Navigation Links
PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration
Date:2/28/2008

Triggers $15 million milestone payment

WILMINGTON, N.C., Feb. 28 /PRNewswire-FirstCall/ -- PPD, Inc. (Nasdaq: PPDI) today confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, has been accepted for filing by the U.S. Food and Drug Administration. PPD partnered with Takeda to develop the compound.

Under PPD's agreement with Takeda, the FDA's acceptance of the NDA filing triggers a $15 million milestone payment to PPD. This milestone payment was included in PPD's previously issued 2008 financial guidance.

"We are pleased to partner with Takeda, one of the leading pharmaceutical companies in the area of diabetes," said Fred Eshelman, PPD's chief executive officer. "We are also delighted that this important regulatory milestone has been achieved as a result of close cooperation between Takeda and our company."

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 30 countries and more than 10,200 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 alogliptin NDA filing with the FDA, subsequent milestone payments for regulatory approvals for alogliptin, if any, the continued development and commercialization of this drug candidate and the value of this collaboration with Takeda, 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; 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; 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.

Contacts

Media:

Sue Ann Pentecost

+919 456 5890

sueann.pentecost@rtp.ppdi.com

Analysts/Investors:

Craig Eastwood

+910 558 7585

craig.eastwood@wilm.ppdi.com


'/>"/>
SOURCE PPD, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Barr Confirms Patent Challenge of Avodart(R) Soft Gelatin Capsules, 0.5mg
2. Icahn Confirms Intention to Nominate Three Directors at Biogen
3. Barr Confirms Patent Challenge of Namenda(R) Tablets, 5mg & 10mg
4. Barr Confirms Patent Challenge of Eloxatin(R) Injectable, 5mg/mL
5. Barr Confirms Patent Challenge of Focalin(R) XR
6. Recent Study Confirms Alimentary Healths Bifantis(R) Demonstrates Efficacy in the Treatment of Irritable Bowel Syndrome
7. Study Published in Clinical Cancer Research Confirms Potential Of Peregrines Bavituximab Combined With Radiation In Lung Cancer
8. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
9. Durameds Lo SEASONIQUE(R) NDA Accepted for Filing by FDA
10. Attagenes Breakthrough Transcription Factor Profiling Technology to be Described in Nature Methods
11. Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2017)... CITY, MISSOURI (PRWEB) , ... July 13, 2017 ... ... has earned URAC accreditation in Specialty Pharmacy. URAC is the independent leader in ... Biologics has demonstrated a comprehensive commitment to quality care, improved processes and better ...
(Date:7/13/2017)... ... July 13, 2017 , ... FireflySci Inc. started ... Blast forward seven years and now they are home to a tremendous line ... wavelength accuracy, and resolution testing. , One mega advantage that FireflySci ...
(Date:7/13/2017)... , ... July 13, 2017 , ... ... programs at Philadelphia’s University City Science Center, Christopher Laing, MRCVS, Ph.D. has been ... Austin, Texas. Dr. Laing will become the first Executive Director at the ...
(Date:7/13/2017)... ... July 13, 2017 , ... Microscan , the number-one brand ... sciences, will demonstrate advancements of the MicroHAWK platform for barcode reading and machine vision, ... at the AACC Clinical Lab Expo, taking place on August 1–3 in San Diego, ...
Breaking Biology Technology:
(Date:5/16/2017)... --  Bridge Patient Portal , an enterprise patient ... Systems , an electronic medical record solutions developer ... a partnership to build an interface between the ... products, including Centricity Practice Solution (CPS), Centricity Business ... integrations will allow healthcare delivery networks using GE ...
(Date:4/17/2017)... 17, 2017 NXT-ID, Inc. (NASDAQ: NXTD ... filing of its 2016 Annual Report on Form 10-K on Thursday ... ... available in the Investor Relations section of the Company,s website at ... website at http://www.sec.gov . 2016 Year Highlights: ...
(Date:4/11/2017)... No two people are believed to ... York University Tandon School of Engineering and Michigan ... partial similarities between prints are common enough that ... and other electronic devices can be more vulnerable ... in the fact that fingerprint-based authentication systems feature ...
Breaking Biology News(10 mins):