Helsinn Healthcare SA

Helsinn Birex Therapeutics Ltd. announces the launch of the new 5-HT3 Receptor Antagonist ALOXI(r) (Palonosetron hydrochloride) EU/1/04/306/001 in Ireland

DUBLIN, IRELAND, May 11th, 2005 - HELSINN BIREX THERAPEUTICS LTD, one of the Irish companies of the Swiss pharmaceutical group Helsinn Healthcare SA, announced today that the company received the first delivery of ALOXI" (palonosetron hydrochloride) from Helsinn Birex Pharmaceuticals LTD, Dublin, on 9th May 2005 and that it officially began sales and marketing of the product on 10th May 2005. On 30th March 2005, the European Commission granted ALOXI" marketing authorization through a European Centralised Registration Procedure, with the approved indications 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", available as a single 0.25mg I.V. dose in a 5ml vial, is a second generation of serotonin subtype 3 (5-HT3) receptor antagonists, characterized by a strong and long efficacy to prevent nausea and vomiting in cancer patients undergoing chemotherapy. ALOXI" has a high receptor binding affinity which is at least 30 times higher than that of first-generation 5HT3 receptor antagonists, and it has an extended plasma half-life of approximately 40 hours. 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(r) as with ondansetron and dolasetron, with most common drug-related adverse reactions being headache (9%) and constipation (5%). 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. The product is already commercialized in USA since September 2003 by Helsinn's partner MGI Pharma, where approximately 1.5 million uses have been completed successfully. "After successfully obtaining the Centralized Registration Procedure in Europe for the first time, we are confident that the launch of ALOXI" in the EU countries will mark another significant phase for ALOXI" and for the Helsinn Group". said Dr. Riccardo Braglia, Managing Director of HELSINN HEALTHCARE SA. "This step reinforces Helsinn's focus on Cancer and Supportive Care and strengthens our mission to help cancer patients by offering new therapies to reduce cancer side effects. Moreover we are proud that our subsidiary Helsinn Birex Therapeutics Ltd is the first to launch Aloxi in EU". "We believe that Aloxi is a better 5HT3 drug" said Jim O'Leary, General Manager of the Irish Subsidiary, "and from this month also the Irish cancer patients will benefit of less nausea and vomiting during chemotherapy" Helsinn has recently announced a number of licensing and distribution agreements in many European countries: Cambridge Laboratories for the UK, Ribosepharm for Germany, Italfarmaco for Spain, Galenica for Greece, CSC for Austria and several Central and European countries and PharmaSwiss for Slovenia, the Baltic States and several Eastern countries. For more information about this product please visit our website: www.palonosetron.net and www.aloxi.com 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 HELSINN HEALTHCARE HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and is the worldwide licensor of ALOXI". 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. For more information about HELSINN, please visit www.helsinn.com. ots Originaltext: Helsinn Healtcare SA Internet: www.presseportal.ch Contact person HELSINN: Rachid BenHamza, Ph.D., Head Business Unit Oncology & Supportive Care. Tel.: +41/91/985'21'21 E-Mail: info-hhc@helsinn.com

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