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Our flagship product is ViaDerm-hPTH (1-34), a novel transdermal hPTH (1-34)
product designed to help people manage their osteoporosis by eliminating the
need for daily painful injections. hPTH (1-34), a peptide fragment of PTH which
regulates the metabolism of calcium and phosphate in the body, harbors the same
biological activity as the naturally-occurring, endogenous hormone, hPTH (1-84).
In June 2008, TransPharma Medical and Eli Lilly entered into a licensing
agreement for the development and commercialization of TransPharma’s
ViaDerm-hPTH (1-34) product currently in Phase 2B clinical testing.
As part of the collaboration with Eli Lilly, we have successfully completed a
Phase 2A trial for transdermal hPTH(1-34). The Phase 2A trial was a multi-center
study,randomized, PK/PD, double blinded for two doses of ViaDerm-hPTH(1-34) in
comparison to FORTEO®. One hundred and four post menopausal women with sever
osteoporosis were enrolled and underwent daily administration for 96 days.
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
presented during 2010 in a leading bone conference. A dose-ranging Phase 2B
study, jointly conducted by Eli Lilly and TransPharma, has been initiated.
Transdermal hPTH (1-34) was delivered using TransPharma’s fully integrated
ViaDerm system, which is comprised of a
proprietary pocket-sized device and 1 cm2 dry hPTH (1-34) patch which has
already demonstrated room-temperature stability.
According to the National Osteoporosis Foundation, approximately 10 million
people in the US currently suffer from osteoporosis and another 34 million are
estimated to have low bone mass, placing them at increased risk for the disease.
By 2020, the number of cases of osteoporosis in the US is expected to reach 14
million, with over 47 million cases of low bone mass.
While there are many drugs available on the market for the treatment of
osteoporosis, currently the human parathyroid hormone (hPTH (1-34)) is the only
one to possess anabolic properties, stimulating new bone growth and resulting in
an increase in bone strength and a decrease in fracture risk. It is widely
considered the most effective treatment for osteoporosis; however, it is
currently available only as a daily injection. According to a recent independent
survey, this delivery mechanism is a major barrier to its use and significantly
impedes compliance. Despite this limitation, anabolic agents are projected to be
the fastest growing segment in the US osteoporosis market, reaching $1.24
billion by 2010 at an astounding compound annual growth rate of 52.3%.
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