Pemetrexed

Pemetrexed is a chemotherapy drug (multitargeted antifolate) for the treatment of non-small cell lung cancer (NSCLC) and pleural mesothelioma. It is marketed as ALIMTA^®  by the originator Lilly. ALIMTA^® is administered as IV solution and marketed in vials as lyophilised product.

Pemetrexed Disodium is available in various solid forms. The API's solid form influences the quality of the product in terms of an increase of related substances during its storage and handling.  Dolder will offer Pemetrexed in its 2.5 hydrate crystalline form.  

Market performance & patent situation
Currently, the worldwide market volume of Alimta^® (Lilly) is approximately USD 1.3 billion; it is therefore regarded as a blockbuster. In Europe, patent protection (SPC) expires in December 2015; in the US in July 2016. 

Dolder's strategy
As a result of its new strategic orientation, Dolder has decided to develop its own generic API in a partnership with external R&D partners. Such products will be marketed by Dolder as virtual manufacturer. The chemical and analytical development is fully financed by Dolder and the API will be exclusively toll manufactured for Dolder at  a manufacturing site in India.

Process validation was successfully finished in March 2011 and ASMF preparation is ongoing. Samples, technical documents and the timeline are available upon request.

Swiss quality - at Asian prices
Order your effective ingredient Pemetrexed Dinatrium from the Swiss sourcing specialist that stands for product quality and GMP compliance. As a "virtual API manufacturer," Dolder is in a position to offer Pemetrexed Dinatrium to the generics industry with very high purity and with a shortened and improved manufacturing process as compared to the originator's process. The development of the process completely financed by Dolder AG was taken over by TCG Lifesciences in India. The result is a completely-validated process incl. analytics, a high-quality product, and approval documentation (ASMF) formulated by our Swiss Regulatory Affairs expert team.