Helsinn Healthcare SA

Cancer supportive care: Oral Palonosetron approved in EU

Lugano (ots) - The second generation 5-HT3 receptor antagonist palonosetron, already approved as an intravenous solution formulation in more than 60 countries worldwide including US, EU and Japan, obtains the European Marketing Authorization for 0.5 mg oral capsules Palonosetron 0.5 mg soft gelatine capsule oral formulation has been approved by the EMA (European Medicine Agency) for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy (MEC) in adults. The European Marketing Authorization for the oral formulation of palonosetron, the second generation 5-HT3 receptor antagonist licensed worldwide by the Swiss pharmaceutical group Helsinn, follows the approval obtained in August 2008 in the USA. "As proven by our product pipeline, Helsinn is highly committed to Cancer Supportive Care and we are delighted that cancer patients suffering from nausea and vomiting can now benefit from oral Aloxi beside the injectable form." Riccardo Braglia, Helsinn's Group Chief Executive Officer, said. "We expect this will allow palonosetron to strengthen its leading position in the chemotherapy-induced nausea and vomiting (CINV) prevention", he concluded. About Palonosetron (Aloxi®, Onicit®, Paloxi®) Palonosetron (palonosetron hydrochloride) is a second generation 5-HT3 Receptor Antagonist, developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer, with a long half-life of 40 hours and at least 30 times higher receptor binding affinity than currently available compounds. Palonosetron demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy (MEC). A single intravenous dose of palonosetron provides better protection from CINV than first-generation 5-HT3 receptor antagonists throughout a 5-day post-chemotherapy period*. Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. Palonosetron has been developed by the Helsinn Group in Switzerland and today it is marketed as Aloxi®, Onicit®, and Paloxi® in more than 50 countries worldwide. Palonosetron, marketed as Aloxi®, is the leading brand in the USA within the CINV Day of Chemo segment, and it is steadily growing in the European markets. For more information about palonosetron, please visit the website: www.aloxi.com *This sentence refers to Moderately Emetogenic Chemotherapy (MEC) setting. About the Helsinn Group Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in Ireland and USA. Helsinn's business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of pre- clinical/clinical studies and Chemistry, Manufacturing and Control (CMC), development to the filing for and attainment of their market approval worldwide. Helsinn's products are sold directly through the Group's subsidiaries or out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice. The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinn's cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers. Helsinn is the worldwide licensor of palonosetron, a second generation 5-HT3 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer and of post- operative nausea and vomiting (PONV), and of the original nimesulide, a non-steroidal anti-inflammatory drug (NSAID) distributed in more than 50 countries worldwide. Helsinn, with a workforce of around 440 employees in Switzerland, Ireland and USA, reported a 2009 turnover of over C HF 305 million (about EUR 200 million), covering 85 countries worldwide, with over 20% of this turnover invested in R&D. For more information about Helsinn Group, please visit the website: www.helsinn.com ots Originaltext: Helsinn Healthcare SA Internet: www.presseportal.ch Contact: Paolo Ferrari Head of International Marketing HELSINN Healthcare SA Tel.: +41/91/985'21'21 E-Mail: info-hhc@helsinn.com

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