Healthcare Industry News: Paladin Labs
News Release - December 12, 2006
Auxilium Pharmaceuticals, Inc. Announces Distribution Agreement With Paladin Labs for Testim(R) in CanadaMALVERN, Pa., Dec. 12 (HSMN NewsFeed) -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL ) today announced an exclusive agreement with Paladin Labs (TSX: PLB ) for the Canadian distribution rights to Testim®, its topical testosterone gel, indicated for the treatment of patients with hypogonadism.
Under the agreement, Auxilium will be responsible for manufacturing and supplying Testim to Paladin. Paladin will be responsible for all sales, marketing and distribution activities in Canada. Financial details of the agreement were not disclosed.
Testim is approved for sale in 15 countries outside the United States. The Company and Bayer Inc. of Canada recently agreed to mutually terminate their distribution agreement for Testim in Canada.
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.
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 180-person sales and marketing team. Auxilium has four projects in clinical development. Auxilium believes that AA4500, an injectable enzyme, is in phase III of development for the treatment of Dupuytren's contracture and is in phase II of development for the treatment of Peyronie's disease and Frozen Shoulder Syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in phase I of development. The Company is currently seeking a partner to further develop this product candidate. 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, and options to all indications using AA4500 for non-topical formulations. 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, statements regarding the size of the market for Testim, the sales of Testim by Paladin Labs in Canada, the effect of the distribution agreement with Paladin on the Company's revenues, the ability of Paladin Labs to fulfill its obligations under the distribution agreement, and the timing for the commencement of various clinical trials for Auxilium's product candidates, including AA4500, during 2006. 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, financial guidance 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 Annual Report on Form 10-K for the period ended December 31, 2005 and the Company's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 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
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