Date: 2016-07-27
Type of information: Commercialisation agreement
Compound: Beleodaq® (belinostat)
Company: Onxeo (France) Pint Pharma (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: licensing commercialisation
Action mechanism: histone deacetylase inhibitor. Belinostat is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin, cis-retinoic acid, azacytidine, 5-FU, etoposide and bortezomib for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: Arrest growth of cancer cells (including drug-resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents.
Disease: peripheral T-cell lymphoma (PTCL)
Details: * On July 27, 2016, Onxeo announced it has entered into an exclusive license agreement with Pint Pharma, a private specialty pharma company well experienced in commercializing orphan drugs and highly specialized products in South American healthcare markets, for the commercialization of Beleodaq® (belinostat), Onxeo’s pan-HDAC inhibitor for PTCL (peripheral T-cell lymphoma), in key South American countries. Under the terms of the agreement, Pint Pharma will register, commercialize, and promote Beleodaq® in seven countries: Argentina, Brazil, Chile, Colombia, Ecuador, Peru, and Venezuela. While initiating the regulatory procedures to obtain market approval, Pint Pharma also plans to make Beleodaq® available to PTCL patients through Early Access Programs (EAPs) in eligible countries by the end of 2016. Beleodaq® is approved in the US, and has been marketed by Spectrum Pharmaceuticals since July 2014 as a 2nd-line treatment for PTCL.
Financial terms: Onxeo will receive an upfront payment from Pint Pharma, regulatory and commercial milestone as well as double-digit royalties on the net sales of Beleodaq® in these territories, representing a deal value of over $ 20 million.
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