PPD Announces Takeda to Conduct Additional Study for Alogliptin MAA in the EU
Takeda to postpone MAA submissions for alogliptin and alogliptin/ACTOS
WILMINGTON, N.C. (June 3, 2009) - PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited has notified the European Medicines Agency, or EMEA, that it will postpone its marketing authorization applications (MAA) for alogliptin (SYR-322) and alogliptin/ACTOS (SYR-322-4833), originally planned for mid-2009, because it is initiating a long-term clinical trial for alogliptin.
The additional two-year study is to evaluate the efficacy and safety of alogliptin compared to glipizide when used in combination with metformin in subjects with type 2 diabetes, whose blood sugar level is inadequately controlled with metformin. Takeda believes alogliptin and alogliptin/ACTOS could be valuable new options for type 2 diabetes patients, especially when weight gain or hypoglycaemia is of concern.
Due to Takeda's decision to postpone its MAA submissions, PPD is no longer forecasting the receipt of the $10.0 million MAA acceptance milestone payment from Takeda in 2009. Takeda's target timing for the MAA submissions is now 2012.
Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda's wholly-owned U.S. subsidiary, Takeda San Diego, Inc.
PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 38 countries and approximately 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients. For more information, visit our Web site at http://www.ppdi.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release, including expectations and assumptions relating to PPD's financial guidance for 2009 and the prospects for regulatory approval of alogliptin in Europe, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause results to differ materially include the following: risks associated with the development and commercialization of drugs, including obtaining regulatory approvals; risks associated with and dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; competition in the development and commercialization of DPP-4 inhibitors; the ability to attract and retain key personnel; continued success in sales growth; loss of large contracts; increased cancellation rates; economic conditions and outsourcing trends in the pharmaceutical, biotechnology, medical device, academic and government industry segments; competition within the outsourcing industry; risks associated with acquisitions and investments, such as impairments; risks that we may not continue our dividend policy; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.