Alliance between the firms began in June 2005.
Vitae Pharmaceuticals has reacquired full rights to its renin inhibitor program from GlaxoSmithKline. The companies inked a deal in June 2005 vaued at $175 million to develop and commercialize novel renin inhibitor drug compounds for the treatment of hypertension and related cardiovascular disorders.
When the original deal was inked, GSK was financially responsible for development, while IP was pooled from both firms. Now, Vitae owns all the related IP, reports Jeffrey S. Hatfield, CEO of Vitae.
The renin inhibitor program, which was in the lead optimization phase when GSK signed on as a partner, now has a lead compound, which will undergo GLP tox studies in the first quarter of 2009. The candidate is expected to enter the clinic in the latter half of that year, Hatfield says.
“Renin continues to be a much sought-after target, and our team has been one of the few that has been able to generate highly potent and bioavailable inhibitors that we believe will lead to important drug candidates in this large market.” The program will target hypertension, diabetic nephropathy, congestive heart failure, and related cardiovascular indications.
Hatfield believes that the company is financially strong enough to independantly advance the lead compound into the clinic up to the completion of Phase I trials. The firm will then consider repartnering the drug, notes Hatfield who adds that there are already several interested parties.
GSK returned rights to this program after announcing a refocussed R&D strategy in July, around the time of CEO transition, points out Hatfield. Cardiovascular disease was not outlined as one of the priorities by Andrew Witty, the newly appointed CEO. Vitae and GSK began discussions in spring to faciliate a smooth transition of assets back to Vitae.