PPD Confirms Takeda's NDA Submission Of Alogliptin (highly Selective DPP-4 Inhibitor For The Treatment Of Type 2 Diabetes) In Japan

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 01 Oct 2008 - 5:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

PPD, Inc. (NASDAQ:PPDI) today confirmed that Takeda Pharmaceutical Company Limited has submitted a new drug application for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, to the Ministry of Health, Labour and Welfare in Japan. PPD partnered with Takeda to develop the compound.

"We are very pleased with Takeda's regulatory strategy in Japan and the achievement of this important regulatory milestone for alogliptin," said Fred Eshelman, PPD's chief executive officer. "This milestone supports our compound partnering strategy and commitment to leveraging our clinical expertise to drive long-term shareholder value."

Under PPD's agreement with Takeda, submission of the NDA in Japan triggered a $3 million USD milestone payment to PPD.

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 in Japan and regulatory approvals for alogliptin, 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.