pharmaceutical corporation
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...
based in Basel, Switzerland and
Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-locations It is one of the largest pharmaceutical companies in the world.
Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren; sold to
GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
March 1996
File:1996 Events Collage.png, From left, clockwise: A bomb explodes at Centennial Olympic Park in Atlanta, set off by a radical anti-abortionist; The center fuel tank explodes on TWA Flight 800, causing the plane to crash and killing everyone on ...
, 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 drug
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
s businesses into a single subsidiary and named it Sandoz. Novartis divested its agrochemical and
genetically modified crops
Genetically modified crops (GM crops) are plants used in agriculture, the DNA of which has been modified using genetic engineering methods. Plant genomes can be engineered by physical methods or by use of ''Agrobacterium'' for the delivery of ...
business in 2000 with the spinout of
Syngenta
Syngenta AG is a provider of agricultural science and technology, in particular seeds and pesticides with its management headquarters in Basel, Switzerland. It is owned by ChemChina, a Chinese state-owned enterprise.
Syngenta was founded in 2 ...
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.
Novartis's businesses are divided into three operating divisions: Innovative Medicines, Sandoz (generics) and Alcon (eyecare). In April 2019, Novartis spun off Alcon into a separate company. In August 2022, Novartis announced plans to spin off Sandoz as part of restructuring. The Innovative Medicines division comprises two business units: Novartis Pharmaceuticals and Novartis Oncology. 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
Novartis AG also held 33.3 percent of the shares of Roche until 2022, however it did not exercise control over Roche. Novartis also has two significant license agreements with
Genentech
Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within R ...
, a Roche subsidiary. One agreement is for Lucentis; the other is for Xolair.
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. The center supports the drug major's operations in the pharmaceuticals (Novartis), eye care (Alcon) and generic drugs segments (Sandoz).
Place in its market segments
Novartis is the world's second-largest pharmaceutical company by market cap in 2019.
*Alcon: At the time Novartis bought Alcon, they had annual sales of $6.5 billion and a net income of $2 billion. In April 2019, Novartis completed the spin-off of Alcon as a separate commercial entity.
*Sandoz: , Sandoz has been recognized as the world's second-largest generic drug company. Sandoz' biosimilars lead its field, getting the first biosimilar approvals in the EU. In 2018, Sandoz reported US$9.9 billion in net sales. In August 2022, Novartis announced plans to spin off Sandoz by second half of 2023.
*Vaccines and Diagnostics Division: In 2013, Novartis announced it was considering selling the vaccines and diagnostics division off. This sale was completed in late 2015, and the division was integrated into CSL's BioCSL operation, with the combined entity trading as Seqirus. In 2018, Novartis sold its consumer healthcare joint venture vaccines division to GlaxoSmithKline for US$13.0 billion.
*Consumer: Novartis is not a leader in the over-the-counter or animal health segments; its leading OTC brands are Excedrin and
Theraflu
Cold medicines are a group of medications taken individually or in combination as a treatment for the symptoms of the common cold and similar conditions of the upper respiratory tract. The term encompasses a broad array of drugs, including a ...
, but sales have been slowed by problems at its key US manufacturing plant.
In 2018, Novartis ranked second on the Access to Medicine Index, which "ranks companies on how readily they make their products available to the world's poor."
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.
History
Novartis was created in March 1996 from the merger of Ciba-Geigy and Sandoz Laboratories, both Swiss companies.
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).
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.
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
A dye is a colored substance that chemically bonds to the substrate to which it is being applied. This distinguishes dyes from pigments which do not chemically bind to the material they color. Dye is generally applied in an aqueous solution an ...
extraction plant. Two years later, they began the production of synthetic fuchsine. In 1901, they formed the public limited company Geigy, and the name of the company was changed to J. R. Geigy Ltd in 1914.
CIBA and Geigy merged in 1970 to form Ciba‑Geigy Ltd. .
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
Superfund is a United States federal environmental remediation program established by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA). The program is administered by the United States Environmental Pro ...
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
The Pulitzer Prize () is an award for achievements in newspaper, magazine, online journalism, literature, and musical composition within the United States. It was established in 1917 by provisions in the will of Joseph Pulitzer, who had made h ...
winning book, examined the issue of industrial pollution at the site in detail.
