BioCryst Announces Mundipharma Receives Approval for Mundesine® in Japan

BioCryst Pharmaceuticals, Inc. announced that Mundipharma has obtained regulatory approval of Mundesine® (Forodesine hydrochloride) for the treatment of relapsed/refractory PTCL (Peripheral T-Cell Lymphoma) by the Ministry of Health, Labor and Welfare in Japan. Mundesine is a Purine-nucleoside phosphorylase (PNP) inhibitor developed by BioCryst, under an exclusive license with Albert Einstein College of Medicine and Victoria Link Limited. The Ministry’s decision follows successful clinical trials and makes Japan the first country in the world to make Mundesine available for treatment of PTCL.

In 2006, BioCryst entered into an exclusive sub-licensing agreement with Mundipharma for the development and commercialization of forodesine in the field of oncology.  This agreement was amended and restated in 2011. As stated in their press release, Mundipharma is working to ensure that patients in Japan receive access to Mundesine as early as possible, which represents another positive step forward, as they strive to deliver more treatment options for cancer patients in Japan.  Under the terms of the agreement with Mundipharma, BioCryst will receive tiered royalties ranging from the mid- to high-single digit percentages of net sales of Mundesine.