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Obesity Discussion · 06-22-06, 12:41 PM

E.U. approval of Sanofi obesity treatment paves way for U.S. nod

Last Update: 6:25 AM ET Jun 22, 2006

By Laetitia Fontaine
Of DOW JONES NEWSWIRES
PARIS (MarketWatch) -- Sanofi-Aventis' (SNY) winning approval to market its obesity treatment Acomplia in the European Union increases the chances of the potential blockbuster's acceptance in the more profitable U.S. market, according to analysts.
The European Commission on Wednesday approved the drug for sale in all 25 European member states as a 20 milligram once-daily pill to treat obesity and associated health risks such as Type 2 diabetes.
The marketing approval came after the European Medicines Agency issued a positive recommendation for the use of the drug at the end of April Acomplia, also known as Rimonabant, could contribute around EUR4 billion to Sanofi's sales by 2010, analysts estimate.
At 0937 GMT, shares of the world's third largest drugmaker by sales, were up EUR1.10 or 1.5% at EUR74.05
"The European label looks about as good as we could have hoped for in terms of both indications and contra-indications," JP Morgan analysts said in a note. The label granted by the European Commission mentions Acomplia use for type 2 diabetes and dyslipidemia, a major cardiovascular risk factor. European health authorities will potentially reimburse treatment for these conditions.
According to JP Morgan, "the fact that there were no dissenting views among the 25-member states points to the broad acceptance of Acomplia's safety and Sanofi will go on to receive U.S. approval for Acomplia in the coming months."
The U.S. Food and Drug Administration, has asked the French drugmaker to provide it with extra information on Acomplia before approving it as an obesity treatment.
Sanofi has said U.S. approval could come by the end of this year.
Acomplia has attracted widespread interest because it is focused on a highly lucrative market that has so far eluded other weight-loss drugs.
Among competitors' drugs, Roche Holding AG's (RHHBY) Xenical has been dogged by unwanted side effects, while tolerability issues have limited the uptake of Abbott Laboratories' (ABT) Meridia.
The first launch of Acomplia will take place in Britain in July and be followed by launches in Denmark, Ireland, Germany, Finland and Norway in the second half of this year, Sanofi said.

Article

06-22-06, 12:41 PM	#1 (permalink)
Obesity Discussion Administrator Join Date: Jan 2005 Location: Phoenix, AZ Posts: 7,851 Weight Statistics 8/1/2006 Start Date: 185 lb Start Weight: 152 lb Current Weight: 155 lb Goal Weight: -33 lb Weight Loss: 5/1/2007 Goal Date:	E.U. approval of Sanofi obesity treatment paves way for U.S. nod E.U. approval of Sanofi obesity treatment paves way for U.S. nod Last Update: 6:25 AM ET Jun 22, 2006 By Laetitia Fontaine Of DOW JONES NEWSWIRES PARIS (MarketWatch) -- Sanofi-Aventis' (SNY) winning approval to market its obesity treatment Acomplia in the European Union increases the chances of the potential blockbuster's acceptance in the more profitable U.S. market, according to analysts. The European Commission on Wednesday approved the drug for sale in all 25 European member states as a 20 milligram once-daily pill to treat obesity and associated health risks such as Type 2 diabetes. The marketing approval came after the European Medicines Agency issued a positive recommendation for the use of the drug at the end of April Acomplia, also known as Rimonabant, could contribute around EUR4 billion to Sanofi's sales by 2010, analysts estimate. At 0937 GMT, shares of the world's third largest drugmaker by sales, were up EUR1.10 or 1.5% at EUR74.05 "The European label looks about as good as we could have hoped for in terms of both indications and contra-indications," JP Morgan analysts said in a note. The label granted by the European Commission mentions Acomplia use for type 2 diabetes and dyslipidemia, a major cardiovascular risk factor. European health authorities will potentially reimburse treatment for these conditions. According to JP Morgan, "the fact that there were no dissenting views among the 25-member states points to the broad acceptance of Acomplia's safety and Sanofi will go on to receive U.S. approval for Acomplia in the coming months." The U.S. Food and Drug Administration, has asked the French drugmaker to provide it with extra information on Acomplia before approving it as an obesity treatment. Sanofi has said U.S. approval could come by the end of this year. Acomplia has attracted widespread interest because it is focused on a highly lucrative market that has so far eluded other weight-loss drugs. Among competitors' drugs, Roche Holding AG's (RHHBY) Xenical has been dogged by unwanted side effects, while tolerability issues have limited the uptake of Abbott Laboratories' (ABT) Meridia. The first launch of Acomplia will take place in Britain in July and be followed by launches in Denmark, Ireland, Germany, Finland and Norway in the second half of this year, Sanofi said. Article __________________