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Novartis

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Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland. Novartis is one of the largest pharmaceutical companies in the world and was the eighth largest by revenue in 2024.<ref>Template:Cite web</ref><ref>Template:Cite web</ref>

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; produced by Sandoz since 2023), terbinafine (Lamisil), deferasirox (Exjade), and others.

Novartis was formed in 1996 by the merger of Ciba-Geigy and Sandoz.<ref name=":4">Template:Cite book</ref> It was considered the largest corporate merger in history during that time.<ref name=":4" /> The pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. The name Novartis was based on the Latin terms, novae artes (new skills).<ref name=":4" />

After the merger, 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. The new company also acquired a series of acquisitions in order to strengthen its core businesses.<ref name=":4" />

Novartis is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA),<ref>Template:Cite news</ref> the Biotechnology Innovation Organization (BIO),<ref>Template:Cite web</ref> the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA),<ref>Template:Cite web</ref> and the Pharmaceutical Research and Manufacturers of America (PhRMA).<ref>Template:Cite web</ref> Novartis is the third most valuable pharmaceutical company in Europe, after Novo Nordisk and Roche.

History

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Novartis was created in March 1996 and began operations on 20 December from the merger of Ciba-Geigy and Sandoz Laboratories, both Swiss companies.<ref name=":3">Template:Cite web</ref>

Ciba-Geigy

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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).<ref name=":3" />

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 "Template:Lang" (Company for Chemical Industry Basel). The acronym, CIBA, was adopted as the company's name in 1945.<ref>Template:Cite web</ref>

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.<ref>Template:Cite web</ref> In 1901, they formed the public limited company Geigy, and the name of the company was changed to J. R. Geigy Ltd in 1914.<ref>Template:Cite web</ref>

CIBA and Geigy merged in 1970 to form Ciba‑Geigy Ltd. Template:IPAc-en.<ref>Template:Cite web</ref>

Mid-1990s controversy

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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, and the Reich Farm/Union Carbide.<ref>Template:Cite book</ref> 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

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Template:Main

File:Sandoz-Logo.svg
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.<ref>Template:Cite web</ref> 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.<ref>Template:Cite web</ref><ref>Template:Cite web</ref> 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,<ref>Template:Cite web</ref> 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.<ref>Template:Cite news</ref> 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.<ref>Template:Cite web</ref> 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.<ref>Anna Bálint: Clariant clareant. The beginnings of a specialty chemicals company, Campus Verlag, Frankfurt am Main/New York 2012, Template:ISBN.</ref>

Merger

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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.<ref>Magnus Grimond for The Independent. 8 March 1996 Ciba-Geigy and Sandoz to merge into pounds 40bn giant Template:Webarchive</ref><ref name="NYTmerger">Glenn Collins for The New York Times. 7 March 1996 2 Swiss Drug Giants In a Surprise Merger To Be 2d in World Template:Webarchive</ref> notably Ciba Specialty Chemicals.<ref name=NYTmerger/><ref name="Fisher">Lawrence M. Fisher for strategy + business. 1 April 1998 Post-Merger Integration: How Novartis Became No. 1 Template:Webarchive</ref> 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.<ref name=Fisher/>

Post-merger

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File:Novartis.jpg
Suffern, New York: one of the Novartis pharmaceutical production facilities in the United States
File:Novartis Hyderabad office.jpg
Novartis Knowledge Center headquarters in HITEC City, Hyderabad, India

In 1998, the company entered into a biotechnology licensing agreement with the University of California at Berkeley Department of Plant and Microbial Biology.<ref>Template:Cite journal</ref> Critics of the agreement expressed concern over prospects that the agreement would diminish academic objectivity, or lead to the commercialization of genetically modified plants.<ref>Template:Cite journal</ref> The agreement expired in 2003.<ref>Template:Cite journal</ref>

2000–2010

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In 2000, Novartis and AstraZeneca combined their agrobusiness divisions to create a new company, Syngenta.<ref>Andrew Ross Sorkin for The New York Times. 3 December 1999 AstraZeneca and Novartis To Shed Agricultural Units Template:Webarchive Accessed 27 May 2013</ref><ref>Staff, PRNewsWire. 13 November 2000. Syngenta Begins Trading on the New York Stock Exchange Accessed 27 May 2013 Template:Dead linkTemplate:Cbignore</ref>

