Sanofi

Sanofi S.A.
Société Anonyme
Traded as Euronext: SAN, NYSE: SNY
Industry Pharmaceuticals
Founded 20 August 2004 (by acquisition) as Sanofi Aventis
6 May 2011 as Sanofi
Headquarters 82, Avenue Raspail, Gentilly, France
Key people
 Olivier Brandicourt (CEO, 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 €33.77 billion (2014)[1]
€6.14 billion (2014)[1]
Profit €4.39 billion (2014)[1]
Total assets €96.07 billion (2013)[2]
Total equity €56.89 billion (2013)[2]
Number of employees
 112,128 (2013)[2]
Subsidiaries Sanofi Pasteur
Genzyme
Shantha Biotechnics
Chattem
Zentiva
Medley
Nichi-Iko
Merial
Website www.sanofi.com

Sanofi S.A. is a French multinational pharmaceutical company headquartered in Gentilly, France, as of 2013 the world's fifth-largest by prescription sales.[3] 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. The company is a component of the Euro Stoxx 50 stock market index.[4]

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 seven 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).[5]

History

Sanofi-Synthélabo

Sanofi was founded in 1973[6] as subsidiary of Elf Aquitaine (a French oil company subsequently acquired by Total), when Elf Aquitaine took control of the Labaz group, a pharmaceutical company. In 1993 Sanofi made a move into the Eastern Europe market by acquiring a controlling interest in Chinoin, a Hungarian drug company that had about US$104 million in sales in 1992.[7][8] In that same year, Sanofi's made its first significant venture into the U.S., and strengthened its presence in Eastern Europe, by first partnering with Sterling Winthrop and then acquiring the prescription pharmaceuticals business n 1994.[7][9] Sanofi was incorporated under the laws of France in 1994 as a société anonyme, a form of limited liability company.[10]: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.[10]:19 In 1991, Synthelabo acquired Laboratories Delalande.[11]

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.[10]: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.[10]:19

Aventis

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 Cassella, Roussel Uclaf and Marion Merrell Dow. The merged company was based in Schiltigheim, near Strasbourg, France.[12]:13[13]:9–11[14]: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.[13]: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).[13]:9 Merieux has been in the business of selling blood products, and In the 1980s during the AIDS epidemic, Merieux and other companies were involved in scandals related to HIV-contaminated haemophilia blood products that were sold to developing nations.[15]

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 $250M investment in Millennium and would pay $200M to Millennium in research fees over five years, one of the largest such deals between a big pharmaceutical company and a biotech company at the time.[16]

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.[17] 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.[18]

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.[19] 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;[20] after several setbacks in clinical trials,[21] Regeneron and Sanofi got the drug approved in metastatic colorectal cancer in combination with other agents, under the brand name ZALTRAP in 2012.[22]

Merger: Sanofi-Aventis

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.[23] 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[24] and by rejecting Aventis' poison pill proposal.[25] 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.[26]

Sanofi-Aventis activities

In 2006, Iraqis infected with HIV sued Sanofi and Baxter due to HIV-contaminated haemophilia blood products sold by Merieux in the 1980s.[27]

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,[28] the case became complicated when settlement negotiations fell apart twice - the second time due to 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.[29] 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,[30] which it paid in full by February 2012.[31] 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.[32]

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.[33] In 2009 the companies expanded the deal to $160 million per year and extended it through 2017.[33][34] 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.[34]

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.[35][36][37] The dealmaking continued beyond 2010, and included:

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.[44]

Acquisition history

The following is an illustration of the company's major mergers, acquisitions and historical predecessors:

Sanofi






Sanofi–Aventis
Aventis
(Merged 2004)


Rhône-Poulenc
(Merged 1999)

Rorer

Centeon

Pasteur Merieux

Rhône-Poulenc Agro

Rhône-Poulenc Animal Nutrition

Merial

Rhodia
Hoechst Marion Roussel

Hoechst Marion Roussel

AgrEvo

HR Vet

Dade Behring

Centeon

Celanese

Messer

Aventis Cropscience
(Spun off 2000)




