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Novartis

novartis, novartis.com
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland, ranking number one in sales 579 billion US$ among the world-wide industry in 2013 In July 2015, Novartis had a market-cap of around $280 billion making it the largest healthcare company by this metric

Novartis manufactures such drugs as clozapine Clozaril, diclofenac Voltaren, carbamazepine Tegretol, valsartan Diovan and imatinib mesylate Gleevec/Glivec Additional agents include ciclosporin Neoral/Sandimmun, letrozole Femara, methylphenidate Ritalin, terbinafine Lamisil, and others

In 1996, Ciba-Geigy merged with Sandoz, and 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 3 years, but was revived in 2003 when Novartis consolidated its generic drugs businesses into a single subsidiary and named it Sandoz Novartis divested its agrochemical and genetically modified crops business in 2000 with the spinout of Syngenta in partnership with AstraZeneca, which also divested its agrochemical business

Novartis is a full member of the European Federation of Pharmaceutical Industries and Associations EFPIA, the International Federation of Pharmaceutical Manufacturers and Associations IFPMA, and the Pharmaceutical Research and Manufacturers of America PhRMA

Contents

  • 1 Corporate structure
  • 2 Place in its market segments
  • 3 History
    • 31 Ciba-Geigy
    • 32 Sandoz before formation of Novartis
    • 33 Post-merger
      • 331 2015
    • 34 Acquisition history
  • 4 Research
  • 5 Basel headquarters campus redesign
  • 6 Products
    • 61 Pharmaceuticals
    • 62 Consumer health
    • 63 Animal health
      • 631 Pet Care
      • 632 Livestock
      • 633 Bioprotection insect and rodent control
  • 7 Controversies and criticism
    • 71 Challenge to India's patent laws
    • 72 Sexual discrimination suit
    • 73 Marketing violations
    • 74 Fighting off-label prescribing
    • 75 Valsartan data scandal
  • 8 See also
  • 9 Notes and references
  • 10 Further reading
  • 11 External links

Corporate structure

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:117

The businesses of Novartis are divided into three operating divisions: Pharmaceuticals, Alcon eye care and Sandoz generics:150 Novartis operates directly and through dozens of subsidiaries in countries around the world, each of which fall under one of the divisions, and that Novartis categorizes as fulfilling one or more of the following functions: "Holding/Finance: the entity is a holding company and/or performs finance functions for the Group; Sales: the entity performs sales and marketing activities for the Group; Production: the entity performs manufacturing and/or production activities for the Group; and Research: the entity performs research and development activities for the Group":251–253

Novartis AG also holds 333% of the shares of Roche however, it does not exercise control over Roche Novartis also owned 249% of Idenix Pharmaceuticals prior to its sale to Merck & Co, Inc:117 Novartis also has two significant license agreements with Genentech, a Roche subsidiary One agreement is for Lucentis; the other is for Xolair, both of which Novartis markets outside the US:239

Novartis has established a multi-functional centre at Hyderabad, India in order to offshore several of its R&D, clinical development, medical writing and administrative functions The global service centre began in 2001 with 17 people and Hyderabad was chosen from a shortlist of 23 cities including Pune, Chennai and Gurgaon The centre supports the drug major’s operations in the pharmaceuticals Novartis, eye care Alcon and generic drugs segments Sandoz This centre is more than 870,000 square feet in size, large enough to house 8000 people

Novartis
CEO Joseph Jimenez & Executive Committee of Novartis
Innovative Business Division Surgical and Vision Care Division Generics Division
Novartis Pharmaceuticals
CEO Paul Hudson
Novartis Oncology
CEO Bruno Strigini
Alcon Sandoz

Place in its market segments

Overall, Novartis was the world's second largest pharmaceutical company in 2011 An IMS Health report ranked Novartis as the biggest pharma company in 2012

Alcon: Alcon was already the world's largest and most profitable eye care company when Novartis bought it, with 2009 annual sales of $65 billion and net income of $2 billion At that time, Novartis stated that it believed the two companies could generate approximately $200 million of potential annual pre-tax cost synergies

Sandoz: As of 2013, Sandoz was the world's second largest generic drug company, contributing US$109 billion to Novartis' operating profit on US$870 billion in revenue in 2012 Sandoz' biosimilars leads its field, getting the first biosimilar approvals in the EU

