Solvias AG and Vitae Pharmaceuticals, Inc. announce GMP manufacturing agreement

02-10-2010: Solvias AG and Vitae Pharmaceuticals announced the companies have entered into an agreement for the manufacturing of the active pharmaceutical ingredient (API) for Vitae's lead product candidate, VTP-27999. Solvias will provide ongoing process R&D support and deliver the VTP-27999 API, produced in its new GMP-approved API manufacturing facility, for use in planned Phase 2 clinical studies.

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.