PPD Confirms Takeda's NDA Submission Of Alogliptin And ACTOS(R) To U.S. FDA - Single Tablet For Diabetes Type 2

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Sep 2008 - 8:00 PST

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PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited has submitted a new drug application to the U.S. Food and Drug Administration for marketing approval of alogliptin (SYR-322) and ACTOS® (pioglitazone HCl) in a single tablet for the treatment of type 2 diabetes.

"We are very pleased with Takeda's progression of the development of alogliptin/ACTOS," said Fred Eshelman, PPD's chief executive officer. "If approved by the FDA, this product would be the first type 2 diabetes treatment option that includes a DPP-4 inhibitor and a thiazolidinedione, or TZD."

Under PPD's agreement with Takeda, the submission of the NDA for alogliptin/ACTOS does not trigger a milestone payment to PPD. If the NDA is approved by the FDA, PPD will be entitled to receive royalties on sales of this product.

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 31 countries and more than 10,400 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 about the NDA submission to the U.S. FDA and regulatory approval for alogliptin/ACTOS®, 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 approval(s); risks associated with and dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; 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; the ability to attract and retain key personnel; 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.

PPD, Inc.