Vaccines and Diagnostics: As of 2013 Novartis was considering selling this division off While "sales in the unit were up 14% for the first half of 2013, it reported an operating loss of $240 million in the first half of 2013 after a $250 million loss for all 2012 Vaccine revenue was $14 billion in 2012 and has been forecast to more than double to $314 billion by 2018"

Consumer: Novartis is not a leader in the over the counter or animal health segments; its leading OTC brands are Excedrin and Theraflu, but sales have been slowed by problems at its key US manufacturing plant

In 2012, Novartis ranked 7th on the Access to Medicine Index,:88 which "ranks companies on how readily they make their products available to the world’s poor" In 2010, Novartis was in the top three pharma companies as it was in 2008

History

Novartis was created in 1996 from the merger of Ciba-Geigy and Sandoz Laboratories, both Swiss companies with long histories Ciba-Geigy was formed in 1970 by the merger of J R Geigy Ltd founded in Basel in 1758 and CIBA founded in Basel in 1859 Combining the histories of the merger partners, the company's effective history spans 250 years

Ciba-Geigy

In 1859, Alexander Clavel 1805–1873 took up the production of fuchsine in his factory for silk-dyeing works in Basel In 1864, a new site for the production of synthetic dyes was constructed, and in 1873, Clavel sold his dye factory to the new company Bindschedler and Busch In 1884, Bindschedler and Busch was transformed into a joint-stock company with the name "Gesellschaft für Chemische Industrie Basel" Company for Chemical Industry Basel The acronym, CIBA, was adopted as the company's name in 1945

Johann Rudolf Geigy-Gemuseus 1733–1793 began trading in 1758 in "materials, chemicals, dyes and drugs of all kinds" in Basel, Switzerland Johann Rudolf Geigy-Merian 1830–1917 and Johann Muller-Pack acquired a site in Basel in 1857, where they built a dyewood mill and a dye 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

In 1925, J R Geigy Ltd began producing textile auxiliaries, an activity which Ciba took up in 1928

In 1939, Geigy chemist Paul Hermann Müller discovered that DDT was effective against malaria-bearing insects He received the 1948 Nobel Prize in Medicine for this work

CIBA and Geigy merged in 1971 to form Ciba‑Geigy Ltd /ˌsiːbə ˈɡaɪɡi/ In the United States, the Geigy staff relocated to join the CIBA staff at its American headquarters for research in Ardsley, New York

In 1980, Ciba-Geigy set up the company, Ciba Vision, to enter the contact lens market

In 1992 Ciba-Geigy agreed to pay New Jersey $62 million for illegal waste dumping

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 Notably, Ciba Specialty Chemicals was spun out as an independent company, and "Sandoz's Master Builders Technologies, a producer of chemicals for the construction industry, was sold off to SKW Trostberg AG, a subsidiary of the German energy company Viag, and its North American corn herbicide business was sold off to the German chemical maker BASF AG"

Sandoz before formation of Novartis

"Sandoz" redirects here For other uses, see Sandoz disambiguation

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 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 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, 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 Sandoz withdrew the drug from the market in the mid-1960s The drug became a cultural novelty of the 1960s after psychologist Timothy Leary at Harvard University began to promulgate 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 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

In 1996 Sandoz merged with Ciba-Geigy, with the pharmaceutical and agrochemical divisions of both staying together to form Novartis

Post-merger

Suffern, New York: one of the Novartis pharmaceutical production facilities in the United States Novartis India headquarters in Genome Valley, India

In 1998, the company made headlines with its biotechnology licensing agreement with the University of California at Berkeley Department of Plant and Microbial 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

In 2000 Novartis and AstraZeneca combined their agrobusiness divisions to create a new company, Syngenta

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 though the US$829 billion acquisition of Hexal, one of Germany's leading generic drug 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 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% 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 $393 billion to fully acquire Alcon, the world's largest eye-care company, including a majority stake held by Nestlé Novartis had bought 25% 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

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, most 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 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 for $1525 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 has acquired CoStim Pharmaceuticals

In May 2014, Novartis bought the rights to market Ophthotech's Fovista an anti-PDGF aptamer, also being investigated for use in combination with anti-VEGF treatments outside the United States for up to $1 billion Novartis will acquire exclusive rights to market the eye drug outside of America whilst retaining US 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's cancer drug business for $16 billion as well as selling its vaccines business to GlaxoSmithKline for $71 billion

