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
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