LUGANO, Switzerland, February 13 /PRNewswire/ -- HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceuticalgroup, today announced that a five-year Hatch-Waxman patent term extensionhas been granted by the U.S. Patent and Trademark Office for the patentcovering 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 initialand repeat courses of moderately and highly emetogenic cancer chemotherapyand for the prevention of delayed nausea and vomiting associated with initialand repeat courses of moderately emetogenic cancer chemotherapy. In addition,Aloxi(R) is being developed for the prevention of post-operative nausea andvomiting (PONV), but is not approved for this indication.
"HELSINN HEALTHCARE is extremely pleased to have been grantedthis five-year patent term extension for Aloxi(R)," stated Riccardo Braglia,CEO of HELSINN. "This recognizes the time and efforts spent by Helsinn todevelop and register Aloxi(R) in the U.S. As the first and only 5-HT3receptor antagonist for the prevention of both acute and delayed CINV,Aloxi(R) is an important product for those patients undergoing cancerchemotherapy. We look forward to submitting supplemental New DrugApplications 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. PatentNo. 5,202,333, titled "Tricyclic 5-HT3 Receptor Antagonists," is eligible forpatent term extension of five years. This patent was granted in April 1993and had been originally scheduled to expire in April 2010. Following thisfive year term extension, the patent will now expire in April 2015.
About HELSINN HEALTHCARE
Helsinn HEALTHCARE SA is a privately owned pharmaceuticalgroup with headquarters in Switzerland and is the worldwide licensor ofpalonosetron. Helsinn's core business is the licensing of pharmaceuticals intherapeutic niche areas. The company's business strategy is to in-licenseearly stage new chemical entities and complete their development from theperformance of pre-clinical/clinical studies and CMC development to theattainment of market approvals in strategic markets (U.S. and Europe).HELSINN's products are eventually out-licensed to its marketing partners fordistribution. The active pharmaceutical ingredients and the finished dosageforms are manufactured at HELSINN's cGMP facilities and supplied worldwide toits customers. For more information about HELSINN, please visit the company'sWeb site at www.helsinn.com.
Contact person at HELSINN
Rachid BenHamza, Ph.D., Director Business Unit Oncology & SupportiveCare. Tel: +41 91-985-21-21. info-hhc@helsinn.com
Helsinn Healthcare SA
Contact person at HELSINN: Rachid BenHamza, Ph.D., Director Business Unit Oncology & Supportive Care. Tel: +41 91-985-21-21. info-hhc@helsinn.com