In August 2014 Genetic Engineering & Biotechnology News reported that Novartis had acquired a 15% 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

2015

In March, 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 Further, 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 from GlaxoSmithKline for up to $1 billion 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

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors this is not a comprehensive list:

Novartis














Ciba-Geigy
Merged 1996

J R Geigy Ltd
Merged 1971



CIBA
Merged 1971



Sandoz
Merged 1996
Sandoz




Kern and Sandoz Chemistry Firm
Founded 1886



Wander AG
Acq 1967




Delmark




Wasabröd - from 1999 new ownership: Barilla Alimentare SpA




Gerber Products Company
Sold 2007




Clariant
Spun off 1995






Syngenta
Spun off 2000






Hexal
Acq 2005






Eon Labs
Acq 2005




Chiron Corporation
Acq 2006






Chiron Corporation



Adatomed GmbH




Cetus Corporation




Cetus Oncology
Restructured after Cetus acquisition



Biocine Company
Restructured after Cetus acquisition



Chiron Diagnostics
Restructured after Cetus acquisition



Chiron Intraoptics
Restructured after Cetus acquisition



Chiron Technologies
Restructured after Cetus acquisition




PathoGenesis
Acq 2001




Matrix Pharmaceuticals Inc
Acq 2002




PowderJect
Acq 2003








Zhejiang Tianyuan Bio-Pharmaceutical Co, Ltd
Acq 2009




Alcon
Acq 2010

Alcon



Texas Pharmacal Company
Acq 1979






Genoptix
Acq 2011






Fougera Pharmaceuticals
Acq 2012






CoStim Pharmaceuticals
Acq 2014






GlaxoSmithKline
Cancer drug div, Acq 2014






Spinifex Pharmaceuticals
Acq 2015






Admune Therapeutic
Acq 2015




Research

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 malariam 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

Basel headquarters campus redesign

An ongoing Basel Campus Project has the aim to transform Novartis headquarters in Basel "from an industrial complex to a place of innovation, knowledge, and encounter" The pharmaceutical giant decided to transform the existing Sandoz office buildings and chemical factories of its headquarters in 2001

In 1999 PWP Landscape Architecture won the competition for a landscape master plan that would transform a 51-acre site beside the Rhine River from a paved industrial landscape crisscrossed with train tracks into a modern—and largely pedestrian—research and administrative campus filled with outdoor art, trees, greens, and parks The plan also dealt with an extensive network of existing underground infrastructure

The buildings were gradually demolished and replaced with works by architects and artists of international stature Frank Gehry, Rafael Moneo, and from SANAA, Kazuyo Sejima and Ryue Nishizawa were among the architects and Jenny Holzer and Richard Serra among the artists Marked diversity of forms now dominates the campus Novel features and technologies were introduced by Gehry to conform to the building standards of the Swiss government that prohibit air-conditioning, while still selecting a contemporary style of massive use of glass exteriors One adaptation by the architect includes the integration of a building vent, teepee-style, through the roof, which creates a chimney effect that draws cool air in at the lower levels and vents warmer air

