered in Basel, Switzerland (as was Ciba-Geigy), and was best known for developing drugs such as Sandimmune for organ transplantation, the antipsychotic Clozaril, Mellaril Tablets and Serentil Tablets for treating psychiatric disorders, and Cafergot Tablets and Torecan Suppositories for treating migraine headaches.

The Chemiefirma Kern und Sandoz ("Kern and Sandoz Chemistry Firm") was founded in 1886 by Alfred Kern (1850–1893) and Edouard Sandoz (1853–1928). The first dyes manufactured by them were alizarinblue and auramine. After Kern's death, the partnership became the corporation Chemische Fabrik vormals Sandoz in 1895. The company began producing the fever-reducing drug antipyrin in the same year. In 1899, the company began producing the sugar substitute saccharin. Further pharmaceutical research began in 1917 under Arthur Stoll (1887–1971), who is the founder of Sandoz's pharmaceutical department in 1917.[38] In 1918, Arthur Stoll isolated ergotamine from ergot; the substance was eventually used to treat migraine and headaches and was introduced under the trade name Gynergen in 1921.

Between the World Wars, Gynergen (1921) and Calcium-Sandoz (1929) were brought to market. Sandoz also produced chemicals for textiles, paper, and leather, beginning in 1929. In 1939, the company began producing agricultural chemicals.

The psychedelic effects of lysergic acid diethylamide (LSD) were discovered at the Sandoz laboratories in 1943 by Arthur Stoll and Albert Hofmann.[39][40] Sandoz began clinical trials and marketed the substance, from 1947 through the mid-1960s, under the name Delysid as a psychiatric drug, thought useful for treating a wide variety of mental ailments, ranging from alcoholism to sexual deviancy. Sandoz suggested in its marketing literature that psychiatrists take LSD themselves,[41] to gain a better subjective understanding of the schizophrenic experience, and many did exactly that and so did other scientific researchers. The Sandoz product received mass publicity as early as 1954, in a Time Magazine feature.[42] Research on LSD peaked in the 1950s and early 1960s. The CIA purchased quantities of LSD from Sandoz for use in its illegal human experimentation program known as MKUltra.[43] Sandoz withdrew the drug from the market in 1965. The drug became a cultural novelty of the 1960s after psychologist Timothy Leary at Harvard University began to promote its use for recreational and spiritual experiences among the general public.

Sandoz opened its first foreign offices in 1964. In 1967, Sandoz merged with Wander AG (known for Ovomaltine and Isostar). Sandoz acquired the companies Delmark, Wasabröd (a Swedish manufacturer of crisp bread), and Gerber Products Company (a baby food company). On 1 November 1986, a fire broke out in a production plant storage room, which led to the Sandoz chemical spill and a large amount of pesticide being released into the upper Rhine river. This exposure killed many fish and other aquatic life. In 1995, Sandoz spun off its specialty chemicals business to form Clariant. In 1997, Clariant merged with the specialty chemicals business that was spun off from Hoechst AG in Germany.[44]

Merger

In 1996 Ciba-Geigy merged with Sandoz, with the pharmaceutical and agrochemical divisions of both staying together to form Novartis. Other Ciba-Geigy and Sandoz businesses were spun off as independent companies.[45][46] notably Ciba Specialty Chemicals.[46][47] Sandoz's Master Builders Technologies, a producer of chemicals for the construction industry, was sold off to SKW Trostberg A.G., a subsidiary of the German energy company VIAG, while its North American corn herbicide business became part of the German chemical maker BASF.[47]

Post-merger

 
Suffern, New York: one of the Novartis pharmaceutical production facilities in the United States
 
Novartis India headquarters in HITEC City, Hyderabad

In 1998, the company entered into a biotechnology licensing agreement with the University of California at Berkeley Department of Plant and Microbial Biology.[48] Critics of the agreement expressed concern over prospects that the agreement would diminish academic objectivity, or lead to the commercialization of genetically modified plants.[49] The agreement expired in 2003.[50]

2000–2010

In 2000, Novartis and AstraZeneca combined their agrobusiness divisions to create a new company, Syngenta.[51][52]

In 2003, Novartis organized all its generics businesses into one division, and merged some of its subsidiaries into one company, reusing the predecessor brand name of Sandoz.[53]

In 2005, Novartis expanded its subsidiary Sandoz significantly through the US$8.29 billion acquisition of Hexal, one of Germany's leading generic drug companies, and Eon Labs, a fast-growing United States generic pharmaceutical company.[54]

In 2006, Novartis acquired the California-based Chiron Corporation. Chiron had been divided into three units: Chiron Vaccines, Chiron Blood Testing, and Chiron BioPharmaceuticals. The biopharmaceutical unit was integrated into Novartis Pharmaceuticals, while the vaccines and blood testing units were made into a new Novartis Vaccines and Diagnostics division.[55] Also in 2006, Sandoz became the first company to have a biosimilar drug approved in Europe with its recombinant human growth hormone drug.[56]

In 2007, Novartis sold the Gerber Products Company to Nestlé as part of its continuing effort to shed old Sandoz and Ciba-Geigy businesses and focus on healthcare.[57]

In 2009, Novartis reached an agreement to acquire an 85 percent stake in the Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. as part of a strategic initiative to build a vaccines industry leader in this country and expand the group's limited presence in this fast-growing market segment. This proposed acquisition will require government and regulatory approvals in China.[58]

In 2010, Novartis offered to pay US$39.3 billion to fully acquire Alcon, the world's largest eye-care company, including a majority stake held by Nestlé. Novartis had bought 25 percent of Alcon in 2008.[59] Novartis created a new division and called it Alcon, under which it placed its CIBA VISION subsidiary and Novartis Ophthalmics, which became the second-largest division of Novartis.[60] The total cost for Alcon amounted to $60 billion. [61]

2011–present

In 2011, Novartis acquired the medical laboratory diagnostics company Genoptix to "serve as a strong foundation for our (Novartis') individualized treatment programs".[62]

In 2012, the Company cut ~2000 positions in the United States, primarily in sales, in response to anticipated revenue downturns from the hypertension drug Diovan, which was losing patent protection, and the realization that the anticipated successor to Diovan, Rasilez, was failing in clinical trials.[63] The 2012 personnel reductions follow ~2000 cut positions in Switzerland and the United States in 2011, ~1400 cut positions in the United States in 2010, and a reduction of "thousands" and several site closures in previous years.[64] Also in 2012, Novartis became the biggest manufacturer of generic skin care medicine, after agreeing to buy Fougera Pharmaceuticals for $1.525 billion in cash.[65]

In 2013, the Indian Supreme Court issued a decision rejecting Novartis' patent application in India on the final form of Gleevec, Novartis's cancer drug; the case caused great controversy.[66] In 2013, Novartis was sued again by the US government, this time for allegedly bribing doctors for a decade so that their patients are steered towards the company's drugs.[67]

In January 2014, Novartis announced plans to cut 500 jobs from its pharmaceuticals division.[68] In February 2014, Novartis announced that it acquired CoStim Pharmaceuticals.[69]

In May 2014, Novartis purchased the rights to market Ophthotech's Fovista (an anti-PDGF aptamer, also being investigated for use in combination with anti-VEGF treatments) outside the U.S. for up to $1 billion.[70] Novartis acquired exclusive rights to market the eye drug outside of the states while retaining U.S. marketing rights. The company agreed to pay Ophthotech $200 million upfront, and $130 million in milestone payments relating to Phase III trials.[70] Ophthotech is also eligible to receive up to $300 million dependent upon future marketing approval milestones outside of America and up to $400 million relating to sales milestones.[70] In September 2014, Ophthotech received its first $50 million phase III trial milestone payment from Novartis.[71] In April 2014, Novartis announced that it would acquire GlaxoSmithKline's cancer drug business for $16 billion as well as selling its vaccines business to GlaxoSmithKline for $7.1 billion.[72] In August 2014 Genetic Engineering & Biotechnology News reported that Novartis had acquired a 15 percent stake in Gamida Cell for $35 million, with the option to purchase the whole company for approximately $165 million.[73] In October 2014, Novartis announced its intention to sell its influenza vaccine business (inclusive of its development pipeline), subject to regulatory approval, to CSL for $275 million.[74]

In March 2015, the company announced BioPharma had completed its acquisition of two Phase III cancer-drug candidates; the MEK inhibitor binimetinib (MEK 162) and the BRAF inhibitor encorafenib (LGX818), for $85 million.[75] In addition, the company sold its RNAi portfolio to Arrowhead Research for $10 million and $25 million in stock.[76] In June, the company announced it would acquire Spinifex Pharmaceuticals for more than $200 million.[77] In August, the company acquired the remaining rights to the CD20 monoclonal antibody Ofatumumab from GlaxoSmithKline for up to $1 billion.[78][79] In October the company acquired Admune Therapeutics for an undisclosed sum, as well as licensing PBF-509, an adenosine A2A receptor antagonist which is in Phase I clinical trials for non-small cell lung cancer, from Palobiofarma.[80]

In November 2016, the company announced it would acquire Selexys Pharmaceuticals for $665 million.[81] In December, the company acquired Encore Vision, gaining the company's principle compound, EV06, is a first-in-class topical therapy for presbyopia.[82] In December Novartis acquired Ziarco Group Limited, bolstering its presence in eczema treatments.[83]

In late October 2017, Reuters announced that Novartis would acquire Advanced Accelerator Applications for $3.9 billion, paying $41 per ordinary share and $82 per American depositary share representing a 47 percent premium.[84]

In March 2018, GlaxoSmithKline announced that it has reached an agreement with Novartis to acquire Novartis' 36.5 percent stake in their Consumer Healthcare Joint Venture for $13 billion (£9.2 billion).[85][86] In April of the same year, the business utilised some of the proceeds from the aforementioned GlaxoSmithKline deal to acquire Avexis for $218 per share or $8.7 billion in total, gaining the lead compound AVXS-101 used to treat spinal muscular atrophy.[87] In August 2018, Novartis signed a deal with Laekna-a Shanghai-based pharmaceutical company for its two clinical-stage cancer drugs.[88] Novartis gave Laekna the exclusive international rights for the drugs that are oral pan-Akt kinase inhibitors namely; afuresertib (ASB138) and uprosertib (UPB795).[89] In mid-October, the company announced it would acquire Endocyte Inc for $2.1 billion ($24 per share) merging it with a newly created subsidiary.[90][91] Endocyte will bolster Novartis' offering in its radiopharmaceuticals business, with Endocyte's first in class candidate 177Lu-PSMA-617 being targeted against metastatic castration-resistant prostate cancer.[92] In late December the company announced it would acquire France-based contract manufacturer, CellforCure from LFB, boosting its capacity to produce cell and gene therapies.[93]

On April 9, 2019, Novartis announced that it had completed the spin-off of Alcon as a separate commercial entity. Alcon was listed on the SIX exchange in Switzerland and NYSE exchange in the U.S.[20] Novartis announced during late 2019 a five-year artificial intelligence "alliance" with Microsoft. The companies aim to create applications for "Microsoft's AI capabilities", in turn improving the other's drug development processes. Microsoft seeks to "test AI products it is already working on in 'real-life' situations". The deal will pursue solutions for "organizing and using" data generated from Novartis' laboratory experiments, clinical trials, and manufacturing plants. It will also look at improving manufacturing of Chimeric antigen receptor T cell (CAR T cells). Finally, the deal "will also apply AI to generative chemistry to enhance drug design".[94] In November 2019, Sandoz announced it would acquire the Japanese business of Aspen Global inc for €300 million (around $330 million), boosting the business's presence in Asia.[95] In late November 2019, the business announced it would acquire The Medicines Company for US$9.7 billion ($85 per share) in order to acquire amongst other assets, the cholesterol lowering therapy; inclisiran.[96][97]

In April 2020, the company announced it would acquire Amblyotech.[98]

In September 2020, Novartis was imposed a fine of €385 million by the French competition authority on accusations of abusive practices to preserve sales of Lucentis over a cheaper drug.[99] Also in September, BioNTech has leased a large production facility from Novartis to follow all advance demands for its coronavirus vaccine in Europe and sell it to China.[100]

In October Novartis announced it would acquire Vedere Bio for $280 million boosting the businesses cell and gene therapy offerings.[101][102]

In October 2020, as part of a joint venture to develop therapeutic drugs to combat COVID-19, Novartis bought 6% of all shares outstanding in Swiss DARPin research company Molecular Partners AG at CHF 23 per share.[103]