Sandoz
Sandoz is the
generic drug
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
s 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 antipsychoticClozaril,
Mellaril
Thioridazine (Mellaril or Melleril) is a first generation antipsychotic drug belonging to the phenothiazine drug group and was previously widely used in the treatment of schizophrenia and psychosis. The branded product was withdrawn worldwide ...
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
Auramine O is a diarylmethane dye used as a fluorescent stain (biology), stain. In its pure form, Auramine O appears as yellow needle crystals. It is insoluble in water and soluble in ethanol and Dimethyl sulfoxide, DMSO.
Auramine O can be used ...
. 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
Arthur Stoll (8 January 1887 – 13 January 1971) was a Swiss biochemist.
Education and career
The son of a teacher and school headmaster, he studied chemistry at the ETH Zurich, with a PhD in 1911, where he studied with Richard Willstätter. ...
(1887–1971), who is the founder of Sandoz's pharmaceutical department in 1917. In 1918, Arthur Stoll isolated ergotamine from
ergot
Ergot ( ) or ergot fungi refers to a group of fungi of the genus ''Claviceps''.
The most prominent member of this group is ''Claviceps purpurea'' ("rye ergot fungus"). This fungus grows on rye and related plants, and produces alkaloids that ca ...
; 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
Psychedelics are a subclass of hallucinogenic drugs whose primary effect is to trigger non-ordinary states of consciousness (known as psychedelic experiences or "trips").Pollan, Michael (2018). ''How to Change Your Mind: What the New Science of ...
Arthur Stoll
Arthur Stoll (8 January 1887 – 13 January 1971) was a Swiss biochemist.
Education and career
The son of a teacher and school headmaster, he studied chemistry at the ETH Zurich, with a PhD in 1911, where he studied with Richard Willstätter. ...
and Albert Hofmann. 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
Paraphilia (previously known as sexual perversion and sexual deviation) is the experience of intense sexual arousal to atypical objects, situations, fantasies, behaviors, or individuals. It has also been defined as sexual interest in anything ot ...
. Sandoz suggested in its marketing literature that psychiatrists take LSD themselves, 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. 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. 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
Swedish or ' may refer to:
Anything from or related to Sweden, a country in Northern Europe. Or, specifically:
* Swedish language, a North Germanic language spoken primarily in Sweden and Finland
** Swedish alphabet, the official alphabet used by ...
pesticide
Pesticides are substances that are meant to control pests. This includes herbicide, insecticide, nematicide, molluscicide, piscicide, avicide, rodenticide, bactericide, insect repellent, animal repellent, microbicide, fungicide, and lampri ...
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
Clariant AG is a Swiss multinational speciality chemicals company, formed in 1995 as a spin-off from Sandoz. The company is focused on four business areas: care chemicals (consumer and industrial); catalysis; natural resources (oil & mining, mine ...
. In 1997, Clariant merged with the specialty chemicals business that was spun off from Hoechst AG in Germany.
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.Glenn Collins for ''The New York Times''. 7 March 199 2 Swiss Drug Giants In a Surprise Merger To Be 2d in World notably Ciba Specialty Chemicals.Lawrence M. Fisher for strategy + business. 1 April 199 Post-Merger Integration: How Novartis Became No. 1 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.
Microbial
A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...
Biology. Critics of the agreement expressed concern over prospects that the agreement would diminish academic objectivity, or lead to the commercialization of genetically modified plants. The agreement expired in 2003.
2000–2010
In 2000, Novartis and AstraZeneca combined their agrobusiness divisions to create a new company,
Syngenta
Syngenta AG is a provider of agricultural science and technology, in particular seeds and pesticides with its management headquarters in Basel, Switzerland. It is owned by ChemChina, a Chinese state-owned enterprise.
Syngenta was founded in 2 ...
.
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.
In 2005, Novartis expanded its subsidiary Sandoz significantly through the US$8.29 billion acquisition of Hexal, one of Germany's leading
generic drug
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
companies, and Eon Labs, a fast-growing United States generic pharmaceutical company.
