In 2008, Solvias conducted initial process R&D studies for the VTP-27999 API, conducting analytical and solid-state chemistry development and supplying API for preclinical studies. Several process improvements were successfully achieved during the development program, which has significantly improved the cost, purity and ease of synthesis of this API.

Vitae is developing VTP-27999 as an orally available renin inhibitor for the management of hypertension and end-organ protection. Renin is the first and rate-limiting step in the renin-angiotensin system (RAS), the primary biochemical pathway for regulating blood volume, arterial pressure and vascular function. In addition to systemic activity, RAS impacts critical organs at a tissue level throughout the body, such as the heart, brain and kidney. Therefore, in addition to controlling blood pressure, compounds that directly inhibit renin are expected to offer improved end organ protection, with the potential to improve patient outcomes. Vitae anticipates initiating a multiple ascending dose Phase 1 study of VTP-27999 by mid-2010.

“The Solvias process development and solid state teams improved Vitae’s original process by optimizing yields, minimizing impurities and streamlining the route for synthesis of our renin inhibitor,” said Richard Gregg, Chief Scientific Officer of Vitae Pharmaceuticals. “The Solvias GMP facility enables us to significantly improve our timelines by eliminating the need for tech transfer between process optimization and GMP manufacturing. The quality, capability and our confidence in Solvias led us to choose them for this critically important work.”

“We are pleased to extend our collaboration with Vitae Pharmaceuticals and to support the development and manufacturing of VTP-27999 in anticipation of Phase 2 clinical studies,” stated Stephan Haitz, Executive Vice President of Solvias. “Vitae Pharmaceuticals is a valuable customer for Solvias and to be awarded this GMP manufacturing and analytical development contract underlines the attractiveness of our integrated service offerings to such innovative companies.”

Solvias’ SwissMedic-approved GMP kilolab facility complements the existing kilolab infrastructure and provides rapid, cost-effective manufacturing of materials for use in Phase 1/2a clinical programs. The facility is equipped with state-of-the-art 30L to 100L multipurpose reactors capable of running a wide range of reactions from -85°C to +160°C and includes a segregated finishing area.

About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical-stage biopharmaceutical company building a portfolio of novel, small molecule, best-in-class compounds that address large markets, including hypertension, diabetes and Alzheimer’s disease. Vitae’s pipeline of programs focuses on high-value, hard-to-drug targets, integrating a proprietary, structure-based drug design platform with the experience and insights of a world-class R&D team.

The company’s lead compound, VTP-27999, is a novel, potent and selective renin inhibitor designed to offer a superior therapeutic profile, most importantly, improved end organ protection, compared to current antihypertensives. In addition, Vitae is rapidly advancing programs against two key therapeutic targets: 11beta-hydroxysteroid dehydrogenase (HSD)-1 for the treatment of diabetes and other metabolic diseases, and beta-secretase (BACE) for the treatment of Alzheimer’s disease. Vitae has partnered with Boehringer Ingelheim for both 11beta-HSD-1 and BACE.

Vitae is located in Fort Washington, Pennsylvania. For more information on Vitae, please visit the company’s website at www.vitaepharma.com.