Sanofi

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Sanofi S.A.
Type Société Anonyme
Traded as EuronextSAN, NYSESNY, LSE0I42, FWBSNW
Industry Pharmaceuticals
Founded 20 August 2004 (by acquisition) as Sanofi Aventis
6 May 2011 as Sanofi
Headquarters 54, rue La Boétie, 8th arrondissement, Paris, France
Key people Chris Viehbacher (CEO), Serge Weinberg (Chairman), Jean-François Dehecq (Original Founder)
Products Prescription and over-the-counter drugs for thrombosis, cardiovascular disease, diabetes, central nervous system disorders, oncology and internal medicine, vaccines (list...)
Revenue 32.95 billion (2013)[1]
Operating income €5.11 billion (2013)[1]
Profit €3.72 billion (2013)[1]
Total assets €96.07 billion (2013)[1]
Total equity €56.89 billion (2013)[1]
Employees 112,128 (2013)[1]
Subsidiaries Sanofi Pasteur
Genzyme
Shantha Biotechnics
Chattem
Zentiva
Medley
Nichi-Iko
Merial
Website www.sanofi.com

Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, as of 2014 the world's fifth-largest by prescription sales.[2] The company was formed as Sanofi-Aventis in 2004 by the merger of Aventis and Sanofi-Synthélabo, which were each the product of several previous mergers. It changed its name to Sanofi in May 2011.

Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical drugs principally in the prescription market, but the firm also develops over-the-counter medication. The company covers 7 major therapeutic areas: cardiovascular, central nervous system, diabetes, internal medicine, oncology, thrombosis and vaccines (it is the world's largest producer of the latter through its subsidiary Sanofi Pasteur).[3]

History[edit]

Sanofi-Synthélabo[edit]

Sanofi was founded in 1973 as subsidiary of Elf Aquitaine (a French oil company that subsequently acquired by Total), when Elf Aquitaine took control of the Labaz group, a pharmaceutical company. Sanofi's first significant venture into the U.S. market was the acquisition of the prescription pharmaceuticals business of Sterling Winthrop — an affiliate of Eastman Kodak — in 1994. Sanofi was incorporated under the laws of France in 1994 as a société anonyme, a form of limited liability company.[4]:18

Synthélabo was founded in 1970 through the merger of two French pharmaceutical laboratories, Laboratoires Dausse (founded in 1834) and Laboratoires Robert & Carrière (founded in 1899). In 1973, the French cosmetics group L’Oréal acquired the majority of its share capital.[4]:19

Sanofi-Synthélabo was formed in 1999 when Sanofi merged with Synthélabo; at the time of the merger Sanofi was the second largest pharmaceutical group in France in terms of sales and Synthélabo was the third largest. The merged company was based in Paris, France.[4]:18–19

The merged companies focused on pharmaceuticals, divesting several businesses soon after the merger, including beauty, diagnostics, animal health and nutrition, custom chemicals, and two medical equipment businesses.[4]:19

Aventis[edit]

Aventis logo.png

Aventis was formed in 1999 when French company Rhône-Poulenc S.A. merged with the German corporation Hoechst Marion Roussel, which itself was formed from the 1995 merger of Hoechst AG with Roussel Uclaf and Marion Merrell Dow. The merged company was based in Schiltigheim, near Strasbourg, France.[5]:13[6]:9–11[7]:40–41

At the time of the merger, Rhône-Poulenc's business included the pharmaceutical businesses Rorer, Centeon (blood products), and Pasteur Merieux (vaccines), the plant and animal health businesses Rhône-Poulenc Agro, Rhône-Poulenc Animal Nutrition, and Merial, and a 67 percent share in Rhodia, a speciality chemicals company.[6]:10 Hoechst had seven primary businesses: Hoechst Marion Roussel (pharmaceuticals), AgrEvo (a joint venture with Schering in crop protection agents and pest control products), HR Vet (veterinary products), Dade Behring (diagnostics), Centeon, Celanese (chemicals), and Messer (chemicals).[6]:9

