BioAlliance Pharma will acquire Topotarget in a merger deal designed to create an orphan oncology drug developer with a combined pipeline of late-stage products addressing significant unmet medical needs. The value of the deal was not disclosed.

Topotarget’s primary product is belinostat, a pan-HDAC (histone deacetylase) inhibitor with more than 1,100 patients treated. Belinostat is in a preregistration phase with the FDA for the treatment of relapsed or refractory PTCL (peripheral T-cell lymphoma).

Belinostat has a PDUFA decision date of August 9. FDA approval of belinostat would trigger a $25 million milestone cash payment from Topotarget’s U.S. partner, Spectrum Pharmaceuticals, as well as double-digit royalties on sales going forward.

The companies reason that Belinostat has potential for being explored into other rare cancer indications within hematology and solid tumors, with Topotarget holding exclusive rights outside North America and India.

BioAlliance Pharma has two products in late-stage development:

  • Livatag®, now in a pivotal phase III clinical trial in primary liver cancer, with potential estimated blockbuster-level sales of €800 million ($1.1 billion) and patent protection until 2032. 
  • Validive®, the second most advanced product of BioAlliance Pharma’s orphan oncology program, which was granted Fast Track Designation by the FDA for the prevention and treatment of oral mucositis induced by anticancer treatments in January. Preliminary data from a large international phase II trial is expected to be reported in Q4 2014 

Under the deal, Topotarget shareholders will receive two new shares in BioAlliance Pharma for every 27 shares of Topotarget. As a result, Topotarget shareholders would own about one-third of the shares in the new company, leaving BioAlliance Pharma with the remaining two thirds.

The merger agreement is endorsed by the largest institutional shareholders of both companies—by Financière de la Montagne and Idinvest Partners, which represent 18.8% of BioAlliance Pharma’s share capital; and by HealthCap funds and HBM Healthcare Investments, representing 12.6% of the nondiluted share capital of Topotarget.

The merger with Topotarget will strengthen and diversify our position in rare oncology diseases,” Patrick Langlois, chairman of the Board of Directors of BioAlliance Pharma, said in a statement. “Topotarget is managed by a highly experienced team of executives, and the merger will enable both teams to combine their respective expertise to create a new company with a robust and innovative pipeline that is primed for success.”

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