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Eisai nausea drug gets US additional use approval

Mon Mar 3, 2008 12:14am EST
 
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TOKYO, March 3 (Reuters) - Japan's Eisai Co Ltd (4523.T: Quote, Profile, Research, Stock Buzz), Japan's fourth-largest drug maker, said on Monday U.S. regulators had approved its nausea treatment Aloxi to be used to prevent vomiting after surgery.

Aloxi has been on the market in the United States since 2003 to treat chemotherapy-induced nausea. The drug is part of the line-up of cancer specialist MGI Pharma, which was recently acquired by Eisai.

Eisai said it expects Aloxi to produce sales of $550 million to $600 million for both indications combined in the business year starting April 2011.

In the treatment of post-surgery nausea, Aloxi will compete 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.

The marketing and distribution rights for Aloxi were licensed from Swedish firm Helsinn Healthcare.

Eisai also said it had received approval in Japan for its Vasolan tablets to be used to treat atrial fibrillation, or irregular heartbeat, in addition to coronary heart disease.

The statements follow news at the weekend that U.S. regulators have granted priority review for Eisai's Aciphex acid reflux drug to also be used in patients aged 12 to 16.

A priority review means the Food and Drug Administration (FDA) likely will decide within six months whether to approve the treatment, rather than the usual 10-month review period.

Eisai shares were down 2.4 percent at 3,690 yen in afternoon trade, outperforming a 3.5 percent decline in the Nikkei benchmark average. (Reporting by Edwina Gibbs; Editing by Mike Miller)

 

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