In mid 2000 Aventis and Millennium Pharmaceuticals, a US biotechnology company formed to discover new drugs based on the then-new science of genomics, announced that Aventis would make a $250 investment in Millennium and would pay $200M to Millennium in research fees over five years, one of the largest such deals between a big pharma company and a biotech company at the time.[8]

In late 2000, in the midst of the recall of Starlink, its genetically modified maize product, Aventis announced that it had determined to sell off Aventis Cropscience, the seed and pesticide business unit it had created from the agriculture businesses of its predecessors.[9] In October 2011, Bayer and Aventis announced that Bayer would acquire the unit for about $6.6 billion, with the unit becoming Bayer CropScience and making Bayer the world's second-largest agrochemical company behind Syngenta.[10]

In 2003 Aventis entered into a collaboration with Regeneron, a New York biotechnology company, to develop Regeneron's VEGF-inhibiting drug, aflibercept, in the field of cancer, which was then in Phase I clinical trials. Aventis invested $45 million in Regeneron and made an upfront payment of $80 million in cash.[11] Regeneron partnered the drug with Bayer Healthcare in the field of proliferative eye diseases, and under the name Eylea it was approved by the FDA in 2011;[12] after several setbacks in clinical trials,[13] Regeneron and Sanofi got the drug approved in metastatic colorectal cancer in combination with other agents, under the brand name ZALTRAP in 2012.[14]

Merger: Sanofi-Aventis[edit]

Sanofi-Aventis was formed in 2004 when Sanofi-Synthélabo acquired Aventis. In early 2004, Sanofi-Synthélabo made a hostile takeover bid worth €47.8 billion for Aventis. Initially, Aventis rejected the bid because it felt that the bid offered inferior value based on the company's share value, and the board of Aventis went so far as to enact poison pill provisions and to invite Novartis to enter merger negotiations.[15] The three-month takeover battle concluded when Sanofi-Synthélabo launched a friendly bid of €54.5 billion in place of the previously rejected hostile bid. The French government played a strong role, desiring what it called a "local solution", by putting heavy pressure on Sanofi-Synthélabo to raise its bid for Aventis and for Aventis to accept the offer[16] and by rejecting Aventis' poison pill proposal.[17] One of the largest risks in the deal for both sides, was the fate of the patents protecting Clopidogrel (Plavix) which was one of the top-selling drugs in the world at the time and the major source of Aventis' revenue.[18]

Sanofi-Aventis activities[edit]

In 2006 the US patents on clopidogrel (Plavix) were challenged when a Canadian generics company, Apotex, filed an Abbreviated New Drug Application under the Hatch-Waxman Act, received FDA approval, and started marketing a generic clopidogrel. While Sanofi-Aventis and its partner on the drug, Bristol Myers Squibb (BMS), were able to get an injunction to stop Apotex from selling the drug,[19] the case became complicated when settlement negotiations fell apart twice - the second time due an oral agreement made by BMS CEO Peter Dolan that BMS failed to disclose to the Federal Trade Commission during the review of the settlement agreement to ensure that it did not violate antitrust law. When Apotex disclosed the oral agreement to the FTC, the FTC launched an investigation that led to Dolan being fired by BMS.[20] Apotex finally lost on the patent litigation issues after its third appeal was decided in favor of BMS/Sanofi in November 2011; Apotex had to pay ~$442 million in damages and ~$108 million in interest for infringing the patent,[21] which it paid in full by February 2012.[22] Apotex also sued BMS and Sanofi for $3.4 billion for allegedly breaching the settlement agreement, and Apotex lost a jury trial in March 2013.[23]

In 2007 Sanofi-Aventis expanded on Aventis' prior relationship with Regeneron; in the new deal Sanofi-Aventis agreed to pay Regeneron $100 million each year for five years, under which Regeneron would use its monoclonal antibody discovery platform to create new biopharmaceuticals, which Sanofi-Aventis gained the exclusive right to co-develop.[24] In 2009 the companies expanded the deal to $160 million per year and extended it through 2017.[24][25] As of 2009 the collaboration had four antibodies in clinical development and had filed an IND for a fifth. Two were against undisclosed targets, one targeted the interleukin-6 receptor as a treatment for rheumatoid arthritis, another targeted nerve growth factor for the treatment of pain, and another targeted delta-like ligand 4 as a treatment of cancer.[25]