In December 2020, Novartis announced it would acquire Cadent Therapeutics for up to $770 million, gaining full rights to CAD-9303 (a NMDAr positive allosteric modulator), MIJ-821 (a NMDAr negative allosteric modulator) and CAD-1883 a clinical-stage SK channel positive allosteric modulator.[104][105]

In September 2021, the company announced it would acquire gene-therapy business, Arctos Medical, broadening its optogenetics range.[106] In December, Novartis announced it would purchase Gyroscope Therapeutics from health care investment company, Syncona Ltd, for up to $1.5 billion.[107]

In February 2022, New York City-based biotechnology company Cambrian Biopharma announced it had licensed rights to mTOR inhibitor programs from Novartis.[108] As part of the deal, Cambrian was setting up a subsidiary called Tornado Therapeutics.[108]

In August 2022, the company announced its plan to spin off Sandoz generic drugs unit to form a publicly traded business as part of a restructuring.[11] With the unit having generated US$9.69 billion in 2021, the spin-off would create the biggest generic drugs company in Europe by sales.[109]

Acquisition history

Novartis Acquisitions
  • Novartis
    • Novartis (Merger of Ciba-Geigy and Sandoz, 1996)
      • Ciba-Geigy
        • J. R. Geigy Ltd (Merged 1971)
        • CIBA (Merged 1971)
      • Sandoz
        • Kern and Sandoz Chemistry Firm (Founded 1886)
        • Wander AG (Acq 1967)
        • Lek d.d. (Slovenia) (Acq 2002)
        • Aspen Global inc (Japanese business) (Acq 2019)
    • Hexal (Acq 2005)
    • Eon Labs (Acq 2005)
    • Chiron Corporation (Acq 2006)
      • Matrix Pharmaceuticals Inc (Acq 2002)
      • PowderJect (Acq 2003)
      • PathoGenesis (Acq 2001)
      • Cetus Corporation
        • Cetus Oncology
        • Biocine Company
        • Chiron Diagnostics
        • Chiron Intraoptics
        • Chiron Technologies 
      • Adatomed GmbH
    • Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd (Acq 2009)
    • Alcon (Founded 1945, Acq 2010)
      • Texas Pharmacal Company (Acq 1979)
    • Genoptix (Acq 2011)
    • Fougera Pharmaceuticals (Acq 2012)
    • CoStim Pharmaceuticals (Acq 2014)
    • GlaxoSmithKline (Cancer drug division) (Acq 2014)
    • Spinifex Pharmaceuticals (Acq 2015)
    • Admune Therapeutic (Acq 2015)
    • Selexys Pharmaceuticals (Acq 2016)
    • Ziarco Group Limited (Acq 2016)
    • Advanced Accelerator Applications (Acq 2018)
    • AveXis (Acq 2018)
    • Endocyte (Acq 2018)
    • CellforCure (Acq 2018)
    • The Medicines Company (Acq 2019)
    • Amblyotech (Acq 2020)
    • Vedere Bio (Acq 2020)
    • Cadent Therapeutics (Acq 2020)
      • Luc Therapeutics (Merged 2017)
      • Ataxion Therapeutics (Merged 2017)
    • Arctos Medical (Acq 2021)
    • Gyroscope Therapeutics (Acq 2021)

Research

 
Novartis in Cambridge, Massachusetts in November 2019.

The company's global research operations, called "Novartis Institutes for BioMedical Research (NIBR)" have their global headquarters in Cambridge, Massachusetts, United States.[110][111] Two research institutes reside within NIBR that focus on diseases in the developing world: Novartis Institute for Tropical Diseases, which works on tuberculosis, dengue, and malaria, and Novartis Vaccines Institute for Global Health, which works on salmonella typhi (typhoid fever) and shigella.[112]

Novartis is also involved in publicly funded collaborative research projects, with other industrial and academic partners. One example in the area of non-clinical safety assessment is the InnoMed PredTox project.[113][114] The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission.[115]

Novartis is working with Science 37 in order to allow video based telemedicine visits instead of physical traveling to clinics for patients. It is planning for ten clinical trials over three years using mobile technology to help free patients from burdensome hospital trips.[116]

Products

Pharmaceuticals

Name Indication(s) or drug type/class Sales US$1,000,000 Sales year % Change Notes
Aclasta/Reclast (zoledronic acid) Osteoporosis 590 2012[117] −4%
Adelphane-Esidrex (reserpine/dihydralazine/hydrochlorothiazide) Hypertension
Afinitor/Certican/Zortress (everolimus) Prevention of transplant rejection, various cancers 797 2012[117] 80%
Amturnide (aliskiren/amlodipine/hydrochlorothiazide) Hypertension
Anafranil (clomipramine) Major depressive disorder, obsessive-compulsive disorder
Arcapta Neohaler/Onbrez Breezhaler (indacaterol) COPD
Brinaldix (clopamide) Hypertension
Clozaril/Leponex (clozapine) Treatment-resistant schizophrenia
Co-Diovan (Valsartan/hydrochlorothiazide) Hypertension
Coartem/Riamet (artemether/lumefantrine) Malaria (uncomplicated)
Comtan (entacapone) Parkinson's disease 530 2012[117] −14%
Cosentyx (secukinumab) Psoriasis
Diovan (valsartan) Hypertension 4,417 2012[117] −22%
Entresto (sacubitril/valsartan) Heart failure
Enterovioform (clioquinol) Amoebiasis
Eucreas/Galvus Met (vildagliptin/metformin) Diabetes mellitus type 2
Exelon Patch (rivastigmine) Alzheimer's disease 1,050 2012[117] −2%
Exforge (amlodipine/valsartan) Hypertension 1,352 2012[117] 12%
Exjade (deferasirox) Chronic iron overload 870 2012[117] 2% Manufactured as tablets for oral suspension; tablets for oral use are marketed under the brand name Jadenu
Famvir (famciclovir) Herpes zoster and other Herpesvirus infection
Fanapt (iloperidone) Schizophrenia
Femara (letrozole) Breast cancer 438 2012[117] −52%
Focalin (dexmethylphenidate) ADHD First US generics of Focalin became available in 2007[118] Focalin XR became available in 2012.[119]
Foradil/Foradile (formoterol) Asthma, COPD
Galvus (vildagliptin) Diabetes mellitus type 2 910 2012[117] 39%
Gilenya (fingolimod) Multiple sclerosis 1,195 2012[117] 142%
Gleevec/Glivec (imatinib) Oncology, Chronic myelogenous leukemia 4,675 2012[117] 0%
Hygroton (chlortalidone) Hypertension
Ilaris (canakinumab) Cryopyrin-associated periodic syndrome
Jadenu (deferasirox) Chronic iron overload Deferasirox tablets for oral use—a new formulation of Exjade (which comes in tablets for oral suspension)
Jakavi/Jakafi (ruxolitinib) Myelofibrosis (of intermediate to high risk)
Kymriah (tisagenlecleucel) Acute lymphoblastic leukemia
Lamisil (terbinafine) Fungal infections
Lescol (fluvastatin) Hypercholesterolemia 665 2007[120] −8%
Lioresal (baclofen) Spasticity
Lotrel (amlodipine/benazepril) Hypertension 748 2007[120] −34%
Lucentis (ranibizumab) Age-related macular degeneration 2,398 2012[117] 17%
Ludiomil (maprotiline) Major depressive disorder
Mayzent[121] (siponimod) Treatment for secondary progressive multiple sclerosis (SPMS) FDA approved March 26, 2019[122]
Mellaril (thioridazine) Schizophrenia
Myfortic (mycophenolic acid) Prevention of transplant rejection 579 2012[117] 12%
Navoban (tropisetron) Chemotherapy-induced nausea and vomiting
Odomzo (sonidegib) Locally advanced basal cell carcinoma
Ritalin (methylphenidate) ADHD 554 2012[117] 1%
Sandimmune/Neoral (ciclosporin) Prevention of transplant rejection 821 2012[117] −9%
Sandostatin (octreotide) Acromegaly 1,512 2012[117] 5%
Sertraline Sandoz (sertraline hydrochloride) Depression, obsessive-compulsive disorder, panic disorder[123] Generic form of sertraline.
Signifor (pasireotide) Cushing's disease[124][125]
Simulect (basiliximab) Prevention of transplant rejection
Sirdalud (tizanidine) Spasticity
Spersallerg (antazoline/tetrahydrozoline) Allergic conjunctivitis
Stalevo (carbidopa/levodopa/entacapone) Parkinson's disease
Tasigna (nilotinib) Chronic myelogenous leukemia (first-line treatment[126]) 998 2012[117] 39% NICE formulary approval, January 2012[126]
Tegretol (carbamazepine) Epilepsy, bipolar disorder 413 2007[120] 6%
Tekamlo (aliskiren/amlodipine) Hypertension
Tekturna/Rasilez (aliskiren) Hypertension
Termalgin (paracetamol) Fever, mild pain
Tobi (tobramycin) Prevention of Pseudomonas aeruginosa infection in cystic fibrosis 350 (US only) 2012[127] Teva introduced generic in the US in 2013[127]
Tofranil (imipramine) Major depressive disorder, enuresis
Trileptal (oxcarbazepine) Epilepsy, bipolar disorder 690 (US only) 2007[128] Teva introduced generic in 2008[128]
Tyzeca/Sebivo (telbivudine) Chronic hepatitis B
Visudyne (verteporfin) Age-related macular degeneration (wet form)
Voltaren (diclofenac) Acute pain, inflammatory disorders (such as rheumatoid arthritis) 759 (excl. OTC) 2012[117] −4%
Zometa (zoledronic acid) Prevention of bone fractures in cancer patients 1,288 2012[117] −13%
Xolair (omalizumab) Moderate-to-severe asthma not controlled by inhaled steroids
Chronic idiopathic urticaria
504 2012[117] 4%
Zaditen (ketotifen) Asthma, allergic conjunctivitis

Consumer health

In January 2009, the United States Department of Health and Human Services awarded Novartis a $486 million contract for construction of the first US plant to produce cell-based influenza vaccine, to be located in Holly Springs, North Carolina. The stated goal of this program is the capability of producing 150,000,000 doses of pandemic vaccine within six months of declaring a flu pandemic.[129]

In April 2014, Novartis divested its consumer health section with $3,5 billion worth of assets into a new joint venture with GlaxoSmithKline, named GSK Consumer Healthcare, of which Novartis will hold a 36,5% stake.[130] In March 2018, GSK announced that it has reached an agreement with Novartis to acquire Novartis' 36.5% stake in their Consumer Healthcare Joint Venture for $13 billion (£9.2 billion).[86]

Animal health

Pet care

Livestock

  • Acatalk Duostar (Fluazuron, Ivermectin), tick control for cattle
  • CLiK (Dicyclanil), blowfly control for sheep
  • Denagard (Tiamulin), antibiotic for the treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema)
  • Fasinex (Triclabendazole), oral drench for cattle that is used for the treatment and control of all three stages of liver fluke
  • ViraShield, For use in healthy cattle, including pregnant cows and heifers, as an aid in the prevention of disease caused by infectious bovine rhinotracheitis (IBR), bovine virus diarrhoea (BVD Type 1 and BVD Type 2), parainfluenza Type 3 (PI3), and bovine respiratory syncytial (BRSV) viruses

Bioprotection (insect and rodent control)

Controversies and criticism

Challenge to India's patent laws

Novartis fought a seven-year, controversial battle to patent Gleevec in India, and took the case all the way to the Indian Supreme Court, where the patent application was finally rejected. The patent application at the center of the case was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement. As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, afterwards they were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent application waited in a "mailbox" with others until then, under procedures that India instituted to manage the transition. India also passed certain amendments to its patent law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.[66]

The patent application[131][132] claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate).[133]: 3  In 1993 before India allowed patents on products, Novartis had patented imatinib, with salts vaguely specified, in many countries but could not patent it in India.[134][135] The key differences between the two patent applications were that the 1998 patent application specified the counterion (Gleevec is a specific salt - imatinib mesylate) while the 1993 patent application did not claim any specific salts nor did it mention mesylate, and the 1998 patent application specified the solid form of Gleevec - the way the individual molecules are packed together into a solid when the drug itself is manufactured (this is separate from processes by which the drug itself is formulated into pills or capsules) - while the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta crystalline.[136]

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the EMR was granted in November 2003.[137] Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India.[138] Novartis set the price of Gleevec at US$2666 per patient per month; generic companies were selling their versions at US$177 to 266 per patient per month.[139] Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.[140]

When examination of Novartis' patent application began in 2005, it came under immediate attack from oppositions initiated by generic companies that were already selling Gleevec in India and by advocacy groups. The application was rejected by the patent office and by an appeal board. The key basis for the rejection was the part of Indian patent law that was created by amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. That section, Paragraph 3d, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy."[138][141] At one point, Novartis went to court to try to invalidate Paragraph 3d; it argued that the provision was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal.[142] Novartis did appeal the rejection by the patent office to India's Supreme Court, which took the case.