Sanofi-Synthélabo
(Merged 1999)
Sanofi


Sanofi
(Founded 1973 as subsidiary of Elf Aquitaine)

Sterling Winthrop
(Acq 1994)
Synthélabo

Laboratoires Dausse
(Founded 1834, merged 1970)

Robert & Carrière
(Founded 1899, merged 1970)

Zentiva
(Acq 2008)

Sicomed SA Bucharest
(Acq 2005)

Leciva Slovakofarma
(Acq 2003)

Medley Farma
(Acq 2009)

Shantha Biotechnics
(Acq 2009)

Chattem
(Acq 2010)

Nepentes Pharma
(Acq 2010)

BMP Sunstone Corporation
(Acq 2010)

Genzyme Corporation
(Acq 2011)




Rename to Sanofi and beyond

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.[45]

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.[46]

In January 2014, Genzyme 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,[47] and obtained rights to other compounds in Alnylam's pipeline.[48]

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.[49]

In October 2014, Sanofi's directors fired US-resident chief executive Chris Viehbacher, blaming his alleged lack of communication with the board and poor execution of his strategy.[50] Board chairperson Serge Weinberg took over as interim CEO until 2 April 2015 when Bayer Healthcare board chairperson Olivier Brandicourt (appointed by Sanofi on 19 February 2015[51]) took over. Before Brandicourt even started his new job, French government ministers Stéphane Le Foll and Ségolène Royal attacked the $4.5 million golden handshake he was getting from Sanofi - and his pay of about $4.7 million a year.[52]

In July 2015, Genzyme announced it would acquire the rare cancer drug Caprelsa (vandetanib) from AstraZeneca for up to $300 million.[53] In the same month In July 2015, the company announced a new global collaboration with Regeneron to discover, develop, and commercialise new immuno-oncology drugs, which could generate more than $2 billion for Regeneron,[54] with $640 million upfront, $750 million for proof of concept data and $650 million from the development of REGN2810.[55]

Products

Prescription medications

Autoimmune

Product Recall and Effects: The Epinephrine auto-injection devices made by Sanofi SA currently on the market in the U.S. and Canada were voluntarily recalled on October 28, 2015.[59][60] The reason stated by Sanofi was that the products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug. [61][62]

Sanofi US also added the following warning: If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition.[63]

In its news Release on October 28, 2015, Sanofi Canada stated that it was "actively working with suppliers of alternative epinephrine auto-injectors to have a full stock available in Canada as soon as possible. Canadian customers were asked to immediately return the Allerject product to their local pharmacy to obtain an alternate epinephrine auto-injector."[64]

The U.S. Food and Drug Administration also filed a news release[65] confirming that the recall involves all Auvi-Q currently on the market in the U.S. The FDA release went on to provide information for consumers re: exchanging the device for another brand of product, also provided on the Auivi-Q web site. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new, alternate epinephrine auto-injectors with proof of purchase.

The alternate products expected to most commonly replace the recalled Sanofi devices are the EpiPens made by Mylan in the US and by Pfizer -- under license from Mylan -- in Canada.[66] Mylan already had an 85% market share of the auto-injectors in the US[67] in the first half of 2015. Maylan is expected to benefit from the recall by its competitor Sanofi, according to a report published in the Fierce Pharma newsletter of November 2, 2015: ".... it is very hard to see Auvi-Q returning to the market, as it will need to be redesigned and face uphill battle to recapture patient trust after the recall," Bernstein analyst Ronny Gal wrote in a note to clients on Monday.[68] Gal also believes that the company will eventually have 95% of the Epinephrine auto-injector market, according to another Fierce Pharma report on November 3, 2015.[69]

Cardiovascular

Infectious disease

Metabolic

Neurology

Oncology

Pain

Diabetes

Over the counter

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

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.[74] Sanofi's drug was discovered by Regeneron and is called alirocumab.[75] 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.[76]

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.[77]

Management

Stockholders

As of 31 December 2013:[2]:185

Head office

Head office 54 rue de la Boétie, Paris 8th around.
Former head office 174 avenue de France, Paris 13th around.

