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Biopharmaceuticals Regulatory

 News Release - May 23, 2006

Auxilium Pharmaceuticals Receives Approval to Sell Testim(R) in Canada

MALVERN, Pa., May 23 (HSMN NewsFeed) -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL ), a specialty pharmaceutical company, today announced that Health Canada's Therapeutic Products Directorate has granted marketing approval of TestimĀ® 1%, its topical testosterone gel, indicated for the treatment of patients with hypogonadism (low testosterone). Testim is now approved for sale in 15 countries outside the United States.

"The Health Canada approval complements Testim's regulatory approvals in the U.S. and in Europe," said Ms. Gerri Henwood, Auxilium's Chief Executive Officer. "We are pleased to expand Testim's global reach to include Canada, the fourth fastest growing pharmaceutical market in the world."

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 TestimĀ® 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) has commenced Phase III of development and should commence pivotal Phase III trials later in the second quarter. 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 .

Safe Harbor Statement

This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the size of the market for Testim, 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, statements regarding forward-looking financial information 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 or by means of the Company's home page on the Internet at 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

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