The Supreme Court case hinged on the interpretation of Paragraph 3d. The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts.[143]

Although the court ruled narrowly,[144] and took care to note that the subject application was filed during a time of transition in Indian patent law,[145] the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing, innovation with affordability etc.[146][147][148]

Had Novartis won and had its patent issued, it could not have prevented generics companies in India from selling generic Gleevec, but it could have obliged them to pay a reasonable royalty under a grandfather clause included in India's patent law.[149][150]

In reaction to the decision, Ranjit Shahani, vice-chairman and managing director of Novartis India Ltd was quoted as saying "This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."[151] He also said that companies like Novartis would invest less money in research in India as a result of the ruling.[66] Novartis also emphasised that it continues to be committed to good access to its drugs; according to Novartis, by 2013, "95% of patients in India—roughly 16,000 people—receive Glivec free of charge... and it has provided more than $1.7 billion worth of Glivec to Indian patients in its support program since it was started...."[140]

Sexual discrimination

On 17 May 2010, a jury in the United States District Court for the Southern District of New York awarded $3,367,250 in compensatory damages against Novartis, finding that the company had committed sexual discrimination against twelve female sales representatives and entry-level managers since 2002, in matters of pay, promotion, and treatment after learning that the employees were pregnant. Two months later the company settled with the remaining plaintiffs for $152.5 million plus attorney fees.[152]

Marketing violations

In September 2008, the US Food and Drug Administration (FDA) sent a notice to Novartis Pharmaceuticals regarding its advertising of Focalin XR, an ADHD drug, in which the company overstated its efficacy while marketing to the public and medical professionals.[153]

In 2005, federal prosecutors opened an investigation into Novartis' marketing of several drugs: Trileptal, an antiseizure drug; three drugs for heart conditions - Diovan (the company's top-selling product), Exforge, and Tekturna; Sandostatin, a drug to treat a growth hormone disorder; and Zelnorm, a drug for irritable bowel syndrome.[154] In September 2010, Novartis agreed to pay US$422.5 million in criminal and civil claims and to enter into a corporate integrity agreement with the US Office of the Inspector General.[155] According to The New York Times, "Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February, the company denied wrongdoing."[154] In the same New York Times article, Frank Lichtenberg, a Columbia professor who receives pharmaceutical financing for research on innovation in the industry, said off-label prescribing was encouraged by the American Medical Association and paid for by insurers, but off-label marketing was clearly illegal. "So it's not surprising that they would settle because they don't have a legal leg to stand on."

In April 2013, federal prosecutors filed two lawsuits against Novartis under the False Claims Act for off-label marketing and kickbacks; in both suits, prosecutors are seeking treble damages.[156][157] The first suit "accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts".[156] In the second, the Justice Department joined a qui tam, or whistleblower, lawsuit brought by a former sales rep over off-label marketing of three drugs: Lotrel and Valturna (both hypertension drugs), and the diabetes drug, Starlix.[157] Twenty-seven states, the District of Columbia and Chicago and New York also joined.[156]

Avastin

Outside the US, Novartis markets the drug ranibizumab (trade name Lucentis), which is a monoclonal antibody fragment derived from the same parent mouse antibody as bevacizumab (Avastin). Both Avastin and Lucentis were created by Genentech which is owned by Roche; Roche markets Avastin worldwide, and also markets Lucentis in the US. Lucentis has been approved worldwide as a treatment for wet macular degeneration and other retinal disorders; Avastin is used to treat certain cancers. Because the price of Lucentis is much higher than Avastin, many ophthalmologists began having compounding pharmacies formulate Avastin for administration to the eye and began treating their patients with Avastin.[158] In 2011, four trusts of the National Health Service in the UK issued policies approving use and payment for administering Avastin for macular degeneration, in order to save money, even though Avastin had not been approved for that indication.[159] In April 2012, after failing to persuade the trusts that it was uncertain whether Avastin was as safe and effective as Lucentis, and in order to retain the market for Lucentis, Novartis announced it would sue the trusts.[159][160] However, in July Novartis offered significant discounts (kept confidential) to the trusts, and the trusts agreed to change their policy,[161] and in November, Novartis dropped the litigation.[162]

Valsartan

In the summer of 2013, two Japanese universities retracted several publications of clinical trials that purported to show that Valsartan (branded as Diovan) had cardiovascular benefits, when it was found that statistical analysis had been manipulated, and that a Novartis employee had participated in the statistical analysis but had not disclosed his relationship with Novartis but only his affiliation with Osaka City University, where he was a lecturer.[163][164] As a result, several Japanese hospitals stopped using the drug, and media outlets ran reports on the scandal in Japan.[163] In January 2014 Japan's Health Ministry filed a criminal complaint with the Tokyo public prosecutor's office against Novartis and an unspecified number of employees, for allegedly misleading consumers through advertisements that used the research to support the benefits of Diovan.[165] On 1 July 2014 the prosecutor's office announced it was formally charging the company and one of its employees.[166]

Corruption

In January 2018, Novartis began being investigated by US and Greek authorities for allegedly bribing Greek public officials in the 2006-2015 period, in a scheme which included two former prime ministers, several former health ministers, many high ranking party members of the Nea Dimokratia and PASOK ruling parties, as well as bankers.[167] The manager of Novartis' Greek branch was prohibited from leaving the country.[168] The minister's deputy described the allegations as "the biggest scandal since the creation of the Greek state", which caused "annual state expenditure on medicine to explode".[169] Most of the ministers involved in the scandal have denied the allegations and sought to paint the case as "political targeting" and "fabrication" by the Syriza opposition party.[167] However, the Greek Judicial Council ruled that the scandal was real.[170] Besides bribery that involves artificial increases in the price of several medicines, the case also involves money laundering, with suspicions of "illegal funds of more than four billion euros ($4.2 billion)" were involved.[171]

In June 2020, Novartis reached settlements with the US Department of Justice (DOJ) and the US Securities and Exchange Commission (SEC) resolving all Foreign Corrupt Practices Act (FCPA) investigations into historical conduct by the company and its subsidiaries. As part of the resolutions, Novartis and some of its current and former subsidiaries would pay US$233.9 million to the DOJ and US$112.8 million to the SEC.[172][173]

Michael Cohen

 
Senate Finance Committee report on Michael Cohen's dealings with Novartis entitled "White House Access for Sale"

Novartis paid $1.2 million to Essential Consultants, an entity owned by Michael Cohen, following the 2017 inauguration of Donald Trump. Cohen was paid monthly, with each payment just under $100,000. Novartis claims it paid Cohen to help it understand and influence the new administration's approach to drug pricing and regulation.[174]

In July 2018, the US Senate committee report "White House Access for Sale" revealed that Novartis Ag's relationship with Cohen was "longer and more detailed". Novartis initially stated that the relationship ceased a month after entering the US$1.2 million contract with Cohen's consulting firm since the consultants were not able to provide the information the pharmaceutical company needed. Later, it became clear, however, that then-CEO Joseph Jimenez and Cohen communicated via email multiple times during 2017, which included ideas to lower drug prices to be discussed with the president. According to the report, several of the ideas appeared later in Trump's drug pricing plan, released in early 2018, in which pharmaceutical companies were protected from reduced revenues.[175][176]

AveXis data integrity

Having already received approval for Zolgensma in May 2019, on June 28 AveXis (a Novartis company) voluntarily disclosed to the FDA that some data previously submitted to the agency as part of the Biologics License Application (BLA) package was inaccurate. Specifically, the data manipulation related to an in vivo murine potency assay used in the early development of the product but the issue the FDA and wider community has taken is that AveXis was aware of the data manipulation as early as 14 March 2019, almost two months before the BLA was approved. To compound the problem in early August it emerged a senior manager sold almost $1 million worth of stock immediately before the FDA probe became public on August 6, but after the company had informed the FDA of the problem. As of September 2019, the FDA was still preparing its response to the scandal.[citation needed]

Philanthropy

Fight against Leprosy

Novartis has been committed for decades to eliminate Leprosy by providing free, multidrug therapy to all endemic countries since 2000.[177][178][179]

See also

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Further reading

  • Kirkland, Rik; Jimenez, Joseph (June 2015). "Novartis on digitizing medicine in an aging world". Insights & Publications (Interview). McKinsey & Company. Retrieved 16 August 2015.

External links

  • Official website
  • Business data for Novartis:
    • Bloomberg
    • Google
    • Reuters
    • SEC filings
    • Yahoo!

