MALVERN, PA, USA and Saint-Prex, Switzerland (December 01, 2008)
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) and Ferring International S.A. today announced an exclusive agreement between them for the European distribution and license rights to Testim®, a proprietary, topical 1% testosterone once-a-day gel indicated for the treatment of hypogonadism.
"We are very pleased to have Ferring as our partner, given the strength of their European specialty urology and endocrinology franchises, their existing commercial infrastructure across Europe, and the successful track record they have established in commercializing differentiated products in the European Union," said Armando Anido, Chief Executive Officer and President of Auxilium. "This agreement enables us to bring our innovative testosterone replacement product to patients in all of the 15 countries where Testim has been approved and potentially in additional new countries within Europe, thus expanding the reach of our Testim franchise outside the United States."
"Testim will be an excellent complement to our urology portfolio, where we already have Minirin® for primary nocturnal enuresis and hope to receive approval for our prostate cancer treatment, degarelix, in the first half of next year," commented Ferring's Chief Operating Officer, Michel Pettigrew. "It is a great pleasure to have cemented this partnership with Auxilium, with whom we share a commitment to the field of urology and a strong focus on patients."
Under the agreement, Auxilium will be responsible for manufacturing and supplying Testim to Ferring, while Ferring will be responsible for all regulatory, sales, marketing and distribution activities in Europe. Under the agreement with Ferring, Auxilium will receive a combination of upfront, milestone and royalty payments. Financial details of the agreement were not disclosed. Testim is currently approved for sale in 15 countries in Europe. The Company and Ipsen Pharma GmbH recently agreed to mutually terminate their distribution agreement for Testim in Europe and other countries outside North America and Japan.
Testim is a novel, topical gel formulation that normalizes low levels of testosterone in men with hypogonadism, a condition that occurs when a man's body does not produce adequate amounts of testosterone. Men with hypogonadism or androgen deficiency may suffer from a decrease in energy, reduced muscle mass, an increase in abdominal fat, decline in libido, decreased sexual function, anemia, fatigue, depression and reduced bone density that may result in an increased risk of osteoporosis.
Testim was developed by Auxilium using a proprietary technology licensed from CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX), and was launched in the U.S. by Auxilium's sales force in the first quarter of 2003. Auxilium received its first European regulatory approval for Testim in the UK in 2003 and currently has regulatory approval in 15 countries in Europe through the Mutual Recognition Procedure.
A 2006 study that was published in The International Journal of Clinical Practice showed 39% of men over 45 years of age have low testosterone (total testosterone levels below 300 ng / dL). 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. Auxilium research estimates that approximately 10% of men with hypogonadism currently receive TRT and that this low diagnosis rate stems primarily from low patient and physician awareness of the symptoms, treatment options and monitoring requirements
About Ferring Pharmaceuticals
Ferring is a Swiss-based, research driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of urology, gastroenterology, and infertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in 45 countries. To learn more about Ferring or our products please visit www.ferring.com.
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 190-person sales and marketing team. Auxilium has five projects in clinical development. XIAFLEXTM (clostridial collagenase for injection), formerly referred to as AA4500, 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 also has one pain product (fentanyl) using its transmucosal film delivery system in phase I of development. Auxilium has rights to seven additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. For additional information, visit www.auxilium.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
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 Ferring in Europe, the effect of the distribution agreement with Ferring on the Company's revenues, the ability of Ferring to fulfill its obligations under the distribution agreement, and products in development for the treatment of Dupuytren's contracture, Peyronie's disease, Frozen Shoulder syndrome, overactive bladder and pain. 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, 2007 and the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2008 under the heading "Risk Factors", which are 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.
James E. Fickenscher
Chief Financial Officer, Auxilium Pharmaceuticals, Inc.
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
Senior Corporate Communications Manager
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