Bioxel submits DMF for docetaxel
(DMF) to the US Food and Drug Administration (FDA) for docetaxel in
the lead up to the patent expiring on Sanofi-Aventis' version of
the cytotoxic chemical at the end of this year.
In March, active pharmaceutical ingredient (API) specialist ScinoPharm was the first company to be assigned a DMF number for docetaxel in the US in a bid to help secure customers for the generics market. Docetaxel, a chemotherapeutic drug widely used in the treatment of various cancers, is the active ingredient in Sanofi-Aventis' Taxotere, which generated worldwide sales of $2.2bn in 2006. "This DMF registration is one of the most critical milestones in the development of our docetaxel," Bioxel Pharma president and chief executive Pascal Delmas said. "Sanofi-Aventis' patent on docetaxel will begin to expire at the end of 2007, opening the door to the development of the generic Taxotere market. Having the proper regulatory fillings before the opening of the generic market is a distinctive asset that strengthens our market position." The DMF would add to the DMFs the Canadian corporation already holds in the US, Canada, Europe and Asia for the taxane drug paclitaxel, which is the API in Bristol Myers Squibb's anti-cancer drug Taxol. In 2005, Bioxel filed two patents covering a unique synthetic route to taxane drugs, including docetaxel. These patents were extended in 2006 through international applications, allowing for broad protection of Bioxel's technology platform. The synthesis process starts with 9-dihydro-13-acetylbaccatin III (9-DHB), a taxane precursor extracted exclusively from the Canada yew that Bioxel presently isolates during production of its taxane drug paclitaxel. Bioxel expected to have its paclitaxel and docetaxel DMFs registered in 34 countries by the end of this year. Sanofi-Aventis' Taxotere was first approved in 1995 and is currently marketed in over 100 countries in eight indications for four forms of cancer. With patent expiration looming, Sanofi-Aventis has several other taxane derivatives in development, some of which appear to be showing greater efficacy than Taxotere in clinical studies. The market for taxane-based drugs is massive, driven by a demand for cancer treatment. In 2006, the taxane drug market was estimated at $4bn.