novartis, swiss, multinational, pharmaceutical, corporation, based, basel, switzerland, cambridge, massachusetts, united, states, global, research, largest, pharmaceutical, companies, world, agheadquarters, baseltypepublic, aktiengesellschaft, traded, assix, n. Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel Switzerland and Cambridge Massachusetts United States global research 1 It is one of the largest pharmaceutical companies in the world Novartis AGHeadquarters in BaselTypePublic Aktiengesellschaft Traded asSIX NOVN NYSE NVSISINCH0012005267IndustryPharmaceuticalsPredecessorsCiba Geigy Sandoz via merger FoundedMarch 1996 26 years ago 1996 03 from merger FoundersJohann RudolfAlexander ClavelHeadquartersBasel Switzerland 47 34 28 N 7 34 35 E 47 5744252 N 7 5764914 E 47 5744252 7 5764914 Coordinates 47 34 28 N 7 34 35 E 47 5744252 N 7 5764914 E 47 5744252 7 5764914 Cambridge Massachusetts United States global research 1 Area servedWorldwideKey peopleVasant Narasimhan CEO 2 ProductsPharmaceutical drugs generic drugs over the counter drugs vaccines diagnostics contact lenses animal health list RevenueUS 51 63 billion 2021 3 Operating incomeUS 11 69 billion 2021 3 Net incomeUS 24 02 billion 2021 3 Total assetsUS 131 79 billion 2021 3 Total equityUS 67 82 billion 2021 3 Number of employees110 000 2021 3 Websitewww wbr novartis wbr comNovartis manufactures the drugs clozapine Clozaril diclofenac Voltaren sold to GlaxoSmithKline in 2015 deal carbamazepine Tegretol valsartan Diovan imatinib mesylate Gleevec Glivec cyclosporine Neoral Sandimmune letrozole Femara methylphenidate Ritalin production ceased 2020 terbinafine Lamisil deferasirox Exjade and others In March 1996 the companies Ciba Geigy and Sandoz merged to form Novartis the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity Other Ciba Geigy and Sandoz businesses were sold or like Ciba Specialty Chemicals spun off as independent companies The Sandoz brand disappeared for three years but was revived in 2003 when Novartis consolidated its generic drugs businesses into a single subsidiary and named it Sandoz Novartis divested its agrochemical and genetically modified crops business in 2000 with the spinout of Syngenta in partnership with AstraZeneca which also divested its agrochemical business Novartis is a full member of the European Federation of Pharmaceutical Industries and Associations EFPIA 4 the International Federation of Pharmaceutical Manufacturers and Associations IFPMA 5 and the Pharmaceutical Research and Manufacturers of America PhRMA 6 Contents 1 Corporate structure 2 Place in its market segments 2 1 Finance 3 History 3 1 Ciba Geigy 3 2 Mid 1990s controversy 3 3 Sandoz 3 4 Merger 3 5 Post merger 3 5 1 2000 2010 3 5 2 2011 present 3 6 Acquisition history 4 Research 5 Products 5 1 Pharmaceuticals 5 2 Consumer health 5 3 Animal health 5 3 1 Pet care 5 3 2 Livestock 5 3 3 Bioprotection insect and rodent control 6 Controversies and criticism 6 1 Challenge to India s patent laws 6 2 Sexual discrimination 6 3 Marketing violations 6 4 Avastin 6 5 Valsartan 6 6 Corruption 6 7 Michael Cohen 6 8 AveXis data integrity 7 Philanthropy 7 1 Fight against Leprosy 8 See also 9 References 10 Further reading 11 External linksCorporate structure EditShareholders of Novartis by country of origin as of 2019 7 Switzerland 42 38 United Kingdom 26 15 United States 25 41 Others 6 06 Novartis AG is a publicly traded Swiss holding company that operates through the Novartis Group Novartis AG owns directly or indirectly all companies worldwide that operate as subsidiaries of the Novartis Group 8 Novartis s businesses are divided into three operating divisions Innovative Medicines Sandoz generics and Alcon eyecare 9 In April 2019 Novartis spun off Alcon into a separate company 10 In August 2022 Novartis announced plans to spin off Sandoz as part of restructuring 11 The Innovative Medicines division comprises two business units Novartis Pharmaceuticals and Novartis Oncology 12 150 13 Novartis operates directly through subsidiaries each of which fall under one of the divisions and that Novartis categorizes as fulfilling one or more of the following functions Holding Finance Sales Production and Research 8 12 251 253 Novartis AG also held 33 3 percent of the shares of Roche until 2022 however it did not exercise control over Roche 14 Novartis also has two significant license agreements with Genentech a Roche subsidiary 15 One agreement is for Lucentis the other is for Xolair 12 239 better source needed In 2014 Novartis established a center in Hyderabad India in order to offshore several of its R amp D clinical development medical writing and administrative functions 16 The center supports the drug major s operations in the pharmaceuticals Novartis eye care Alcon and generic drugs segments Sandoz 17 Place in its market segments EditThis section needs to be updated Please help update this article to reflect recent events or newly available information September 2018 Novartis is the world s second largest pharmaceutical company by market cap in 2019 18 Alcon At the time Novartis bought Alcon they had annual sales of 6 5 billion and a net income of 2 billion 19 In April 2019 Novartis completed the spin off of Alcon as a separate commercial entity 20 Sandoz As of 2013 update Sandoz has been recognized as the world s second largest generic drug company citation needed Sandoz biosimilars lead its field getting the first biosimilar approvals in the EU 21 22 In 2018 Sandoz reported US 9 9 billion in net sales 23 In August 2022 Novartis announced plans to spin off Sandoz by second half of 2023 11 Vaccines and Diagnostics Division In 2013 Novartis announced it was considering selling the vaccines and diagnostics division off 24 This sale was completed in late 2015 and the division was integrated into CSL s BioCSL operation with the combined entity trading as Seqirus 25 26 In 2018 Novartis sold its consumer healthcare joint venture vaccines division to GlaxoSmithKline for US 13 0 billion 27 Consumer Novartis is not a leader in the over the counter or animal health segments its leading OTC brands are Excedrin and Theraflu but sales have been slowed by problems at its key US manufacturing plant 28 In 2018 Novartis ranked second on the Access to Medicine Index 29 88 which ranks companies on how readily they make their products available to the world s poor 30 31 Finance Edit For the fiscal year 2020 Novartis reported earnings of US 8 072 billion with an annual revenue of US 49 898 billion an increase of 2 51 percent over the previous fiscal cycle Novartis shares traded at over 84 38 per share and its market capitalization was valued at 190 3B as of September 16 2020 32 Year Revenuein mil USD Net incomein mil USD Price per Sharein USD Employees2005 29 753 6 130 32 032006 35 105 7 175 36 992007 38 947 11 946 37 102008 42 584 8 195 35 442009 45 103 8 400 31 982010 51 561 9 794 39 412011 59 375 8 940 44 422012 51 971 9 270 46 502013 52 716 9 175 61 40 135 6962014 53 634 10 210 76 50 133 4132015 50 387 17 783 86 92 122 9662016 49 436 6 712 71 10 122 9852017 50 135 7 703 77 33 126 4572018 46 099 12 614 91 13 129 9242019 48 677 11 732 88 14 103 9142020 49 898 8 072 84 38 110 0002021 51 626 24 018 87 47 110 000History EditNovartis was created in March 1996 from the merger of Ciba Geigy and Sandoz Laboratories both Swiss companies 33 Ciba Geigy Edit Ciba Geigy was formed in 1970 by the merger of J R Geigy Ltd founded in Basel in 1857 and CIBA founded in Basel in 1859 33 Ciba began in 1859 when Alexander Clavel 1805 1873 took up the production of fuchsine in his factory for silk dyeing works in Basel By 1873 he sold his dye factory to the company Bindschedler and Busch In 1884 Bindschedler and Busch was transformed into a joint stock company named Gesellschaft fur Chemische Industrie Basel Company for Chemical Industry Basel The acronym CIBA was adopted as the company s name in 1945 34 The foundation for Geigy was established in 1857 when Johann Rudolf Geigy Merian 1830 1917 and Johann Muller Pack acquired a site in Basel where they built a dyewood mill and a dye extraction plant Two years later they began the production of synthetic fuchsine 35 In 1901 they formed the public limited company Geigy and the name of the company was changed to J R Geigy Ltd in 1914 36 CIBA and Geigy merged in 1970 to form Ciba Geigy Ltd ˌ s iː b e ˈ ɡ aɪ ɡ i 37 Mid 1990s controversy Edit In the mid 1990s state and federal health and environmental agencies identified an increased incidence of childhood cancers in Toms River New Jersey from the 1970 1995 period Multiple investigations by state and federal environmental and health agencies indicated that the likely source of the increased cancer risk was contamination from Toms River Chemical Plant then operated by Ciba Geigy which had been in operation since 1952 The area was designated a United States Environmental Protection Agency Superfund site in 1983 after an underground plume of toxic chemicals was identified The following year a discharge pipe was shut down after a sinkhole at the corner of Bay Avenue and Vaughn Avenue revealed that it had been leaking The plant ceased operation in 1996 A follow up study from the 1996 2000 period indicated that while there were more cancer cases than expected rates had significantly fallen and the difference was statistically insignificant compared to normal statewide cancer rates Since 1996 the Toms River water system has been subject to the most stringent water testing in New Jersey and is considered safe for consumption Dan Fagin s Toms River A Story of Science and Salvation the 2014 Pulitzer Prize winning book examined the issue of industrial pollution at the site in detail Sandoz Edit Sandoz redirects here For other uses see Sandoz disambiguation The Sandoz brand exists today as a subsidiary of Novartis Sandoz is the generic drugs division of Novartis Before the 1996 merger with Ciba Geigy to form Novartis Sandoz Pharmaceuticals Sandoz AG was a pharmaceutical company headquartered in Basel Switzerland as was Ciba Geigy and was best known for developing drugs such as Sandimmune for organ transplantation the antipsychotic Clozaril Mellaril Tablets and Serentil Tablets for treating psychiatric disorders and Cafergot Tablets and Torecan Suppositories for treating migraine headaches The Chemiefirma Kern und Sandoz Kern and Sandoz Chemistry Firm was founded in 1886 by Alfred Kern 1850 1893 and Edouard Sandoz 1853 1928 The first dyes manufactured by them were alizarinblue and auramine After Kern s death the partnership became the corporation Chemische Fabrik vormals Sandoz in 1895 The company began producing the fever reducing drug antipyrin in the same year In 1899 the company began producing the sugar substitute saccharin Further pharmaceutical research began in 1917 under Arthur Stoll 1887 1971 who is the founder of Sandoz s pharmaceutical department in 1917 38 In 1918 Arthur Stoll isolated ergotamine from ergot the substance was eventually used to treat migraine and headaches and was introduced under the trade name Gynergen in 1921 Between the World Wars Gynergen 1921 and Calcium Sandoz 1929 were brought to market Sandoz also produced chemicals for textiles paper and leather beginning in 1929 In 1939 the company began producing agricultural chemicals The psychedelic effects of lysergic acid diethylamide LSD were discovered at the Sandoz laboratories in 1943 by Arthur Stoll and Albert Hofmann 39 40 Sandoz began clinical trials and marketed the substance from 1947 through the mid 1960s under the name Delysid as a psychiatric drug thought useful for treating a wide variety of mental ailments ranging from alcoholism to sexual deviancy Sandoz suggested in its marketing literature that psychiatrists take LSD themselves 41 to gain a better subjective understanding of the schizophrenic experience and many did exactly that and so did other scientific researchers The Sandoz product received mass publicity as early as 1954 in a Time Magazine feature 42 Research on LSD peaked in the 1950s and early 1960s The CIA purchased quantities of LSD from Sandoz for use in its illegal human experimentation program known as MKUltra 43 Sandoz withdrew the drug from the market in 1965 The drug became a cultural novelty of the 1960s after psychologist Timothy Leary at Harvard University began to promote its use for recreational and spiritual experiences among the general public Sandoz opened its first foreign offices in 1964 In 1967 Sandoz merged with Wander AG known for Ovomaltine and Isostar Sandoz acquired the companies Delmark Wasabrod a Swedish manufacturer of crisp bread and Gerber Products Company a baby food company On 1 November 1986 a fire broke out in a production plant storage room which led to the Sandoz chemical spill and a large amount of pesticide being released into the upper Rhine river This exposure killed many fish and other aquatic life In 1995 Sandoz spun off its specialty chemicals business to form Clariant In 1997 Clariant merged with the specialty chemicals business that was spun off from Hoechst AG in Germany 44 Merger Edit In 1996 Ciba Geigy merged with Sandoz with the pharmaceutical and agrochemical divisions of both staying together to form Novartis Other Ciba Geigy and Sandoz businesses were spun off as independent companies 45 46 notably Ciba Specialty Chemicals 46 47 Sandoz s Master Builders Technologies a producer of chemicals for the construction industry was sold off to SKW Trostberg A G a subsidiary of the German energy company VIAG while its North American corn herbicide business became part of the German chemical maker BASF 47 Post merger Edit Suffern New York one of the Novartis pharmaceutical production facilities in the United States Novartis India headquarters in HITEC City Hyderabad In 1998 the company entered into a biotechnology licensing agreement with the University of California at Berkeley Department of Plant and Microbial Biology 48 Critics of the agreement expressed concern over prospects that the agreement would diminish academic objectivity or lead to the commercialization of genetically modified plants 49 The agreement expired in 2003 50 