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Release issued 25th April 2009
FOR IMMEDIATE RELEASE
Palm Beach Gardens, Florida
TransDermal Technologies today announced the publication of a peer-reviewed article in the International Journal of Clincal Pharmacology and Therapeutics. The article is titled "Correcting endogenous concentrations of testosterone influences bioequivalence and shows the superiority of TDS®-testosterone Versus AndroGel®" and can be viewed on the company's website at www.Transdermaltechnologies.com .
Company President and Langford Institute Managing Director Kennneth Kirby said, "Obviously we are most pleased with this further acknowledgement of the superiority of the TDS system over alternative transdermal systems."
The fast-drying, rapidly-absorbing TDS-testosterone product was previously discussed in a 2007 article in the British Journal of Clinical Pharmacology. "We believe that the TDS-testosterone system is advantaged in several key areas over gel delivery," Kirby said. "Transference concerns, lifestyle limitations imposed to avoid washing out the dose and cost and complexity of production are just a few of the patient compliance, safety and business factors where TDS exceeds expectations," said Kirby.
"Many leading gel products must be imported from Europe to maintain quality standards while TDS systems can be made by virtually any FDA-licensed manufacturer with equipment they already possess," said Kirby.
Looking forward, TransDermal will now progress the project apace. Plans are to initiate stability studies in the next weeks on the batches for the Phase III program agreed with FDA last year.
With an estimated net present value of $55 Million U.S. and a world market exceeding a Billion dollars annually, and clear path to approval under an NDA in the U.S. and with branded generic status in the EU, accomplishing a market registration in either market will dramaticlly increase the value of this project. The company has also met with potential partners in Asia who are well-positioned to leverage these approvals as they come on line.
"We are still seeking a partner for this project as we advance it," Kirby relayed, "but we are being encouraged to complete the development ourselves and then harvest a higher value later" .
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