Between 2008, when Chris Viebacher was hired as CEO, and 2010, the company spent more than $17 billion in mergers and acquisitions to strengthen its consumer healthcare and generics platforms especially in emerging markets, in the face of looming patent cliffs and the growth of the consumer healthcare segment.[26][27][28] The dealmaking continued beyond 2010, and included:

  • In 2008, for about €1.8 billion, the Prague-based branded generics group Zentiva, which focused on eastern European markets[29]
  • In 2009, for about $635 million, Medley Farma, the third largest pharmaceutical company in Brazil and a leading generics company in that country;[30] Sanofi outbid Teva Pharmaceuticals.[31] The deal was approved by Brazil's antitrust authorities in May 2010.[30]
  • In 2010, for around $1.9 billion, Chattem, Inc., a U.S. consumer healthcare company with products such as Selsun Blue dandruff shampoo, Cortizone-10, Gold Bond skin care products and Icy Hot pain medicine.[28]
  • In 2010, for around $130 million, Nepentes Pharma, a Polish dermocosmetics company.
  • In 2010, for around $520.6 million in cash, BMP Sunstone Corporation a leading Chinese pharmaceutical company focused on consumer health-care products (e.g., maker of China's Hao Wa Wa, China’s top pediatric cold brand).[32]
  • In 2011, for around $20.1 billion, Genzyme Corporation, a biotechnology company headquartered in Cambridge, Massachusetts and specialized in the treatment of orphan diseases, renal diseases, endocrinology, oncology and biosurgery.[33]

In October 2009 Sanofi-Aventis announced that it would lay off about 1,700 US employees (about 25% of its US workforce) due to restructuring triggered by growing generic competition and other factors, and that the company would focus its US operations on diabetes, atrial fibrillation and oncology.[34]

Rename to Sanofi and beyond[edit]

The company dropped the -Aventis suffix of its name on 6 May 2011 after receiving approval at its annual general meeting. The reason given by the company for the change was to make its name easier to pronounce in countries such as China.[35]

In January 2012, Sanofi co-invested in the $125 million Series A financing of Warp Drive Bio. Sanofi sought support for its internal cancer research program and also took on an obligation to acquire Warp Drive if certain milestones were met.[36]

In January 2014, Genyzme and Alnylam Pharmaceuticals, a US biotechnology company developing RNAi therapeutics, announced that Genyzme would invest $700 million in Alnylam. Under the deal, Genzyme obtained further rights to patisiran, an RNAi treatment for transthyretin-mediated amyloidosis - a condition that can result in familial amyloidotic polyneuropathy and familial amyloidotic cardiomyopathy,[37] and obtained rights to other compounds in Alnylam's pipeline.[38]

In March 2014 Sanofi joined the bidding for Merck & Co.’s over-the-counter health-products unit, the maker of Coppertone sunblock and Claritin allergy medicine; bids were expected to range between $10 billion and $12 billion.[39]

Contaminated products and legal issues[edit]

In 1984 and 1985, the Marion institute which is now owned by Sanofi issued factors contaminated with HIV for hemophiliacs from West Germany, Italy, Argentina, Saudi Arabia, and Iran. The latter country's Blood Transfusion Organization has so far been unsuccessful in making the company make up for the damage, despite compensations it has paid to the patients.[40]

Products[edit]

Prescription medications[edit]

Autoimmune[edit]

Cardiovascular[edit]

Infectious disease[edit]

  • Menactra for meningitis
  • antibiotics:claforan (cefotaxime)-wintriaxone (cefatriaxone)
  • Amoxicillin/clavulanic acid (amoklavin)
  • vaccines:Bacterial diseases:Cholera Diphtheria -Haemophilus influenzae type b-infections Meningococcal- Infections Pertussis Pneumococcal- Infections Tetanus -Tuberculosis Typhoid Fever
  • Viral diseases:Hepatitis A Hepatitis B Influenza Japanese Encephalitis Measles Mumps Poliomyelitis Rabies Rubella VaricellaYellow Fever And Smallpox, eradicated in 1980 (vaccine produced as a measure in response to the threat of bioterrorism)

