Merck KGaA has signed licensing deals with a pair of North American biotechnology companies in the fields of HIV-related lipodystrophy and cancer.

The most clinically-advanced of these deals is with Canada’s Theratechnologies and gives the Darmstadt-based firm’s US unit EMD Serono exclusive rights in that country to tesamorelin. The compound is a growth hormone-releasing factor analogue “with therapeutic potential in a variety of anabolic and lipolytic indications”, said Merck.

Specifically, tesamorelin is in the final stages of a second Phase III trial to assess its safety and efficacy when used to reduce visceral adipose tissue in HIV patients with lipodystrophy. The purpose of the study is to confirm the results of the first Phase III trial concluded in October 2007.

Cashwise, Theratechnologies will receive an upfront payment of $30 million – a license fee of $22 million and an equity investment of $8 million in – providing Merck with a 3.6% stake in the Montreal-based firm. The latter may receive up to $215 million in development, regulatory and sales milestones, plus increasing royalties.

Fereydoun Firouz, chief executive of EMD Serono, said the partnership “reinforces our commitment to our endocrinology franchise in the USA and specifically to the field of HIV-associated disorders. He added that tesamorelin, “with its strong clinical data, will address an important market that we currently cannot serve”.

Access to Lpath’s Asonep antibody
Merck said the pact was an example of its “pursuit of alliances in the US marketplace”, just after it announced a deal with Lpath to develop and commercialise Asonep, a monoclonal antibody in Phase I currently being evaluated for the treatment of various cancer types.

Under the terms of the agreement, the firm’s Merck Serono unit will provide Lpath up to $23 million in upfront payments and R&D funding to support the completion of the Phase I trial. If this proves successful, Lpath will receive an additional $28 million and could milestones up to $422 million should Asonep be approved in multiple indications.