Sanofi: Difference between revisions

In 2006, Iraqis infected with HIV sued Sanofi and Baxter due to HIV-[[contaminated haemophilia blood products]] sold by Merieux in the 1980s.<ref>Paul von Zielbauer for the New York Times. 4 September 2006 [https://www.nytimes.com/2006/09/04/world/middleeast/04aids.html?pagewanted=all&_r=0 Iraqis Infected by H.I.V.-Tainted Blood Try New Tool: A Lawsuit]</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 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,<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 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.<ref>Aaron Smith for CNNMoney.com 26 October 2006 [http://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, and 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>

In the fall of 2011 the Sanofi Pasteur plant flooded causing problems with mold.<ref name="FDA_2012">{{citation |url=http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm310376.htm |series=Vaccines, Blood & Biologics |title=April 2012 Inspectional Observations (form 483) |work=U.S. Food and Drug Administration |date=12 April 2012 |accessdate=29 January 2016}}</ref> The facility, located in Toronto, Ontario, Canada, produced [[BCG vaccine]] products, made with the Glaxo 1077 strain,<ref name="WHO_2004">{{cite book | author=Fine, P.E.M | title=Issues relating to the use of BCG in immunization programmes: A discussion document, WHO/V&B/99.23 | publisher=[[World Health Organization|WHO]] | year=2004 | location=Geneva | url=http://www.who.int/vaccines-documents/DocsPDF99/www9943.pdf | deadurl=yes | archiveurl=https://web.archive.org/web/20121021215237/http://www.who.int/vaccines-documents/DocsPDF99/www9943.pdf | archivedate=21 October 2012 | df=dmy-all }}</ref> 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.<ref name="FDA_2012" /> The resulting closure of the plant for over two years resulting in shortages of bladder cancer and tuberculosis vaccines.<ref name="Sanofi_2014_BCG_vaccine">{{citation |title=Merck again shipping BCG cancer treatment but Sanofi still is not: Shortages of bladder cancer and tuberculosis treatment have persisted for two years |date=10 September 2014 |first=Eric |last=Palmer |work=FiercePharma}}</ref> The Toronto Sanofi plant<ref name="Sanofi_2012_BCG_vaccine">{{citation |title=Merck again shipping BCG cancer treatment but Sanofi still is not: Shortages of bladder cancer and tuberculosis treatment have persisted for two years |date=12 July 2012|first=Eric |last=Palmer |work=FiercePharma }}</ref> On October 29, 2014 [[Health Canada]] gave the permission for Sanofi to resume production of BCG.<ref name="FiercePharma_mar_2015">{{citation |title=Sanofi Canada vax plant again producing ImmuCyst bladder cancer drug |url=http://www.fiercepharmamanufacturing.com/story/sanofi-vaccine-plant-canada-again-producing-immucyst-bladder-drug/2015-03-31 |date=31 March 2015 |accessdate=29 January 2016 |first=Eric |last=Palmer|work=FiercePharma }}</ref>

* [https://web.archive.org/web/20130728190032/http://www.bio-itworld.com/els/01/11/12/Sanofi-inks-genomics-partnerships-in-Boston.html/ BIO IT world.com]