Helsinn Healthcare and MGI PHARMA announce submission of supplemental new drug application for Aloxi® oral capsules
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Oral Formulations of 5-HT3 receptor Antagonists Represent Approximately 10% of the Day-of-Chemotherapy Market -
Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, and its partner MGI PHARMA, INC., (Nasdaq: MOGN), a biopharmaceutical company focused in oncology and acute care, today announced that a supplemental New Drug Application (sNDA) for Aloxi® (palonosetron hydrochloride) Capsules for oral administration has been submitted to the U.S. Food and Drug Administration (FDA). Aloxi Injection is approved by the FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. The sNDA submission includes results from a multicenter, double-blind, dose ranging trial in 651 patients receiving moderately emetogenic chemotherapy (MEC). Patients were stratified by gender and history of chemotherapy and were randomly assigned to receive one of three doses of oral Aloxi (0.25 mg, 0.50 mg, or 0.75 mg) or a single intravenous (IV) 0.25 mg dose of Aloxi. The primary objective of the study was to determine an oral dose which was non-inferior to the IV 0.25 mg dose of Aloxi. Endpoints of the trial included complete response (CR; no emesis, no rescue therapy) at multiple time intervals.
Overall, results of the study indicate that the 0.50 mg oral dose of Aloxi was non-inferior to the 0.25 mg IV dose at inducing a CR during both the early (0-24 hr) and delayed phases (0-48, 0-72, 0-120 hr) following administration of MEC. Specifically, CR rates for the 0.50 mg dose of oral Aloxi were 76.3% and 58.8% for the 0-24 hours and 0-120 hours time periods versus 70.4% and 59.3% for the 0.25 mg IV dose of Aloxi, respectively.
Adverse events were similar in nature and rate for the oral and IV Aloxi groups and typical for this class of drug (headache and constipation). Results from this trial were presented on September 26, 2007, at the 14th European Cancer Conference.
"Helsinn is extremely pleased with this submission as it represents an important step in broadening the Aloxi franchise", said Dr. Sergio Cantoreggi, Senior Director, Research & Development of HELSINN HEALTHCARE SA. "We believe an oral formulation of Aloxi may offer important benefits to the medical community and cancer patients".
"The submission of the sNDA for an oral formulation of Aloxi represents another key milestone in the efforts of Helsinn Healthcare and MGI to seek indications that expand the Aloxi label and accelerate the growth of the Aloxi franchise" said Mary Lynne Hedley, Executive Vice President and Chief Scientific Officer of MGI PHARMA. "We believe Aloxi's unique pharmacodynamic profile and long-lasting activity would be desirable in clinical settings where an oral formulation may be preferred"
About Aloxi® (palonosetron hydrochloride) Injection
Aloxi is approved by the U.S. FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Aloxi is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of delayed CINV caused by moderately emetogenic cancer chemotherapy. The most common adverse reactions related to Aloxi were headache (9%) and constipation (5%). Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components. Please see the Aloxi package insert, available at www.mgipharma.com and www.aloxi.com, for important additional details.
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi® (palonosetron hydrochloride) Injection, Dacogen® (decitabine) for Injection, and Gliadel® Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.
About HELSINN HEALTHCARE
Helsinn HEALTHCARE SA, a privately owned pharmaceutical group with headquarters in Switzerland, 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 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
Contact:
Helsinn Healthcare SA
Paolo Ferrari
Head of Marketing - Oncology and Supportive Care
Phone: +41/91/985'21'21
E-Mail: info-hhc@helsinn.com
MGI PHARMA
Timothy J. Smith
Phone: +1/952/406'31'00
E-Mail: IR@mgipharma.com