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.<ref>Press Release, Novartis. 21 January 2003 Novartis to Unite Its Generics Businesses Under One Single Global Brand: Sandoz Template:Webarchive</ref>

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.<ref>Emily Church for MarketWatch 21 February 2005 Novartis in $8.29 billion generics deals: to buy Hexal and its US division Eon Labs Template:Webarchive</ref>

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.<ref>Novartis press release. 19 April 2006 Novartis acquisition of Chiron approved by Chiron shareholders Template:Webarchive</ref> Also in 2006, Sandoz became the first company to have a biosimilar drug approved in Europe with its recombinant human growth hormone drug.<ref>Staff, Biosimilars News. 15 August 2011 Biosimilars approved in Europe Template:Webarchive</ref>

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.<ref>Andrew Martin and Andrew Ross Sorkin for The New York Times. 13 April 2007 Nestlé Agrees to Buy Gerber From Novartis Template:Webarchive</ref>

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.<ref>Template:Cite web</ref>

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.<ref>Template:Cite news</ref> 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.<ref>Novartis Press Release. 8 April 2011 Stronger together: Novartis and Alcon creating the global leader in eye care Template:Webarchive</ref> The total cost for Alcon amounted to $60 billion.<ref>Template:Cite web</ref>

2011–present

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In 2011, Novartis acquired the medical laboratory diagnostics company Genoptix to "serve as a strong foundation for our (Novartis') individualized treatment programs".<ref>Template:Cite news</ref>

In 2012, the Company cut approximately 2,000 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.<ref name="APjp2012">Template:Citation</ref> 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.<ref>Template:Citation</ref> 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.<ref>Template:Cite news</ref>

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.<ref name="NYTimesIndiaDecision">Template:Cite news</ref> 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.<ref>Template:Cite news Note: Link provides access to first of two pages; second page is here Template:Webarchive.</ref>

In January 2014, Novartis announced plans to cut 500 jobs from its pharmaceuticals division.<ref>Template:Cite web</ref> In February 2014, Novartis announced that it acquired CoStim Pharmaceuticals.<ref>Template:Cite news</ref>

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.<ref name=":0">Template:Cite news</ref> 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.<ref name=":0" /> 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.<ref name=":0" /> In September 2014, Ophthotech received its first $50 million phase III trial milestone payment from Novartis.<ref name="genengnews2">Template:Cite news</ref> 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.<ref>Template:Cite web</ref> 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.<ref name="genengnews3">Template:Cite web</ref> 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.<ref>Template:Cite web</ref>

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.<ref>Template:Cite web</ref> In addition, the company sold its RNAi portfolio to Arrowhead Research for $10 million and $25 million in stock.<ref>Template:Cite journal Note: appears on page 10 of 1 April 2015 print issue.</ref> In June, the company announced it would acquire Spinifex Pharmaceuticals for more than $200 million.<ref>Template:Cite web</ref> In August, the company acquired the remaining rights to the CD20 monoclonal antibody Ofatumumab from GlaxoSmithKline for up to $1 billion.<ref>Template:Cite web</ref><ref>Template:Cite web</ref> 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.<ref>Template:Cite web</ref>

In November 2016, the company announced it would acquire Selexys Pharmaceuticals for $665 million.<ref>Template:Cite web</ref> In December, the company acquired Encore Vision, gaining the company's principle compound, EV06, is a first-in-class topical therapy for presbyopia.<ref>Template:Cite web</ref> In December Novartis acquired Ziarco Group Limited, bolstering its presence in eczema treatments.<ref>Template:Cite web</ref>

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.<ref>Template:Cite news</ref>

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).<ref>Template:Cite web</ref><ref name=":1">Template:Cite news</ref> 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.<ref>Template:Cite news</ref> In August 2018, Novartis signed a deal with Laekna-a Shanghai-based pharmaceutical company for its two clinical-stage cancer drugs.<ref>Template:Cite web</ref> Novartis gave Laekna the exclusive international rights for the drugs that are oral pan-Akt kinase inhibitors namely; afuresertib (ASB138) and uprosertib (UPB795).<ref>Template:Cite news</ref> 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.<ref>Template:Cite news</ref><ref>Template:Cite news</ref> 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.<ref>Template:Cite web</ref> 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.<ref>Template:Cite news</ref>

