Sanofi: Difference between revisions

At the time of the merger, Rhône-Poulenc's business included the pharmaceutical businesses Rorer, Centeon (blood products), and [[Sanofi Pasteur|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 (company)|Rhodia]], a speciality chemicals company.<ref name=Bris/>{{rp|10}}  Hoechst, one of the companies that resulted from the post-WWII split of [[IG Farben]], had seven primary businesses: Hoechst Marion Roussel (pharmaceuticals), [[AgrEvo]] (a joint venture with [[Schering AG|Schering]] in crop protection agents and pest control products), HR Vet (veterinary products), [[Dade Behring]] (diagnostics), Centeon, [[Celanese]] (chemicals), and Messer (chemicals).<ref name=Bris/>{{rp|9}} [[Institut Mérieux|Merieux]] has been in the business of selling blood products, and in the 1980s, during the [[History of HIV/AIDS#1981–1982: From GRID to AIDS|AIDS epidemic]], Merieux and other companies were involved in scandals related to HIV-[[contaminated haemophilia blood products]] that were sold to developing nations.<ref name="NYTimes1996">{{cite news |last=Meier |first=Barry |date=1996-06-11 |title=Blood, Money and AIDS: Haemophiliacs Are Split; Liability Cases Bogged Down in Disputes |work=The New York Times |url=https://www.nytimes.com/1996/06/11/business/blood-money-aids-hemophiliacs-are-split-liability-cases-bogged-down-disputes.html}}</ref>

In 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.<ref>{{cite news |last=Pollack |first=Andrew |date=24 June 2000 |title=Aventis Unit Sets Big Investment in Biotechnology Start-Up |work=The New York Times |url=https://www.nytimes.com/2000/06/24/business/international-business-aventis-unit-sets-big-investment-biotechnology-start-up.html |access-date=27 November 2019}}</ref>

In late 2000, in the midst of the [[StarLink corn recall|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.<ref>{{cite news |date=16 November 2000 |title=Aventis to Sell Agriculture Unit |work=The New York Times |agency=Bloomberg News |url=https://www.nytimes.com/2000/11/16/business/aventis-to-sell-agriculture-unit.html |access-date=27 November 2019}}</ref> In October 2001, [[Bayer]] and Aventis announced that Bayer would acquire the unit for about $6.6 billion; the unit became [[Bayer CropScience]], making Bayer the world's second-largest agrochemical company behind [[Syngenta]].<ref>CNN Money.  2 October 2001 [http://cnnfn.cnn.com/2001/10/02/europe/bayer/ Bayer buys CropScience]</ref>

Sanofi-Aventis was formed in 2004, when Sanofi-Synthélabo acquired Aventis. In early 2004, Sanofi-Synthélabo made a [[Takeover|hostile takeover]] bid for Aventis worth €47.8 billion. 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 [[Shareholder rights plan|poison pill]] provisions and to invite [[Novartis]] to enter merger negotiations.<ref>{{cite news |last=Timmons |first=Heather |date=3 April 2004 |title=Aventis Invites Novartis To Counter Sanofi's Bid |work=The New York Times |url=https://www.nytimes.com/2004/04/03/business/international-business-aventis-invites-novartis-to-counter-sanofi-s-bid.html |access-date=27 November 2019}}</ref> 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<ref>{{cite news |last=Timmons |first=Heather |date=27 April 2004 |title=France Helped Broker the Aventis-Sanofi Deal |work=The New York Times |url=https://www.nytimes.com/2004/04/27/business/france-helped-broker-the-aventis-sanofi-deal.html |access-date=27 November 2019}}</ref> and by rejecting Aventis's poison pill proposal.<ref>{{cite news |date=24 April 2004 |title=Aventis Plan Is Rejected |work=The New York Times |agency=Bloomberg News |url=https://www.nytimes.com/2004/04/24/business/aventis-plan-is-rejected.html |access-date=27 November 2019}}</ref> 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 Sanofi's revenue.<ref>Kimberly S Cleaves and Ann M Thayer [http://pubs.acs.org/subscribe/archive/mdd/v07/i08/pdf/804business2.pdf Warning, merge with care: Sanofi-Aventis] Modern Drug Discovery, August 2004:21-26</ref>

