PPD GenuPro Announces Interim Analysis for Phase II
8.09.1999, 11:30
Genitourinary Compound / Collaboration Between PPD and Eli LillyProves Effective Wilmington, N.C. (PROTEXT) - PPD, Inc. (Nasdaq: PPDI) todayreported on the progress of its virtual drug development servicessubsidiary, PPD GenuPro, Inc. GenuPro was established in 1998from 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 aselective serotonin reuptake inhibitor thought to have promisefor treating premature ejaculation. The planned interim analysisrevealed a statistically significant prolongation of ejaculatorylatency compared to placebo. "This trial is the first double-blind placebo-controlled trialto report significant differences from placebo using an objectiveassessment of ejaculatory latency," stated Dr. Karl Thor, chiefscientific officer for GenuPro. "The trial is considered uniquein 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 aprotocol that allows for comparison of parallel verses cross-overtrial design, and determination of each consenting subject'smetabolic enzyme and serotonin transporter genotyping. "We are especially pleased to have interim results providingproof-of- concept clinical data for a condition affecting up to30% of men," stated Dr. Fred Eshelman, chief executive officerfor PPD. "This is a condition for which there is no approvedmedical therapy and the speed and innovation of GenuPro incollaboration with the clinical expertise of PPD Developmentdemonstrates how R&D service organizations can work effectivelywith big pharma in non-traditional ways." PPD is a leading global provider of contract and consultingresearch and development services for pharmaceutical andbiotechnology companies. With a corporate mission to help clientsmaximize the return on their massive R&D investments, PPD offersinnovative technologies, therapeutic expertise and comprehensiveresources for drug discovery, Phase I-IV clinical development andpost-market support. The company employs more than 3,300professionals 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 theCompany's business, are forward looking statements that involve anumber of risks and uncertainties. Although the Company has usedits best efforts to be accurate in making those forward-lookingstatements, it is possible that the assumptions made bymanagement may not materialize. In addition, other importantfactors which could cause results to differ materially includethe following: economic conditions in the pharmaceutical andbiotechnology industries; outsourcing trends in thepharmaceutical and biotechnology industries; risks associatedwith acquisitions; loss of large contracts; competition withinthe CRO industry; continued success in sales growth; the abilityto attract and retain key personnel; and the risk factors setforth from time to time in the Company's SEC filings, copies ofwhich are available upon request from PPD's investor relationsdepartment. 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
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