-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NwYunqjNojlkDhwazQK/yPZZwEwz9oJO333FLacNW1KRZXRNCcFnPK+E5FEaUUjb kF8bF88baONYAIIHifZdRw== 0001193125-08-046206.txt : 20080304 0001193125-08-046206.hdr.sgml : 20080304 20080304145217 ACCESSION NUMBER: 0001193125-08-046206 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080228 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080304 DATE AS OF CHANGE: 20080304 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PHARMACEUTICAL PRODUCT DEVELOPMENT INC CENTRAL INDEX KEY: 0001003124 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 561640186 STATE OF INCORPORATION: NC FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27570 FILM NUMBER: 08663178 BUSINESS ADDRESS: STREET 1: 929 NORTH FRONT STREET CITY: WILMINGTON STATE: NC ZIP: 28401 BUSINESS PHONE: 9102510081 MAIL ADDRESS: STREET 1: 929 NORTH FRONT STREET CITY: WILMINGTON STATE: NC ZIP: 28401 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) February 28, 2008

 

 

PHARMACEUTICAL PRODUCT DEVELOPMENT, INC.

(Exact name of registrant as specified in its charter)

 

 

North Carolina

(State or other jurisdiction of incorporation)

 

0-27570   56-1640186
(Commission File Number)   (IRS Employer ID Number)

929 North Front Street, Wilmington, North Carolina 28401

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (910) 251-0081

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01. Other Events.

On February 28, 2008, Pharmaceutical Product Development, Inc. issued a press release confirming that Takeda Pharmaceutical Company Limited’s new drug application for alogliptin has been accepted for filing by the U.S. Food and Drug Administration. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

  

Description

99.1

   Press release, dated February 28, 2008.

 

2


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  PHARMACEUTICAL PRODUCT DEVELOPMENT, INC.
Date: March 4, 2008  
 

/s/ Daniel G. Darazsdi

  Daniel G. Darazsdi,
  Chief Financial Officer

 

3

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

EXHIBIT 99.1

 

  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

FOR IMMEDIATE RELEASE

PPD Confirms Takeda’s NDA Filing of Alogliptin

with U.S. Food and Drug Administration

Triggers $15 million milestone payment

WILMINGTON, N.C. (February 28, 2008) – 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.

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