Bendamustine Hydrochloride

Dolder AG announces cooperation with Chongqing Huapont Pharmaceutical Co., Ltd. (HUAPONT) on Bendamustine

Dolder AG has gained a significant partner in the Chinese active pharmaceutical ingredient manufacturer Chongqing Huapont Pharmaceutical Co. Ltd. (HUAPONT).

Transferring the exclusive distribution rights for the active pharmaceutical ingredient Bendamustine Hydrochloride for Europe, North America and Japan underlines Dolder’s strategic adjustment to the indication of oncology. This exclusive agreement for mutual development and cooperation was made between Dolder and HUAPONT in September 2009 and includes various milestone payments.

Introducing HUAPONT
HUAPONT - established in 1992 - is equipped with state-of-the-art facilities and a strong R&D force. It is dedicated primarily to the manufacturing and marketing of APIs as well as drug products for dermatology, fighting tuberculosis, and oncology.

Indication
Bendamustine Hydrochloride (Ribomustin^® MUNDIPHARMA and Treanda^® CEPHALON) is an antineoplastic alkylating agent. It is given intravenously as the hydrochloride for the treatment of chronic lymphocytic leukemia (CLL). It may also be used for non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD), multiple myeloma (MM, Kahler’s disease), and breast cancer.

Market performance
Currently, the world-wide market volume of Ribomustin^® / Treanda^® is approximately USD 150 million. It is therefore considered a growing product with future blockbuster potential.

Patent situation
The regulatory authorities granted new data exclusivity to Ribomustin^®. Although there are no unexpired patents, the generic entry is hindered by the validity of the data exclusivity.

Advantages for general medicinal product manufacturers

• Availability of an active substance from an emergent Chinese active pharmaceutical ingredient manufacturer with strong growth, an attractive cost structure, as well as exceptional scientific expertise.
• The latter will be combined with the regulatory expertise and quality guarantee of a dependable, long-standing Swiss company.
• Particularly in fraught economic conditions, these are important criteria for a reliable integration of active pharmaceutical ingredients into our customers’ product portfolios.