LUGANO, Switzerland, February 13 /PRNewswire/ -- 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 Aloxi(R) (palonosetron hydrochloride) Injection.
Helsinn's partner MGI Pharma has been commercializing Aloxi(R) in the U.S. since 2003.
Aloxi(R) 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(R) is being developed for the prevention of post-operative nausea and vomiting (PONV), but is not approved for this indication.
"HELSINN HEALTHCARE is extremely pleased to have been granted this five-year patent term extension for Aloxi(R)," stated Riccardo Braglia, CEO of HELSINN. "This recognizes the time and efforts spent by Helsinn to develop and register Aloxi(R) in the U.S. As the first and only 5-HT3 receptor antagonist for the prevention of both acute and delayed CINV, Aloxi(R) is an important product for those patients undergoing cancer chemotherapy. We look forward to submitting supplemental New Drug Applications for Aloxi(R) for the prevention of PONV and for an oral Aloxi(R) capsule. "
A Notice of Final Determination has been made that U.S. Patent No. 5,202,333, titled "Tricyclic 5-HT3 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 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.
Contact person at HELSINN
Rachid BenHamza, Ph.D., Director Business Unit Oncology & Supportive Care. Tel: +41 91-985-21-21. email@example.com
SOURCE Helsinn Healthcare SA