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Ιούν 01

It is time to know more about NOVARTIS

Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales.

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).

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.

The businesses of Novartis are divided into three operating divisions: Pharmaceuticals, Alcon (eye care) and Sandoz (generics). 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.»

Novartis AG also holds 33.3% of the shares of Roche however, it does not exercise control over Roche. Novartis also owned 24.9% of Idenix Pharmaceuticals prior to its sale to Merck & Co, Inc. 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.

Hyderabad,India New technology campus

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[9]
CEO Joseph Jimenez & Executive Committee of Novartis
Innovative Business Division Surgical and Vision Care Division Generics Division
Novartis Pharmaceuticals
CEO Paul Hudson[10]
Novartis Oncology
CEO Bruno Strigini[11]
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 $6.5 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$1.09 billion to Novartis’ operating profit on US$8.70 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 $1.4 billion in 2012 and has been forecast to more than double to $3.14 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, 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 (mosquitoes). 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 A.G., a subsidiary of the German energy company Viag, and its North American corn herbicide business (was sold off) to the German chemical maker BASF A.G.»

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 (including CIA agents). 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$8.29 billion acquisition of Hexal, one of Germany’s leading generic drug companies, and Eon Labs, a fast-growing United States generic pharmaceutical company.

In 2006, Novartis acquired the California-based Chiron Corporation. Chiron had been divided into three units: 1)Chiron Vaccines, 2)Chiron Blood Testing, and 3)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 $39.3 billion to fully acquire Alcon, the world’s largest eye-care company, including a majority stake held by Nestlé. Novartis had bought 25% 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 $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 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 $7.1 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

2016

In November 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.[67]

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 S.p.A..
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)
Selexys Pharmaceuticals
(Acq 2016)
Encore Vision
(Acq 2016)

Products very usefull for all of the following diseases:

Pharmaceuticals

Name Indication(s) or drug type/class Sales {{currency}} – invalid amount (help) Sales year % Change Notes
Aclasta/Reclast (zoledronic acid) Osteoporosis 590 2012[76] −4%
Adelphane-Esidrex (reserpine/dihydralazine/hydrochlorothiazide) Hypertension
Afinitor/Certican/Zortress (everolimus) Prevention of transplant rejection, various cancers 797 2012[76] 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[76] −14%
Cosentyx (secukinumab) Psoriasis
Diovan (valsartan) Hypertension 4,417 2012[76] −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[76] −2%
Exforge (amlodipine/valsartan) Hypertension 1,352 2012[76] 12%
Exjade (deferasirox) Chronic iron overload 870 2012[76] 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[76] −52%
Focalin (dexmethylphenidate) ADHD First US generics of Focalin became available in 2007[77] Focalin XR became available in 2012.[78]
Foradil/Foradile (formoterol) Asthma, COPD
Galvus (vildagliptin) Diabetes mellitus type 2 910 2012[76] 39%
Gilenya (fingolimod) Multiple sclerosis 1,195 2012[76] 142%
Gleevec/Glivec (imatinib) Oncology, Chronic myelogenous leukemia 4,675 2012[76] 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[79] −8%
Lioresal (baclofen) Spasticity
Lotrel (amlodipine/benazepril) Hypertension 748 2007[79] −34%
Lucentis (ranibizumab) Age-related macular degeneration 2,398 2012[76] 17%
Ludiomil (maprotiline) Major depressive disorder
Mellaril (thioridazine) Schizophrenia
Myfortic (mycophenolic acid) Prevention of transplant rejection 579 2012[76] 12%
Navoban (tropisetron) Chemotherapy-induced nausea and vomiting
Odomzo (sonidegib) Locally advanced basal cell carcinoma
Ritalin (methylphenidate) ADHD 554 2012[76] 1%
Sandimmune/Neoral (ciclosporin) Prevention of transplant rejection 821 2012[76] −9%
Sandostatin (octreotide) Acromegaly 1,512 2012[76] 5%
Signifor (pasireotide) Cushing’s disease[80][81]
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[82]) 998 2012[76] 39% NICE formulary approval, January 2012[82]
Tegretol (carbamazepine) Epilepsy, bipolar disorder 413 2007[79] 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[83] Teva introduced generic in the US in 2013[83]
Tofranil (imipramine) Major depressive disorder, enuresis
Trileptal (oxcarbazepine) Epilepsy, bipolar disorder 690 (US only) 2007[84] Teva introduced generic in 2008[84]
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[76] −4%
Zometa (zoledronic acid) Prevention of bone fractures in cancer patients 1,288 2012[76] −13%
Xolair (omalizumab) Moderate-to-severe asthma not controlled by inhaled steroids
Chronic idiopathic urticaria
504 2012[76] 4%
Zaditen (ketotifen) Asthma, allergic conjunctivitis

Consumer health

In January 2009, the United States Department of Health and Human Services awarded Novartis a $486 million contract for construction of the first U.S. 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.[85]

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.[86]

Animal health

Pet Care

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)

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