Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced the US Patent
and Trademark office has issued U.S. Patent No. 7,759,360 for Androxal®,
the Company’s lead program for the treatment of low testosterone in men.
This patent specifically claims methods and materials for the treatment
of testosterone deficiency in men with secondary hypogonadism. Repros
has over 35 issued or pending US and European patents involving
Androxal. The term of the patent will expire on March 19, 2023. If a
Patent Term Extension under the Hatch-Waxman Act is granted, patent life
in the US could extend into 2028.
"We are pleased to strengthen our intellectual property portfolio and
expect additional patent grants surrounding Androxal,” stated Joseph
Podolski, President and Chief Executive Officer of Repros Therapeutics.
"This patent is important to the protection of our Androxal program. If
Repros can successfully develop Androxal, it could become a leading
treatment for low testosterone in men.”
Androxal is an oral therapy that restores testicular function in men
experiencing low testosterone due to secondary hypogonadism. Secondary
hypogonadism is a condition commonly related to aging but may result or
be a co morbid state associated with a variety of conditions, including
Type II diabetes. Secondary hypogonadism is not a failure of the testes,
but an inability of the pituitary to respond to a low testosterone state
by secreting sufficient levels of luteinizing hormone (LH) to adequately
stimulate the testes. Androxal stimulates the pituitary to secret normal
levels of important testicular stimulating pituitary hormones.
Secondary hypogonadism is the most common cause of low testosterone
amongst American males. Unlike the topical creams and gels Androxal does
not suppress pituitary secretions of LH and FSH (follicle stimulating
hormone). Topical testosterone suppresses fertility. Androxal enhances
production of both testosterone and sperm. Unlike approved topical
testosterone treatments, unwanted transfer of testosterone to women and
children is not possible. Since, in the case of Androxal, pituitary
regulation is still intact, supernormal levels of testosterone are not
achieved. In an exploratory efficacy and safety study in Androxal
conducted in 2009, Repros showed that Androxal restores normal sperm
counts while increasing testosterone levels in hypogonadal men.
On Monday, August 9, 2010, Repros announced that the FDA agreed with the
Company’s proposal to conduct two Phase III placebo and active
controlled studies in order to demonstrate the benefit of Androxal in
normalizing testosterone levels while preserving fertility.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of oral small molecule
drugs for major unmet medical needs that treat male and female
reproductive disorders.
Any statements that are not historical facts contained in this
release are forward-looking statements that involve risks and
uncertainties, including Repros' ability to obtain FDA approval of
Androxal protocols for conducting Phase II and III clinical studies in
which T is normalized and fertility is preserved, the timing and cost
associated with conducting clinical trials, whether the outcome of more
robust, later stage clinical trials will be consistent with the results
obtained from more limited early stage clinical trials, Repros' ability
to have the partial hold on Proellex® lifted
and to determine a safe and effective dose for Proellex, maintain its
listing on the NASDAQ Capital Market, raise needed additional capital on
a timely basis in order for it to continue to fund its operations and
pursue its development activities, and such other risks which are
identified in the Company's most recent Annual Report on Form 10-K and
in any subsequent quarterly reports on Form 10-Q.
These documents
are available on request from Repros Therapeutics or at www.sec.gov.
Repros disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
For more information, please visit the Company's website at http://www.reprosrx.com.
