MGI PHARMA and HELSINN Announce sNDA for Aloxi Capsules Accepted for Review by U.S. FDA
PDUFA Date of August 22, 2008 Established
MINNEAPOLIS & LUGANO, Switzerland -- Jan. 3, 2008--MGI PHARMA, a biopharmaceutical company focused in oncology and acute care, and its partner HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced that a supplemental New Drug Application (sNDA) for Aloxi(R) (palonosetron hydrochloride) Capsules for oral administration was accepted for filing by 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 for Aloxi Capsules was submitted to the FDA on October 24, 2007. The acceptance for review of the NDA represents the FDA's determination that the application is sufficiently complete to permit a substantive review of the data. The filing of the application by the FDA does not represent any opinion regarding the safety, efficacy or approvability of Aloxi Capsules for oral administration. Under PDUFA (Prescription Drug User Fee Act) III, the FDA's goal is to review and act on the NDA by August 22, 2008.
About Aloxi(R) (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-HT(3) 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 HELSINN HEALTHCARE
HELSINN is a privately owned pharmaceutical group with headquarters in Switzerland. Helsinn's core business is the licensing of pharmaceuticals in therapeutic areas (oncology, cancer supportive care, pain and inflammation, gastrointestinal). The company's business strategy is to in-license early-stage new chemical entities and to 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 worldwide consolidated network of partners for distribution. Helsinn's key products in the US are Aloxi(R) (palonosetron), distributed by MGI Pharma and Gelclair(R). The active pharmaceutical ingredients and the drug products are manufactured at Helsinn's cGMP facilities and supplied worldwide to its customers. Helsinn's chemical business focuses on the pharmaceutical chemical process development and manufacturing of advanced intermediates, Active Pharmaceutical Ingredients (APIs) and High Potency Active Ingredients (HPAIs) for both the Helsinn group and its outsourcing partners. For more information about Helsinn, please visit www.helsinn.com
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(R) (palonosetron hydrochloride) Injection, Dacogen(R) (decitabine) for Injection, and Gliadel(R) 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.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI PHARMA's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the determinations by FDA regarding the safety or efficacy of Aloxi Injection and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities and Exchange Commission including its most recently filed Form 10-K and Form 10-Q. MGI PHARMA undertakes no duty to update any of these forward-looking statements.