Metabolic[edit]

Neurology[edit]

Oncology[edit]

Pain[edit]

Over the counter[edit]

The company also produces a broad range of over-the-counter products, among them Allegra, IcyHot for muscle pain, Gold Bond for skin irritation, and Selsun Blue dandruff shampoo (these brands were acquired in 2010 when Sanofi-Aventis purchased Chattem).

Pipeline[edit]

As of the summer of 2013, Sanofi was in a race with Amgen and Pfizer to win approval for a drug that inhibits PCSK9, a protein that slows the clearance of low-density lipoprotein (LDL) cholesterol - the form of cholesterol that leads to heart attacks.[47] Sanofi's drug was discovered by Regeneron and is called alirocumab.[48] An FDA warning in March 2014 about possible cognitive adverse effects of PCSK9 inhibition threw the competition into disarray, as the FDA asked companies to include neurocognitive testing into their Phase III clinical trials.[49]

In fall 2013 Sanofi announced that another candidate from its collaboration with Regeneron, the monoclonal antibody against the interleukin 6 receptor, sarilumab, had better efficacy than placebo in its first Phase III trial for rheumatoid arthritis.[50]

Management[edit]

Stockholders[edit]

As of December 31, 2013:[1]:185

Head office[edit]

Previous head office in Paris

In January 2012, Sanofi moved its head office location to 54, rue La Boétie in the 8th arrondissement of Paris. This former mansion designed by architect René-Patouillard had previously been the head office of Alcatel-Lucent.

Sanofi's previous head office was located in the 13th arrondissement of Paris, 174 Avenue de France. The architecture of the head office is of the predominate style of the area surrounding the François Mitterrand Library. After Sanofi and Aventis merged, the employees at the former Aventis head office in Schiltigheim, Alsace moved to Paris.[53]

Collaborative research[edit]

In addition to internal research and development activities Sanofi 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.[54][55] The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission.[56]

In June 2010, Sanofi and the Charite University of Berlin signed a cooperation agreement for the research and development of medicines and therapies.[57]

On 25 October Sanofi said its earnings for the third quarter slumped as generic competitors ate into profits of its Eloxatin cancer treatment.[58]

Sanofi pasteur, vaccines division of Sanofi Group, awarded $97 Million HHS contract in 2005.[59]

Associations[edit]

Sanofi is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA),[60] Biotechnology Industry Organization (BIO),[61] and Pharmaceutical Research and Manufacturers of America (PhRMA).[62]

Sanofi's vaccine subsidiary, Sanofi Pasteur, is a member of EuropaBio.[63]

Aventis Foundation[edit]

The Aventis Foundation,[64] a German charitable trust, was established in 1996 as the Hoechst Foundation with an endowment of €50 million. In 2000, the foundation was renamed the Aventis Foundation. Its aim is to promote music, theater, art, literature, higher education and healthcare research.

See also[edit]

Notes[edit]

  1. ^ Total reduced its stake to less than 5% in 2011.[52]

References[edit]