In 2006, Iraqis infected with HIV sued Sanofi and Baxter over HIV-[[contaminated haemophilia blood products]] sold by Merieux in the 1980s.<ref>{{cite news |last=Zielbauer |first=Paul von |date=4 September 2006 |title=Iraqis Infected by H.I.V.-Tainted Blood Try New Tool: A Lawsuit |work=The New York Times |url=https://www.nytimes.com/2006/09/04/world/middleeast/04aids.html |access-date=27 November 2019}}</ref> 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 formulation of clopidogrel. While Sanofi-Aventis and its partner in the drug, [[Bristol Myers Squibb]] (BMS), were able to get an injunction to stop Apotex from selling it,<ref>BMS Press Release. 8 December 2006 [http://www.prnewswire.com/news-releases/preliminary-injunction-against-apotex-upheld-on-appeal-56053592.html Preliminary Injunction Against Apotex Upheld on Appeal]</ref> the case became complicated when settlement negotiations fell apart twice – the second time because of 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's dismissal by BMS.<ref>Aaron Smith for CNNMoney.com 26 October 2006 [https://money.cnn.com/2006/09/12/news/companies/bristol/index.htm?postversion=2006091217 Bristol CEO Dolan gets fired: Company says it heeded request of a federal monitor]</ref> 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,<ref>Donald Zuhn for Patent Docs. 9 November 2011 [http://www.patentdocs.org/2011/11/sanofi-aventis-v-apotex-inc-fed-cir-2011.html Sanofi-Aventis v. Apotex Inc. (Fed. Cir. 2011)]</ref> which it paid in full by February 2012.<ref>Linda a. Johnson for Associated Press 8 February 2012 [https://finance.yahoo.com/news/Apotex-pays-Bristol-Sanofi-apf-2142059502.html Apotex pays Bristol, Sanofi damages over Plavix] {{webarchive|url=https://web.archive.org/web/20160305060611/http://finance.yahoo.com/news/Apotex-pays-Bristol-Sanofi-apf-2142059502.html |date=5 March 2016 }}</ref> Apotex also sued BMS and Sanofi for $3.4 billion for allegedly breaching the settlement agreement; Apotex lost a jury trial in March 2013.<ref>Carolina Bolado for Law360 14 March 2013. [http://www.law360.com/articles/423792/bristol-myers-escapes-3-4b-apotex-suit-over-plavix-deal Bristol-Myers Escapes $3.4B Apotex Suit Over Plavix Deal]</ref>

Between 2008, when [[Chris Viehbacher]] 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 cliff]]s and the growth of the consumer healthcare segment.<ref>FierceBiotech. [http://www.fiercebiotech.com/special-reports/sanofi-aventis-timeline-biopharma-deals Sanofi-Aventis: A timeline of biopharma deals]</ref><ref>Andy Tisman for IMS Health 2010 [http://www.imshealth.com/deployedfiles/ims/Global/Content/Solutions/Healthcare%20Measurement/Consumer%20Health%20Insights/The_Rising_Tide_Of_OTC_Europe.pdf The Rising Tide of OTC in Europe]</ref><ref name=Chattem/> In September, [[Zentiva]] was acquired for €1.8 billion, expanding the group's presence in eastern European markets.<ref>{{cite news |date=22 September 2008 |title=Sanofi-Aventis to buy Czech generic drug maker |work=The New York Times |url=https://www.nytimes.com/2008/09/22/business/worldbusiness/22iht-drug.4.16376740.html |access-date=27 November 2019}}</ref>

In 2010, US consumer healthcare company [[Chattem|Chattem, Inc.]] was acquired for around $1.9 billion.<ref name="Chattem">{{cite news |date=21 December 2009 |title=Drug Maker Sanofi-Aventis Buys Chattem for $1.9 Billion |work=The New York Times |agency=Reuters|url=https://www.nytimes.com/2009/12/22/business/global/22drug.html |access-date=27 November 2019}}</ref> In the same year, Nepentes Pharma was acquired for $130 million and BMP Sunstone Corporation for $520.6 million.<ref>Phil Serafino for Bloomberg News. 28 October 2010 [https://www.bloomberg.com/news/2010-10-28/sanofi-aventis-to-buy-bmp-sunstone-for-520-6-million.html Sanofi-Aventis to Buy BMP Sunstone to Expand in China]</ref>

