UK biotechnology company, Xenova, received a boost yesterday after Sosei – its Japanese partner for its lead brain cancer drug, TransMID – won orphan drug status for the product from the country’s Ministry of Health, Labour and Welfare.
The UK company, which receives a milestone payment from Sosei on the back of this news, says that orphan drug designation will facilitate the start of clinical trials and also provide fast track approval process once studies have been completed and a dossier seeking marketing approval has been filed.
TransMID received fast track status from the FDA in August 2001 and orphan drug status in December of the same year. In addition, the European Commission granted TransMID orphan designation in March 2002 [[22/03/02e]]. Xenova is hoping that the product could be available as early as mid-2007 [[14/08/03b]].