BioWorld International Correspondent

LONDON - Ark Therapeutics Group plc agreed to a multimillion euros license with Boehringer Ingelheim International GmbH centered on Ark's renin-angiotensin system knowledge, and claimed the scope of its intellectual property could lead to similar deals covering all marketed ACE inhibitor and angiotensin II inhibitor antihypertensive drugs.

Financial terms were not disclosed, but London-based Ark received a "material" up-front payment, and would get several multimillion euro payments over the next few years for achieving certain pre-defined milestones, plus royalties on sales on products, which are in development in certain cardiovascular-related indications.

The milestones all refer to progress in ongoing Boehringer Ingelheim trials investigating the role of Micardis, an angiotensin II receptor blocker, alone and in combination with other drugs, in the prevention of primary and secondary stroke, myocardial infarction and cardiovascular death. A number of different trials, involving more than 45,000 patients at cardiovascular risk, are expected to report by 2007.

Nigel Parker, CEO of Ark, said Boehringer was the first to acknowledge the importance of Ark's intellectual property, which covers the use of all agents that affect the renin-angiotensin system for the treatment of complex vascular-related and metabolic disorders.

Paul Higham, director of commercial development at Ark, told BioWorld International: "This is potentially very big for us. When you look at the patent, it covers all currently marketed ACE inhibitors and angiotensin II inhibitors." Higham said concluding the deal with Boehringer gives the patent validity.

"You would think we could do similar deals with other companies," he said.

Higham would not say how Ark and Boehringer Ingelheim got together.

Ark is exploiting its discovery in developing an angiotensin II inhibitor for the prevention of cancer cachexia and in lipodystrophy syndrome. The product is approved to treat hypertension in Japan and some European countries. It was in-licensed by Ark, complete with all the existing data, enabling the company to take it straight into Phase III trials in cancer cachexia, an indication in which the drug has FDA fast-track status.

The use of the drug in preventing cachexia draws on Ark's discovery of the role of the renin-angiotensin system in controlling the ability of mitochondria to generate energy. Cancer cachexia is caused when cytokines are released that interfere with energy production by mitochondria. Ark discovered that the subsequent breakdown of actin and myosin in muscle cells is mediated by angiotensin II.

Ark applied for the patent in 1999. It has been granted in Australia, Singapore and China, and the company expects it to be granted soon in the U.S and Europe.