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FDA Approves Aloxi(R) (Palonosetron HCL) Injection for Prevention of Postoperative Nausea and Vomiting
Date:3/2/2008

utilize anti-emetic therapy for PONV. Of these 15 million procedures, 89%, or 13.4 million, use 5-HT3 receptor antagonists, such as Aloxi.

"This is an important milestone for Aloxi, given the increasing use of antiemetic prophylaxis during surgical procedures," said Riccardo Braglia, CEO, Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, holder of the Aloxi New Drug Application and partner of Eisai Corporation of North America. MGI PHARMA, INC. licensed the North American distribution and marketing rights for Aloxi from Helsinn.

About Postoperative Nausea and Vomiting (PONV)

Postoperative nausea and vomiting are common consequences of anesthetic and surgical procedures, and frequently occur following the procedures. Patients undergoing abdominal, gynecological, ear/nose/throat, or optical procedures are at highest risk for PONV. Additional factors that can increase the risk for PONV include female gender, non-smoking status, prior history of PONV or motion sickness, length of surgery, and the use of volatile anesthetics and opioids.

About Aloxi(R) Injection

In addition to the new PONV indication, Aloxi (palonosetron HCl) injection 0.25 mg is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions in Aloxi chemotherapy-induced nausea and vomiting trials include headache (9%) and constipation (5%).

Please see the Aloxi package insert, available at http://www.aloxi.com, for important additional details.

About HELSINN HEALTHCARE
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SOURCE Eisai Corporation of North America
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