Dueling with diabetes

FORT WASHINGTON, Pa.—Vitae Pharmaceuticals Inc. and German company Boehringer Ingelheim recently joined forces to develop and commercialize 11beta-HSD1 inhibitors, in an effort that will combine their respective 11beta-HSD1 programs to identify and advance candidates for clinical development. Compounds which inhibit 11beta-HSD1, an enzyme involved in cortisol production, may have utility in the treatment of diabetes and corresponding metabolic syndrome-related diseases, the companies report.

"Vitae began work on this as a target in 2006 and we have found it a very interesting target for diabetes and other indications as well," says Jeffrey Hatfield, CEO of Vitae. "In animal models and preliminary human data, we have found that 11beta-HSD1 has a positive effect on lipids and potentially blood pressure and obesity, which are co-morbidities of diabetes. What physicians are looking for these days are not only safe medications but also things that have a positive overall effect on a patient's condition. Other diabetes medications have often had positive effect on blood glucose but negative effects elsewhere."

Already conducting a successful lead program in rennin inhibition for treatment of hypertension, which benefitted from a collaboration deal with GlaxoSmithKline in 2005, Vitae saw signs that its new program in diabetes was showing great promise, Hatfield says, with multiple series of potent, selective and patently distinct molecules that are in later-stage in vivo studies.

"We saw this program as being on a fast track to the clinic and of high potential to physicians and patients, and it seemed that with the likely scope of near-future clinical programs, we were going to expand rapidly," Hatfield notes, "We wanted some more resources and scientific horsepower and that led us to Boehringer Ingelheim."

One of the reasons Boehringer Ingelheim led the list of potential partners, Hatfield says, is because it has a very strong interest in diabetes and metabolic disease.
"There are a number of companies interested in these two areas but Boehringer Ingelheim has a particularly exceptional set of skills and commitment to deliver good products into the marketplace," he says. "This is a company to watch in diabetes and metabolic disease and that's a strong reason to partner with them."

Under the terms of the deal, Vitae will receive $36.5 million from Boehringer Ingelheim, comprising upfront cash, an equity investment in Vitae and research funding. In addition, Vitae will be eligible to receive up to $300 million in milestone payments based on the achievement of development, regulatory and commercial program goals. Further milestone payments may be achieved with additional compounds or additional approved indications. Vitae will receive royalty payments from Boehringer Ingelheim on all potential future product sales.

Boehringer Ingelheim will lead development and commercialization of products, but Vitae will have the right to develop products independently for certain indications.

"Boehringer Ingelheim looks forward to collaborate with Vitae to complement its own diabetes pipeline development activities by combining resources on this exciting target," said Dr. Andreas Barner, vice chairman of the board of managing directors of Boehringer Ingelheim, in a news release about the deal. "We are using our overall expertise in metabolic research, drug development and commercialization to strengthen our current metabolic portfolio and lead to advances for patients suffering from these serious debilitating diseases."