Products

Pharmaceuticals

Name Indications or drug type/class Sales – invalid amount help Sales year % Change Notes
Aclasta/Reclast zoledronic acid Osteoporosis 590 2012 -4%
Adelphane-Esidrex reserpine/dihydralazine/hydrochlorothiazide Hypertension
Afinitor/Certican/Zortress everolimus Prevention of transplant rejection, various cancers 797 2012 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 -14%
Cosentyx secukinumab Psoriasis
Diovan valsartan Hypertension 4,417 2012 -22%
Entresto valsartan/sacubitril Heart failure
Enterovioform clioquinol Amoebiasis
Eucreas/Galvus Met vildagliptin/metformin Diabetes mellitus type 2
Exelon Patch rivastigmine Alzheimer's disease 1,050 2012 -2%
Exforge amlodipine/valsartan Hypertension 1,352 2012 12%
Exjade deferasirox Chronic iron overload 870 2012 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 -52%
Focalin dexmethylphenidate ADHD First US generics of Focalin became available in 2007 Focalin XR became available in 2012
Foradil/Foradile formoterol Asthma, COPD
Galvus vildagliptin Diabetes mellitus type 2 910 2012 39%
Gilenya fingolimod Multiple sclerosis 1,195 2012 142%
Gleevec/Glivec imatinib Oncology, Chronic myelogenous leukemia 4,675 2012 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
Lamisil terbinafine Fungal infections
Lescol fluvastatin Hypercholesterolemia 665 2007 -8%
Lioresal baclofen Spasticity
Lotrel amlodipine/benazepril Hypertension 748 2007 -34%
Lucentis ranibizumab Age-related macular degeneration 2,398 2012 17%
Ludiomil maprotiline Major depressive disorder
Mellaril thioridazine Schizophrenia
Myfortic mycophenolic acid Prevention of transplant rejection 579 2012 12%
Navoban tropisetron Chemotherapy-induced nausea and vomiting
Odomzo sonidegib Locally advanced basal cell carcinoma
Ritalin methylphenidate ADHD 554 2012 1%
Sandimmune/Neoral ciclosporin Prevention of transplant rejection 821 2012 -9%
Sandostatin octreotide Acromegaly 1,512 2012 5%
Signifor pasireotide Cushing's disease
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 998 2012 39% NICE formulary approval, January 2012
Tegretol carbamazepine Epilepsy, bipolar disorder 413 2007 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 Teva introduced generic in the US in 2013
Tofranil imipramine Major depressive disorder, enuresis
Trileptal oxcarbazepine Epilepsy, bipolar disorder 690 US only 2007 Teva introduced generic in 2008
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 -4%
Zometa zoledronic acid Prevention of bone fractures in cancer patients 1,288 2012 -13%
Xolair omalizumab Moderate-to-severe asthma not controlled by inhaled steroids
Chronic idiopathic urticaria
504 2012 4%
Zaditen ketotifen Asthma, allergic conjunctivitis

Consumer health

  • Benefiber
  • Bialcol Alcohol
  • Buckley's cold and cough formula
  • Bufferin
  • ChestEze
  • Comtrex cold and cough
  • Denavir/Vectavir
  • Desenex
  • Doan's pain relief
  • Ex-Lax
  • Excedrin
  • Fenistil
  • Gas-X
  • Habitrol
  • Keri skin care
  • Lamisil foot care
  • Lipactin herpes symptomatic treatment
  • Maalox
  • Nicotinell
  • No-doz
  • Quinvaxem Pentavalent vaccine
  • Otrivine
  • Prevacid 24HR
  • Savlon
  • Tavist
  • Theraflu
  • Triaminic
  • Vagistat
  • Tixylix
  • Voltaren

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

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

Animal health

Pet Care

  • Interceptor Milbemycin oxime, oral worm control product
  • Sentinel Flavor Tabs Milbemycin oxime, Lufenuron, oral flea control product
  • Deramaxx Deracoxib, oral treatment for pain and inflammation from osteoarthritis in dogs
  • Capstar Nitenpyram, oral tablet for flea control
  • Milbemax Milbemycin oxime, Praziquantel, oral worm treatment
  • Program Lufenuron, oral tablet for flea control

Livestock

  • Acatalk Duostar Fluazuron, Ivermectin, tick control for cattle
  • CLiK Dicyclanil, blowfly control for sheep
  • Denagard Tiamulin
  • Fasinex Triclabendazole
  • ViraShield

Bioprotection insect and rodent control

  • Actara Thiamenthoxam
  • Atrazine Atrazine
  • Larvadex Cyromazine
  • Neporex Cyromazine
  • Oxyfly Lambda-cyhalothrin
  • Virusnip Potassium monopersulfate

Controversies and criticism

Challenge to India's patent laws

Main article: Novartis v Union of India & Others

Novartis fought a seven-year, controversial battle to patent Gleevec in India, and took the case all the way to the Indian Supreme Court, where the patent application was finally rejected The patent application at the center of the case was filed by Novartis in India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while 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:3 In 1993, during the time India did not allow 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 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

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 USD 2666 per patient per month; generic companies were selling their versions at USD 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

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" 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 gotten its patent issued, it could not have prevented generics companies in India from continuing to sell generic Gleevec, but it could have obligated 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 emphasized that it continues to be committed to 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 $17 billion worth of Glivec to Indian patients in its support program since it was started"