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. Also in 2006, Sandoz became the first company to have a biosimilar drug approved in Europe with its recombinant
human growth hormone
Growth hormone (GH) or somatotropin, also known as human growth hormone (hGH or HGH) in its human form, is a peptide hormone that stimulates growth, cell reproduction, and cell regeneration in humans and other animals. It is thus important in h ...
drug.
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.
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.
In 2010, Novartis offered to pay US$39.3 billion to fully acquire
Alcon
Alcon is an American Swiss medical company specializing in eye care products with headquarters in Geneva, Switzerland, and incorporated in Fribourg, Switzerland. Alcon began as a US company and its US subsidiary’s headquarters remain in Fort ...
, the world's largest eye-care company, including a majority stake held by Nestlé. Novartis had bought 25 percent of Alcon in 2008. 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. The total cost for Alcon amounted to $60 billion.
2011–present
In 2011, Novartis acquired the medical laboratory diagnostics company Genoptix to "serve as a strong foundation for our (Novartis') individualized treatment programs".
In 2012, the Company cut ~2000 positions in the United States, primarily in sales, in response to anticipated revenue downturns from the
hypertension
Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long-term medical condition in which the blood pressure in the arteries is persistently elevated. High blood pressure usually does not cause symptoms. Long-term high bl ...
drug Diovan, which was losing patent protection, and the realization that the anticipated successor to Diovan,
Rasilez
Aliskiren (brand names Tekturna and Rasilez) is the first in a class of drugs called direct renin inhibitors. It is used for essential (primary) hypertension. While used for high blood pressure, other better studied medications are typically reco ...
, was failing in clinical trials. 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. Also in 2012, Novartis became the biggest manufacturer of generic skin care medicine, after agreeing to buy
Fougera Pharmaceuticals
Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and
Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-loc ...
for $1.525 billion in cash.
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. 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.
In January 2014, Novartis announced plans to cut 500 jobs from its pharmaceuticals division. In February 2014, Novartis announced that it acquired CoStim Pharmaceuticals.
In May 2014, Novartis purchased the rights to market Ophthotech's Fovista (an anti- PDGFaptamer, also being investigated for use in combination with anti- VEGF treatments) outside the U.S. for up to $1 billion. 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. 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. In September 2014, Ophthotech received its first $50 million phase III trial milestone payment from Novartis. In April 2014, Novartis announced that it would acquire
GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
's cancer drug business for $16 billion as well as selling its vaccines business to GlaxoSmithKline for $7.1 billion. 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. 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.
In March 2015, the company announced BioPharma had completed its acquisition of two Phase III cancer-drug candidates; the MEK inhibitor
binimetinib
Binimetinib, also known as Mektovi and ARRY-162, is an anti-cancer small molecule that was developed by Array Biopharma to treat various cancers. Binimetinib is a selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway. ...
encorafenib
Encorafenib, sold under the brand name Braftovi, is a medication for the treatment of certain melanoma cancers. It is a small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway. This pathway occurs in many different ...
(LGX818), for $85 million. In addition, the company sold its RNAi portfolio to Arrowhead Research for $10 million and $25 million in stock. In June, the company announced it would acquire Spinifex Pharmaceuticals for more than $200 million. In August, the company acquired the remaining rights to the CD20 monoclonal antibody
Ofatumumab
Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union ...
from
GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
for up to $1 billion. In October the company acquired Admune Therapeutics for an undisclosed sum, as well as licensing PBF-509, an
adenosine
Adenosine ( symbol A) is an organic compound that occurs widely in nature in the form of diverse derivatives. The molecule consists of an adenine attached to a ribose via a β-N9-glycosidic bond. Adenosine is one of the four nucleoside building ...
A2A receptor antagonist which is in Phase I clinical trials for non-small cell lung cancer, from Palobiofarma.
In November 2016, the company announced it would acquire Selexys Pharmaceuticals for $665 million. In December, the company acquired Encore Vision, gaining the company's principle compound, EV06, is a first-in-class topical therapy for presbyopia. In December Novartis acquired Ziarco Group Limited, bolstering its presence in eczema treatments.
