BioWorld International Correspondent

The progress of Aliskiren, an oral renin inhibitor in development for hypertension, triggered an undisclosed milestone payment from Novartis AG to The Speedel Group, while Novartis also decided to take an equity position in Speedel.

"Novartis Venture Fund was an original shareholder in Speedel," said Speedel's director of communications and investor relations, Nick Miles. "This is the first time the pharma side of the business has come in."

Details of the equity investment were not disclosed, but Speedel's founders and employees remain the company's largest shareholders, Miles said. The deal cements the relationship between the Basel, Switzerland-based companies, which is based on Aliskiren. Novartis discovered the compound and out-licensed it to Speedel, which took it through initial clinical development. Novartis then exercised a callback option in 2002. The molecule recently entered a Phase III trial as a monotherapy and a Phase IIb trial in combination with the Novartis hypertension drug Diovan.

Aliskiren is designed to block the renin angiotensin system cascade, which leads to the production of angiotensin II, a peptide hormone responsible for constricting blood vessels. Renin catalyzes the initial, rate-limiting step in the pathway, but previous efforts to generate renin inhibitors foundered on poor bioavailability and production difficulties.

The product is expected to provide benefit "over and beyond current therapy," Miles said, although it is not yet clear whether it would be available as monotherapy or as a combination therapy. "In terms of positioning it, that's very much Novartis' call," he added.

Speedel's second most advanced development candidate, SPP301, an oral endothelin receptor A antagonist, is nearing the end of a Phase II trial in an undisclosed indication. The company expects to report data later this year, Miles said. Recruitment has commenced for a Phase II trial of SPP200, which is partnered with an unnamed U.S. pharmaceutical firm. "We would hope to get that trial finished toward the end of next year," Miles said.

Behind those are three preclinical renin inhibition projects. The company aims to move at least one into the clinic in the near term. Speedel licensed F. Hoffmann-La Roche Ltd.'s programs in that area two years ago and has been building up its research and preclinical development arm, Speedel Experimenta, which now has 25 scientific staff members.

"The goal of that investment is actually to create de novo our own IP," Miles said. "The long-term intention is to build the capability beyond renin, that's for sure, but always within the cardiovascular and metabolic space."

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