Healthcare Industry News: Helsinn Healthcare
News Release - February 13, 2007
MGI PHARMA and HELSINN HEALTHCARE SA Announce Patent Extension for Aloxi(R) InjectionIntellectual Property Protection Extended to April 2015
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 that a five-year Hatch-Waxman patent term extension has been granted by the U.S. Patent and Trademark Office for the patent covering AloxiŽ (palonosetron hydrochloride) Injection.
Aloxi is approved by the U.S. Food and Drug Administration (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. In addition, Aloxi is being developed for the prevention of post-operative nausea and vomiting (PONV), but is not approved for this indication.
"Aloxi is a key brand franchise for MGI PHARMA, and the five additional years of exclusivity granted by the U.S. Patent and Trademark Office will ensure that we are able to maximize the value of this product to our shareholders," said Lonnie Moulder, President and CEO of MGI PHARMA. "We look forward to working with our partner Helsinn to broaden the market potential of this product through the regulatory submissions planned for 2007."
"Helsinn Healthcare is extremely pleased to have been granted this five-year patent term extension for Aloxi," stated Riccardo Braglia, CEO of HELSINN. "This recognizes the time and effort spent by Helsinn to develop and register Aloxi in the United States. As the first and only 5-HT(3) receptor antagonist for the prevention of both acute and delayed CINV, Aloxi is an important product for those patients undergoing cancer chemotherapy. We look forward to submitting supplemental New Drug Applications for Aloxi for the prevention of PONV and for an oral Aloxi capsule. "
A Notice of Final Determination has been made that U.S. Patent No. 5,202,333, titled "Tricyclic 5-HT(3) Receptor Antagonists," is eligible for patent term extension of five years. This patent was granted in April 1993 and had been originally scheduled to expire in April 2010. Following this five year term extension, the patent will now expire in April 2015.
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-HT(3) 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%). Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components. 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'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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