In late October 2017, '' Reuters'' announced that Novartis would acquire
Advanced Accelerator Applications
Advanced Accelerator Applications (AAA or Adacap) is a France-based pharmaceutical group, specialized in the field of nuclear medicine.
The group operates in all three segments of nuclear medicine (PET, SPECT and therapy) to diagnose and treat ser ...
for $3.9 billion, paying $41 per ordinary share and $82 per American depositary share representing a 47 percent premium.
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). 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
Onasemnogene abeparvovec, sold under the brand name Zolgensma, is a gene therapy medication used to treat spinal muscular atrophy (SMA). It is used as a one-time infusion into a vein.
Onasemnogene abeparvovec works by providing a new copy of ...
used to treat
spinal muscular atrophy
Spinal muscular atrophy (SMA) is a rare neuromuscular disorder that results in the loss of motor neurons and progressive muscle wasting. It is usually diagnosed in infancy or early childhood and if left untreated it is the most common genetic ...
. In August 2018, Novartis signed a deal with Laekna-a Shanghai-based pharmaceutical company for its two clinical-stage cancer drugs. Novartis gave Laekna the exclusive international rights for the drugs that are oral pan-Akt kinase inhibitors namely; afuresertib (ASB138) and uprosertib (UPB795). 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. 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. 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.
On April 9, 2019, Novartis announced that it had completed the spin-off of
Alcon
Alcon is an American Swiss medical company specializing in eye care products with headquarters in Geneva, Switzerland, and incorporated in Fribourg, Switzerland. Alcon began as a US company and its US subsidiary’s headquarters remain in Fort ...
as a separate commercial entity. Alcon was listed on the SIX exchange in Switzerland and NYSE exchange in the U.S. 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". 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. In late November 2019, the business announced it would acquire The Medicines Company for ($85 per share) in order to acquire amongst other assets, the cholesterol lowering therapy; inclisiran.
In April 2020, the company announced it would acquire Amblyotech.
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. 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.
In October Novartis announced it would acquire Vedere Bio for $280 million boosting the businesses cell and gene therapy offerings.
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.
In December 2020, Novartis announced it would acquir 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.
In September 2021, the company announced it would acquire gene-therapy business, Arctos Medical, broadening its optogenetics range. In December, Novartis announced it would purchase Gyroscope Therapeutics from health care investment company, Syncona Ltd, for up to $1.5 billion.
In February 2022, New York City-based biotechnology company Cambrian Biopharma announced it had licensed rights to mTOR inhibitor programs from Novartis. As part of the deal, Cambrian was setting up a subsidiary called Tornado Therapeutics.
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. With the unit having generated US$9.69billion in 2021, the spin-off would create the biggest generic drugs company in Europe by sales.
Alcon
Alcon is an American Swiss medical company specializing in eye care products with headquarters in Geneva, Switzerland, and incorporated in Fribourg, Switzerland. Alcon began as a US company and its US subsidiary’s headquarters remain in Fort ...
The company's global research operations, called "Novartis Institutes for BioMedical Research (NIBR)" have their global headquarters in Cambridge, Massachusetts, United States. 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.
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. The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission.
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.
Products
Pharmaceuticals
Consumer health
*
Benefiber
Fibre supplements (also spelled fiber supplements) are considered to be a form of a subgroup of functional dietary fiber, dietary fibre, and in the United States are defined by the Institute of Medicine (IOM). According to the IOM, functional fi ...
Bufferin
Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat inc ...
Desenex
Miconazole, sold under the brand name Monistat among others, is an antifungal medication used to treat ring worm, pityriasis versicolor, and candidiasis, yeast infections of the skin or vagina. It is used for ring worm of the tinea corporis, body ...
Fenistil Fenistil is a brand name for some over the counter medications distributed by GlaxoSmithKline and Novartis.
Products include:
* Fenistil Gel, containing dimetindene
* Fenistil Cold Sore Cream, containing penciclovir
* FeniHydrocort, containing cort ...
*
Gas-X
Simeticone (International Nonproprietary Name, INN), also known as simethicone (United States Adopted Name, USAN), is an anti-foaming agent used to reduce bloating, discomfort or pain caused by excessive gas.
