To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Helsinn's New Antiemetic Drug Aloxi Receives Marketing Authorization in Europe URL: http://www.pslgroup.com/dg/24BE2A.htm Doctor's Guide April 4, 2005
LUGANO, SWITZERLAND -- April 4, 2005 -- Helsinn Healthcare SA, a Swiss pharmaceutical group, announced today that the European Commission has granted the marketing authorisation for their new drug Aloxi® (palonosetron HCl). This announcement comes approximately three months after the CHMP's recommendation to approve Aloxi for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Aloxi belongs to the second generation of serotonin subtype 3 (5-HT3) receptor antagonists, characterized by a stronger and longer efficacy to prevent nausea and vomiting in cancer patients undergoing chemotherapy. Several clinical trials showed, in comparison with the first generation 5-HT3 receptor antagonists, a great efficacy of Aloxi during the acute and delayed phases after chemotherapy treatment. The product is commercialized in USA since September 2003 by Helsinn's partner MGI Pharma, where approximately 1.5 million uses have been completed successfully. Recently published data (Grunberg S. et al. Incidence of chemotherapy-induced nausea and emesis after modern antiemetics. Cancer, 100 (10): 2261-8, 2004) showed that cancer patients are still missing an adequate control of chemotherapy induced nausea and vomiting (CINV) and the medical community is keeping the antiemetic guidelines updated with new improvements which can help the patients cope with this debilitating side effect. A recent example is the National Comprehensive Cancer Network (NCCN, www.nccn.org), an alliance of 19 of the world's leading cancer centers, which indicated Aloxi as the treatment of choice for the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy. "This news is of great significance for Helsinn", said Dr. Enrico Braglia, Managing Director of Helsinn Healthcare SA. "After having completed the US registration a year and a half ago, we have now successfully completed the Centralized Procedure Registration in Europe for the first time. Helsinn's focus is Cancer and Supportive Care, and our mission is to keep helping cancer patients to better deal with the disease by either bringing new cancer treatments or by offering new therapies to reduce cancer side effects. Aloxi is in this second group and Helsinn will make sure it is made available in each country of the EU as soon as possible through its local partners and distributors." Helsinn recently announced a number of licensing and distribution agreements in most European countries: Cambridge Laboratories for the UK, Ribosepharm for Germany, Italfarmaco for Italy and Spain, Galenica for Greece, CSC for Austria and several Central and Eastern European countries and PharmaSwiss for Slovenia, Baltic States and several other Eastern countries. About Chemotherapy-Induced Nausea and Vomiting (CINV) CINV is estimated to affect 85% of cancer patients undergoing chemotherapy and can result in a delay or discontinuation of chemotherapy treatments. The supportive care area is becoming of paramount importance to help patients deal with adverse events of anticancer therapies. With good supportive care drugs, cancer patients are able to tolerate the anti-cancer treatment to a greater extent, improving their chances of completing their treatment course successfully with a better quality of life. About Aloxi Aloxi is a selective 5-HT3 receptor antagonist with high receptor binding affinity, which is at least 30 times higher than that of first-generation 5HT3 receptor antagonists. Aloxi has an extended plasma half-life of approximately 40 hours. Aloxi 0.25 mg i.v. is approved for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy. In clinical trials, Aloxi demonstrated prevention of acute CINV and persistence of protection in delayed phase, especially during the period of major risk (days 2 and 3). In these trials, Aloxi was compared with active comparators, and showed a consistent and favourable difference with respect to ondansetron and dolasetron. Adverse reactions observed in the pivotal trials were similar in frequency, intensity, and duration with Aloxi as with ondansetron and dolasetron, with most common drug-related adverse reactions being headache (9%) and constipation (5%). SOURCE: Helsinn Healthcare SA --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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