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We earn royalty revenues on sales of Testim, a testosterone gel that incorporates our CPE-215
drug delivery technology. The product is licensed to Auxilium and was successfully launched in
the U.S. in early 2003 as a testosterone replacement therapy. Testim has been approved for
marketing in Canada and 15 countries in Europe. Auxilium uses its sales force to market Testim
in the U.S. and has partnered with Paladin Labs Inc. to market the drug in Canada and with Ferring
International S.A. to market the drug in Europe.
The testosterone replacement market has expanded as more baby-boomers enter middle age and more
attention is focused on male hormonal deficiency and the benefits of replacement therapy. Hypogonadism,
a condition in men where insufficient amounts of testosterone are produced is thought to affect one out
of every five men in the U.S. and Europe aged over 50. Symptoms associated with low testosterone levels
in men include depression, decreased libido, erectile dysfunction, muscular atrophy, loss of energy, mood
alterations, increased body fat and reduced bone density. This condition is currently significantly
under-treated and growing patient awareness together with education continue to spur demand for
testosterone replacement therapy.
Currently marketed testosterone replacement therapies deliver hormones through injections, transdermal
patches or gels. Gels provide commercially attractive and efficacious alternatives to the other current
methods of delivery by providing a more steady state of absorption rather than the bolus surge of injections
or the irritation caused by patches resulting in a less desirable dosage regimen.
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