On 9 April 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.<ref name="auto" /> 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".<ref>Template:Cite news</ref> In November 2019, Sandoz announced it would acquire the Japanese business of Aspen Global inc for €300 million (around $330 million), boosting the business's presence in Asia.<ref>Template:Cite web</ref> In late November 2019, the business announced it would acquire The Medicines Company for Template:US$ ($85 per share) in order to acquire amongst other assets, the cholesterol lowering therapy; inclisiran.<ref>Template:Cite web</ref><ref>Template:Cite web</ref>

In April 2020, the company announced it would acquire Amblyotech.<ref>Template:Cite web</ref>

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.<ref>Template:Cite web</ref> 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.<ref>Template:Cite web</ref>

In July 2020, Novartis agreed to pay $678 million to settle allegations that the company violated the False Claims Act and Anti-Kickback Statute by paying physicians to induce them to prescribe certain of the company's drugs. Novartis allegedly spent hundreds of millions of dollars on fraudulent speaker programs that served as a means to bribe doctors with cash payments and other extravagant rewards.<ref>Template:Cite web</ref> Many of these speaking programs were allegedly nothing more than social gatherings at expensive restaurants, with limited or no discussion about the Novartis drugs.<ref>Template:Cite web</ref>

In October Novartis announced it would acquire Vedere Bio for $280 million boosting the businesses cell and gene therapy offerings.<ref>Template:Cite web</ref><ref>Template:Cite web</ref>

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.<ref>Global Legal Chronicle Template:Webarchive Molecular Partners Option and License Agreement with Novartis (30 October 2020)</ref>

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.<ref>Template:Cite web</ref><ref>Template:Cite news</ref>

In September 2021, the company announced it would acquire gene-therapy business, Arctos Medical, broadening its optogenetics range.<ref>Template:Cite web</ref> In December, Novartis announced it would purchase Gyroscope Therapeutics from health care investment company, Syncona Ltd, for up to $1.5 billion.<ref>Template:Cite news</ref>

In February 2022, New York City-based biotechnology company Cambrian Biopharma announced it had licensed rights to mTOR inhibitor programs from Novartis.<ref name=endpts3>Template:Cite news</ref> As part of the deal, Cambrian was setting up a subsidiary called Tornado Therapeutics.<ref name=endpts3/>

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.<ref name=sandoz-ft /> 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.<ref name=sandoz-bn>Template:Cite news</ref>

In June 2023, Novartis announced it would acquire Chinook Therapeutics and its drug pipeline for up to $3.5 billion.<ref>Template:Cite news</ref>

In July 2023, Novartis acquired DTx Pharma, a developer of technology for delivering RNA-based therapies, upfront for $500 million and an additional $500 million subject to reaching certain targets.<ref>Template:Cite news</ref> Also in June, Novartis announced it would it would sell Xiidra to Bausch & Lomb for $1.75 billion and receive additional $750 million linked to future sales for Xiidra as well as two pipeline assets.<ref>Template:Cite news</ref><ref>Template:Cite news</ref>

In September 2023, Novartis announced that the spin-off had been approved by its shareholders and that it would be completed by the next month, resulting in Novartis shareholders receiving one Sandoz share for every five Novartis shares.<ref>Template:Cite news</ref><ref name="ft-spinoff">Template:Cite news</ref> Sandoz will be listed on the SIX Swiss Exchange with a market capitalization between $18 billion and $25bn.<ref>Template:Cite news</ref><ref name="ft-spinoff" />

On 4 October 2023, Novartis completed the spin-off of Sandoz as a stand-alone company.<ref name="spinoff-complete" />

In November 2023, Legend Biotech and Novartis signed an out-license deal to develop and manufacture Legend's chimeric antigen receptor (CAR-T) therapies, that go after delta-like ligand protein 3 (DLL3) including large cell neuroendocrine carcinoma candidate LB2102 for $100 million upfront, and Legend Biotech will be eligible to receive up to $1.01 billion in clinical, regulatory, and commercial milestone payments and tiered royalties.<ref>Template:Cite webTemplate:Dead link</ref>

