MALVERN, Pa., June 29 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty pharmaceutical company, today announced that it has begun enrolling patients with hypogonadism in a pivotal Phase III trial of AA2600, the Company's testosterone replacement transmucosal film product candidate. Hypogonadism is a condition that is estimated to affect approximately 20% of the U.S. male population over age 50 and is characterized by reduced or deficient secretion of testosterone which can lead to symptoms such as loss of libido, adverse changes in body composition, irritability and poor attention span.
"Delivering testosterone replacement therapy through an oral transmucosal film may provide men efficacy results equivalent to approved transdermal treatments but with quicker release of testosterone and lower dosing," said Dr. Jyrki Mattila, Auxilium's Executive Vice President, Research and Development. "We believe that, if confirmed, these delivery advantages will be viewed favorably by physicians and patients."
The open-label, multi-center, randomized, controlled trial is designed to evaluate the efficacy and safety of AA2600 in patients diagnosed with hypogonadism. The trial is expected to enroll 240 patients at approximately 25 centers across the United States. Patients will be randomized at a 2:1 ratio to receive either AA2600 (5 mg or 7.5 mg BID) or a buccal testosterone tablet (30 mg BID), respectively. Patients' outcomes will be evaluated after three months of treatment for both impact on serum testosterone levels and secondary efficacy parameters, as well as for tolerability.
"We believe that the initiation of this trial represents a significant milestone for Auxilium and underscores our continued commitment to delivering novel treatments to patients," said Ms. Gerri Henwood, Auxilium's Chief Executive Officer. "AA2600 represents a potential new formulation of testosterone that could complement Testim(R), our 1% testosterone gel, that is currently marketed for the treatment of hypogonadism."
About Hypogonadism
According to a 2001 article published in The Journal of Clinical Endocrinology & Metabolism, hypogonadism affects approximately 20% of the U.S. male population over age 50. Hypogonadism is defined as reduced or absent secretion of testosterone which can lead to symptoms such as loss of libido, adverse changes in body composition, irritability and poor concentration. The U.S. Food and Drug Administration estimates that only 5% of men with hypogonadism currently receive testosterone replacement therapy.
About Auxilium Pharmaceuticals
Auxilium Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on developing and marketing products for urology, sexual health and other indications within specialty markets. Auxilium markets Testim(R) 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 130-person sales and marketing team. Auxilium has five projects in clinical development. Auxilium believes that AA4500, an injectable enzyme, has completed Phase II of development for the treatment of Dupuytren's Disease and is in Phase II of development for the treatment of Peyronie's Disease and Frozen Shoulder Syndrome (Adhesive Capsulitis). Auxilium's testosterone replacement transmucosal film product candidate for the treatment of hypogonadism (AA2600) is in Phase III of development. Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in Phase I of development. Auxilium has two pain products using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to six additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system, options to all indications using AA4500 for non-topical formulations, and other products for urology and sexual health. For additional information, visit http://www.auxilium.com.
Safe Harbor Statement
This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, the results of the study, the opinions of physicians and patients regarding AA2600, and the timing for the commencement of various clinical trials for Auxilium's product candidates during 2006, if at all, and products in development for pain, urology and sexual health. All statements other than statements of historical facts contained in this release, including but not limited to, statements regarding future expectations, plans and prospects for the Company, and other statements containing the words "believe," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," and similar expressions, as they relate to the Company, constitute forward-looking statements. Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in the Company's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2006 under the heading "Risk Factors", which is on file with the Securities and Exchange Commission (the "SEC") and may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "Investor Relations - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.
In addition, forward-looking statements provide the Company's expectations, plans or forecasts of future events and views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this release.
SOURCE Auxilium Pharmaceuticals, Inc.