Healthcare Industry News:  Helsinn Healthcare 

Biopharmaceuticals FDA

 News Release - September 4, 2007

MGI PHARMA and HELSINN Announce Aloxi(R) sNDA Approval Allowing for Repeated Dosing for Cancer Patients Receiving Multiple Day Chemotherapy Regimens

Approximately Ten Percent of 5-HT3 Receptor Antagonist Doses Administered for CINV are Associated With Multi-Day Chemotherapy

MINNEAPOLIS--(HSMN NewsFeed)--MGI PHARMA, INC. (Nasdaq:MOGN ), a biopharmaceutical company focused in oncology and acute care, and its partner Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, today announced approval of a supplemental New Drug Application (sNDA) for AloxiŽ (palonosetron hydrochloride) Injection by the United States Food and Drug Administration (FDA). This sNDA includes the removal of a dosing recommendation, which limited Aloxi use to once per seven day interval, from the product's label. Data from several safety and efficacy trials that evaluated multiple day dosing of Aloxi were included in the sNDA. Aloxi 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.

Multi-day chemotherapy regimens frequently used to treat certain lung, colon and testicular cancers, and leukemias, often present a significant challenge in preventing chemotherapy induced nausea and vomiting (CINV) due to the overlap of the acute and delayed phases of CINV. The elimination of this dosing restriction from the Aloxi label removes a barrier to health care providers administering Aloxi more than once per week, which may be necessary when treating cancer with multi-day chemotherapy regimens.

"The approval of this sNDA further supports the safety profile of Aloxi and represents one of several efforts we have undertaken to expand the Aloxi franchise. At least ten percent of all 5-HT3 receptor antagonist doses administered for the prevention of CINV are associated with multi-day chemotherapy regimens," said Eric Loukas, Executive Vice President and Chief Operating Officer of MGI PHARMA. "The Aloxi post-operative nausea and vomiting sNDA is under review with a PDUFA date of March 4, 2008 and pre-launch activities are underway".

"We are glad to have achieved this label change and to be able to offer the medical community more flexible dosing for Aloxi. The data provided to the FDA underscore the safety and efficacy profile of this important cancer supportive care product," said Dr. Sergio Cantoreggi, Senior Director R&D, Helsinn Healthcare. "Our objective is to continue to enhance the Aloxi label and we look forward to the submission of the sNDA for an oral Aloxi formulation later this year."

About AloxiŽ 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 chemotherapy-induced nausea and vomiting (CINV) caused by moderately emetogenic cancer chemotherapy. The most common adverse reactions related to Aloxi were headache (9%) and constipation (5%). Please see the Aloxi package insert, available www.mgipharma.com and www.aloxi.com, for important additional details.

About Helsinn Healthcare

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.

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 AloxiŽ (palonosetron hydrochloride) Injection, DacogenŽ (decitabine) for Injection, and GliadelŽ 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 ability of MGI PHARMA to continue to increase sales of its marketed products, the successful completion of clinical trials for the Company's other product candidates, 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.


Source: MGI PHARMA

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