  1. ^ a b c d e f g "Annual Report 2013". Sanofi-Aventis. Retrieved 13 April 2014. 
  2. ^ Eric Palmer and Carly Helfand for FiercePharma. March 4, 2014 The top 10 pharma companies by 2013 revenue
  3. ^ "Sanofi-Aventis to sign deal to build flu vaccine plant in China - source". AFX News (Forbes). 23 November 2007. Retrieved 2009-04-19. 
  4. ^ a b c d Sanofi-Synthélabo Form 20F for the Fiscal Year ended December 31, 2002
  5. ^ Aventis Form 20-F for the fiscal year ended December 31, 2002
  6. ^ a b c Arturo Bris and Christos Cabolis, Corporate Governance Convergence Through Cross-Border Mergers The Case of Aventis, Chapter 4 in Corporate Governance and Regulatory Impact on Mergers and Acquisitions: Research and Analysis on Activity Worldwide Since 1990. Eds Greg N. Gregoriou, Luc Renneboog. Academic Press, Jul 26, 2007
  7. ^ Lawton Robert Burns The Business of Healthcare Innovation Cambridge University Press, Jul 26, 2012
  8. ^ Andrew Pollack for the New York Times. June 24, 2000 Aventis Unit Sets Big Investment in Biotechnology Start-Up
  9. ^ New York Times, November 16, 2000 Aventis to Sell Agriculture Unit
  10. ^ CNN Money. October 2, 2001 Bayer buys CropScience
  11. ^ Candace Hoffmann for First Word Pharma. September 8th, 2003 Aventis inks deal with Regeneron for collaboration on cancer therapy
  12. ^ Gever, John (November 19, 2011). "FDA Approves Eylea for Macular Degeneration". MedpageToday.com. Retrieved 2013-10-16. 
  13. ^ Ciombor KK et al. Aflibercept Clin Cancer Res. Apr 15, 2013; 19(8): 1920–1925. PMID 23444216
  14. ^ a b "Ziv-Aflibercept". FDA Drug Approvals Database. Food and Drug Administration. August 3, 2012. Retrieved 2013-10-16. 
  15. ^ Heather Timmons for the New York Times. April 3, 2004 Aventis Invites Novartis To Counter Sanofi's Bid
  16. ^ Heather Timmons for the New York Times. April 27, 2004 France Helped Broker the Aventis-Sanofi Deal
  17. ^ New York Times April 24, 2004 Aventis Plan Is Rejected
  18. ^ Kimberly S Cleaves and Ann M Thayer Warning, merge with care: Sanofi-Aventis Modern Drug Discovery, August 2004:21-26
  19. ^ BMS Press Release. December 8, 2006 Preliminary Injunction Against Apotex Upheld on Appeal
  20. ^ Aaron Smith for CNNMoney.com October 26, 2006 Bristol CEO Dolan gets fired: Company says it heeded request of a federal monitor
  21. ^ Donald Zuhn for Patent Docs. November 09, 2011 Sanofi-Aventis v. Apotex Inc. (Fed. Cir. 2011)
  22. ^ Linda a. Johnson for Associated Press February 8, 2012 Apotex pays Bristol, Sanofi damages over Plavix
  23. ^ Carolina Bolado for Law360 March 14, 2013. Bristol-Myers Escapes $3.4B Apotex Suit Over Plavix Deal
  24. ^ a b Ron Winslow for the Wall Street Journal. Nov. 10, 2009 Sanofi Expands Regeneron Deal
  25. ^ a b Genetic Engineering and Biotechnology News. Nov 11, 2009 Sanofi-Aventis Commits Over $2.8B to Regeneron in mAb Discovery Alliance
  26. ^ FierceBiotech. Sanofi-Aventis: A timeline of biopharma deals
  27. ^ Andy Tisman for IMS Health 2010 The Rising Tide of OTC in Europe
  28. ^ a b Reuters, December 21, 2009 Drug Maker Sanofi-Aventis Buys Chattem for $1.9 Billion
  29. ^ New York Times. September 22, 2008 Sanofi-Aventis to buy Czech generic drug maker
  30. ^ a b Leigh Kamping-Carder for Law360. May 20, 2010 Brazil Clears Sanofi's $635M Medley Pharma Buy
  31. ^ Gareth Macdonald for PharmaTechnologist, April 15, 2009 Sanofi beats Teva in Medley melee
