Licencing agreements for Helsinn and Roche
Helsinn Healthcare and CSC, a pharmaceutical company based in Austria, have signed an agreement granting CSC the exclusive licence and distribution rights for ALOXI (Palonosetron hydrochloride) in Austria and other countries in central and eastern Europe.
Helsinn Healthcare and CSC, a pharmaceutical company based in Austria, have signed an agreement granting CSC the exclusive licence and distribution rights for ALOXI (Palonosetron hydrochloride) in Austria and other countries in central and eastern Europe.
ALOXI is a strong and long acting antiemetic belonging to the second generation of serotonin (5-HT3) antagonists, the leading class for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
Last December the CHMP recommended ALOXI approval in Europe for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy; and of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. In the US, where the product is currently commercialised and more than a million uses have been successfully completed, National Comprehensive Cancer Network (NCCN) guidelines, published in 2004, indicated ALOXI as the treatment of choice for CINV.
CINV is estimated to affect 85% of cancer patients undergoing chemotherapy and can result in a delay or discontinuation of chemotherapy treatments. Successful prevention of these symptoms would allow patients to tolerate anticancer treatment to a greater extent, thereby improving their chances of successfully completing treatment, and giving them a better quality of life.
Roche has retained an option to licence MEM 3454 from US company Memory Pharmaceuticals, which will receive a $2m milestone payment in return. The agreement is in relation to the companies' nicotinic alpha-7 collaboration, forged in 2003 for the development of nicotinic alpha-7 receptor agonists for the treatment of CNS, neurological and psychiatric disorders.
Roche elected to make this first milestone payment to maintain its option to obtain an exclusive license for MEM 3454, Memory Pharmaceuticals' lead drug candidate in the nicotinic alpha-7 agonist programme. It was triggered by Memory's satisfaction of certain criteria in its pre-clinical work on MEM 3454, and the initiation of a Phase I clinical trial for MEM 3454 in February 2005 under Memory 's leadership. The study is a single centre, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of the drug. Memory has also entered into a collaboration for the development of PDE4 inhibitors.