In 2011, [[Genzyme Corporation]] was acquired for around $20.1 billion. This biotechnology company, headquartered in Cambridge, Massachusetts, specializes in the treatment of [[orphan diseases]], renal diseases, endocrinology, oncology, and biosurgery.<ref>{{cite news |last=Nicholson |first=Chris V. |date=16 February 2011 |title=Sanofi Agrees to Buy Genzyme for $20.1 Billion |work=The New York Times |url=https://dealbook.nytimes.com/2011/02/16/sanofi-agrees-to-buy-genzyme-for-at-least-20-1-billion/ |access-date=27 November 2019}}</ref>

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<ref>{{Cite web |title=TTR Amyloidosis (FAP) |url=http://www.alnylam.com/product-pipeline/ttr-amyloidosis-fap/ |publisher=Alnylam Pharmaceuticals |access-date=13 April 2014 |archive-date=14 April 2014 |archive-url=https://web.archive.org/web/20140414172941/http://www.alnylam.com/product-pipeline/ttr-amyloidosis-fap/ |url-status=dead }}</ref> and obtained rights to other compounds in Alnylam's pipeline.<ref>{{cite news |last=Bray |first=Chad |date=13 January 2014 |title=Sanofi Unit to Buy $700 Million Stake in Rare Disease Company |work=The New York Times |url=https://dealbook.nytimes.com/2014/01/13/sanofi-unit-to-buy-700-million-stake-in-rare-disease-company/ |access-date=27 November 2019}}</ref>

* [[Auvi-Q]] ([[Epinephrine autoinjector]]), licensed from Intelliject<ref>{{Cite web |title=kaléo |url=http://www.kaleopharma.com/intelliject-inc-receives-fda-approval-for-auvi-qtm-epinephrine-injection-usp/ |website=kaléo}}</ref> and approved by the FDA in 2012, for emergency treatment of life-threatening [[allergic reactions]].<ref>{{cite news |last=Thomas |first=Katie |date=1 February 2013 |title=Brothers Develop New Device to Halt Allergy Attacks |work=The New York Times |url=https://www.nytimes.com/2013/02/02/business/auvi-q-challenges-epipen-with-a-new-shape-and-size.html |access-date=27 November 2019}}</ref>

* [[Kynamro]] ([[Mipomersen]]), an [[antisense drug]] invented by [[Isis Pharmaceuticals]] and acquired by Genzyme in 2008, (pre-Sanofi)<ref>Lisa M. Jarvis for Chemical and Engineering News. 14 January 2008 [http://cen.acs.org/articles/86/i2/Isis-Genzyme-Heart-Drug-Deal.html Isis, Genzyme In Heart Drug Deal]</ref> and approved by the FDA in 2013, for the [[orphan disease]] [[Familial hypercholesterolemia|homozygous familial hypercholesterolemia]].<ref>{{cite news |date=29 January 2013 |title=F.D.A. Approves Genetic Drug to Treat Rare Disease |work=The New York Times |url=https://www.nytimes.com/2013/01/30/business/fda-approves-genetic-drug-to-treat-rare-disease.html |access-date=27 November 2019}}</ref>

{{As of|2013}}, Sanofi was in a race with [[Amgen]] and [[Pfizer]] to win approval for a [[PCSK9 inhibitor|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.<ref>{{cite news |last=Kolata |first=Gina |date=9 July 2013 |title=Rare Mutation Ignites Race for Cholesterol Drug |work=The New York Times |url=https://www.nytimes.com/2013/07/10/health/rare-mutation-prompts-race-for-cholesterol-drug.html |access-date=27 November 2019}}</ref> Sanofi's drug, a [[monoclonal antibody]], was discovered by [[Regeneron Pharmaceuticals]] and is called [[alirocumab]].<ref>{{Cite web |title=Alirocumab on Regeneron's website |url=http://www.regeneron.com/regn727 |url-status=dead |archive-url=https://web.archive.org/web/20120416102019/http://www.regeneron.com/regn727 |archive-date=16 April 2012 |access-date=11 December 2020}}</ref> 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]].<ref>John Carroll for FierceBiotech 7 March 2014 [http://www.fiercebiotech.com/story/regeneron-sanofi-and-amgen-shares-suffer-fdas-frets-about-pcsk9-drug/2014-03-07 UPDATED: Regeneron, Sanofi and Amgen shares suffer on FDA's frets about PCSK9 class]</ref>