  32. ^ Phil Serafino for Bloomberg News. October 28, 2010 Sanofi-Aventis to Buy BMP Sunstone to Expand in China
  33. ^ Chris V. Nicholson for the New York Times' Dealbook. February 16, 2011 Sanofi Agrees to Buy Genzyme for $20.1 Billion
  34. ^ Thomas Gryta and Mimosa Specer for the Wall Street Journal. Updated Oct. 9, 2010 Sanofi Cuts Jobs, Counters Genzyme
  35. ^ Mennella, Noelle (6 May 2011). "Sanofi changes name, pace of acquisitions to slow". Reuters. Retrieved 7 May 2011. 
  36. ^ Arlene Weintraub for Xconomy. January 10, 2012 Warp Drive Bio Launches With $125M from Third Rock, Greylock, Sanofi
  37. ^ Alnylam, TTR Amyloidosis (FAP)
  38. ^ Chad Bray for the New York Times' Dealbook. January 13, 2014 Sanofi Unit to Buy $700 Million Stake in Rare Disease Company
  39. ^ Bloomberg News [1] March 24, 2014
  40. ^ Iran not experienced enough to charge French company for contaminated blood. Yjc.ir (2013-09-17). Retrieved on 2013-12-23.
  41. ^ Katie Thomas for the New York Times. February 1, 2013 Brothers Develop New Device to Halt Allergy Attacks
  42. ^ "FDA approves new multiple sclerosis treatment Aubagio" (Press release). US FDA. Retrieved 2012-09-14. 
  43. ^ "Annual Review 2008". Sanofi-Aventis. Retrieved 2009-04-19. 
  44. ^ Lisa M. Jarvis for Chemical and Engineering News. January 14, 2008 Isis, Genzyme In Heart Drug Deal
  45. ^ Andrew Pollack for the New York Times. January 29, 2013 F.D.A. Approves Genetic Drug to Treat Rare Disease
  46. ^ "Mozobil approved for non-Hodgkin’s lymphoma and multiple myeloma" (Press release). Monthly Prescribing Reference. December 18, 2008. Retrieved January 3, 2009. 
  47. ^ Gina Kolata for the New York Times. July 9, 2013 Rare Mutation Ignites Race for Cholesterol Drug
  48. ^ Alirocumab on Regeneron's website
  49. ^ John Carroll for FierceBiotech March 7, 2014 UPDATED: Regeneron, Sanofi and Amgen shares suffer on FDA's frets about PCSK9 class
  50. ^ John Carroll for FierceBiotech November 22, 2013 Regeneron, Sanofi hit a trio of goals in first PhIII test of rheumatoid arthritis drug
  51. ^ Keller, Greg (10 September 2008). "Sanofi names Viehbacher as new CEO". USA Today. Associated Press. Retrieved 2009-04-19. 
  52. ^ MarketWatch April 29, 2011 Total CFO says firm cut Sanofi stake to under 5%
  53. ^ "Sanofi-Aventis : regroupement à Paris." Le Journal du Net. Retrieved on 28 September 2010.
  54. ^ 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:10.1007/978-1-60327-048-9_11. ISBN 978-1-58829-638-2. PMID 18449490.  edit
  55. ^ "InnoMed PredTox Member Organizations". Retrieved 2008-08-25. 
  56. ^ Innovative Medicines Initiative. "IMI Call Topics 2008". IMI-GB-018v2-24042008-CallTopics.pdf. European Commission. Retrieved 2008-08-25. [dead link]
  57. ^ Sanofi-aventis, Charite University Sign Cooperation Agreement News article from InfoGrok.
  58. ^ "Sanofi Earns Slump in Q3 as Competition Heats Up". The New York Times. 25 October 2012. 
  59. ^ "Sanofi pasteur Awarded $97 Million HHS Contract to Accelerate Cell-Culture Pandemic Influenza Vaccine Development". 4 January 2005. Retrieved 12 June 2013. 
  60. ^ "The Pharmaceutical Industry in Figures - 2008 Edition". European Federation of Pharmaceutical Industries and Associations (EFPIA). p. 49. Retrieved 2008-08-25. 
  61. ^ BIO member list Accessed April 19, 2014
  62. ^ PhRMA member list Accessed April 19, 2014
  63. ^ EuropaBio member list Accessed April 19, 2014
  64. ^ Home. Aventis Foundation (2013-11-27). Retrieved on 2013-12-23.

External links[edit]