Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), and its U.S. subsidiary Eisai Inc. (Headquarters: New Jersey, United States, Chairman & CEO: Hajime Shimizu) and its partner Helsinn Healthcare SA (Headquarters: Switzerland, CEO: Riccardo Braglia) announced the availability of ALOXI® (palonosetron hydrochloride) injection 0.075 mg for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. The introduction of ALOXI for PONV represents the first launch with an additional indication of an MGI PHARMA, INC. product since Eisai acquired the organization in January 2008.
Approved by the U.S. Food and Drug Administration (FDA) for PONV on February 29, 2008, ALOXI injection 0.075 mg is administered as a single I.V. dose immediately before induction of anesthesia to prevent PONV for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. ALOXI has been available in the United States since 2003, when it was approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV). A supplemental New Drug Application for ALOXI Capsules for oral administration for CINV is currently under review by the FDA.
Postoperative nausea and vomiting are common consequences of anesthesia and surgical procedures. Twenty to 30 percent of patients undergoing surgery experience PONV at some point during their recovery, and rates can approach 70 to 80 percent for patients with multiple risk factors, such as female gender, non-smoker, history of motion sickness or PONV, and use of postoperative opioids. Many patients report that the prevention of PONV is more important than the avoidance of postoperative pain.
An estimated 38 million general anesthesia procedures are performed each year in the United States (2006 figures), and 39% of these - 15 million procedures - utilize anti-emetic therapy for PONV. Of these 15 million procedures, 89%, or 13.4 million, use 5-hydroxytryptamine-3 (5-HT3
) receptor antagonists.
In addition to the new PONV indication (ALOXI injection 0.075 mg), ALOXI (palonosetron HCl) injection 0.25 mg is the first and only 5-hydroxytryptamine-3 (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.
About HELSINN HEALTHCARE SA
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and is the worldwide licensor of palonosetron. HELSINN's core business is the licensing of pharmaceuticals in therapeutic niche areas. The company's business strategy is to in-license early stage new chemical entities and complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe). HELSINN's products are eventually out-licensed to its marketing partners for distribution. The active pharmaceutical ingredients and the finished dosage forms are manufactured at HELSINN's cGMP facilities and supplied worldwide to its customers. For more information about HELSINN, please visit the company's Web site at www.helsinn.com