2000 2010 Edit In 2000 Novartis and AstraZeneca combined their agrobusiness divisions to create a new company Syngenta 51 52 In 2003 Novartis organized all its generics businesses into one division and merged some of its subsidiaries into one company reusing the predecessor brand name of Sandoz 53 In 2005 Novartis expanded its subsidiary Sandoz significantly through the US 8 29 billion acquisition of Hexal one of Germany s leading generic drug companies and Eon Labs a fast growing United States generic pharmaceutical company 54 In 2006 Novartis acquired the California based Chiron Corporation Chiron had been divided into three units Chiron Vaccines Chiron Blood Testing and Chiron BioPharmaceuticals The biopharmaceutical unit was integrated into Novartis Pharmaceuticals while the vaccines and blood testing units were made into a new Novartis Vaccines and Diagnostics division 55 Also in 2006 Sandoz became the first company to have a biosimilar drug approved in Europe with its recombinant human growth hormone drug 56 In 2007 Novartis sold the Gerber Products Company to Nestle as part of its continuing effort to shed old Sandoz and Ciba Geigy businesses and focus on healthcare 57 In 2009 Novartis reached an agreement to acquire an 85 percent stake in the Chinese vaccines company Zhejiang Tianyuan Bio Pharmaceutical Co Ltd as part of a strategic initiative to build a vaccines industry leader in this country and expand the group s limited presence in this fast growing market segment This proposed acquisition will require government and regulatory approvals in China 58 In 2010 Novartis offered to pay US 39 3 billion to fully acquire Alcon the world s largest eye care company including a majority stake held by Nestle Novartis had bought 25 percent of Alcon in 2008 59 Novartis created a new division and called it Alcon under which it placed its CIBA VISION subsidiary and Novartis Ophthalmics which became the second largest division of Novartis 60 The total cost for Alcon amounted to 60 billion 61 2011 present Edit In 2011 Novartis acquired the medical laboratory diagnostics company Genoptix to serve as a strong foundation for our Novartis individualized treatment programs 62 In 2012 the Company cut 2000 positions in the United States primarily in sales in response to anticipated revenue downturns from the hypertension drug Diovan which was losing patent protection and the realization that the anticipated successor to Diovan Rasilez was failing in clinical trials 63 The 2012 personnel reductions follow 2000 cut positions in Switzerland and the United States in 2011 1400 cut positions in the United States in 2010 and a reduction of thousands and several site closures in previous years 64 Also in 2012 Novartis became the biggest manufacturer of generic skin care medicine after agreeing to buy Fougera Pharmaceuticals for 1 525 billion in cash 65 In 2013 the Indian Supreme Court issued a decision rejecting Novartis patent application in India on the final form of Gleevec Novartis s cancer drug the case caused great controversy 66 In 2013 Novartis was sued again by the US government this time for allegedly bribing doctors for a decade so that their patients are steered towards the company s drugs 67 In January 2014 Novartis announced plans to cut 500 jobs from its pharmaceuticals division 68 In February 2014 Novartis announced that it acquired CoStim Pharmaceuticals 69 In May 2014 Novartis purchased the rights to market Ophthotech s Fovista an anti PDGF aptamer also being investigated for use in combination with anti VEGF treatments outside the U S for up to 1 billion 70 Novartis acquired exclusive rights to market the eye drug outside of the states while retaining U S marketing rights The company agreed to pay Ophthotech 200 million upfront and 130 million in milestone payments relating to Phase III trials 70 Ophthotech is also eligible to receive up to 300 million dependent upon future marketing approval milestones outside of America and up to 400 million relating to sales milestones 70 In September 2014 Ophthotech received its first 50 million phase III trial milestone payment from Novartis 71 In April 2014 Novartis announced that it would acquire GlaxoSmithKline s cancer drug business for 16 billion as well as selling its vaccines business to GlaxoSmithKline for 7 1 billion 72 In August 2014 Genetic Engineering amp Biotechnology News reported that Novartis had acquired a 15 percent stake in Gamida Cell for 35 million with the option to purchase the whole company for approximately 165 million 73 In October 2014 Novartis announced its intention to sell its influenza vaccine business inclusive of its development pipeline subject to regulatory approval to CSL for 275 million 74 In March 2015 the company announced BioPharma had completed its acquisition of two Phase III cancer drug candidates the MEK inhibitor binimetinib MEK 162 and the BRAF inhibitor encorafenib LGX818 for 85 million 75 In addition the company sold its RNAi portfolio to Arrowhead Research for 10 million and 25 million in stock 76 In June the company announced it would acquire Spinifex Pharmaceuticals for more than 200 million 77 In August the company acquired the remaining rights to the CD20 monoclonal antibody Ofatumumab from GlaxoSmithKline for up to 1 billion 78 79 In October the company acquired Admune Therapeutics for an undisclosed sum as well as licensing PBF 509 an adenosine A2A receptor antagonist which is in Phase I clinical trials for non small cell lung cancer from Palobiofarma 80 In November 2016 the company announced it would acquire Selexys Pharmaceuticals for 665 million 81 In December the company acquired Encore Vision gaining the company s principle compound EV06 is a first in class topical therapy for presbyopia 82 In December Novartis acquired Ziarco Group Limited bolstering its presence in eczema treatments 83 In late October 2017 Reuters announced that Novartis would acquire Advanced Accelerator Applications for 3 9 billion paying 41 per ordinary share and 82 per American depositary share representing a 47 percent premium 84 In March 2018 GlaxoSmithKline announced that it has reached an agreement with Novartis to acquire Novartis 36 5 percent stake in their Consumer Healthcare Joint Venture for 13 billion 9 2 billion 85 86 In April of the same year the business utilised some of the proceeds from the aforementioned GlaxoSmithKline deal to acquire Avexis for 218 per share or 8 7 billion in total gaining the lead compound AVXS 101 used to treat spinal muscular atrophy 87 In August 2018 Novartis signed a deal with Laekna a Shanghai based pharmaceutical company for its two clinical stage cancer drugs 88 Novartis gave Laekna the exclusive international rights for the drugs that are oral pan Akt kinase inhibitors namely afuresertib ASB138 and uprosertib UPB795 89 In mid October the company announced it would acquire Endocyte Inc for 2 1 billion 24 per share merging it with a newly created subsidiary 90 91 Endocyte will bolster Novartis offering in its radiopharmaceuticals business with Endocyte s first in class candidate 177Lu PSMA 617 being targeted against metastatic castration resistant prostate cancer 92 In late December the company announced it would acquire France based contract manufacturer CellforCure from LFB boosting its capacity to produce cell and gene therapies 93 On April 9 2019 Novartis announced that it had completed the spin off of Alcon as a separate commercial entity Alcon was listed on the SIX exchange in Switzerland and NYSE exchange in the U S 20 Novartis announced during late 2019 a five year artificial intelligence alliance with Microsoft The companies aim to create applications for Microsoft s AI capabilities in turn improving the other s drug development processes Microsoft seeks to test AI products it is already working on in real life situations The deal will pursue solutions for organizing and using data generated from Novartis laboratory experiments clinical trials and manufacturing plants It will also look at improving manufacturing of Chimeric antigen receptor T cell CAR T cells Finally the deal will also apply AI to generative chemistry to enhance drug design 94 In November 2019 Sandoz announced it would acquire the Japanese business of Aspen Global inc for 300 million around 330 million boosting the business s presence in Asia 95 In late November 2019 the business announced it would acquire The Medicines Company for US 9 7 billion 85 per share in order to acquire amongst other assets the cholesterol lowering therapy inclisiran 96 97 In April 2020 the company announced it would acquire Amblyotech 98 In September 2020 Novartis was imposed a fine of 385 million by the French competition authority on accusations of abusive practices to preserve sales of Lucentis over a cheaper drug 99 Also in September BioNTech has leased a large production facility from Novartis to follow all advance demands for its coronavirus vaccine in Europe and sell it to China 100 In October Novartis announced it would acquire Vedere Bio for 280 million boosting the businesses cell and gene therapy offerings 101 102 In October 2020 as part of a joint venture to develop therapeutic drugs to combat COVID 19 Novartis bought 6 of all shares outstanding in Swiss DARPin research company Molecular Partners AG at CHF 23 per share 103 In December 2020 Novartis announced it would acquire Cadent Therapeutics for up to 770 million gaining full rights to CAD 9303 a NMDAr positive allosteric modulator MIJ 821 a NMDAr negative allosteric modulator and CAD 1883 a clinical stage SK channel positive allosteric modulator 104 105 In September 2021 the company announced it would acquire gene therapy business Arctos Medical broadening its optogenetics range 106 In December Novartis announced it would purchase Gyroscope Therapeutics from health care investment company Syncona Ltd for up to 1 5 billion 107 In February 2022 New York City based biotechnology company Cambrian Biopharma announced it had licensed rights to mTOR inhibitor programs from Novartis 108 As part of the deal Cambrian was setting up a subsidiary called Tornado Therapeutics 108 In August 2022 the company announced its plan to spin off Sandoz generic drugs unit to form a publicly traded business as part of a restructuring 11 With the unit having generated US 9 69 billion in 2021 the spin off would create the biggest generic drugs company in Europe by sales 109 Acquisition history Edit Novartis AcquisitionsNovartis Novartis Merger of Ciba Geigy and Sandoz 1996 Ciba Geigy J R Geigy Ltd Merged 1971 CIBA Merged 1971 Sandoz Kern and Sandoz Chemistry Firm Founded 1886 Wander AG Acq 1967 Lek d d Slovenia Acq 2002 Aspen Global inc Japanese business Acq 2019 Hexal Acq 2005 Eon Labs Acq 2005 Chiron Corporation Acq 2006 Matrix Pharmaceuticals Inc Acq 2002 PowderJect Acq 2003 PathoGenesis Acq 2001 Cetus Corporation Cetus Oncology Biocine Company Chiron Diagnostics Chiron Intraoptics Chiron Technologies Adatomed GmbH Zhejiang Tianyuan Bio Pharmaceutical Co Ltd Acq 2009 Alcon Founded 1945 Acq 2010 Texas Pharmacal Company Acq 1979 Genoptix Acq 2011 Fougera Pharmaceuticals Acq 2012 CoStim Pharmaceuticals Acq 2014 GlaxoSmithKline Cancer drug division Acq 2014 Spinifex Pharmaceuticals Acq 2015 Admune Therapeutic Acq 2015 Selexys Pharmaceuticals Acq 2016 Ziarco Group Limited Acq 2016 Advanced Accelerator Applications Acq 2018 AveXis Acq 2018 Endocyte Acq 2018 CellforCure Acq 2018 The Medicines Company Acq 2019 Amblyotech Acq 2020 Vedere Bio Acq 2020 Cadent Therapeutics Acq 2020 Luc Therapeutics Merged 2017 Ataxion Therapeutics Merged 2017 Arctos Medical Acq 2021 Gyroscope Therapeutics Acq 2021 Research Edit Novartis in Cambridge Massachusetts in November 2019 The company s global research operations called Novartis Institutes for BioMedical Research NIBR have their global headquarters in Cambridge Massachusetts United States 110 111 Two research institutes reside within NIBR that focus on diseases in the developing world Novartis Institute for Tropical Diseases which works on tuberculosis dengue and malaria and Novartis Vaccines Institute for Global Health which works on salmonella typhi typhoid fever and shigella 112 Novartis is also involved in publicly funded collaborative research projects with other industrial and academic partners One example in the area of non clinical safety assessment is the InnoMed PredTox project 113 114 The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission 115 Novartis is working with Science 37 in order to allow video based telemedicine visits instead of physical traveling to clinics for patients It is planning for ten clinical trials over three years using mobile technology to help free patients from burdensome hospital trips 116 Products EditPharmaceuticals Edit Name Indication s or drug type class Sales US 1 000 000 Sales year Change NotesAclasta Reclast zoledronic acid Osteoporosis 590 2012 117 4 Adelphane Esidrex reserpine dihydralazine hydrochlorothiazide HypertensionAfinitor Certican Zortress everolimus Prevention of transplant rejection various cancers 797 2012 117 80 Amturnide aliskiren amlodipine hydrochlorothiazide HypertensionAnafranil clomipramine Major depressive disorder obsessive compulsive disorderArcapta Neohaler Onbrez Breezhaler indacaterol COPDBrinaldix clopamide HypertensionClozaril Leponex clozapine Treatment resistant schizophreniaCo Diovan Valsartan hydrochlorothiazide HypertensionCoartem Riamet artemether lumefantrine Malaria uncomplicated Comtan entacapone Parkinson s disease 530 2012 117 14 Cosentyx secukinumab PsoriasisDiovan valsartan Hypertension 4 417 2012 117 22 Entresto sacubitril valsartan Heart failureEnterovioform clioquinol AmoebiasisEucreas Galvus Met vildagliptin metformin Diabetes mellitus type 2Exelon Patch rivastigmine Alzheimer s disease 1 050 2012 117 2 Exforge amlodipine valsartan Hypertension 1 352 2012 117 12 Exjade deferasirox Chronic iron overload 870 2012 117 2 Manufactured as tablets for oral suspension tablets for oral use are marketed under the brand name JadenuFamvir famciclovir Herpes zoster and other Herpesvirus infectionFanapt iloperidone SchizophreniaFemara