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Transpharma-Medical To Announce Promising Results of Clinical Trials With its
hPTH (1-34) -Transdermal Delivery Product For Osteoporosis Treatment Lod,
Israel (March 29th, 2006) – TransPharma-Medical Ltd., the Israeli-based
specialty pharma company that develops pharmaceutical products based on its
unique RF-MicroChannels™ transdermal drug delivery technology, announces
promising results of first human clinical trials demonstrating transdermal
delivery of human Parathyroid Hormone 1-34 fragment, (hPTH 1-34)for the
treatment of osteoporosis.
The results of the study, presented at IIR's Drug Delivery Partnerships 2006
conference held in London, prove systemic delivery of therapeutic dosages of
bioactive hPTH (1-34) with relative bioavailability in comparison to sub-cutaneous
administration of over 50%. These results show the ability to deliver the
required hPTH (1-34) dose via TransPharma’s pen size system incorporating a 1cm2
small patch.
The patch utilized in the study is TransPharma’s proprietary dry protein
patch developed particularly for the ViaDerm system. Scientists at TransPharma
have formulated hPTH (1-34) into a stable printed dry-form patch that allows for
the hPTH (1-34) to deliver into the patients’ systemic circulation with a peak
blood profile. Analysis of two biomarkers (ionized calcium and phosphorus)
confirmed that the bioactivity of the delivered hormone was fully maintained.
The ViaDerm delivery system incorporates a device, which creates microscopic
passageways through the outer layer of the skin allowing for therapeutic
administration of a wide variety of drugs from a patch. This device designed to
deliver the Teriparatide is a hand-held pen-size unit, which provides a
painless, very low-cost, easy to use application.
According to Dr. Daphna Heffetz, CEO of TransPharma, "the results of this
trial demonstrate TransPharma's ability to deliver transdermally a state of the
art peptide-molecule for osteoporosis treatment, with our proven ViaDerm
delivery system, thus improving patients quality of life."
Over the next five years, the osteoporosis population is expected to reach 52
million, with an anticipated market potential of $10.4 billion by 2011. The hPTH
(1-34) which is the only anabolic (capable of bone building) osteoporosis
drug-molecule is currently being administered by injection only and is expected
to reach $3 billion sale in 2010. The osteoporosis market is underserved and is
open for emerging products to provide better efficacy and more patient friendly
administration routes. Thus, we are expecting TransPharma's breakthrough
technology to be in high demand.
Dr Heffetz adds that the "the very high bioavailability of the drug together
with a low cost system has great potential to lead to extremely high gross
margins when the product reaches the market."
Currently, TransPharma plans to continue the development of hPTH (1-34) to
late stage clinical trials, when they plan to strategically ally with a major
pharmaceutical company who can bring this product to the market. Parallel to its
own development pipeline, TransPharma plans to continuously develop products in
collaboration with other companies similar to the collaboration agreement signed
with Teva Pharmaceuticals in 2004.
About TransPharma
Established in 2000, TransPharma Medical Ltd. is a specialty pharma company
focusing on the development and commercialization of pharmaceutical products
utilizing RF- MicroChannel technology. TransPharma's technologies are aimed to
increase the portfolio of drugs delivered via a patch. TransPharma has developed
a unique and clinically proven transdermal drug delivery system, ViaDerm™. The
system is based on TransPharma's RF-MicroChannels™ technology which creates
microscopic passageways through the outer layer of the skin allowing for
therapeutic administration of a wide variety of drugs from a patch. Currently,
available systems are limited to delivery of small-size drug molecules. ViaDerm™
overcomes these limits, enabling delivery of a large variety of drugs including
proteins in a pain-free, low-cost, user friendly manner. The system was
successfully tested in human clinical studies, using both small molecules and
large molecules. For more information, visit the company's website at
www.transpharma-medical.com.
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For more information please contact:
Judith Kornfeld
Vice President of Business Development
judithk@transpharma.co.il
Office: +972-8-9152201
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