Complete response to hold on anemia drugs

The US Food and Durg Administration has accepted as complete the response to its clinical hold on two oral anemia drugs co-developed by USA-based FibroGen and Japanese drug major Astellas. Clinical studies of the hypoxia-inducible factor prolyl hydroxylase inhibitors, FG-2216 and FG-4592, were put on hold last year after a death due to fulminant hepatitis was reported in a Phase II US trial of the former in predialysis chronic kidney disease patients (Marketletter May 21, 2007).

Astellas in-licensed the compounds from US drugmaker FibroGen for exclusive development and marketing in Japan and Europe (Marketletter May 8, 2006). Under the terms of their agreement, the Tokyo-based company will pay a licensing fee of $300.0 million upon signing, milestones totaling $465.0 million and share in the costs of a transAtlantic development program and patent support.

FibroGen submitted a response to the FDA in February and was informed that it was complete on March 24. The firm noted that study protocols it proposed were broadly accepted. If all sales targets are achieved, Astellas could pay the firm more than $2.0 billion during the 10 to 15 years after 2010. In addition, Astellas will purchase $50.0 million worth of shares in the US biotechnology firm.