Compound Pipeline

PPD uses its scientific expertise and resources for early compound assessment and development within a proven, innovative compound partnering program. We are currently advancing several partnered programs and continue to pursue and evaluate other compound partnering opportunities.

Priligy™ (dapoxetine), Partnered with Johnson & Johnson

In February 2009, Johnson & Johnson received regulatory approvals for Priligy (dapoxetine) in Finland and Sweden, generating milestone payments to PPD, followed by approvals in Portugal, Austria, Germany, Spain and Italy. Priligy is the first approved prescription treatment designed specifically to treat premature ejaculation. Once the drug is marketed and sold, PPD will be entitled to receive royalties on sales and milestones on the achievement of specified sales levels.

The approvals follow the positive outcome of a decentralized marketing authorization procedure in these seven European Union countries.

Alogliptin, Partnered with Takeda Pharmaceutical Company Limited

In October 2008, the U.S. Food and Drug Administration (FDA) announced it would not complete its review of Takeda's new drug application (NDA) for alogliptin by the Prescription Drug User Fee Act (PDUFA) date because of insufficient FDA resources. The FDA subsequently set a new PDUFA date in second quarter 2009. In addition to the U.S. regulatory review, Takeda submitted an NDA for alogliptin to Japan's Ministry of Health, Labour and Welfare in September 2008, triggering a milestone payment to PPD.

If approved, alogliptin will be one of a new class of drugs for the treatment of type 2 diabetes. PPD's collaboration with Takeda to develop alogliptin demonstrates the effectiveness of PPD's compound partnering program in accelerating the drug development process. PPD took the compound from lead optimization to NDA submission in a total of 49 months, trouncing traditional development timelines. If approved and marketed, PPD will be entitled to receive milestone payments and royalties on drug sales.

Alogliptin, in Combination with Actos®, Partnered with Takeda

Takeda submitted an NDA to the FDA in September 2008 for marketing approval of alogliptin and ACTOS (pioglitazone HCl) in a single tablet for the treatment of type 2 diabetes. If approved, this will be the first type 2 diabetes treatment option that includes a DPP-4 inhibitor and a thiazolidinedione, or TZD, and PPD will be entitled to receive royalties on the product's sales.

DPP-4 inhibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. ACTOS is a TZD that directly targets insulin resistance, a condition in which the body doesn't efficiently use the insulin it produces to control blood glucose levels. By combining these two medications, it is expected that patients with type 2 diabetes will be able to control their blood glucose levels more effectively.

SYR—472, Partnered with Takeda

Takeda is developing SYR—472, a follow–on DPP–4 inhibitor for the treatment of type 2 diabetes. The compound is currently in Phase II.

PPD10558

PPD continues to seek a commercialization partner for its novel statin, for which the company acquired an exclusive worldwide license from Ranbaxy Laboratories, Ltd., in 2007 to develop, manufacture and market for the treatment of dyslipidemia. After conducting additional preclinical studies, PPD filed an investigational new drug (IND) application with the FDA and completed five clinical studies. The drug was well tolerated, and a preliminary review of results suggested it compares favorably to statins currently marketed.