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Last updated on April 16, 2014 at 17:34 EDT

FDA Approves ALOXI(R) (Palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-Induced Nausea and Vomiting

August 23, 2008

WOODCLIFF LAKE, N.J., Aug. 23 /PRNewswire/ — Eisai Corporation of North America and its partner Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved a new oral formulation of ALOXI(R) (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV). ALOXI Capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5 mg ALOXI Capsule is administered approximately one hour prior to the start of chemotherapy.

ALOXI (palonosetron hydrochloride) injection 0.25 mg, a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist, has been available in the United States for intravenous administration since 2003 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. A single 0.25 mg intravenous dose of ALOXI is administered approximately 30 minutes before the start of chemotherapy.

About Chemotherapy-Induced Nausea and Vomiting (CINV)

Research has shown that patients with cancer consider CINV among the most dreaded side effects following therapy. Despite prophylactic antiemetics, on the day of chemotherapy, about 30-45 percent of patients experience nausea or vomiting or require rescue therapy following administration of moderately emetogenic chemotherapy. Failure to control acute nausea and vomiting on the first day of chemotherapy will increase the risk of nausea and vomiting on subsequent days and in subsequent cycles of chemotherapy.

About ALOXI Capsules for Oral Administration

ALOXI (palonosetron HCl) Capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. One ALOXI 0.5 mg capsule is administered approximately one hour prior to the start of chemotherapy.

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components. There were no adverse reactions that occurred greater than or equal to 5 percent for the 0.5 mg oral dose. The most commonly reported adverse reactions were headache (3.7 percent) and constipation (0.6 percent).

Please see the ALOXI prescribing information, available at http://www.aloxi.com/, for important additional details.

About ALOXI Injection

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. ALOXI injection 0.075 mg is also approved as a single intravenous dose administered immediately before the induction of anesthesia for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions (incidence greater than or equal to 2 percent) in ALOXI CINV trials were headache (9 percent) and constipation (5 percent), and in PONV trials, the most commonly reported adverse reactions were QT prolongation (5 percent), bradycardia (4 percent), headache (3 percent), and constipation (2 percent).

Please see the ALOXI prescribing information, available at http://www.aloxi.com/, for important additional details.

Eisai licensed the North American distribution and marketing rights for ALOXI from Helsinn Healthcare SA.

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 http://www.helsinn.com/.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.

Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.

Eisai Corporation of North America

CONTACT: Media, Judee Shuler of Eisai Inc., +1-201-746-2241; orInvestors, Bob Laverty of Eisai Corporation of North America, +1-201-746-2265

Web site: http://www.aloxi.com/http://www.helsinn.com/