letrozole Breast cancer 438 2012 117 52 Focalin dexmethylphenidate ADHD First US generics of Focalin became available in 2007 118 Focalin XR became available in 2012 119 Foradil Foradile formoterol Asthma COPDGalvus vildagliptin Diabetes mellitus type 2 910 2012 117 39 Gilenya fingolimod Multiple sclerosis 1 195 2012 117 142 Gleevec Glivec imatinib Oncology Chronic myelogenous leukemia 4 675 2012 117 0 Hygroton chlortalidone HypertensionIlaris canakinumab Cryopyrin associated periodic syndromeJadenu deferasirox Chronic iron overload Deferasirox tablets for oral use a new formulation of Exjade which comes in tablets for oral suspension Jakavi Jakafi ruxolitinib Myelofibrosis of intermediate to high risk Kymriah tisagenlecleucel Acute lymphoblastic leukemiaLamisil terbinafine Fungal infectionsLescol fluvastatin Hypercholesterolemia 665 2007 120 8 Lioresal baclofen SpasticityLotrel amlodipine benazepril Hypertension 748 2007 120 34 Lucentis ranibizumab Age related macular degeneration 2 398 2012 117 17 Ludiomil maprotiline Major depressive disorderMayzent 121 siponimod Treatment for secondary progressive multiple sclerosis SPMS FDA approved March 26 2019 122 Mellaril thioridazine SchizophreniaMyfortic mycophenolic acid Prevention of transplant rejection 579 2012 117 12 Navoban tropisetron Chemotherapy induced nausea and vomitingOdomzo sonidegib Locally advanced basal cell carcinomaRitalin methylphenidate ADHD 554 2012 117 1 Sandimmune Neoral ciclosporin Prevention of transplant rejection 821 2012 117 9 Sandostatin octreotide Acromegaly 1 512 2012 117 5 Sertraline Sandoz sertraline hydrochloride Depression obsessive compulsive disorder panic disorder 123 Generic form of sertraline Signifor pasireotide Cushing s disease 124 125 Simulect basiliximab Prevention of transplant rejectionSirdalud tizanidine SpasticitySpersallerg antazoline tetrahydrozoline Allergic conjunctivitisStalevo carbidopa levodopa entacapone Parkinson s diseaseTasigna nilotinib Chronic myelogenous leukemia first line treatment 126 998 2012 117 39 NICE formulary approval January 2012 126 Tegretol carbamazepine Epilepsy bipolar disorder 413 2007 120 6 Tekamlo aliskiren amlodipine HypertensionTekturna Rasilez aliskiren HypertensionTermalgin paracetamol Fever mild painTobi tobramycin Prevention of Pseudomonas aeruginosa infection in cystic fibrosis 350 US only 2012 127 Teva introduced generic in the US in 2013 127 Tofranil imipramine Major depressive disorder enuresisTrileptal oxcarbazepine Epilepsy bipolar disorder 690 US only 2007 128 Teva introduced generic in 2008 128 Tyzeca Sebivo telbivudine Chronic hepatitis BVisudyne verteporfin Age related macular degeneration wet form Voltaren diclofenac Acute pain inflammatory disorders such as rheumatoid arthritis 759 excl OTC 2012 117 4 Zometa zoledronic acid Prevention of bone fractures in cancer patients 1 288 2012 117 13 Xolair omalizumab Moderate to severe asthma not controlled by inhaled steroidsChronic idiopathic urticaria 504 2012 117 4 Zaditen ketotifen Asthma allergic conjunctivitisConsumer health Edit Benefiber Bialcol Alcohol Buckley s cold and cough formula Bufferin ChestEze Comtrex cold and cough Denavir Vectavir Desenex Doan s pain relief Ex Lax Excedrin Fenistil Gas X Habitrol Keri skin care Lamisil foot care Lipactin herpes symptomatic treatment Maalox Nicotinell No doz Quinvaxem Pentavalent vaccine Otrivine Prevacid 24HR Savlon Tavist Theraflu Vagistat Tixylix Voltaren In January 2009 the United States Department of Health and Human Services awarded Novartis a 486 million contract for construction of the first US plant to produce cell based influenza vaccine to be located in Holly Springs North Carolina The stated goal of this program is the capability of producing 150 000 000 doses of pandemic vaccine within six months of declaring a flu pandemic 129 In April 2014 Novartis divested its consumer health section with 3 5 billion worth of assets into a new joint venture with GlaxoSmithKline named GSK Consumer Healthcare of which Novartis will hold a 36 5 stake 130 In March 2018 GSK announced that it has reached an agreement with Novartis to acquire Novartis 36 5 stake in their Consumer Healthcare Joint Venture for 13 billion 9 2 billion 86 Animal health Edit Pet care Edit Interceptor Milbemycin oxime oral worm control product Sentinel Flavor Tabs Milbemycin oxime Lufenuron oral flea control product Deramaxx Deracoxib oral treatment for pain and inflammation from osteoarthritis in dogs Capstar Nitenpyram oral tablet for flea control Milbemax Milbemycin oxime Praziquantel oral worm treatment Program Lufenuron oral tablet for flea controlLivestock Edit Acatalk Duostar Fluazuron Ivermectin tick control for cattle CLiK Dicyclanil blowfly control for sheep Denagard Tiamulin antibiotic for the treatment of swine dysentery associated with Brachyspira formerly Serpulina or Treponema Fasinex Triclabendazole oral drench for cattle that is used for the treatment and control of all three stages of liver fluke ViraShield For use in healthy cattle including pregnant cows and heifers as an aid in the prevention of disease caused by infectious bovine rhinotracheitis IBR bovine virus diarrhoea BVD Type 1 and BVD Type 2 parainfluenza Type 3 PI3 and bovine respiratory syncytial BRSV virusesBioprotection insect and rodent control Edit Actara Thiamethoxam Atrazine Atrazine Larvadex Cyromazine Neporex Cyromazine Oxyfly Lambda cyhalothrin Virusnip Potassium monopersulfate Controversies and criticism EditChallenge to India s patent laws Edit Main article Novartis v Union of India amp Others Novartis fought a seven year controversial battle to patent Gleevec in India and took the case all the way to the Indian Supreme Court where the patent application was finally rejected The patent application at the center of the case was filed by Novartis in India in 1998 after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement As part of this agreement India made changes to its patent law the biggest of which was that prior to these changes patents on products were not allowed afterwards they were albeit with restrictions These changes came into effect in 2005 so Novartis patent application waited in a mailbox with others until then under procedures that India instituted to manage the transition India also passed certain amendments to its patent law in 2005 just before the laws came into effect which played a key role in the rejection of the patent application 66 The patent application 131 132 claimed the final form of Gleevec the beta crystalline form of imatinib mesylate 133 3 In 1993 before India allowed patents on products Novartis had patented imatinib with salts vaguely specified in many countries but could not patent it in India 134 135 The key differences between the two patent applications were that the 1998 patent application specified the counterion Gleevec is a specific salt imatinib mesylate while the 1993 patent application did not claim any specific salts nor did it mention mesylate and the 1998 patent application specified the solid form of Gleevec the way the individual molecules are packed together into a solid when the drug itself is manufactured this is separate from processes by which the drug itself is formulated into pills or capsules while the 1993 patent application did not The solid form of imatinib mesylate in Gleevec is beta crystalline 136 As provided under the TRIPS agreement Novartis applied for Exclusive Marketing Rights EMR for Gleevec from the Indian Patent Office and the EMR was granted in November 2003 137 Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India 138 Novartis set the price of Gleevec at US 2666 per patient per month generic companies were selling their versions at US 177 to 266 per patient per month 139 Novartis also initiated a program to assist patients who could not afford its version of the drug concurrent with its product launch 140 When examination of Novartis patent application began in 2005 it came under immediate attack from oppositions initiated by generic companies that were already selling Gleevec in India and by advocacy groups The application was rejected by the patent office and by an appeal board The key basis for the rejection was the part of Indian patent law that was created by amendment in 2005 describing the patentability of new uses for known drugs and modifications of known drugs That section Paragraph 3d specified that such inventions are patentable only if they differ significantly in properties with regard to efficacy 138 141 At one point Novartis went to court to try to invalidate Paragraph 3d it argued that the provision was unconstitutionally vague and that it violated TRIPS Novartis lost that case and did not appeal 142 Novartis did appeal the rejection by the patent office to India s Supreme Court which took the case The Supreme Court case hinged on the interpretation of Paragraph 3d The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug the raw form of imatinib which was publicly disclosed in the 1993 patent application and in scientific articles that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib and that therefore the patent application was properly rejected by the patent office and lower courts 143 Although the court ruled narrowly 144 and took care to note that the subject application was filed during a time of transition in Indian patent law 145 the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing innovation with affordability etc 146 147 148 Had Novartis won and had its patent issued it could not have prevented generics companies in India from selling generic Gleevec but it could have obliged them to pay a reasonable royalty under a grandfather clause included in India s patent law 149 150 In reaction to the decision Ranjit Shahani vice chairman and managing director of Novartis India Ltd was quoted as saying This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options 151 He also said that companies like Novartis would invest less money in research in India as a result of the ruling 66 Novartis also emphasised that it continues to be committed to good access to its drugs according to Novartis by 2013 95 of patients in India roughly 16 000 people receive Glivec free of charge and it has provided more than 1 7 billion worth of Glivec to Indian patients in its support program since it was started 140 Sexual discrimination Edit On 17 May 2010 a jury in the United States District Court for the Southern District of New York awarded 3 367 250 in compensatory damages against Novartis finding that the company had committed sexual discrimination against twelve female sales representatives and entry level managers since 2002 in matters of pay promotion and treatment after learning that the employees were pregnant Two months later the company settled with the remaining plaintiffs for 152 5 million plus attorney fees 152 Marketing violations Edit In September 2008 the US Food and Drug Administration FDA sent a notice to Novartis Pharmaceuticals regarding its advertising of Focalin XR an ADHD drug in which the company overstated its efficacy while marketing to the public and medical professionals 153 In 2005 federal prosecutors opened an investigation into Novartis marketing of several drugs Trileptal an antiseizure drug three drugs for heart conditions Diovan the company s top selling product Exforge and Tekturna Sandostatin a drug to treat a growth hormone disorder and Zelnorm a drug for irritable bowel syndrome 154 In September 2010 Novartis agreed to pay US 422 5 million in criminal and civil claims and to enter into a corporate integrity agreement with the US Office of the Inspector General 155 According to The New York Times Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs advisory boards entertainment travel and meals But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February the company denied wrongdoing 154 In the same New York Times article Frank Lichtenberg a Columbia professor who receives pharmaceutical financing for research on innovation in the industry said off label prescribing was encouraged by the American Medical Association and paid for by insurers but off label marketing was clearly illegal So it s not surprising that they would settle because they don t have a legal leg to stand on In April 2013 federal prosecutors filed two lawsuits against Novartis under the False Claims Act for off label marketing and kickbacks in both suits prosecutors are seeking treble damages 156 157 The first suit accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts 156 In the second the Justice Department joined a qui tam or whistleblower lawsuit brought by a former sales rep over off label marketing of three drugs Lotrel and Valturna both hypertension drugs and the diabetes drug Starlix 157 Twenty seven states the District of Columbia and Chicago and New York also joined 156 Avastin Edit Outside the US Novartis markets the drug ranibizumab trade name Lucentis which is a monoclonal antibody fragment derived from the same parent mouse antibody as bevacizumab Avastin Both Avastin and Lucentis were created by Genentech which is owned by Roche Roche markets Avastin worldwide and also markets Lucentis in the US Lucentis has been approved worldwide as a treatment for wet macular degeneration and other retinal disorders Avastin is used to treat certain cancers Because the price of Lucentis is much higher than Avastin many ophthalmologists began having compounding pharmacies formulate Avastin for administration to the eye and began treating their patients with Avastin 158 In 2011 four trusts of the National Health Service in the UK issued policies approving use and payment for administering Avastin for macular degeneration in order to save money even though Avastin had not been approved for that indication 159 In April 2012 after failing to persuade the trusts that it was uncertain whether Avastin was as safe and effective as Lucentis and in order to retain the market for Lucentis Novartis announced it would sue the trusts 159 160 However in July Novartis offered significant discounts kept confidential to the trusts and the trusts agreed to change their policy 