In December 2023, Novartis sold its 15 ophthalmology drugs to JB Chemicals for ₹1,089 crore ($116 million).<ref>Template:Cite web</ref>

In 2023, the World Intellectual Property Organization (WIPO)’s Madrid Yearly Review ranked Novartis's number of marks applications filled under the Madrid System as 4th in the world, with 110 trademarks applications submitted during 2023.<ref>Template:Cite web</ref>

In February 2024, Novartis announced it would acquire the German biotech firm MorphoSys AG for €2.7bn.<ref>Template:Cite web</ref> Germany's antitrust regulator, the Federal Cartel Office, approved the takeover in March 2024.<ref>Template:Cite web</ref>

In May 2024, Novartis announced it would acquire Mariana Oncology for $1 billion upfront and up to $750 million more if certain milestones were met.<ref>Template:Cite web</ref>

In July 2024, Novartis entered into a strategic collaboration with Dren Bio to develop therapeutic bispecific antibodies for cancer, with the deal worth up to $3 billion.<ref>Template:Cite web</ref><ref>Template:Cite web</ref>

In November 2024, Novartis and Ratio Therapeutics entered into a worldwide licence and collaboration agreement worth $745m to advance a somatostatin receptor 2 (SSTR2)-targeting radiotherapeutic candidate for cancer.<ref>Template:Cite web</ref>

In February 2025, Novartis announced the acquisition of Anthos Therapeutics for $925m.<ref>Template:Cite web</ref>

In April 2025, Novartis announced plans to spend $23 billion to build and expand 10 facilities in the USA.<ref>Template:Cite web</ref>

In April 2025, Novartis agreed to buy Regulus Therapeutics Inc. in a deal that could be valued at up to $1.7 billion.<ref>Template:Cite web</ref>

Acquisition history

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Corporate structure

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Template:Pie chart

Novartis AG is a publicly traded Swiss holding company that operates through the Novartis Group and owns, directly or indirectly, all companies worldwide that operate as subsidiaries of the Novartis Group.<ref name=":2">Template:Cite web</ref>

Novartis's businesses are divided into two operating divisions: Innovative Medicines and Sandoz (generics).<ref>Template:Cite news</ref> The eye-care division Alcon was spun off into an independent company in April 2019.<ref>Template:Cite news</ref><ref>Template:Cite web</ref><ref>Template:Cite web</ref><ref>Template:Cite web</ref> In August 2022, Novartis announced plans to spin off Sandoz as part of restructuring. The spin-off was completed in October 2023.<ref name="spinoff-complete">Template:Cite web</ref><ref>Template:Cite news</ref><ref name=sandoz-ft>Template:Cite news</ref>

The Innovative Medicines business is made up of two commercial units: Innovative Medicines International and Innovative Medicines US.<ref>Template:Cite web</ref><ref>Template:Cite web</ref> The two business units combine the pharmaceutical and oncology divisions and commercially focus on global and US market respectively.<ref>Template:Cite web</ref><ref>Template:Cite web</ref>

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<ref name=":2" /><ref name="AR2012">Template:Cite web</ref>Template:Rp

Novartis AG also held 33.3 percent of the shares of Roche until 2022, however it did not exercise control over Roche.<ref>Template:Cite web</ref> Novartis also has two significant license agreements with Genentech, a Roche subsidiary.<ref>Template:Cite web</ref> One agreement is for Lucentis;<ref>Template:Cite press release</ref> the other is for Xolair.<ref>Template:Cite web</ref><ref name="AR2012" />Template:Rp

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.<ref>Template:Cite web</ref> The center supports the drug major's operations in the pharmaceuticals (Novartis), eye care (Alcon), and generic drugs segments (Sandoz).<ref>Template:Cite news</ref>

Place in its market segments

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Template:Update section Novartis is the world's first largest in life sciences and agribusiness markets.<ref name=":4" /> It is also the second-largest pharmaceutical company by market cap in 2019.<ref>Template:Cite web</ref>

In 2018, Novartis ranked second on the Access to Medicine Index,<ref>Staff, WHO. Access to Medicine Index, 2012</ref>Template:Rp which "ranks companies on how readily they make their products available to the world's poor."<ref>Template:Cite web</ref><ref>Template:Cite news</ref>

