WILMINGTON, N.C., Nov. 19 /PRNewswire-FirstCall/ -- PPD, Inc. and privately held Syrrx, Inc. today reported the signing of agreements to jointly develop and commercialize Syrrx-designed human dipeptidyl peptidase IV (DP4) inhibitors as drug products for the treatment of type 2 diabetes and other major human diseases. PPD and Syrrx expect to advance multiple DP4 inhibitors into preclinical and clinical studies with the objective of developing a drug product with a once or twice-a-day oral dosing profile.
Under the terms of the agreements, PPD made a $25 million equity investment in Syrrx convertible preferred stock. PPD also will provide 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 DP4 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.
Studies to date indicate that DP4 plays an important role in regulating insulin levels in the body. In early-stage clinical trials conducted primarily by large pharmaceutical companies, orally-delivered DP4 inhibitors reduced blood glucose and increased insulin response in patients. These data indicate that small-molecule inhibitors that target DP4 could be potential treatments for major human diseases including type 2 diabetes, obesity, high cholesterol and other forms of metabolic syndrome.
Syrrx first reported the atomic level structure details of DP4 in October 2002, and since that time has used the information to design a collection of novel small-molecule DP4 inhibitors. Syrrx believes these compounds may have advantages over currently known DP4 inhibitors undergoing clinical evaluation. Initial efforts of the PPD-Syrrx collaboration will focus on further preclinical studies of these compounds, potentially leading to the initiation of Phase I clinical trials.
"The selection of several DP4 clinical candidates completes Syrrx's transition from a platform company to one that can make potentially meaningful therapeutics," said Stephen W. Kaldor, Syrrx president and chief scientific officer. "I am particularly excited about the speed of our research. We have designed multiple high quality clinical candidates in less than two years and as part of our ongoing research program, we are creating a pipeline of potential DP4 clinical candidates to maximize our chances of capturing the largest possible share of this substantial market opportunity. We look forward to collaborating with PPD on the development of multiple promising candidates."
The PPD-Syrrx collaboration reflects PPD's goal of building a balanced portfolio of partnered compounds that complements the wide variety of integrated discovery and development services that PPD already provides. The alliance is strategic to the medium and long-term goals of PPD. In the near- term, PPD and Syrrx will conduct further preclinical studies of DP4 inhibitors and expect to file an investigational new drug application in the second half of 2004. Based on this objective and the current development plan, PPD anticipates that the earnings dilution associated with its share of the costs during 2004 will be in the range of $.06 to $.08 per diluted share. PPD expects to fund its share of these development costs from existing cash resources.
"PPD entered this collaboration because of Syrrx's promising DP4 inhibitor collection and rational drug discovery capabilities," said Fred Eshelman, chief executive officer of PPD. "We believe this compound partnering transaction will capitalize on our global development expertise and strong balance sheet as well as Syrrx's drug discovery engine. While expected to generate earnings dilution, the collaboration offers PPD the potential for enhanced earnings per share gains in the long-term."
According to the American Diabetes Association, almost 17 million Americans have diabetes. This accounts for approximately six percent of the entire U.S. population, including 20 percent of people over the age of 65. Type 2 diabetes accounts for approximately 90 percent of the diabetes population, with approximately one million new cases of type 2 diabetes diagnosed each year. All these numbers double if pre-diabetics are included. Despite increasing maturity and a high level of generics, the global anti- diabetic market achieved sales of nearly $12.4 billion in 2002.
Diabetes is a lifelong, chronic and often debilitating disease that develops when the body cannot effectively control the level of sugar (glucose) in the blood stream. Most people with type 2 diabetes make insulin, which helps control blood glucose levels, but their bodies are not able to use the insulin effectively. Inhibitors of DP4 have been shown to block the destruction of glucagon-like peptide-1 (GLP-1), which is an important protein the body makes to help insulin work properly. By treating small-molecule inhibitors of DP4, GLP-1 can be spared, blood glucose can be lowered and insulin response can be improved.
PPD and Syrrx will conduct a live conference call and audio Webcast on November 20, 2003, at 11:00 a.m. EST to discuss the collaboration. To access the Webcast, please visit http://www.ppdi.com/ and follow the directions on the PPD investors page. A replay of the Webcast will be available shortly after the call. If you have difficulty accessing the Webcast via the Internet, you may access the teleconference by dialing +800 915 4836.
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 early discovery through post-market resources, the company also offers compound partnering opportunities. PPD has more than 5,600 professionals in 26 countries around the world. For more information on PPD, visit our Web site at http://www.ppdi.com/.
Syrrx is a drug discovery company with a focus on drug targets that have been validated in human clinical trials. Syrrx endeavors to discover and develop pharmaceutical products independently, and with partners. Syrrx exploits its competitive advantage in high-throughput structural biology to determine the three-dimensional structures of known drug targets ahead of competitors. Syrrx then uses the atomic level structural information to drive an iterative, structure-based drug discovery programs to produce drug candidates for the potential treatment of metabolic diseases, cancer, and inflammation. For more information, visit the Syrrx Web site at http://www.syrrx.com/.
Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions about the investment in and collaboration with Syrrx and promise and value of any potential compounds resulting from the collaboration, contained in this news release are forward- looking statements that involve a number of risks and uncertainties. Although PPD and Syrrx attempt 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 actual results to differ materially include the following: risks associated with drug development and commercialization; rapid technological advances that make compounds and products from the collaboration less competitive; risks associated with collaborations and investments; dependence on collaborative relationships and collaboration parties; the ability of the collaboration parties to attract and retain key personnel; economic conditions in the pharmaceutical industry; competition within the pharmaceutical industry; success in obtaining drug approval and sales; 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.
For Syrrx For PPD
Keith P. Wilson, Ph.D. Nancy Zeleniak
+858 731 3684 +919 462 4088
Jean Lockhart Steve Smith
+858 731 3512 +910 772 7585
CONTACT: media, Keith P. Wilson, Ph.D., +1-858-731-3684, orkeith.Wilson@syrrx.com, or analysts - investors, Jean Lockhart,+1-858-731-3512, or firstname.lastname@example.org, both of Syrrx, or media, NancyZeleniak, +1-919-462-4088, or email@example.com, or analysts -investors, Steve Smith, +1-910-772-7585, or Stephen.firstname.lastname@example.org, bothof PPD, Inc.