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UPDATE 1-Eisai nausea drug gets U.S. additional use approval

Mon Mar 3, 2008 5:48am EST
 
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By Edwina Gibbs

TOKYO, March 3 (Reuters) - Japanese drug maker Eisai Co Ltd (4523.T: Quote, Profile, Research, Stock Buzz) said on Monday U.S. regulators approved nausea treatment Aloxi to prevent vomiting after surgery -- its first approval for a drug from recently acquired cancer specialist MGI Pharma.

MGI Pharma's product line-up has taken on added importance for Japan's fourth-largest drug maker after recent drug setbacks including a Parkinson's disease medicine which failed to meet its key goal in a late-stage trial and the loss of an opportunity to win an early approval for a cancer drug.

Aloxi has been on the market in the United States since 2003 to treat chemotherapy-induced nausea and Eisai expects Aloxi to produce sales of $550 million to $600 million for both indications combined in the business year starting April 2011, up from around $230 million in calendar 2007.

Around 90 percent of those sales will come from chemotherapy-induced nausea prevention, where Aloxi currently has a 40 percent market share, as competitors' products are not being aggressively promoted.

"There is a large market opportunity for us," Lonnie Moulder, vice chairman of Eisai's North American operations, told a news conference.

Aloxi competes with GlaxoSmithKline's (GSK.L: Quote, Profile, Research, Stock Buzz) Zofran and Roche's (ROG.VX: Quote, Profile, Research, Stock Buzz) Kytril, which are now off-patent, as well as Sanofi-Aventis's (SASY.PA: Quote, Profile, Research, Stock Buzz) Anzemet.

Eisai is also seeking approval for an oral capsule formulation of the drug and the Food and Drug Administration may hand down a decision in August.  Continued...

 

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