Sexual discrimination suit

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 $1525 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 XR, an ADHD 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, and Tekturna; 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$4225 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 drugs, and the diabetes drug, Starlix Twenty-seven states, the District of Columbia and Chicago and New York also joined

Fighting off-label prescribing

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 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 data scandal

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 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

See also

  • List of pharmaceutical companies
  • Pharmaceutical industry in Switzerland

Notes and references

  1. ^ a b c d e f "2015 annual results" Novartis AG 
  2. ^ "Novartis Annual Report 2013" PDF Novartis Retrieved 2014-05-15 
  3. ^ "Healthcare – Google Finance" googlecouk 
  4. ^ "The Pharmaceutical Industry in Figures - 2008 Edition" PDF European Federation of Pharmaceutical Industries and Associations EFPIA p 49 Retrieved 2008-08-25 
  5. ^ IFPMA Member List Archived 7 February 2014 at the Wayback Machine
  6. ^ PhRMA Member List Archived 6 October 2013 at the Wayback Machine
  7. ^ a b c d e 2012 Novartis Group Annual Report
  8. ^ "Novartis slashing thousands more jobs in global reorganization, shifting many to India" FiercePharma 
  9. ^ PT Jyothi Datta "Novartis consolidates global services operations at Hyderabad centre" The Hindu Business Line 
  10. ^ "Novartis India strikes 87 lakh square feet office space deal in Hyderabad" timesofindia-economictimes 
  11. ^ https://wwwnovartiscom/about-us/divisions-businesses
  12. ^ https://wwwnovartiscom/news/media-releases/novartis-focuses-pharmaceuticals-division-creating-two-business-units-novartis
  13. ^ https://wwwnovartiscom/news/media-releases/novartis-focuses-pharmaceuticals-division-creating-two-business-units-novartis
  14. ^ Staff, EP Vantage 25 April 2012 Novartis on track to become world's biggest drug maker
  15. ^ Carolyn Gauntlett and Sarah Rickwood for IMS Health 2013 The changing face of the top 10 pharmaceutical companies
  16. ^ Melly Alazraki for Daily Finance 26 August 2010 Novartis Completes Purchase of Alcon Majority Stake from Nestle Archived 20 October 2013 at the Wayback Machine
  17. ^ Staff, Generics Bulletin 7 June 2013 Novartis difference puts Sandoz in prime position
  18. ^ Reuters, 21 October 2010 Biosimilars take off at Novartis generics unit Archived 20 October 2013 at the Wayback Machine
  19. ^ Staff, Generics and Biosimilars Initiative, 9 November 2012 Sandoz starts phase III US trial for biosimilar epoetin alfa Archived 20 October 2013 at the Wayback Machine
  20. ^ Eric Palmer for FiercePharma, 11 October 2013 Novartis whacks vaccine jobs as it eyes unit for disposal Archived 14 October 2013 at the Wayback Machine
  21. ^ Staff and wire reports for the Journal Star LIncoln, Nebraska 14 August 2013 Novartis reviews business; analyst urges selling OTC unit
  22. ^ Staff, WHO Access to Medicine Index, 2012
  23. ^ a b Donald G McNeil Jr for the New York Times 28 June 2010 The Drug Industry: GlaxoSmithKline, Merck and Novartis Again Rank Highest on Access to Poor
  24. ^ "Company history", corporate website, Novartis, novartiscom, archived from the original on 30 December 2010 
  25. ^ "Archive of Ciba, now a part of BASF: History" Cibacom Archived from the original on 2010-01-03 Retrieved 2013-05-27 
  26. ^ Staff, The Mineralogical Record Biographical Archive JR Geigy 1830-1917 Archived 22 October 2013 at the Wayback Machine
  27. ^ "Textile auxiliaries" are in the class of specialty chemicals and "enable a processing operation in preparation, dyeing, printing, or finishing to be carried out more effectively or which is essential if a given effect is to be obtained Certain Textile Auxiliaries are also required in order to produce special finishing effects such as wash & wear, water repellence, flame retardancy, aroma finish, anti odour, colour deepening etc" from Handbook on Textile Auxiliaries, Dyes and Dye Intermediates Technology, by the NPCS Board of Consultants & Engineers Asia Pacific Business Press Inc, 2009 Archived 22 October 2013 at the Wayback Machine
