BioAlliance Pharma and Topotarget have announced a merger agreement with an aim to create an orphan oncology company with increased scale and a highly complementary pipeline of late-stage products targeting significant unmet medical needs.

Under the terms of the agreement, BioAlliance Pharma will be the continuing company and it will now apply for a dual listing of its shares at NASDAQ OMX Copenhagen.

The new company is expected to benefit from operational efficiencies, combined pool of knowledge, and a diversified revenue stream.

Approved by the BioAlliance Pharma and Topotarget boards of directors, the merger is expected to result in a broadened shareholder base with increased market capitalisation and a strengthened value proposition for the US and European-based investors.

The merger agreement has been backed by BioAlliance Pharma’s two largest institutional shareholders, Financière de la Montagne and Idinvest Partners, as well as Topotarget’s two largest institutional shareholders, HealthCap funds and HBM Healthcare Investments.

"It is a unique and timely opportunity to develop an orphan oncology portfolio, which addresses a wider range of life-threatening medical conditions."

Subject to approval, the deal is expected to close in July or August.

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The merger will be structured as a tax exempt cross-border merger in accordance with Danish, French, and the EU legislation.

BioAlliance Pharma CEO Judith Greciet will lead the combined company and Patrick Langlois will continue to serve as chairman of the board of directors of BioAlliance Pharma.

Topotarget current board chairman Bo Jesper Hansen and Topotarget current board of directors member Per Samuelsson are expected to be appointed as members of the board of directors of BioAlliance Pharma.

Centerview Partners and Nordea acted as financial advisors to BioAlliance Pharma, while Altana and Bech Bruun as legal counsel in connection with the merger.

Topotarget CEO Anders Vadsholt noted that the positioning of BioAlliance Pharma, their late stage assets and expertise makes BioAlliance Pharma a perfect fit as a company to merge with, allowing the acceleration of belinostat development in several new orphan oncology indications by leveraging on both team’s synergistic expertise.

"We are confident that this merger will deliver to our shareholders the best possible value and the opportunity to jointly shape a dynamic new player in the orphan oncology market," Vadsholt said.

A novel pan-histone deacetylase inhibitor, belinostat is Topotarget’s primary product. Currently, belinostat is in a pre-registration phase with the US Food and Drug Administration (FDA) for treatment of relapsed or refractory peripheral T-cell lymphoma.

The compound has potential for being explored into other rare cancer indications within haematology and solid tumours.

BioAlliance Pharma has two products in late-stage development, including Livatag and Validive. Livatag is currently in a pivotal Phase III clinical trial in primary liver cancer.

In January, Validive received fast-track designation from the FDA for prevention and treatment of oral mucositis induced by anticancer treatments and preliminary data from a Phase II trial are expected in the fourth quarter of 2014.

BioAlliance Pharma CEO Judith Greciet, said that the merger with Topotarget will strengthen and diversify our position in rare oncology diseases.

"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," Greciet said.

"It is a unique and timely opportunity to develop an orphan oncology portfolio, which addresses a wider range of life-threatening medical conditions, while creating value for our shareholder."