MGI Pharma, Inc., a biopharmaceutical company focused in oncology and acute care, and its partner Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, announced that a five-year Hatch-Waxman patent term extension has been granted by the US Patent and Trademark Office for the patent covering Aloxi (palonosetron hydrochloride) Injection.
Aloxi is approved by the US 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 US 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 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 US Patent No. 5,202,333, titled "Tricyclic 5-HT 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.
Aloxi is approved by the US 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 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.