PPD, Inc. 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.
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
Source: PPD, Inc.
“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.
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
Source: PPD, Inc.
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