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  34. ^ "Albert Hofmann, 102, Invented LSD - The New York Sun" Nysuncom Archived from the original on 2013-10-20 Retrieved 2013-10-23 
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  43. ^ Novartis press release 19 April 2006 Novartis acquisition of Chiron approved by Chiron shareholders Archived 20 October 2013 at the Wayback Machine
  44. ^ Staff, Biosimilars News 15 August 2011 Biosimilars approved in Europe Archived 20 October 2013 at the Wayback Machine
  45. ^ Andrew Martin and Andrew Ross Sorkin for the New York Times 13 April 2007 Nestlé Agrees to Buy Gerber From Novartis
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  52. ^ "Novartis to Buy Fougera Pharmaceuticals for $15 Billion" The New York Times 2 May 2012 
  53. ^ a b c Harris, Gardiner; Thomas, Katie 2013-04-01 "Top Court in India Rejects Novartis Drug Patent" New York Times Retrieved 2013-04-01 
  54. ^ "US sues Novartis again, says it bribed doctors for patents" Indian Express Archived from the original on 2013-06-01 Retrieved 2013-04-29 
  55. ^ Tracy Staton 2014-01-21 "Novartis to cut 500 Swiss pharma jobs, then staff up in OTC, generics" FiercePharma Archived from the original on 2014-03-26 Retrieved 2014-02-19 
  56. ^ "Novartis acquires CoStim Pharmaceuticals" Drug Store News 18 January 2014 Archived from the original on 2014-02-25 Retrieved 2014-02-19 
  57. ^ a b Staff 15 June 2014 "Novartis Buys Ex-US Rights to Ophthotech's Fovista for Up to $1B" News | Industry Watch Genetic Engineering & Biotechnology News Paper 34 12 p 8 
  58. ^ Staff 20 May 2014 "Novartis Buys Ex-US Rights to Ophthotech's Fovista for Up to $1B" Genetic Engineering & Biotechnology News Retrieved 2014-09-14 
  59. ^ Staff 8 September 2014 "Ophthotech Pockets $50M Milestone from Novartis for AMD Treatment" GEN News Highlights Genitc Engineering & Biotechnology News Retrieved 2014-09-14 
  60. ^ BBC 2014-04-22 "Novartis and GSK exchange assets" BBC Archived from the original on 2014-04-29 Retrieved 2014-04-22 
  61. ^ "GEN | News Highlights:Novartis Takes Stake in Gamida with Option to Fully Buy" genengnewscom Retrieved 2014-09-14 
  62. ^ "Novartis Selling Flu Vaccine Business to CSL for $275M" GEN 
  63. ^ "Array BioPharma Completes Deal with Novartis for 2 Cancer Compounds - GEN News Highlights - GEN" GEN 
  64. ^ Staff 5 March 2015 "Novartis Sells RNAi R&D Portfolio to Arrowhead in $35M Agreement" Genetic Engineering & Biotechnology News Retrieved 8 June 2016  Note: appears on page 10 of 1 April 2015 print issue
  65. ^ "Novartis Acquires Spinifex for $200M+" GEN 
  66. ^ "Novartis shells out up to $1B to test GSK's Arzerra in MS" FiercePharma 
  67. ^ "Novartis Acquires All Remaining Rights to GSK's Ofatumumab" GEN 
  68. ^ "Novartis Buys Admune; Licenses Palobiofarma, XOMA Compounds" GEN 
  69. ^ Ross, Casey 2010-10-27 "Novartis doubles plan for Cambridge" Boston Globe Archived from the original on 2012-11-03 Retrieved 2010-10-31 
  70. ^ Novartis Institutes for BioMedical Research Official SIte Archived 2 May 2014 at the Wayback Machine
  71. ^ Innovation for the developing world Archived 9 February 2014 at the Wayback Machine
  72. ^ Mattes, William B 2008 "Public Consortium Efforts in Toxicogenomics" In Mendrick, Donna L; Mattes, William B Essential Concepts in Toxicogenomics Methods in Molecular Biology 460 pp 221–238 doi:101007/978-1-60327-048-9_11 ISBN 978-1-58829-638-2 PMID 18449490 
  73. ^ InnoMed PredTox Member Organizations web page, InnoMed, archived from the original on 2008-09-26, retrieved 2008-08-25 
  74. ^ Innovative Medicines Initiative, ed 2008, "IMI-GB-018v2-24042008-CallTopicspdf" PDF, IMI 1st Call 2008: Information Package ZIP archive, European Commission, retrieved 2012-01-16 
  75. ^ "Basel Campus Project" Novartis Archived from the original on 2011-02-02 Retrieved 2007-10-11 
