Healthcare Industry News:  Helsinn Healthcare 

Biopharmaceuticals

 News Release - May 7, 2007

MGI PHARMA and HELSINN Announce Submission of Supplemental New Drug Application for Aloxi(R) Injection in Post-Operative Nausea and Vomiting

MINNEAPOLIS & LUGANO, Switzerland--(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 that a supplemental New Drug Application (sNDA) for AloxiŽ (palonosetron hydrochloride) Injection for the prevention of post-operative nausea and vomiting (PONV) has been submitted to the U.S. Food and Drug Administration (FDA). 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.

"PONV affects approximately one-third of patients who undergo surgery, and can lead to increased health care costs resulting from delayed discharge from hospitals or ambulatory surgical centers, and hospital re-admissions. Studies have demonstrated an ongoing need for effective long-term agents that can improve the control of both nausea and vomiting post-surgery," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. "The unique pharmacodynamic profile and extended duration of activity of Aloxi may prevent PONV for up to three days with a single dose. We believe this submission is an important step in maximizing the potential of Aloxi."

"The achievement of today's milestone is a testament of the hard work and dedication of Helsinn Healthcare to explore new uses for Aloxi," said Riccardo Braglia, Chief Executive Officer of HELSINN. "We look forward to bringing Aloxi for PONV to the medical community and their patients."

This sNDA submission is based on results from two randomized, multi-center, phase 3 trials conducted to evaluate the safety and efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. In these two trials, a total of 1,219 patients undergoing elective outpatient abdominal or gynecological laparoscopic surgery (Study PALO-04-06) or elective inpatient gynecological or breast surgery (Study PALO-04-07) were randomized to receive one of three single intravenous doses of Aloxi or placebo prior to administration of anesthesia. Both clinical trials successfully met the primary efficacy endpoint of complete response, defined as no emesis or use of rescue medication, for the 0-24 hour time period following surgery for the selected dose of 0.075 mg. In addition, both trials achieved the secondary endpoints of complete response for the 0-48 and 0-72 hour time periods. The incidence, pattern, and intensity of adverse events were similar among all treatment groups including placebo, and the most frequently observed side effects were headache and constipation.

About Post-Operative Nausea and Vomiting (PONV)

Post-operative nausea and vomiting, or PONV, is a common consequence affecting more than one-third of patients undergoing anesthetic care and surgical procedures. In the United States, approximately 30 million doses of 5-HT3 receptor antagonists are used annually for the management of PONV. The primary factors that can increase the risk for PONV include female gender, non-smoking status, prior history of PONV or motion sickness, length of surgery and the use of volatile anesthetics and opioids. If not prevented, PONV can result in delayed discharge from the post-anesthesia care unit (PACU) or ambulatory surgical center facility, hospital re-admissions and increased healthcare costs.

About AloxiŽ (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 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 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's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; ability of MGI PHARMA to successfully complete the integration of Guilford with its existing operations; the risk that the perceived advantages of the Guilford transaction may not be achieved; 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-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements.


Source: MGI PHARMA

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