West Coast Editor

Talk about making the pulse race: Privately held Vitae Pharmaceuticals Inc., with its renin inhibitor program still in the preclinical stage, nailed down a potential $175 million deal with GlaxoSmithKline plc to develop drugs for hypertension and related cardiovascular disorders.

Under the terms, Vitae gets an up-front payment comprised of cash and an equity investment, along with funding of research and payments as milestones are reached, plus royalties on any resulting compounds. Vitae retains the right to co-promote products.

Jeff Hatfield, CEO of Fort Washington, Pa.-based Vitae, said London-based GSK prohibited him from being more specific about the agreement, "but I believe we will be able to, in about 30 days or so, give more detail about the equity investment, because GSK is the lead investor in our Series C. It's linked to the deal, and we need the deal to clear the regulatory hurdles."

Formerly known as Concurrent Pharmaceuticals Inc., privately held Vitae changed its name and raised $34 million in equity financing at the start of the year to boost its renin inhibitors, which now will be pooled with GSK's compounds in the same area, as the firms collaborate to select which ones to work on further. (See BioWorld Today, Jan. 5, 2005.)

At the time of the fund raising, Vitae said it had two years to three years of cash.

"We knew that we would be working toward a deal in renin," Hatfield said. "We're probably looking toward the three-year end of the runway [now], based on the quality of this deal."

The kidney enzyme renin induces vascular constriction and strengthens vascular resistance, thus pushing blood pressure higher. By suppressing the renin-angiotensin system, and working farther upstream in the pathway than currently available therapies, renin inhibitors knock the blood pressure down while reducing plasma renin activity and sparing damage to other organs.

"I think it's safe to say that any pharmaceutical company you've heard of has had a renin program on or off for the past 30 years," Hatfield noted, calling renin "the very first and rate-limiting step" in blocking the cascade that causes high blood pressure.

"Virtually all of the big pharmas ended with nothing for years," he said. "Eventually people moved downstream and we got ACE inhibitors. It's a very effective step in the cascade."

Next came angiotensin receptor blockers, "great products, very successful commercially," Hatfield said. "But it's never escaped the pharmaceutical industry's sights that renin is the preferred target."

Vitae "started discussions with partners toward the end of last year," he told BioWorld Today. "We had several big pharma companies express interest." Vitae and GSK soon developed a "mutual respect for each others' prowess" - and Vitae knew it needed a heavy hitter to fund large studies necessary to advance renin inhibitors, Hatfield said.

"Our strategy is to partner when it's appropriate, and renin makes sense to partner now, as opposed to much further down the line," he said. "We have no rule that says we'll partner everything."

Vitae's pipeline also includes a lymphoma compound, a drug for neutropenia and a topical agent for psoriasis.

"It's not fair to say which one is our favorite," Hatfield said. "They're all making their way toward the clinic."

The renin program, he noted, "was purely created by the drug discovery engine we had within the company," and went from concept to proof of concept in animals in 12 months, putting Vitae "at the forefront of a trend which is really important right now, [which is] to execute on rapid product creation."