The Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion on PALONOSETRON (AloxiTM)
Lugano, Switzerland, 16th December 2004, - Helsinn Healthcare SA, announced today that, following the Centralised Procedure, and on the basis of quality, safety and efficacy data submitted, CHMP has adopted a positive opinion and recommended to grant a marketing authorisation for one of its most recent medicinal products, the antiementic, PALONOSETRON, which will be marketed in EU countries under the trademark AloxiTM.
CHMP recommends approval of AloxiTM for the following indications:
ˇ the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, and
ˇ the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
"This marks another significant milestone in the life of this innovative product and a
a rewarding achievement for Helsinn's primary focus on Supportive Care in Cancer." said Dr. Enrico Braglia, Managing Director of Helsinn Healthcare SA. "We are delighted to offer the oncology community our product AloxiTM through our network of licensees in order to help cancer patients better cope with chemotherapy side effects".
About Chemotherapy-Induced Nausea and Vomiting (CINV)CINV is estimated to afflict 85% of cancer patients undergoing chemotherapy and can result in a delay or even discontinuation of chemotherapy treatment. The advent of 5-HT3 receptor antagonists has revolutionized the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy. Due to increased number of cancers in the world, the supportive care area is becoming of paramount importance to help patients dealing with adverse events of anticancer therapies. When patients support better the anticancer treatment they increase their chances to a better quality of life and to a successful treatment.
About Aloxi AloxiTM is a selective 5-HT3 receptor antagonist with high receptor binding affinity and an extended 40-hour plasma half-life has demonstrated its efficacy and safety in 3 pivotal phase III trials, involving over 2,800 patients, in both moderately and highly emetogenic settings. The product was approved by the FDA in July 2003
For more information about Aloxi please visit the web site:
About HELSINN HEALTHCARE SAHELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and is the worldwide licensor of PALONOSETRON HCl - AloxiTM. HELSINN's core business is the licensing of pharmaceuticals in niche therapeutic 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.
Paola Bonvicini, Media Relations
E-mail: mediarelations@Helsinn.com
Tel. +41 (0) 91-985-21-21