Medical uses
Simeticone is used to ...
*
Habitrol
Nicorette is the brand name of a number of products for nicotine replacement therapy (NRT) that contain nicotine polacrilex. Developed in the late 1970s in Sweden by in the form of a chewing gum, Nicorette was the first nicotine replacement pr ...
Lamisil
Terbinafine, sold under the brand name Lamisil among others, is an antifungal medication used to treat pityriasis versicolor, fungal nail infections, and ringworm including jock itch and athlete's foot. It is either taken by mouth or applied to ...
Quinvaxem
A pentavalent vaccine, also known as a 5-in-1 vaccine, is a combination vaccine with five individual vaccines conjugated into one.
Pentavalent vaccine frequently refers to the 5-in-1 vaccine protecting against diphtheria, tetanus, whooping cough, ...
Theraflu
Cold medicines are a group of medications taken individually or in combination as a treatment for the symptoms of the common cold and similar conditions of the upper respiratory tract. The term encompasses a broad array of drugs, including a ...
influenza vaccine
Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...
, 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.
In April 2014, Novartis divested its consumer health section with $3,5 billion worth of assets into a new joint venture with
GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
, named GSK Consumer Healthcare, of which Novartis will hold a 36,5% stake. 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).
Animal health
Pet care
* Interceptor (
Milbemycin oxime
Milbemycin oxime, sold under the brand name Interceptor among others, is a veterinary medication from the group of milbemycins, used as a broad spectrum antiparasitic. It is active against worms (anthelmintic) and mites (miticide).
Mechanism of ...
), oral worm control product
*
Sentinel Flavor Tabs
The combination milbemycin oxime/lufenuron (trade names Sentinel Flavor Tabs, by Novartis Animal Health, and Program plus) is a parasite control drug in which the active ingredient, milbemycin oxime, eliminates worms, while a second active ingredie ...
(Milbemycin oxime, Lufenuron), oral flea control product
* Deramaxx (
Deracoxib
Deracoxib (trade name Deramaxx) is a nonsteroidal anti-inflammatory drug (NSAID) of the coxib class, used in dogs to treat pain associated with osteoarthritis, or to prevent pain following orthopedic or dental surgery. It is available as beef-fla ...
), oral treatment for pain and inflammation from osteoarthritis in dogs
* Capstar ( Nitenpyram), oral tablet for flea control
* Milbemax (
Milbemycin oxime
Milbemycin oxime, sold under the brand name Interceptor among others, is a veterinary medication from the group of milbemycins, used as a broad spectrum antiparasitic. It is active against worms (anthelmintic) and mites (miticide).
Mechanism of ...
, Praziquantel), oral worm treatment
* Program ( Lufenuron), oral tablet for flea control
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
''Brachyspira'' is a genus of bacteria classified within the phylum Spirochaetota.See the List of Prokaryotic names with Standing in Nomenclature. Data extracted from
See the NCBIbr>webpage on SpirochaetesData extracted from
''Brachyspira sp ...
'' (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
Cyromazine
Cyromazine is a triazine insect growth regulator used as an insecticide. It is a cyclopropyl derivative of melamine. Cyromazine works by affecting the nervous system of the immature larval stages of certain insects.Cyromazine
Cyromazine is a triazine insect growth regulator used as an insecticide. It is a cyclopropyl derivative of melamine. Cyromazine works by affecting the nervous system of the immature larval stages of certain insects.Lambda-cyhalothrin)
* Virusnip (
Potassium monopersulfate
Potassium peroxymonosulfate is widely used as an oxidizing agent. It is the potassium salt of peroxymonosulfuric acid. Usually potassium peroxymonosulfate refers to the triple salt known as oxone.
The standard electrode potential for potassium p ...
)
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
The Supreme Court of India (IAST: ) is the supreme judicial authority of India and is the highest court of the Republic of India under the constitution. It is the most senior constitutional court, has the final decision in all legal matters ...
, 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.