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.[80] In June 2015, the seat was moved to Gentilly, just south of Paris.

Collaborative research

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 project[81][82] The company is expanding its activities in joint research projects within the framework of the Innovative Medicines Initiative of EFPIA and the European Commission.[83]

In June 2010, Sanofi and the Charite University of Berlin signed a cooperation agreement for the research and development of medicines and therapies.[84]

On 25 October 2012, Sanofi said its earnings for the third quarter slumped as generic competitors ate into profits of its Eloxatin cancer treatment.[85]

Sanofi Pasteur

Main article: Sanofi Pasteur

In 2005 Sanofi pasteur, vaccines division of Sanofi Group, was awarded a $97 Million HHS contract in 2005.[86]

BCG supply shortage 2012-

In the fall of 2011 the Sanofi Pasteur plant flooded causing problems with mold.[87] The facility, located in Toronto, Ontario, Canada, produced BCG vaccine products, made with the Glaxo 1077 strain,[88] such as a tuberculosis vaccine ImmuCYST, a BCG Immunotherapeutic -a bladder cancer drug. By April 2012 the FDA had found dozens of documented problems with sterility at the plant including mold, nesting birds and rusted electrical conduits.[87] The resulting closure of the plant for over two years resulting in shortages of bladder cancer and tuberculosis vaccines.[89] The Toronto Sanofi plant [90] On October 29, 2014 Health Canada gave the permission for Sanofi to resume production of BCG.[91]

Associations

Sanofi is a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA),[92] Biotechnology Industry Organization (BIO),[93] and Pharmaceutical Research and Manufacturers of America (PhRMA).[94]

Sanofi's vaccine subsidiary, Sanofi Pasteur, is a member of EuropaBio.[95]

Aventis Foundation

The Aventis Foundation,[96] 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

Notes

  1. ↑ Total reduced its stake to less than 5% in 2011.[79]

References

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  2. 1 2 3 4 "Annual Report 2013" (PDF). Sanofi-Aventis. Retrieved 13 April 2014.
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  47. ↑ Alnylam, TTR Amyloidosis (FAP)
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  87. 1 2 "April 2012 Inspectional Observations (form 483)", U.S. Food and Drug Administration, Vaccines, Blood & Biologics, 12 April 2012, retrieved 29 January 2016
  88. ↑ Fine, P.E.M (2004). Issues relating to the use of BCG in immunization programmes: A discussion document, WHO/V&B/99.23 (PDF). Geneva: WHO.
  89. ↑ Palmer, Eric (10 September 2014), "Merck again shipping BCG cancer treatment but Sanofi still is not: Shortages of bladder cancer and tuberculosis treatment have persisted for two years", FiercePharma
  90. ↑ Palmer, Eric (12 July 2012), "Merck again shipping BCG cancer treatment but Sanofi still is not: Shortages of bladder cancer and tuberculosis treatment have persisted for two years", FiercePharma
  91. ↑ Palmer, Eric (31 March 2015), "Sanofi Canada vax plant again producing ImmuCyst bladder cancer drug", FiercePharma, retrieved 29 January 2016
  92. ↑ "The Pharmaceutical Industry in Figures - 2008 Edition". European Federation of Pharmaceutical Industries and Associations (EFPIA). p. 49. Retrieved 2008-08-25.
  93. ↑ BIO member list Accessed 19 April 2014
  94. ↑ PhRMA member list Accessed 19 April 2014
  95. ↑ EuropaBio member list Accessed 19 April 2014
  96. ↑ Home. Aventis Foundation (2013-11-27). Retrieved on 2013-12-23.

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