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TransPharma Receives European CE Mark Approval for its Transdermal Drug
Delivery Device
Lod, Israel, December 15, 2008 – 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 that it received European CE Mark approval for its ViaDerm, a
transdermal drug delivery device.
"We are excited about receiving the European CE approval for our unique
ViaDerm device. This achievement confirms the safety of the ViaDerm device and
brings us closer to offering patients a method for the accurate delivery of
biologics, thus avoiding the need for injections," said Dr. Daphna Heffetz, CEO
of TransPharma Medical.
The device incorporates a reusable, battery-operated handheld electronic
control unit and a disposable microelectrode array that together with a patch
containing a drug comprises the ViaDerm System. Once applied to the skin,
microscopic pores are created utilizing TransPharma's proprietary
RF-MicroChannel technology, which are covered seamlessly with the patch. The
drug is then diffused from the patch, through the microscopic passageways, into
the skin’s inner layers, and from there into the systemic circulation. The
ViaDerm 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.
TransPharma has completed fourteen clinical studies with over 350 subjects,
as well as numerous pre-clinical trials, demonstrating excellent skin
tolerability and efficacious transdermal delivery of various sizes and types of
drug-molecules. The Company's lead product is ViaDerm-hPTH (1-34), a transdermal
hPTH (1-34) drug-product, for the treatment of osteoporosis, currently in Phase
2 clinical studies. This drug-product will enable patients to better manage
their disease by eliminating the need for daily painful injections while easing
handling and administration. In a recent collaboration, TransPharma out-licensed
the ViaDerm-PTH (1-34) to Eli Lilly, and was granted, in return, an upfront
payment of $35 million and may also receive development and sales milestones, as
well as royalties on sales if the product is successfully commercialized.
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 campany
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.
Press Contact:
Tsipi Haitovsky
Media Liaison
TransPharma Medical Ltd.
Tel: +972-52-598-9892
Email: tsipih@netvision.net.il
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