WILMINGTON, N.C.--(BUSINESS WIRE)-- PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited’s new drug application for NESINA® (alogliptin), a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, was approved by the Japanese Ministry of Health, Labour and Welfare on April 16. PPD’s compound partnering division collaborated with Takeda to develop this product.
Under PPD’s agreement with Takeda, PPD is entitled to a $7.5 million milestone payment from Takeda upon approval of all regulatory and pricing matters in Japan. The approval of the NDA for NESINA noted above constitutes the regulatory approval required for the milestone payment. Upon pricing approval for NESINA in Japan, PPD will be entitled to receive the milestone payment.
“We are pleased that Takeda has received NDA approval for NESINA in Japan,” said Fred Eshelman, executive chairman of PPD. "This approval is an important milestone and confirms our strategy of partnering with pharmaceutical companies such as Takeda to bring new therapies to market.”
As previously announced, PPD expects to complete the spin-off of its compound partnering business as Furiex Pharmaceuticals, Inc., by mid-2010. Furiex Pharmaceuticals will operate as an independent, publicly traded company.
PPD is a leading global contract research organization, celebrating 25 years of providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 41 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit 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 pricing approval for NESINA® and the potential sales thereof if approved, 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 and pricing approvals; risks associated with and dependence on collaborative relationships; rapid technological advances that make our or our partners’ products less competitive; competition in the pharmaceutical industry; economic conditions and outsourcing trends in the pharmaceutical, biotechnology, medical device, academic and government industry segments; 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.
KEYWORDS: United States Asia Pacific North America North Carolina Japan
INDUSTRY KEYWORDS: Technology Data Management Health Biotechnology Clinical Trials Pharmaceutical