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PPD, Inc. (PPDI) And Syrrx, Inc. File Investigational New Drug Application For DPP IV Inhibitor To Treat Type II Diabetes


10/19/2005 5:11:50 PM

WILMINGTON, N.C., and SAN DIEGO, Oct. 13 /PRNewswire-FirstCall/ -- PPD, Inc. and privately held Syrrx, Inc. today announced the submission of an investigational new drug (IND) application for a Syrrx- designed human dipeptidyl peptidase IV (DPP IV) inhibitor for the treatment of type II diabetes. Pending FDA review, Phase I studies could begin in late October.

The IND was submitted within the time-frame objective originally set by the parties when they signed a collaboration agreement in November 2003 to jointly develop and commercialize Syrrx-designed DPP IV inhibitors for the treatment of diabetes and other human diseases.

"We are pleased to have submitted our first DPP IV inhibitor IND application on schedule in less than 30 months from our first experiments on this target," said Stephen W. Kaldor, Syrrx president and chief scientific officer. "Our compound exhibits excellent potency and selectivity for DPP IV, along with superb oral bioavailability and an encouraging safety profile. We believe DPP IV is an attractive, clinically validated target and think our inhibitor has the potential to be a best-in-class drug in the large and growing diabetes market."

Studies to date indicate that DPP IV plays an important role in regulating insulin levels in the body. In early-stage clinical trials conducted primarily by large pharmaceutical companies, orally-delivered DPP IV inhibitors reduced blood glucose and increased insulin response in patients. These data indicate that small molecule inhibitors that target DPP IV could be potential treatments for human diseases including type II diabetes, obesity, high cholesterol and other forms of metabolic syndrome.

PPD and Syrrx expect to advance additional DPP IV inhibitors into preclinical and clinical studies with the objective of developing a drug product with a once-a-day oral dosing profile. The two companies anticipate submitting an IND application for a second compound soon.

"The compound partnering collaboration between Syrrx's efficient research engine and PPD's global development expertise is working well," said Fred Eshelman, chief executive officer of PPD. "We look forward to implementing an aggressive development plan to progress the compound and will look for ways to collaborate on additional drug discovery targets to sustain our momentum."

Under the terms of the agreements announced in November 2003, PPD made an equity investment in Syrrx, is providing preclinical and clinical development resources and expertise for the collaboration, and will fund the majority of preclinical and clinical studies through Phase IIb development of selected DPP IV inhibitors. PPD and Syrrx have agreed to share equally the costs of Phase III development. In addition, PPD will make milestone payments to Syrrx upon the occurrence of certain clinical and regulatory events. In the event of approval to market a drug product, PPD and Syrrx will share equally the profits from drug sales.

According to the American Diabetes Association, nearly 18.2 million Americans have diabetes, representing approximately 6.3 percent of the entire U.S. population. Type II diabetes accounts for about 90 percent of the diabetes population, with approximately one million new cases of type II diabetes diagnosed each year. All these numbers double if pre-diabetics are included. The global anti-diabetic market achieved sales of nearly $12.4 billion in 2002. Med Ad News projects an aging and increasingly obese population will spur the market for type II diabetes drugs to $20.5 billion by 2012.

About PPD

As a leading global provider of discovery and development services and products for pharmaceutical, biotechnology and medical device companies, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients maximize the return on their R&D investments. With proven discovery through post-market resources, the company also offers compound partnering opportunities. PPD has more than 6,300 professionals in 27 countries around the world. For more information on PPD, visit our Web site at http://www.ppdi.com/ .

About Syrrx

Headquartered in San Diego, Calif., privately held Syrrx, Inc. focuses on drug targets that have been validated in human clinical trials and directs its efforts toward therapeutics to treat cancer, metabolic diseases and inflammation. Syrrx exploits its competitive advantage in high-throughput structural biology to be the first organization to determine the three- dimensional structure of known drug targets. Syrrx then uses these structures to drive iterative, structure-based drug design programs to efficiently generate drug candidates. Syrrx has an ongoing partnership with PPD for the joint development and commercialization of Syrrx-designed human dipeptidyl peptidase IV (DPP IV) inhibitors as drug products for the treatment of type II diabetes and other major human diseases. Syrrx also recently established a strategic alliance with Roche for the discovery and early development of inhibitors targeting human HDACs and HSD1, and announced multiple success milestones in a technology-based alliance with Biogen-Idec. For more information, please consult http://www.syrrx.com/ .

Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions about the commencement of Phase I studies, the filing of additional IND applications, the collaboration with Syrrx and the promise and value of any potential compounds developed under the collaboration, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making those 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: delay in or failure to obtain necessary regulatory approvals; rapid technological advances that make our products less competitive; dependence on collaborative relationships; risks associated with drug development; economic conditions in the pharmaceutical and biotechnology industries; risks associated with investments; loss of large contracts; competition within the drug development industry; the ability to attract and retain key personnel; 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: For Syrrx For PPD Media: Media: Keith P. Wilson, Ph.D. Nancy Zeleniak +858 731 3684 +919 462 4088 keith.wilson@syrrx.comnancy.zeleniak@rtp.ppdi.com Analysts/Investors: Analysts/Investors: Jean Lockhart Steve Smith +858 731 3512 +910 772 7585 jean.lockhart@syrrx.comstephen.smith@wilm.ppdi.com

PPD, Inc.

CONTACT: Media, Nancy Zeleniak, +1-919-462-4088, ornancy.zeleniak@rtp.ppdi.com , or Investors, Steve Smith, +1-910-772-7585, orstephen.smith@wilm.ppdi.com , both of PPD, Inc.; or Media, Keith P. Wilson,Ph.D., +1-858-731-3684, or keith.wilson@syrrx.com , or Investors, JeanLockhart, +1-858-731-3512, or jean.lockhart@syrrx.com , both of Syrrx, Inc.


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