BioCryst Announces Mundipharma Receives Approval for Mundesine® in Japan

RESEARCH TRIANGLE PARK, N.C., April 03, 2017 -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today 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.

About Forodesine

Forodesine hydrocloride is an orally-available transition-state analog inhibitor of purine nucleoside phosphorylase (PNP), a purine salvage pathway enzyme that is essential for the proliferation of T-cells and B-cells.  Typically, T-cells and B-cells are an essential part of the body's immune system, but when they multiply uncontrollably they can cause various forms of cancer.  Inhibiting PNP produces selective suppression of T-cells and B-cells, inducing apoptosis in both types of cells.

About BioCryst

BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: BCX7353 and second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitment development activities are ongoing, as well as activities to support regulatory approvals in other territories. For more information, please visit the Company's website at www.BioCryst.com.

This press release contains forward-looking statements, including statements regarding future results and achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Please refer to the documents BioCryst files periodically with the SEC and located at http://investor.shareholder.com/biocryst/sec.cfm.

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MUNDESINE is a registered trade mark (in Japan) of Mundipharma AG.

CONTACT: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910