BioAlliance Pharma and Topotarget said they signed a definitive plan to merge their businesses—as announced last month—into a new company called Oxneo that will focus on developing drugs for orphan oncology indications and other unmet medical needs.

While the value of the deal was not disclosed, the companies said that Oxneo is in line for a $25 million milestone payment from partner Spectrum Pharmaceuticals, plus future double-digit royalties, for Topotarget’s single compound Belinostat (PXD101). The histone deacetylase (HDAC) inhibitor—indicated for blood cancers and solid tumors—is under priority review by the FDA, with an expected response date in early August.

The companies cited among advantages of the merger the resulting larger European shareholder base and deeper pipeline, as well as the prospect of positive developments for several drugs.  

Also in Oxneo’s pipeline are BioAlliance Pharma candidates Livatag (doxorubicin Transdrug™), a nanoparticle formulation of doxorubicin now in Phase III studies for primary liver cancer, and given Fast Track designation by the FDA; and Validive (clonidine Lauriad®), a mucoadhesive buccal tablet for oral mucositis, for which results of Phase II studies in Europe and the U.S. are expected in the fourth quarter. Both programs are set to reach key milestones in short- or medium-term clinical development, BioAlliance Pharma and Topotarget said.

The pipeline also includes BioAlliance Pharma’s Amep®, a preclinical plasmid which encodes a protein targeting 2 specific receptors (integrins a5b1 and avb3) expressed on melanoma cells.

BioAlliance Pharma CEO Judith Greciet and Chairman Patrick Langlois will hold the same roles with Oxneo. The new company’s board will include Topotarget Chairman Bo Jesper Hansen, M.D., Ph.D., and Per Samuelsson, partner in the HealthCap venture capital funds.

“With a promising portfolio, recognized expertise and greater critical mass, I am confident that Onxeo will rapidly become a major company in the field of orphan oncology treatments, thus realizing its potential to create value for shareholders and, most importantly, making available innovative therapeutic solutions to patients with urgent and unmet medical needs,” Greciet said in a statement.

Topotarget shareholders will receive two new BioAlliance Pharma ordinary shares for every 27 Topotarget shares they hold. Shareholders of BioAlliance Pharma, which Shareholders will hold about two-thirds of the shares in Oxneo, with the remaining one-third being held by Topotarget shareholders.

The merger has the support of the two largest institutional shareholders of both companies—Financière de la Montagne and Idinvest Partners, representing a combined 18.8% of BioAlliance Pharma’s undiluted share capital; and HealthCap funds and HBM Healthcare Investments, a combined 12.6% of Topotarget.

Shareholders are set to vote on the merger at extraordinary general meetings to be held June 27 by Topotarget, and three days later by BioAlliance Pharma. 

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