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TransPharma Announces Successful Completion of Phase 2 Trial of ViaDerm-hPTH
(1-34) in Postmenopausal Women with Osteoporosis
Primary and secondary endpoints for efficacy and
safety were met
Phase 2B is expected to begin later this year
Lod, Israel, September 1, 2009 – TransPharma Medical Ltd., a specialty
pharmaceutical company focused on the development and commercialization of drug
products utilizing a proprietary active transdermal drug delivery technology,
announced today the successful completion of the Phase 2A trial of
ViaDerm-hPTH(1-34) which is being developed for the treatment of severe
osteoporosis.
In June 2008, Eli Lilly and Company and TransPharma entered a licensing and
development agreement relating to TransPharma’s ViaDerm-hPTH(1-34) product for
the treatment of severe osteoporosis. As part of this project, TransPharma has
completed a three-month Phase 2A trial for transdermal PTH(1-34). The primary
and secondary endpoints for efficacy and safety were met. The safety endpoints
included a skin safety endpoint for repeated dosing with the ViaDerm system.
More details of the phase 2A study results are expected to be shared during 2010
in one of the leading Osteoporosis conferences. Initiation of a dose-ranging
Phase 2B study to be jointly conducted by Eli Lilly and TransPharma is planned
for later this year.
"We are very pleased with the results of this trial, which demonstrate
remarkable progress in the use of the ViaDerm system in clinical trials," said
Dr. Daphna Heffetz, CEO of TransPharma Medical. "We have met the primary and
secondary endpoints of the phase 2A trial. We are looking forward to the Phase
2B trial, and hope that, in the future, we will be able to improve therapy for
people suffering from osteoporosis by offering an alternative to daily injection
of PTH.”
About ViaDerm Drug Delivery System
TransPharma’s ViaDerm drug delivery system incorporates a handheld electronic
device, which creates microscopic passageways through the outer layer of the
skin allowing for transdermal delivery of a wide variety of drugs from a patch.
The system provides a cost-effective, easy-to-use, self-administered solution
that enables the safe, reproducible and accurate delivery of a broad range of
product candidates, including hydrophilic small molecules peptides and proteins.
About Osteoporosis
Osteoporosis is a debilitating disease that affects an estimated 75 million
people in Europe, the U.S. and Japan. Osteoporosis, which means “porous bone,”
is a disease in which the density and quality of bone are reduced. As the bones
become more porous and fragile, the risk of fracture is greatly increased. The
loss of bone occurs “silently” and progressively and no symptoms are apparent
until the first fracture occurs. The most common fractures associated with
osteoporosis occur at the hip, spine and wrist. The incidence of these
fractures, particularly at the hip and spine, increases with age in both women
and men. Vertebral fractures can result in serious consequences, including loss
of height, intense back pain and deformity.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers --
through medicines and information -- for some of the world’s most urgent medical
needs. Additional information about Lilly is available at www.lilly.com.
About TransPharma Medical
Established in 2000, TransPharma Medical Ltd. is a specialty pharmaceutical
company focused on the development and commercialization of drug products
utilizing a proprietary active transdermal drug delivery technology. The company
aims to develop multiple drug products through strategic partnerships with
leading pharmaceutical companies and through independent product development.
TransPharma is collaborating with Eli Lilly for the development and
commercialization of its ViaDerm-hPTH (1-34) product for the treatment of
osteoporosis currently in Phase 2 clinical studies. For more information, please
visit the Company's website at www.transpharma-medical.com.
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