161 and in November Novartis dropped the litigation 162 Valsartan Edit In the summer of 2013 two Japanese universities retracted several publications of clinical trials that purported to show that Valsartan branded as Diovan had cardiovascular benefits when it was found that statistical analysis had been manipulated and that a Novartis employee had participated in the statistical analysis but had not disclosed his relationship with Novartis but only his affiliation with Osaka City University where he was a lecturer 163 164 As a result several Japanese hospitals stopped using the drug and media outlets ran reports on the scandal in Japan 163 In January 2014 Japan s Health Ministry filed a criminal complaint with the Tokyo public prosecutor s office against Novartis and an unspecified number of employees for allegedly misleading consumers through advertisements that used the research to support the benefits of Diovan 165 On 1 July 2014 the prosecutor s office announced it was formally charging the company and one of its employees 166 Corruption Edit In January 2018 Novartis began being investigated by US and Greek authorities for allegedly bribing Greek public officials in the 2006 2015 period in a scheme which included two former prime ministers several former health ministers many high ranking party members of the Nea Dimokratia and PASOK ruling parties as well as bankers 167 The manager of Novartis Greek branch was prohibited from leaving the country 168 The minister s deputy described the allegations as the biggest scandal since the creation of the Greek state which caused annual state expenditure on medicine to explode 169 Most of the ministers involved in the scandal have denied the allegations and sought to paint the case as political targeting and fabrication by the Syriza opposition party 167 However the Greek Judicial Council ruled that the scandal was real 170 Besides bribery that involves artificial increases in the price of several medicines the case also involves money laundering with suspicions of illegal funds of more than four billion euros 4 2 billion were involved 171 In June 2020 Novartis reached settlements with the US Department of Justice DOJ and the US Securities and Exchange Commission SEC resolving all Foreign Corrupt Practices Act FCPA investigations into historical conduct by the company and its subsidiaries As part of the resolutions Novartis and some of its current and former subsidiaries would pay US 233 9 million to the DOJ and US 112 8 million to the SEC 172 173 Michael Cohen Edit Senate Finance Committee report on Michael Cohen s dealings with Novartis entitled White House Access for Sale Novartis paid 1 2 million to Essential Consultants an entity owned by Michael Cohen following the 2017 inauguration of Donald Trump Cohen was paid monthly with each payment just under 100 000 Novartis claims it paid Cohen to help it understand and influence the new administration s approach to drug pricing and regulation 174 In July 2018 the US Senate committee report White House Access for Sale revealed that Novartis Ag s relationship with Cohen was longer and more detailed Novartis initially stated that the relationship ceased a month after entering the US 1 2 million contract with Cohen s consulting firm since the consultants were not able to provide the information the pharmaceutical company needed Later it became clear however that then CEO Joseph Jimenez and Cohen communicated via email multiple times during 2017 which included ideas to lower drug prices to be discussed with the president According to the report several of the ideas appeared later in Trump s drug pricing plan released in early 2018 in which pharmaceutical companies were protected from reduced revenues 175 176 AveXis data integrity Edit Having already received approval for Zolgensma in May 2019 on June 28 AveXis a Novartis company voluntarily disclosed to the FDA that some data previously submitted to the agency as part of the Biologics License Application BLA package was inaccurate Specifically the data manipulation related to an in vivo murine potency assay used in the early development of the product but the issue the FDA and wider community has taken is that AveXis was aware of the data manipulation as early as 14 March 2019 almost two months before the BLA was approved To compound the problem in early August it emerged a senior manager sold almost 1 million worth of stock immediately before the FDA probe became public on August 6 but after the company had informed the FDA of the problem As of September 2019 the FDA was still preparing its response to the scandal citation needed Philanthropy EditFight against Leprosy Edit Novartis has been committed for decades to eliminate Leprosy by providing free multidrug therapy to all endemic countries since 2000 177 178 179 See also EditList of pharmaceutical companies Pharmaceutical industry in SwitzerlandReferences Edit a b https www novartis com research development research locations Novartis 1Q profit jumps 12 percent as heart drug sales soar Business The Seattle Times Associated Press 19 April 2018 Archived from the original on 5 August 2020 Retrieved 20 April 2018 a b c d e f Novartis Annual Report 2021 PDF Retrieved 4 February 2022 The Pharmaceutical Industry in Figures 2008 Edition European Federation of Pharmaceutical Industries and Associations EFPIA p 49 Archived from the original PDF on 16 September 2008 Retrieved 25 August 2008 IFPMA Member List Archived from the original on 7 February 2014 Retrieved 29 January 2021 404 www phrma org Archived from the original on 6 October 2013 Retrieved 29 January 2021 a href Template 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10 1038 23772 ISSN 1476 4687 PMID 9817194 Dalton Rex 1 May 1999 Berkeley dispute festers over biotech deal Nature 399 6731 5 Bibcode 1999Natur 399 5D doi 10 1038 19807 ISSN 1476 4687 PMID 10331373 Dalton Rex 1 November 2003 Syngenta ends plant research deal with Berkeley Nature 426 6964 216 Bibcode 2003Natur 426 216D doi 10 1038 426216a ISSN 1476 4687 PMID 14628007 Andrew Ross Sorkin for The New York Times 3 December 1999 AstraZeneca and Novartis To Shed Agricultural Units Archived 11 September 2020 at the Wayback Machine Accessed 27 May 2013 Staff PRNewsWire 13 November 2000 Syngenta Begins Trading on the New York Stock Exchange Accessed 27 May 2013 dead link Press Release Novartis 21 January 2003 Novartis to Unite Its Generics Businesses Under One Single Global Brand Sandoz Archived 17 October 2013 at the Wayback Machine Emily Church for MarketWatch 21 February 2005 Novartis in 8 29 billion generics deals to buy Hexal and its US division Eon Labs Archived 20 October 2013 at the Wayback Machine Novartis press release 19 April 2006 Novartis acquisition of Chiron approved by Chiron shareholders Archived 20 October 2013 at the Wayback Machine Staff Biosimilars News 15 August 2011 Biosimilars approved in Europe Archived 20 October 2013 at the Wayback Machine Andrew Martin and Andrew Ross Sorkin for The New York Times 13 April 2007 Nestle Agrees to Buy Gerber From Novartis Archived 23 November 2020 at the Wayback Machine Merck Provides Update on Status of Supplemental Biologics License Applications sBLA for GARDASIL www worldpharmanews com Archived from the original on 13 November 2009 Retrieved 29 January 2021 Thomasson Emma 4 January 2010 Novartis seeks to buy rest of Alcon for 39 billion Reuters Archived from the original on 20 October 2013 Retrieved 4 January 2010 Novartis Press Release 8 April 2011 Stronger together Novartis and Alcon creating the global leader in eye care Archived 20 October 2013 at the Wayback Machine Can Novartis CEO resist going for a megamerger with cash from asset sales FiercePharma www fiercepharma com 30 May 2017 Archived from the original on 30 October 2020 Retrieved 6 February 2018 Maclucas Neil 24 January 2011 Novartis to Buy Genoptix for 470 Million Health The Wall Street Journal Archived from the original on 10 January 2014 Novartis to cut almost 2 000 US jobs this year The Jakarta Post Associated Press jakartapost com 13 January 2012 archived from the original on 25 May 2013 retrieved 2012 01 15 Reid Katie 13 January 2012 Hans Juergen Peters and Mike Nesbit ed Novartis cuts 2 000 U S jobs after drug setback Reuters reuters com archived from the original on 10 January 2014 retrieved 2012 01 15 De la Merced Michael J 2 May 2012 Novartis to Buy Fougera Pharmaceuticals for 1 5 Billion DealB k The New York Times Archived from the original on 5 August 2020 Retrieved 25 January 2020 a b c Harris Gardiner Thomas Katie 1 April 2013 Top Court in India Rejects Novartis Drug Patent The New York Times Archived from the original on 30 May 2020 Retrieved 1 April 2013 US sues Novartis again says it bribed doctors for patents Indian Express Associated Press Archived from the original on 1 June 2013 Retrieved 29 April 2013 Note Link provides access to first of two pages second page is here Archived 23 April 2020 at the Wayback Machine Staton Tracy 21 January 2014 Novartis to cut 500 Swiss pharma jobs then staff up in OTC generics FiercePharma Questex Archived from the original on 26 March 2014 Retrieved 19 February 2014 Johnson Michael 18 January 2014 Novartis acquires CoStim Pharmaceuticals Drug Store News Lebhar Friedman Archived from the original on 25 February 2014 Retrieved 19 February 2014 a b c Novartis Buys Ex U S Rights to Ophthotech s Fovista for Up to 1B News Industry Watch Genetic Engineering amp Biotechnology News Paper Vol 34 no 12 Mary Ann Liebert 15 June 2014 p 8 Archived from the original on 5 August 2020 Retrieved 25 January 2020 Ophthotech Pockets 50M Milestone from Novartis for AMD Treatment GEN News Highlights Genetic Engineering amp Biotechnology News Mary Ann Liebert 8 September 2014 Archived from the original on 11 May 2018 Retrieved 14 September 2014 BBC 22 April 2014 Novartis and GSK exchange assets BBC Archived from the original on 29 April 2014 Retrieved 22 April 2014 Novartis Takes Stake in Gamida with Option to Fully Buy Genetic Engineering amp Biotechnology News Mary Ann Liebert 19 August 2014 Archived from the original on 11 May 2018 Retrieved 25 January 2020 Novartis Selling Flu Vaccine Business to CSL for 275M Genetic Engineering amp Biotechnology News Mary Ann Liebert 27 October 2014 Archived from the original on 3 September 2018 Retrieved 25 January 2020 Array BioPharma Completes Deal with Novartis for 2 Cancer Compounds Genetic Engineering amp Biotechnology News Mary Ann Liebert 2 March 2015 Archived from the original on 2 July 2017 Retrieved 25 January 2020 Novartis Sells RNAi R amp D Portfolio to Arrowhead in 35M Agreement GEN News Highlights Genetic Engineering amp Biotechnology News Mary Ann Liebert 5 March 2015 Archived from the original on 9 April 2015 Retrieved 8 June 2016 Note appears on page 10 of 1 April 2015 print issue Novartis Acquires Spinifex for 200M Genetic Engineering amp Biotechnology News Mary Ann Liebert 29 June 2015 Archived from the original on 4 March 2016 Retrieved 25 January 2020 Helfand Cindy 21 August 2015 Novartis shells out up to 1B to test GSK s Arzerra in MS FiercePharma Questex Archived from the original on 4 April 2016 Retrieved 25 January 2020 Novartis Acquires All Remaining Rights to GSK s Ofatumumab Genetic Engineering amp Biotechnology News Mary Ann Liebert 21 August 2015 Archived from the original on 23 August 2015 Novartis Buys Admune Licenses Palobiofarma XOMA Compounds Genetic Engineering amp Biotechnology News Mary Ann Liebert 21 October 2015 Archived from the original on 17 August 2017 Retrieved 25 January 2020 Novartis Acquires Selexys Pharmaceuticals GEN Genetic Engineering amp Biotechnology News Biotech from Bench to Business GEN 21 November 2016 Archived from the original on 30 October 2018 Retrieved 21 November 2016 Novartis Buys Encore Vision for Presbyopia Therapy Eyedrops GEN Genetic Engineering amp Biotechnology News Biotech from Bench to Business GEN 20 December 2016 Archived from the original on 21 December 2016 Retrieved 21 December 2016 Terry Mark 19 December 2016 Novartis AG Snaps Up Mid Stage Eczema Rival BioSpace Archived from the original on 6 August 2020 Retrieved 29 October 2018 Reuters Editorial 3 November 2017 Novartis to buy French cancer specialist AAA for 3 9 billion Reuters Archived from the original on 17 November 2018 Retrieved 6 February 2018 a href Template Cite news html title Template Cite news cite news a author has generic name help GSK reaches agreement with Novartis to acquire full ownership of Consumer Healthcare Business GSK www gsk com 27 March 2018 Archived from the original on 27 November 2020 Retrieved 27 March 2018 a b GSK buys out Novartis in 13 billion consumer healthcare shake up Reuters 27 March 2018 Archived from the original on 5 August 2020 Retrieved 9 January 2019 Novartis bets big on gene therapy with 8 7 billion AveXis deal Reuters 9 April 2018 Archived from the original on 5 August 2020 Retrieved 9 January 2019 Novartis licenses out unwanted GlaxoSmithKline cancer drugs to Chinese biotech FierceBiotech www fiercebiotech com August 2018 Archived from the original on 5 August 2020 Retrieved 3 August 2018 China s Laekna Inks Two Drug Deal with Novartis BioSpace BioSpace Archived from the original on 5 August 2020 Retrieved 3 August 2018 Novartis to buy cancer drugmaker Endocyte for 2 1 billion in cash Reuters 18 October 2018 Archived from the original on 5 August 2020 Retrieved 9 January 2019 Novartis pushes deeper into nuclear medicine with 2 1 billion deal Reuters 18 October 2018 Archived from the original on 5 August 2020 Retrieved 9 January 2019 Novartis announces planned acquisition of Endocyte to expand expertise in radiopharmaceuticals and build on commitment to transformational therapeutic platforms Novartis 18 October 2018 Archived from the original on 25 November 2020 Retrieved 18 October 2018 Novartis to buy France s CellforCure to boost cell gene therapy Reuters 20 December 2018 Archived from the original on 6 August 2020 Retrieved 20 December 2018 Neville Sarah Waters Richard October 2019 Novartis and Microsoft join forces to develop drugs using AI Financial Times Archived from the