Finance

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As of January 31, 2025, Novartis shares traded at over $104.72 per share, and its market capitalization was valued at $210.39B.<ref>Template:Cite web</ref>

Year Revenue
in mil. US$ 		Net income
in mil. US$ 		Price per Share
in US$ 		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
2022 50,545 6,955 80.56 101,703
2023 45,440 14,854 100.34 76,057
2024 50,317 11,939 104.72 75,883

Pricing

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Entresto (sacubitril/valsartan)

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In 2023, the Institute for Clinical and Economic Review (ICER) identified Entresto as one of five high-expenditure drugs that experienced significant net price increases without new clinical evidence to justify the hikes. Specifically, Entresto's wholesale acquisition cost rose by 7%, leading to an additional $72 million in costs to U.S. payers.<ref name="icer.org">Template:Cite web</ref>

Research

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File:Novartis 100 Technology Square Cambridge November 2019.jpg
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.<ref>Template:Cite news</ref><ref>Template:Cite web</ref> 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.<ref>Template:Cite web</ref>

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.<ref>Template:Cite book</ref><ref name="InnoMed PredTox official project website">Template:Citation</ref> The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission.<ref name="IMI Call Topics 2008">Template:Citation</ref>

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.<ref>Template:Cite news</ref>

Products

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Pharmaceuticals (66 in total as of 28 April 2023)

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Name Indication(s) or drug type/class Sales Template:Currency Sales year % Change Notes
Aclasta/Reclast (zoledronic acid) Osteoporosis 590 2012<ref name=2012Sales/> −4%
Adelphane-Esidrex (reserpine/dihydralazine/hydrochlorothiazide) Hypertension
Afinitor/Certican/Zortress (everolimus) Prevention of transplant rejection, various cancers 797 2012<ref name=2012Sales/> 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<ref name=2012Sales/> −14%
Cosentyx (secukinumab) Psoriasis
Diovan (valsartan) Hypertension 4,417 2012<ref name=2012Sales/> −22%
Entresto (sacubitril/valsartan) Heart failure One of five high-expenditure drugs that experienced significant net price increases without new clinical evidence to justify the hikes.<ref name="icer.org"/>
Enterovioform (clioquinol) Amoebiasis
Eucreas/Galvus Met (vildagliptin/metformin) Diabetes mellitus type 2
Exelon Patch (rivastigmine) Alzheimer's disease 1,050 2012<ref name=2012Sales/> −2%
Exforge (amlodipine/valsartan) Hypertension 1,352 2012<ref name=2012Sales/> 12%
Exjade (deferasirox) Chronic iron overload 870 2012<ref name=2012Sales/> 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<ref name=2012Sales/> −52%
Focalin (dexmethylphenidate) ADHD First US generics of Focalin became available in 2007.<ref>Teva press release. 30 January 2007 Teva Receives Approval for Generic Focalin™ Tablets Template:Webarchive</ref> Focalin XR became available in 2012.<ref>Template:Cite web</ref>
Foradil/Foradile (formoterol) Asthma, COPD
Galvus (vildagliptin) Diabetes mellitus type 2 910 2012<ref name=2012Sales/> 39%
Gilenya (fingolimod) Multiple sclerosis 1,195 2012<ref name=2012Sales/> 142%
Gleevec/Glivec (imatinib) Oncology, Chronic myelogenous leukemia 4,675 2012<ref name="2012Sales">Novartis Top 20 Products Annual Sales (Novartis Website), accessed 19 October 2013 Template:Webarchive</ref> 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)
Kisqali (ribociclib) Breast Cancer 1,231 2022<ref name=novartis2022sales>Template:Cite web</ref>
Kymriah (tisagenlecleucel) Acute lymphoblastic leukemia
Lamisil (terbinafine) Fungal infections
Lescol (fluvastatin) Hypercholesterolemia 665 2007<ref name="novartis2007sales">Novartis official 2007 product sales From Internet Archive; archive date 13 November 2007</ref> −8%
Lioresal (baclofen) Spasticity
Lotrel (amlodipine/benazepril) Hypertension 748 2007<ref name=novartis2007sales/> −34%
Lucentis (ranibizumab) Age-related macular degeneration 2,398 2012<ref name=2012Sales/> 17%
Ludiomil (maprotiline) Major depressive disorder
Mayzent<ref>Template:Cite web</ref> (siponimod) Treatment for secondary progressive multiple sclerosis (SPMS) FDA approved 26 March 2019<ref>Template:Cite web</ref>
Mellaril (thioridazine) Schizophrenia
Myfortic (mycophenolic acid) Prevention of transplant rejection 579 2012<ref name=2012Sales/> 12%
Navoban (tropisetron) Chemotherapy-induced nausea and vomiting
Odomzo (sonidegib) Locally advanced basal cell carcinoma
Ritalin (methylphenidate) ADHD 554 2012<ref name=2012Sales/> 1%
Sandimmune/Neoral (ciclosporin) Prevention of transplant rejection 821 2012<ref name=2012Sales/> −9%
Sandostatin (octreotide) Acromegaly 1,512 2012<ref name=2012Sales/> 5%
Scemblix (Asciminib) Philadelphia chromosome-positive chronic myeloid leukemia
Sertraline Sandoz (sertraline hydrochloride) Depression, obsessive-compulsive disorder, panic disorder<ref>Template:Cite web</ref> Generic form of sertraline.
Signifor (pasireotide) Cushing's disease<ref>Template:Cite web</ref><ref>Template:Cite web</ref>
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<ref name="wsjtasigna2012">Template:Citation</ref>) 998 2012<ref name=2012Sales/> 39% NICE formulary approval, January 2012<ref name=wsjtasigna2012/>
Tegretol (carbamazepine) Epilepsy, bipolar disorder 413 2007<ref name=novartis2007sales/> 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<ref name=Teva2013/> Teva introduced generic in the US in 2013<ref name="Teva2013">Teva press release. 14 October 2013 Teva Announces FDA Approval of Generic TOBI® in the United States</ref>
Tofranil (imipramine) Major depressive disorder, enuresis
Trileptal (oxcarbazepine) Epilepsy, bipolar disorder 690 (US only) 2007<ref name=teva2007/> Teva introduced generic in 2008<ref name="teva2007">Teva Press Release 12 December 2007 Teva Announces Approval of Generic Trileptal Tablets Template:Webarchive</ref>
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<ref name=2012Sales/> −4%
Zometa (zoledronic acid) Prevention of bone fractures in cancer patients 1,288 2012<ref name=2012Sales/> −13%
Xolair (omalizumab) Moderate-to-severe asthma not controlled by inhaled steroids
Chronic idiopathic urticaria		 504 2012<ref name=2012Sales/> 4%
Zaditen (ketotifen) Asthma, allergic conjunctivitis