The patent application claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate). 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. The key differences between the two patent applications were that the 1998 patent application specified the
counterion
160px, Polystyrene sulfonate, a cation-exchange resin, is typically supplied with as the counterion.">cation-exchange_resin.html" ;"title="Polystyrene sulfonate, a cation-exchange resin">Polystyrene sulfonate, a cation-exchange resin, is typical ...
(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.
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. Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India. 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. Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.R. Jai Krishna and Jeanne Whalen for ''The Wall Street Journal''. 1 April 201 Novartis Loses Glivec Patent Battle in India
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."Shamnad Basheer for Spicy IP 11 March 200 First Mailbox Opposition (Gleevec) Decided in India 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. 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.
Although the court ruled narrowly, and took care to note that the subject application was filed during a time of transition in Indian patent law, the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing, innovation with affordability etc.
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.
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." He also said that companies like Novartis would invest less money in research in India as a result of the ruling. 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...."
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
Pregnancy is the time during which one or more offspring develops (gestation, gestates) inside a woman, woman's uterus (womb). A multiple birth, multiple pregnancy involves more than one offspring, such as with twins.
Pregnancy usually occur ...
. Two months later the company settled with the remaining plaintiffs for $152.5 million plus attorney fees.
Marketing violations
In September 2008, the US Food and Drug Administration (FDA) sent a notice to Novartis Pharmaceuticals regarding its advertising of
Focalin
Dexmethylphenidate, sold under the brand name Focalin among others, is a strong central nervous system (CNS) stimulant medication used to treat attention deficit hyperactivity disorder (ADHD) in those over the age of five years. If no benefit i ...
XR, an
ADHD
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by excessive amounts of inattention, hyperactivity, and impulsivity that are pervasive, impairing in multiple contexts, and otherwise age-inapp ...
drug, in which the company overstated its efficacy while marketing to the public and medical professionals.
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
Amlodipine/valsartan, sold under the brand name Exforge among others, is a blood pressure lowering combination drug. It contains amlodipine, a dihydropyridine-type calcium channel blocker, and valsartan, an angiotensin receptor blocker. This ...
, and
Tekturna
Aliskiren (brand names Tekturna and Rasilez) is the first in a class of drugs called direct renin inhibitors. It is used for essential hypertension, essential (primary) hypertension. While used for high blood pressure, other better studied medica ...
; Sandostatin, a drug to treat a growth hormone disorder; and Zelnorm, a drug for irritable bowel syndrome. 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. 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." 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. 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". 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
Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long-term medical condition in which the blood pressure in the arteries is persistently elevated. High blood pressure usually does not cause symptoms. Long-term high bl ...
drugs), and the diabetes drug, Starlix. Twenty-seven states, the District of Columbia and Chicago and New York also joined.
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
Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, l ...
(Avastin). Both Avastin and Lucentis were created by
Genentech
Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within R ...
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. 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. 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. However, in July Novartis offered significant discounts (kept confidential) to the trusts, and the trusts agreed to change their policy, and in November, Novartis dropped the litigation.
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.Kana Inagaki for ''The Wall Street Journal''. 11 August 201 Novartis Hit by Scandal Over Japanese Drug Studies: Probes Uncover Altered Research Data; Swiss Giant Stands by Heart Medicine Diovan
As a result, several Japanese hospitals stopped using the drug, and media outlets ran reports on the scandal in Japan. 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. On 1 July 2014 the prosecutor's office announced it was formally charging the company and one of its employees.
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. The manager of Novartis' Greek branch was prohibited from leaving the country. 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". 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
The Coalition of the Radical Left – Progressive Alliance ( el, Συνασπισμός Ριζοσπαστικής Αριστεράς – Προοδευτική Συμμαχία, Synaspismós Rizospastikís Aristerás – Proodeftikí Simachía), ...
opposition party. However, the Greek Judicial Council ruled that the scandal was real. 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.
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.
Michael Cohen
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.
In July 2018, the
US Senate committee
This is a complete list of U.S. congressional committees ( standing committees and select or special committees) that are operating in the United States Senate. Senators can be a member of more than one committee.
Standing committees
, there a ...
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.
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.
Philanthropy
Fight against Leprosy
Novartis has been committed for decades to eliminate Leprosy by providing free, multidrug therapy to all endemic countries since 2000.