Takeda to postpone MAA submissions for alogliptin and alogliptin/ACTOS
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.
PPD, Inc.
Media:
Sue Ann Pentecost, 919-456-5890
sueann.pentecost@rtp.ppdi.com
or
Analysts/Investors:
Luke
Heagle, 910-558-7585
luke.heagle@wilm.ppdi.com
