Mundipharma’s Mundesine receives approval from Japan’s MHLW to treat PTCL


Mundipharma has secured regulatory approval of Mundesine (Forodesine hydrochloride) from Japan’s Ministry of Health, Labour and Welfare (MHLW) to treat relapsed / refractory Peripheral T-Cell Lymphoma (PTCL).

BioCryst Pharmaceuticals developed the purine-nucleoside phosphorylase (PNP) inhibitor, Mundesine, under a licence with Albert Einstein College of Medicine and Victoria Link.

The approval follows successful clinical trials of Mundesine.

Mundipharma stated that it is working to ensure that patients in Japan receive access to Mundesine soon. 

BioCryst signed a sub-licensing agreement with Mundipharma in 2006 to develop and commercialise forodesine in the field of oncology. The agreement was amended and restated in 2011.

"Mundipharma stated that it is working to ensure that patients in Japan receive access to Mundesine soon."

Under the agreement, BioCryst is set to receive tiered royalties ranging from the mid- to high-single digit percentages of net sales of Forodesine hydrocloride from Mundipharma.

Forodesine is an orally available, transition-state analog inhibitor of PNP, a purine salvage pathway enzyme required for the proliferation of T-cells and B-cells. 

These cells are an essential part of the body's immune system and when multiplied uncontrollably can cause various forms of cancer. 

By inhibiting PNP, selective suppression of T-cells and B-cells would be produced, inducing apoptosis in both types of cells.

BioCryst designs, optimises and develops small-molecule drugs that block key enzymes involved in rare diseases.