Consumer health

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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.<ref>Template:Cite press release</ref>

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.<ref>Template:Cite web</ref> 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).<ref name=":1" />

Animal health

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Pet care

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Livestock

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  • 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)

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Controversies and criticism

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Challenge to India's patent laws

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Template:Main

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.<ref name=NYTimesIndiaDecision/>

The patent application<ref>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." Template:Webarchive</ref><ref name="PCT">Template:Cite web</ref> claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate).<ref>Staff, European Medicines Agency, 2004. EMEA Scientific Discussion of Glivec Template:Webarchive</ref>Template:Rp 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.<ref>Template:Cite web</ref><ref>Template:Cite web</ref> 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.<ref>Indian Supreme Court Decision paragraphs 5-6 Template:Webarchive</ref>

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.<ref name="Decision8-9">Template:Cite web</ref> Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India.<ref name=SpicyIP1/> 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.<ref>Staff, LawyersCollective. 6 September 2011 Novartis case: background and update – Supreme Court of India to recommence hearing Template:Webarchive</ref> Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.<ref name="WSJ">R. Jai Krishna and Jeanne Whalen for The Wall Street Journal. 1 April 2013 Novartis Loses Glivec Patent Battle in India Template:Webarchive</ref>

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."<ref name="SpicyIP1">Shamnad Basheer for Spicy IP 11 March 2006 First Mailbox Opposition (Gleevec) Decided in India Template:Webarchive</ref><ref name="Appellate">Template:Cite web</ref> 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.<ref name="2007Decn">Template:Cite web</ref> 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.<ref>Template:Cite web</ref>

