Helsinn Healthcare SA

Helsinn announces license agreement with Specialised Therapeutics for palonosetron in Australia
Leading anti-nausea drug available to Australian and New Zealand cancer patients

Lugoano, Switzerland/Melbourne, Australia (ots) - Australians can now access a new drug to prevent acute (and delayed phase) nausea and vomiting which may occur in cancer patients undergoing chemotherapy1. This follows an agreement between the Swiss pharmaceutical group Helsinn and Specialised Therapeutics Australia Pty Ltd (STA). The agreement grants Specialised Therapeutics Australia the exclusive License and Distribution rights for palonosetron (palonosetron hydrochloride) in Australia and New Zealand. Palonosetron is a patented second generation 5-HT3 receptor antagonist, which is differentiated to older 5HT3 antagonists by its higher receptor binding affinity and longer duration of its activity 1,2. Palonosetron has been available internationally after being registered in the USA in 2003, and is indicated for the prevention of acute nausea and vomiting associated with highly emetogenic chemotherapy, and the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy. Today the product is approved in 63 countries, with annual sales of over 400 million US dollars last year. Specialised Therapeutics Australia Chief Executive Officer Mr. Carlo Montagner said the acquisition of palonosetron was an important step in the continued development of the company's drug portfolio, with a commitment to oncology treatment and management. "The Helsinn group has done a first class job of developing palonosetron and we are delighted to become their Australian partner for this product," he said. "We have made clear our strategy of building Specialised Therapeutics Australia through the acquisition and growth of specialist medicines". "By in-licensing palonosetron we are demonstrating our on-going commitment to this strategy. Palonosetron is an excellent fit in our growing portfolio and we look forward to driving its growth." Helsinn group Chief Executive Officer, Dr. Riccardo Braglia said he looked forward to co-operating with STA on the Australian launch. "We are delighted to sign this new agreement with Specialised Therapeutics Australia and look forward to initiating a successful co-operation for palonosetron in Australia," he said. "STA has demonstrated a commitment to grow products in the specialist oncology market, while the patients and the medical community in Australia will enjoy the benefits of an innovative antiemetic like palonosetron". Palonosetron is listed on the Pharmaceutical Benefits Scheme (PBS) from November 1st, 2010 for the management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. References: 1. Aloxi product Information 2. Wong E, et al Br J Pharmacol 1995; 114: 851-859. 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 world-wide. 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 Specialised Therapeutics Australia Pty Ltd Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. ABRAXANE® (nanoparticle albumin-bound paclitaxel) is the first of such therapies. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand. 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 450 employees in Switzerland, Ireland and USA, reported a 2009 turnover of over CHF 305.0 million (about EUR 232.0 million at the current conversion exchange rate), with over 20% of this turnover invested in R&D. The products licensed by Helsinn are sold in 85 countries worldwide. For more information on the 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 Phone: +41/91/985'21'21 E-Mail: info-hhc@helsinn.com Emma Power Monsoon Communications Phone: +61(0)3-9620-3333 or +61(0)419-149-525

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