PPD, Inc. 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.
Contact:
PPD, Inc.
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.
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.
Contact:
PPD, Inc.
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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