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Sanofi-Aventis And Bristol-Myers Squibb Prevail Before The U.S. Court Of Appeals For The Federal Circuit In The U.S Plavix(R) Patent Infringement Case
 
 
  Dec 12 2008 - 4:00 PST
 
Paris, France and Princeton, New Jersey - December 12, 2008. Sanofi-aventis and Bristol-Myers Squibb announced today that the U.S. Court of Appeals for the Federal Circuit has upheld the June 19, 2007 decision by the U.S. District Court for the Southern District of New York holding the U.S. patent 4,847,265 covering clopidogrel bisulphate, the active ingredient in Plavix, valid and enforceable. As a result of this ruling, the '265 patent protection for this product is maintained in the United States until November 2011.
 
Sanofi-aventis and Bristol-Myers Squibb are seeking damages from Apotex, in reparation of harm caused by that company's marketing and sale of an infringing generic version of Plavix in 2006.
 
Bristol-Myers, Biotech Firm to Develop Cancer Drugs
 
Ron Winslow Wall St Jnl
December 12, 2008
 
Bristol-Myers Squibb Co. is joining forces with biotechnology company Exelixis Inc. to develop two experimental cancer drugs in a pact that requires Bristol-Myers to pay at least $240 million.
 
The agreement, to be announced Friday, comes amid turmoil in the biotechnology industry, where the financial crisis has shut hundreds of companies out of the capital markets, depriving them of the cash needed to fully develop promising treatments for cancer and other diseases.
 
Industry trade group BIO says 180, or 45%, of the 370 publicly traded biotech companies have less than one year of cash on hand, and most have little or no revenue.
 
The partnership also reflects a growing trend among major pharmaceutical companies: turning to biotechnology to transform their research-and-development strategies and find new medicines to replace their aging lines of conventional drugs.
 
Under the agreement, Bristol-Myers will pay Exelixis $195 million now and another $45 million in 2009 to codevelop the drugs, known as XL184 and XL281. Several hundred million dollars in additional payments would follow if the drugs pass development and regulatory milestones and hit certain sales targets.
 
The $240 million upfront payment is one of the biggest amounts large pharmaceutical companies have paid in similar agreements. While many biotech assets are said to be available now at bargain-basement prices, Bristol-Myers and Exelixis officials said the agreement reflects a competitive market for compounds viewed as especially promising.
 
"We're not the only company out there looking for good assets," said Jeremy Levin, senior vice president at Bristol-Myers's strategic transaction group. "This transaction is well valued."
 
"We're not looking to buy cheap," Dr. Levin added. "We're looking to create value."
 
Like other traditional drug makers, Bristol-Myers, based in New York, is trying to transform itself into a "biopharmaceutical" company with products and expertise in the protein-based science of biotechnology as well as chemistry-based pills from its conventional drug business. In addition, the hope is that the two compounds, which are being developed to treat a variety of tumors, will bolster the company's plans to reestablish itself as a premier cancer-drug company.
 
The pact is Bristol-Myers's first major cancer transaction since it lost out to Eli Lilly & Co. in October in a bid to acquire the biotech cancer company ImClone Systems Inc. Bristol-Myers continues to comarket ImClone's blockbuster cancer drug Erbitux in the U.S. and gets 61% of the drug's U.S. sales.
 
The transaction comes just a month after Exelixis, based in South San Francisco, Calif., laid off 78 people, or about 10% of its work force, to conserve cash and focus development on its most promising prospects.
 
Exelixis wasn't required to give Bristol-Myers an equity stake at a time its stock price is so low, said George A. Scangos, its president and chief executive. "We bring in a substantial amount of cash and...a very good partner."
 
XL184 and XL281 are among 16 compounds, including seven being developed under other partnerships, that Exelixis has developed since it was founded in 1994. None has yet been approved for marketing, and just one -- XL184 -- has reached Phase III, or late-stage, human testing.
 
Testing for XL184 is most advanced for thyroid cancer, but it is also in human studies for a brain cancer known as glioblastoma and for lung cancer. XL281 is in early-stage testing for several solid tumors.
 
Bristol-Myers and Exelixis previously announced partnerships involving three other compounds and have been working together for about a decade. The initial agreement involved a technology swap that helped Exelixis come up with compounds that the two drug makers hope to bring to market jointly, Dr. Scangos said.
 
The companies said it's too early to say how soon XL184, the more advanced compound, will reach the market if all the milestones are reached.
 
GlaxoSmithKline PLC previously had an option to license XL184 under a separate partnership agreement negotiated in 2002, but the option expired two months ago and the London-based pharmaceutical company decided against developing the compound and returned the rights to Exelixis.

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About sanofi-aventis
 
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: http://www.sanofi-aventis.com.
 
About Bristol-Myers Squibb
 
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information visit http://www.bms.com.
 
 
 
 
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