PPD GenuPro Announces Interim Analysis for Phase II

8.09.1999, 11:30

Genitourinary Compound / Collaboration Between PPD and Eli Lilly Proves Effective Wilmington, N.C. (PROTEXT) - PPD, Inc. (Nasdaq: PPDI) today reported on the progress of its virtual drug development services subsidiary, PPD GenuPro, Inc. GenuPro was established in 1998 from a collaboration between PPD and Eli Lilly and Company (NYSE: LLY) to develop compounds for genitourinary conditions. One of the genitourinary compounds being studied, dapoxetine, is in Phase II, proof-of-concept trials. Dapoxetine is a selective serotonin reuptake inhibitor thought to have promise for treating premature ejaculation. The planned interim analysis revealed a statistically significant prolongation of ejaculatory latency compared to placebo. "This trial is the first double-blind placebo-controlled trial to report significant differences from placebo using an objective assessment of ejaculatory latency," stated Dr. Karl Thor, chief scientific officer for GenuPro. "The trial is considered unique in its use of a psychometric instrument to assess the quality-of- life issues related to this condition." The other unique aspects of the study Thor noted are a protocol that allows for comparison of parallel verses cross-over trial design, and determination of each consenting subject's metabolic enzyme and serotonin transporter genotyping. "We are especially pleased to have interim results providing proof-of- concept clinical data for a condition affecting up to 30% of men," stated Dr. Fred Eshelman, chief executive officer for PPD. "This is a condition for which there is no approved medical therapy and the speed and innovation of GenuPro in collaboration with the clinical expertise of PPD Development demonstrates how R&D service organizations can work effectively with big pharma in non-traditional ways." PPD is a leading global provider of contract and consulting research and development services for pharmaceutical and biotechnology companies. With a corporate mission to help clients maximize the return on their massive R&D investments, PPD offers innovative technologies, therapeutic expertise and comprehensive resources for drug discovery, Phase I-IV clinical development and post-market support. The company employs more than 3,300 professionals in 45 offices in 19 countries around the world. Except for historical information, all of the statements, expectations and assumptions contained in the foregoing, including effects of the above noted Phase II study upon the Company's business, are forward looking statements that involve a number of risks and uncertainties. Although the Company has used its best efforts to be accurate in making those forward-looking statements, it is possible that the assumptions made by management may not materialize. In addition, other important factors which could cause results to differ materially include the following: economic conditions in the pharmaceutical and biotechnology industries; outsourcing trends in the pharmaceutical and biotechnology industries; risks associated with acquisitions; loss of large contracts; competition within the CRO industry; continued success in sales growth; the ability to attract and retain key personnel; and the risk factors set forth from time to time in the Company's SEC filings, copies of which are available upon request from PPD's investor relations department. ots Original Text Service: PPD, Inc. Internet: http://www.newsaktuell.de Contact: Nancy Zeleniak of PPD, Inc., (USA) 919-462-4088, or Jim Kappel of Eli Lilly & Company, (USA) 317-276-5795 Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT

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