Imatinib Mesilate

Cooperation with Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (ZJPC) on Imatinib Mesilate

Dolder has gained an outstanding partner in the Chinese active pharmaceutical ingredient manufacturer Zhejiang Jiuzhou Pharmaceutical Co. Ltd. (JIUZHOU).

Transferring the exclusive European distribution rights for the active pharmaceutical ingredient Imatinib Mesilate underlines Dolder’s strategic adjustment to the indication of oncology. This exclusive agreement for mutual cooperation was made between Dolder and JIUZHOU in October 2009 after a successful GMP audit in accordance with ICH Q7.

Introducing Jiuzhou
JIUZHOU is a medium-sized private enterprise focusing on the production of APIs. Originally founded in 1973, JIUZHOU is now a medium to large-sized private pharmaceutical enterprise with 1,400 employees working at seven manufacturing + development sites. In recent years, JIUZHOUhas been inspected successfully by the US FDA, the EDQM, the Italian AIFA, the Australian TGA, and the Korean FDA respectively. Additionally, JIUZHOU is ISO 9001 certified, it has deposited various US-DMF for different APIs, and it holds a set of CEPs granted by the EDQM.

Imatinib Mesilate: Indication
Imatinib Mesilate (Glivec^®) is a tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase created by the Philadelphia chromosome abnormality in chronic myeloid and acute lymphoblastic leukemia. It also inhibits the tyrosine kinase for platelet-derived growth factor and stem cell factor [c-kit (CD117)], which is overexpressed in gastrointestinal stromal tumors. Imatinib Mesilate is also indicated for patients with myelodysplastic syndromes, hypereosinophilic syndrome, aggressive systemic mastocytosis, and dermatofibrosarcoma protuberans.

Market performance: blockbuster
Currently, the world-wide market volume of Glivec^® is approximately USD 3.1 billion. It is therefore considered a blockbuster product.

Patent: protection expires 2016
The basic patent EP0564409 expires in March 2013. By virtue of the SPC (Supplementary Protection Certificate), Glivec^® is protected in EU countries against competition from generics until the middle of June 2016.

Advantages for the general medicinal product manufacturer

• The availability of an active substance from one of the top three Chinese active pharmaceutical ingredient manufacturers 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.