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Release issued 1st February 2005
LUGANO, SWITZERLAND, and Munich, GERMANY, January 26th, 2005 - HELSINN HEALTHCARE SA, a Swiss pharmaceutical group, and RIBOSEPHARM GmbH, a Pharmaceutical company based in Germany, announce the signing of an agreement granting RIBOSEPHARM the exclusive License and Distribution rights for ALOXI(R) (Palonosetron hydrochloride) in Germany.
ALOXI(R) is the second generation of 5-HT3 antagonists, the leading class for the prevention of nausea and vomiting induced by chemotherapy. ALOXI(R) has the special features of a strong and long lasting activity demonstrated in several clinical trials worldwide. In Europe the CHMP recommended ALOXI(R) approval 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.
ALOXI(R) is already registered and successfully marketed in USA by Helsinn's licensee MGI Pharma. Total sales for 2004 are expected to be $ 155 to 160 millions with over 1 million uses for the product. Antiemetic guidelines such as the 2004 US National Comprehensive Cancer Network guidelines indicated ALOXI(R) as the treatment of choice for the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapies.
"HELSINN is very excited to start its cooperation with RIBOSEPHARM", said Dr. Riccardo Braglia, Managing Director of HELSINN HEALTHCARE SA. "RIBOSEPHARM has a great knowledge of the German oncology market and has demonstrated a real interest and a strong determination to make ALOXI(R) a leading product in the market. ALOXI(R) benefited already to many German patients during our clinical trials and we hope to help more patients to deal with the side effects of chemotherapy".
"ALOXI(R) will help RIBOSEPHARM to enforce its scientific competence in oncology and will give RIBOSEPHARM the possibility to enter the area of supportive care drugs." said Dr. Kudielka, General Manager of RIBOSEPHARM. "ALOXI(R) fits very well into the portfolio strategy of RIBOSEPHARM. We are happy to offer to cancer patients, the focus of our business, several cytostatics with supportive care drugs needed for an efficient and safe treatment."
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 improved supportive care 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(R) 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 has been over 2,800 patients treated during the phase 3 clinical trials and over 1 million uses after its commercialization in USA. ALOXI(R) is effective in preventing both acute and delayed CINV in patients receiving 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(R). 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.
RIBOSEPHARM GmbH, a subsidiary of ratiopharm GmbH/Ulm, a leading European producer of pharmaceutical products, is a Germany based company focused on the development and distribution of drugs for the treatment of different types of cancer. Bendamustine, the leading cytostatic is an innovative drug developed by RIBOSEPHARM GmbH and registered in Germany for the haematological entities multiple myeloma, CLL, NHL and breast cancer.
Additionally RIBOSEPHARM GmbH offers cytostatics as epirubicin, doxorubicin, carboplatin, folinic acid, 5-fluorouracil, and others. In 2005 additional registrations are expected for further relevant cytostatics. RIBOSEPHARM GmbH will start its European business in 2005 by building up an own sales force line for hospitals by using the existing subsidiaries of ratiopharm as logistic platform. For more information please visit www.ribosepharm.de.
Contact person HELSINN: Rachid BenHamza, Ph.D., Head Business Unit Oncology & Supportive Care. (+41) 91-985-21-21. firstname.lastname@example.org
Contact person RIBOSEPHARM: Elfi Biedermann, Ph.D., Senior Product Manager (+49) 89-45450-302 email@example.com
If you want to find out more about the company visit Helsinn Healthcare profile.
(14th July 2005) ALOXI(R) AT THE MASCC 2005 CONGRESS
(13th June 2005) EXELIXIS AND HELSINN SIGN AGREEMENT FOR XL119 (Becatecarin)
(1st June 2005) Helsinn Healthcare Licenses a Supportive Care Product from Roche
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