Although the court ruled narrowly,<ref>Template:Cite web</ref> and took care to note that the subject application was filed during a time of transition in Indian patent law,<ref name="Decision24">Template:Cite web</ref> the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing, innovation with affordability etc.<ref>Template:Cite web</ref><ref>Template:Cite web</ref><ref>Template:Cite web</ref>

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.<ref>Kevin Grogan for PharmaTimes. 27 February 2012 Novartis explains stance over India patent law challenge Template:Webarchive</ref><ref>Erklärung von Bern. 8 May 2007 Short questions and answers about the court case initiated by Novartis in India Template:Webarchive</ref>

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."<ref>Template:Cite web</ref> He also said that companies like Novartis would invest less money in research in India as a result of the ruling.<ref name=NYTimesIndiaDecision/> 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...."<ref name=WSJ />

Sexual discrimination

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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.<ref>Template:Cite web</ref>

Marketing violations

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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.<ref>Template:Cite web</ref>

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.<ref name=NYTtrileptal/> 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.<ref>Template:Cite web</ref> 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."<ref name="NYTtrileptal">Template:Cite news</ref> 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.<ref name="NYTapril2013">Template:Cite news</ref><ref name="DOJ2013">Template:Cite web</ref> 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".<ref name=NYTapril2013/> 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.<ref name=DOJ2013/> Twenty-seven states, the District of Columbia and Chicago and New York also joined.<ref name=NYTapril2013/>

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.<ref>Andrew Pollack for The New York Times. 28 April 2011 Cheaper Drug to Treat Eye Disease Is Effective Template:Webarchive</ref> 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.<ref name="BBClucentis">Template:Cite news</ref> 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.<ref name=BBClucentis/><ref name="copleyreuters2012">Template:Citation</ref> However, in July Novartis offered significant discounts (kept confidential) to the trusts, and the trusts agreed to change their policy,<ref>Ben Adams for Pharmafile. 26 July 2012 Lucentis price cut ends PCT-Novartis dispute Template:Webarchive</ref> and in November, Novartis dropped the litigation.<ref>Ben Adams for Pharma Times. 3 October 2012. Novartis to drop legal case against NHS body Template:Webarchive</ref>

Valsartan

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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.<ref name="WSJaug">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 Template:Webarchive</ref><ref>Kana Inagaki for The Wall Street Journal. 12 August 2013. Novartis Drug Studies in Japan–Tracing Back the Questions Template:Webarchive</ref> As a result, several Japanese hospitals stopped using the drug, and media outlets ran reports on the scandal in Japan.<ref name=WSJaug/> 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.<ref>Template:Cite news</ref> On 1 July 2014 the prosecutor's office announced it was formally charging the company and one of its employees.<ref name="NovartisJapan">Template:Cite news</ref>

Corruption

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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.<ref name="greece.greekreporter.com">Template:Cite web</ref> The manager of Novartis' Greek branch was prohibited from leaving the country.<ref>Template:Cite web</ref> 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".<ref>Template:Cite news</ref> 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.<ref name="greece.greekreporter.com" /> However, the Greek Judicial Council ruled that the scandal was real.<ref>Template:Cite web</ref> 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.<ref>Template:Cite web</ref>

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.<ref>Template:Cite web</ref><ref>Template:Cite web</ref>

Michael Cohen

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File:REPORT White House Access for Sale Michael Cohen and Novartis.pdf
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.<ref>Template:Cite news</ref>

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.<ref>Emma Court (16 July 2018.) Novartis had 'longer and more detailed' relationship with Trump lawyer Michael Cohen, Senate report finds Template:Webarchive. MarketWatch. Retrieved 21 August 2018.</ref><ref>White House Access for Sale: Michael Cohen, Novartis and the bid to sell access to the Trump administration Template:Webarchive. Retrieved 21 August 2018.</ref>

AveXis data integrity

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Having already received approval for Zolgensma in May 2019, on 28 June 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 6 August, 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. Template:Citation needed

Philanthropy

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Fight against leprosy

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Novartis has been committed for decades to eliminate leprosy by providing free, multidrug therapy to all endemic countries since 2000.<ref>Template:Cite web</ref><ref>Template:Cite web</ref><ref>Template:Cite web</ref>

See also

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References

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Further reading

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