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LUGANO, SWITZERLAND, and VIENNA, AUSTRIA (ots) - HELSINN HEALTHCARE SA, a Swiss pharmaceutical group, and CSC, a Pharmaceutical company based in AUSTRIA, announce the signing of an agreement granting CSC the exclusive License and Distribution rights for ALOXI® (Palonosetron hydrochloride) in Austria and other countries in Central and Eastern Europe.
ALOXI® is a strong and long acting antiemetic belonging to the second generation of serotonin (5-HT3) antagonists, the leading class for the prevention of nausea and vomiting induced by chemotherapy. Several clinical studies have been conducted on a worldwide basis and presented in international congresses showed ALOXI® efficacy during the acute and delayed phase after chemotherapy treatment. The product is currently commercialized in USA where over a million uses have been completed successfully.
Last December the CHMP recommended ALOXI® approval in Europe for the following indications:
- 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.
Nausea and Vomiting is still an important medical need for chemotherapy treated patients. International guidelines are always updated with novelties to indicate the best treatments available for the medical community. In 2004 the US National Comprehensive Cancer Network (NCCN) guidelines indicated ALOXI® as the treatment of choice for the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapies.
"We are delighted to extend our long lasting cooperation with CSC and enter into this new agreement for ALOXI®", said Dr. Riccardo Braglia, Managing Director of HELSINN HEALTHCARE SA. "Many years of a successful relationship with CSC with our leading NSAID product AULIN and their great expertise and knowledge about oncology and the CEE markets have been the driving factors for this agreement. We believe that CSC will be able to introduce very successfully ALOXI® to the medical community and to the patients suffering from nausea and vomiting induced by chemotherapy".
"We are grateful to HELSINN HEALTHCARE SA. that has confirmed its trust in CSC Pharmaceuticals Group. ALOXI® fits very well with our onco-biotech line and we are sure that the collaboration between the two Companies and their outstanding professional performance will bring this Product in the position of a Market leader in the therapeutic class of anti emetics", said Dr. Iervant Zarmanian, Chief Executive Officer of CSC Pharmaceuticals.
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.
ALOXI® is a selective 5-HT3-receptor antagonist, developed for the prevention of CINV, with a long half-life of 40 hours and at least 30 times higher receptor binding affinity than currently available compounds. There have been over 2,800 patients treated during the phase 3 clinical trials and over 1 million uses after its commercialization in USA. ALOXI® is effective in preventing both acute and delayed CINV in patients receiving highly and moderately emetogenic chemotherapy, the most common chemotherapy regimens used in the treatment of cancer. For more information about this product please visit our website: www.palonosetron.net and www.aloxi.com.
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.
About CSC Pharmaceuticals
CSC Pharmaceuticals is a medium size Pharma Company and a Regional Player in Central Eastern Europe with a product portfolio ranging from onco-biotech line to NSAIDs with also a presence in gynecological and OTC sectors. CSC continued investments in upgrading Human Resources gives the company approximately six hundred people with a level of excellence in Regulatory, Medical and Marketing activities. For more information about CSC Pharmaceuticals, please visit www.cscpharma.com.
ots Originaltext: HELSINN HEALTHCARE SA
Contact person HELSINN:
Ph.D., Head Business Unit Oncology & Supportive Care.
Contact person CSC Pharmaceuticals:
Dr. Ugo Gennaro
Executive Vice President