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belinostat / BELEODAQ®


Belinostat is a histone deacetylase inhibitor (HDACi). It has been assessed in several clinical trials as a sole treatment (monotherapy) or in combination with other anti-cancer treatments for hematological cancers and solid tumors. Its anti-cancer activity is associated with the inhibition of cell proliferation, the induction of apoptosis (programmed cell death), the inhibition of angiogenesis and the induction of cellular differentiation.

Beleodaq® is the commercial name of belinostat for injection.

Beleodaq® has been marketed in the United States by Spectrum Pharmaceuticals (SPPI)  since 2014 in the framework of a conditional FDA approval obtained in July 2014.

In March 2019, Acrotech Biopharma LLC, a fully-owned subsidiary of Aurobindo Pharma, acquired from Spectrum Pharmaceuticals (SPPI) the license to belinostat for certain territories, including the United States, Canada, Mexico, and India. In April 2020, Valerio Therapeutics granted Acrotech a royalty-free license to belinostat in all other territories, as well as transfer certain IP and know-how related to belinostat in all its forms. As part of this transaction, Valerio Therapeutics' licensing agreement with Pint Pharma for South America, as well as the contracts with Clinigen plc and iQone for named patient programs in European countries and related agreements, have also been assigned to Acrotech.

This transaction completed Valerio Therapeutics' transition to a company solely focused on development activities in the field of DNA damage response in oncology (DDR).