  76. ^ Brooklyn Digital Foundry "Novartis Headquarters, Landscape Master Plan - PWP Landscape Architecture" pwplacom 
  77. ^ a b c d e f g h i j k l m n o p q r s t Novartis Top 20 Products Annual Sales Novartis Website, accessed 19 October 2013 Archived 28 April 2014 at the Wayback Machine
  78. ^ Teva press release 30 January 2007 Teva Receives Approval for Generic Focalin™ Tablets
  79. ^ "IPCI: FDA Approves First Focalin XR ANDA; Positive Incremental Step Toward Approval and October Launch for IPCI" Archived from the original on 2013-10-20 
  80. ^ a b c Novartis official 2007 product sales From Internet Archive; archive date 13 November 2007
  81. ^ EMEA Approval for Pasireotide Archived 4 February 2014 at the Wayback Machine
  82. ^ "FDA Approves Pasireotide for Cushing's Disease" Archived from the original on 2013-07-30 
  83. ^ a b "NICE Backs Novartis's Tasigna For CML, Rejects BMS's Sprycel", Wall Street Journal, onlinewsjcom, 12 January 2012, archived from the original on 17 May 2013, retrieved 2012-01-15 
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  85. ^ a b Teva Press Release 12 December 2007 Teva Announces Approval of Generic Trileptal Tablets Archived 20 October 2013 at the Wayback Machine
  86. ^ "US Department of Health and Human Services awards Novartis USD 486 million contract to build manufacturing facility for pandemic flu vaccine" Press release Novartis 15 January 2009 Archived from the original on 2010-06-03 Retrieved 2009-11-13 
  87. ^ Staton, Tracy 2014-04-22 "Novartis, GSK team up in consumer JV to save big money, gain big scale" FiercePharma Questex Media Group Retrieved 2016-05-16 
  88. ^ Note: The Indian patent application No1602/MAS/1998 does not appear to be publicly available However according to the decision of the IPAB on 26 June 2009 page 27 discussed below, "The Appellant’s application under the PCT was substantially on the same invention as had been made in India" Archived 22 October 2013 at the Wayback Machine
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  90. ^ Staff, European Medicines Agency, 2004 EMEA Scientific Discussion of Glivec
  91. ^ "Patent US5521184 - Pyrimidine derivatives and processes for the preparation thereof" googlecom 
  92. ^ "Espacenet" 
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  94. ^ Novartis v UoI, para 8-9 Archived 6 July 2013 at the Wayback Machine
  95. ^ a b Shamnad Basheer for Spicy IP 11 March 2006 First Mailbox Opposition Gleevec Decided in India Archived 21 October 2013 at the Wayback Machine
  96. ^ Staff, LawyersCollective 6 September 2011 Novartis case: background and update – Supreme Court of India to recommence hearing Archived 21 October 2013 at the Wayback Machine
  97. ^ a b R Jai Krishna and Jeanne Whalen for the Wall Street Journal 1 April 2013 Novartis Loses Glivec Patent Battle in India
  98. ^ Intellectual Property Appellate Board decision dated 26 June 2009, p 149 Archived 22 October 2013 at the Wayback Machine
  99. ^ WP No24759 of 2006 Archived 20 October 2013 at the Wayback Machine
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  103. ^ "How the Indian judgment will reverberate across the world" Archived from the original on 2014-01-18 
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  105. ^ Patent with a purpose, Prof Shamnad Basheer, Indian Express, 3 April 2013 Archived 26 May 2013 at the Wayback Machine
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  107. ^ Erklärung von Bern 8 May 2007 Short questions and answers about the court case initiated by Novartis in India Archived 21 October 2013 at the Wayback Machine
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  109. ^ "Novartis Reaches $1525 Million Sex-Bias Settlement" 
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Further reading

  • Kirkland, Rik; Jimenez, Joseph June 2015 "Novartis on digitizing medicine in an aging world" Insights & Publications Interview McKinsey & Company Retrieved 2015-08-16 

External links

  • Official website
  • Companies portal
  • Switzerland portal

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