Helsinn Healthcare SA

HELSINN and THERABEL PHARMA announce a license agreement for Aloxi®

    Lugano (ots) - HELSINN HEALTHCARE SA signed an Agreement with
THERABEL PHARMA under which it granted THERABEL PHARMA the exclusive
License and Distribution rights to distribute, market and sell Aloxi®
(palonosetron hydrochloride) in France, Belgium, Luxemburg and The

    Aloxi® is a strong and long-lasting antiemetic belonging to the second generation of serotonin (5-HT3) antagonists, the leading class for the prevention of nausea and vomiting induced by chemotherapy. Aloxi® showed a great efficacy during the acute and delayed phase after chemotherapy treatment vs. other first generation 5-HT3. The products is already commercialised in the US, where over three million uses have been completed successfully. In March 2005, Aloxi® was granted registration approval in Europe under a centralised procedure by the EMEA with the following indications:

    - the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,

    - the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, following single intravenous (IV) administration.

    Aloxi® is currently on the market in some European countries, as well as in several countries of Latin America where the tradename is Onicit®.

    There is still a medical need among cancer patients and the medical community still need a better prevention of Nausea and Vomiting due to chemotherapy treatments. International guidelines are always updated with novelties to indicate the best treatments available for the medical community and 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.

    "HELSINN is delighted to sign this new Aloxi® agreement and to extend our long-lasting co-operation with THERABEL PHARMA" said Dr. Riccardo Braglia, Managing Director of HELSINN HEALTHCARE.

    "THERABEL PHARMA's sound knowledge of the pharmaceutical market, their strong commitment to make Aloxi® a first ranking product in the antiemetic market, as well as our long-standing relationship for our leading NSAID product, nimesulide, have contributed to our decision to enter into this agreement, which will certainly see the successful introduction of Aloxi® to the medical community and to patients suffering from nausea and vomiting induced by chemotherapy".

    "THERABEL PHARMA is very happy to pursue its fruitful collaboration with HELSINN by signing this contract with an exciting and challenging project and to offer to the patients a new efficient antiemetic drug. Aloxi® will reinforce THERABEL PHARMA's position at hospital in France and Benelux by a strategic and complementary area of development. We strongly believe that Aloxi will be a drug of choice for the prevention and treatment of chemotherapy induced nausea and vomiting", said THERABEL PHARMA.

    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, 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. Since its availability in USA in September 2003, there are over 3 million successful uses of Aloxi®. The product showed to be effective in preventing both acute and delayed CINV in patients receiving emetogenic chemotherapies. For more information about this product please visit our website: www.aloxi.com.


    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


    THERABEL PHARMA is a medium size privately-owned pharmaceutical group, operating in 5 European countries, France, Italy, Belgium, Luxemburg and The Netherlands. The consolidated turnover of THERABEL PHARMA is ¤138 million, with a 9% sales increase in 2005. The main objective of THERABEL PHARMA is to focus all its strengths and talents exclusively on serving the medical profession and patients by providing innovative prescription medicines. THERABEL PHARMA aims to become an European pharmaceutical group that is firmly established in all major countries of the European Community, while preserving our human-scale structure, our philosophy, our ethics and our freedom of action.

ots Originaltext: Helsinn Healthcare SA
Internet: www.presseportal.ch/fr

Rachid BenHamza, Ph.D.
Head Business Unit Oncology & Supportive Care.
Tel.      +41/91/985-21-21
E-Mail: info-hhc@helsinn.com

Weitere Meldungen: Helsinn Healthcare SA

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