original on 4 October 2020 Retrieved 5 November 2019 Sandoz Boosts Toehold in Japan with Aspen Acquisition BioSpace Archived from the original on 6 August 2020 Retrieved 4 May 2020 Terry Mark 25 November 2019 Novartis Buys The Medicines Company A 9 7 Billion Gamble on a PCSK9 Cholesterol Drug BioSpace Urbandale Iowa Archived from the original on 6 August 2020 Retrieved 1 December 2019 Novartis set to buy Medicines Co for 9 7 billion Leaders League Paris 26 November 2019 Archived from the original on 5 August 2020 Retrieved 1 December 2019 Amblyotech A Digital Therapeutics Company Announces It Has Been Acquired by Novartis BioSpace Archived from the original on 6 August 2020 Retrieved 4 May 2020 Pharmaceutical giants fined record 444 million for abusive practices The Brussels Times 9 September 2020 Archived from the original on 9 October 2020 Retrieved 13 September 2020 BuyNTech buys Novartis site to boost EU vaccine production Financial Times 17 September 2020 Archived from the original on 15 January 2021 Retrieved 21 September 2020 Novartis Acquires Vedere Bio a Novel Optogenetics AAV Gene Therapy Company BioSpace Archived from the original on 7 November 2020 Retrieved 29 January 2021 Novartis Expands Footprint in Gene and Cell Therapy with Vedere Bio Acquisition BioSpace Archived from the original on 25 November 2020 Retrieved 29 January 2021 Global Legal Chronicle Archived 11 November 2020 at the Wayback Machine Molecular Partners Option and License Agreement with Novartis 30 October 2020 Cadent Therapeutics Enters Agreement to be Acquired by Novartis BioSpace Archived from the original on 5 February 2021 Retrieved 29 January 2021 Reuters Staff 17 December 2020 Novartis buys neuroscience company Cadent for up to 770 million Reuters Archived from the original on 4 February 2021 Retrieved 29 January 2021 via www reuters com a href Template Cite news html title Template Cite news cite news a author has generic name help Novartis Adds to Optogenetics Portfolio with Arctos Medical Buy Archived from the original on 23 September 2021 Retrieved 23 September 2021 Mitra Sinchita 22 December 2021 Novartis buys Gyroscope for 1 5 BLN to add new retinal gene therapy Reuters Archived from the original on 23 December 2021 Retrieved 23 December 2021 a b Novartis vet is getting another shot at mTOR following the implosion of a longevity pioneer Endpoints 16 February 2022 Retrieved 14 March 2022 Kresge Naomi 25 August 2022 Novartis to Spin Off Sandoz Generic Drug Unit by Next Year Bloomberg News Archived from the original on 25 August 2022 Ross Casey 27 October 2010 Novartis doubles plan for Cambridge The Boston Globe Archived from the original on 3 November 2012 Retrieved 31 October 2010 Novartis Institutes for BioMedical Research Novartis Archived from the original on 2 May 2014 Retrieved 29 January 2021 Innovation for the developing world Archived from the original on 9 February 2014 Retrieved 29 January 2021 Mattes William B 2008 Public Consortium Efforts in Toxicogenomics In Mendrick Donna L Mattes William B eds Essential Concepts in Toxicogenomics Methods in Molecular Biology Vol 460 pp 221 238 doi 10 1007 978 1 60327 048 9 11 ISBN 978 1 58829 638 2 PMID 18449490 InnoMed PredTox Member Organizations web page InnoMed archived from the original on 26 September 2008 retrieved 25 August 2008 Innovative Medicines Initiative ed 2008 IMI GB 018v2 24042008 CallTopics pdf IMI 1st Call 2008 Information Package ZIP archive European Commission archived from the original PDF on 24 September 2015 retrieved 16 January 2012 Novartis U S partner plan remote trials to boost participation Reuters 7 March 2018 Archived from the original on 9 November 2020 Retrieved 15 March 2018 a b c d e f g h i j k l m n o p q r s t Novartis Top 20 Products Annual Sales Novartis Website accessed 19 October 2013 Archived 28 April 2014 at the Wayback Machine Teva press release 30 January 2007 Teva Receives Approval for Generic Focalin Tablets Archived 13 August 2020 at the Wayback Machine IPCI FDA Approves First Focalin XR ANDA Positive Incremental Step Toward Approval and October Launch for IPCI Archived from the original on 20 October 2013 a b c Novartis official 2007 product sales From Internet Archive archive date 13 November 2007 Commissioner Office of the 11 September 2019 FDA approves new oral drug to treat multiple sclerosis FDA Archived from the original on 9 February 2021 Retrieved 16 October 2019 Novartis receives FDA approval for Mayzent siponimod the first oral drug to treat secondary progressive MS with active disease Novartis Archived from the original on 20 November 2020 Retrieved 16 October 2019 Sertraline Sandoz Tablet NPS MedicineWise Archived from the original on 9 January 2019 Retrieved 9 January 2019 EU 3 09 671 European Medicines Agency Archived from the original on 4 February 2014 Retrieved 29 January 2021 FDA Approves Pasireotide for Cushing s Disease Archived from the original on 30 July 2013 a b NICE Backs Novartis s Tasigna For CML Rejects BMS s Sprycel The Wall Street Journal online wsj com 12 January 2012 archived from the original on 17 May 2013 retrieved 2012 01 15 a b Teva press release 14 October 2013 Teva Announces FDA Approval of Generic TOBI in the United States permanent dead link a b Teva Press Release 12 December 2007 Teva Announces Approval of Generic Trileptal Tablets Archived 20 October 2013 at the Wayback Machine US Department of Health and Human Services awards Novartis USD 486 million contract to build manufacturing facility for pandemic flu vaccine Press release Novartis 15 January 2009 Archived from the original on 3 June 2010 Retrieved 13 November 2009 Staton Tracy 22 April 2014 Novartis GSK team up in consumer JV to save big money gain big scale FiercePharma Questex Media Group Archived from the original on 26 October 2020 Retrieved 16 May 2016 Note The Indian patent application No 1602 MAS 1998 does not appear to be publicly available However according to the decision of the IPAB on 26 June 2009 page 27 discussed below The Appellant s application under the PCT was substantially on the same invention as had been made in India Archived 22 October 2013 at the Wayback Machine Crystal Modification of a N Phenyl 2 Pyrimidineamine Derivative Processes for Its Manufacture and Its Use Archived from the original on 22 October 2013 Retrieved 29 January 2021 Staff European Medicines Agency 2004 EMEA Scientific Discussion of Glivec Archived 20 September 2018 at the Wayback Machine Patent US5521184 Pyrimidine derivatives and processes for the preparation thereof google com Archived from the original on 15 December 2020 Retrieved 11 November 2016 Espacenet results view worldwide espacenet com Archived from the original on 17 November 2018 Retrieved 29 January 2021 Indian Supreme Court Decision paragraphs 5 6 Archived 6 July 2013 at the Wayback Machine Novartis v UoI para 8 9 Archived from the original on 6 July 2013 Retrieved 29 January 2021 a b Shamnad Basheer for Spicy IP 11 March 2006 First Mailbox Opposition Gleevec Decided in India Archived 21 October 2013 at the Wayback Machine Staff LawyersCollective 6 September 2011 Novartis case background and update Supreme Court of India to recommence hearing Archived 21 October 2013 at the Wayback Machine a b R Jai Krishna and Jeanne Whalen for The Wall Street Journal 1 April 2013 Novartis Loses Glivec Patent Battle in India Archived 26 October 2014 at the Wayback Machine IPAB Order Dated 26 Jun 2009 in Novartis v Union of India Patent Application Patent Scribd Archived from the original on 22 October 2013 Retrieved 29 January 2021 W P No 24759 of 2006 Archived from the original on 20 October 2013 Retrieved 29 January 2021 Supreme Court rejects bid by Novartis to patent Glivec Archived from the original on 17 December 2013 Novartis v UoI Para 191 Archived from the original on 6 July 2013 Retrieved 29 January 2021 Novartis v UoI Para 24 25 Archived from the original on 6 July 2013 Retrieved 29 January 2021 How the Indian judgment will reverberate across the world Archived from the original on 18 January 2014 Patented drugs must be priced smartly Archived from the original on 20 October 2013 Patent with a purpose Prof Shamnad Basheer Indian Express 3 April 2013 Archived from the original on 26 May 2013 Retrieved 29 January 2021 Kevin Grogan for PharmaTimes 27 February 2012 Novartis explains stance over India patent law challenge Archived 16 December 2014 at the Wayback Machine Erklarung von Bern 8 May 2007 Short questions and answers about the court case initiated by Novartis in India Archived 21 October 2013 at the Wayback Machine Shift in Novartis Strategy The Telegraph Archived from the original on 11 May 2013 Retrieved 29 January 2021 Voris Bob Van 14 July 2010 Novartis Reaches 152 5 Million Sex Bias Settlement Archived from the original on 18 May 2018 Retrieved 29 January 2021 via www washingtonpost com Focalin XR dexmethylphenidate hydrochloride extended release capsules CII Warning Letters US Food and Drug Administration 25 September 2008 Archived from the original on 10 February 2012 Retrieved 2009 08 05 a b Wilson Duff 30 September 2010 Novartis Settles Off Label Marketing Case The New York Times Archived from the original on 16 November 2018 Retrieved 16 January 2012 Novartis Pharmaceuticals Corporation a US subsidiary of Novartis AG reaches settlement agreement with US Attorney s Office press release Novartis 30 September 2010 Media Releases Archived from the original on 17 October 2013 Retrieved 16 January 2012 a b c U S Sues Novartis Again Accusing It of Kickbacks The New York Times 26 April 2013 Archived from the original on 5 October 2019 Retrieved 27 April 2013 a b United States Files Complaint Against Novartis Pharmaceuticals Corp for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs The United States Department of Justice 26 April 2013 Archived from the original on 13 April 2014 Retrieved 26 April 2013 Andrew Pollack for The New York Times 28 April 2011 Cheaper Drug to Treat Eye Disease Is Effective Archived 16 September 2018 at the Wayback Machine a b Jeffreys Branwen 6 May 2012 Using Avastin for eye condition wet AMD could save NHS 84m bbc com Archived from the original on 6 November 2013 Retrieved 6 May 2012 Copley Caroline Hirschler Ben 24 April 2012 Potter Mark ed Novartis challenges UK Avastin use in eye disease Reuters archived from the original on 22 May 2013 retrieved 2012 04 29 Ben Adams for Pharmafile 26 July 2012 Lucentis price cut ends PCT Novartis dispute Archived 19 October 2013 at the Wayback Machine Ben Adams for Pharma Times 3 October 2012 Novartis to drop legal case against NHS body Archived 19 October 2013 at the Wayback Machine a b Kana Inagaki for The Wall Street Journal 11 August 2013 Novartis Hit by Scandal Over Japanese Drug Studies Probes Uncover Altered Research Data Swiss Giant Stands by Heart Medicine Diovan Archived 13 October 2013 at the Wayback Machine Kana Inagaki for The Wall Street Journal 12 August 2013 Novartis Drug Studies in Japan Tracing Back the Questions Archived 18 October 2013 at the Wayback Machine Japan Criminal Probe Could Spell More Trouble for Novartis The Wall Street Journal 10 January 2014 Archived from the original on 2 March 2014 Data manipulation by staff gets Novartis into legal mess in Japan Japan Herald Archived from the original on 29 August 2014 Retrieved 2 July 2014 a b Greek Officials Hit Back at Novartis Bribery Allegations GreekReporter com greece greekreporter com 6 February 2018 Archived from the original on 1 November 2020 Retrieved 7 February 2018 Greek officials ban Novartis manager from leaving the country amid widening bribery probe report FiercePharma www fiercepharma com Archived from the original on 9 November 2020 Retrieved 7 February 2018 Greek Govt Alleges Official Ties to Drug Bribery Scandal The New York Times Associated Press 5 February 2018 ISSN 0362 4331 Archived from the original on 16 November 2018 Retrieved 7 February 2018 N Hliopoylos Kai me th boyla ths Dikaiosynhs yparkto to skandalo Novartis capital gr Retrieved 27 July 2022 a href Template Cite web html title Template Cite web cite web a CS1 maint url status link http www dw com Deutsche Welle Novartis under investigation for bribery in Greece Europe News and current affairs from around the continent DW 22 01 2017 DW COM Archived from the original on 12 November 2020 Retrieved 7 February 2018 SEC gov SEC Charges Novartis AG with FCPA Violations www sec gov Archived from the original on 18 January 2021 Retrieved 25 June 2020 Novartis Hellas S A C I and Alcon Pte Ltd Agree to Pay over 233 Million Combined to Resolve Criminal FCPA Cases www justice gov 25 June 2020 Archived from the original on 13 January 2021 Retrieved 25 June 2020 Novartis admits 1 2m in payments to Trump lawyer Financial Times Archived from the original on 9 November 2020 Retrieved 10 May 2018 Emma Court 16 July 2018 Novartis had longer and more detailed relationship with Trump lawyer Michael Cohen Senate report finds Archived 15 November 2020 at the Wayback Machine MarketWatch Retrieved 21 August 2018 White House Access for Sale Michael Cohen Novartis and the bid to sell access to the Trump administration Archived 13 November 2020 at the Wayback Machine Retrieved 21 August 2018 Leprosy www who int Archived from the original on 31 January 2021 Retrieved 19 January 2021 WHO WHO and Novartis extend agreement to treat millions of leprosy patients with free medicines WHO Archived from the original on 19 October 2015 Retrieved 19 January 2021 WHO New Memorandum of Understanding for MDT WHO Archived from the original on 11 October 2014 Retrieved 19 January 2021 Further reading EditKirkland Rik Jimenez Joseph June 2015 Novartis on digitizing medicine in an aging world Insights amp Publications Interview McKinsey amp Company Retrieved 16 August 2015 External links Edit Wikimedia Commons has media related to Novartis Official website Business data for Novartis BloombergGoogleReutersSEC filingsYahoo Portals Companies Switzerland Retrieved from https en wikipedia org w index php title Novartis amp oldid 1135324286, wikipedia, wiki, book, books, library,

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