Auxilium Pharmaceuticals Amends Agreement with Cobra Biologics Ltd.
Wednesday November 29, 7:30 am ET
Horsham Facility to Become Primary Commercial Source of AA4500 Development Relationship with Cobra Continues
MALVERN, Pa., Nov. 29 -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL - News), a specialty biopharmaceutical company, today announced that it has amended its manufacturing agreement with UK-based Cobra Biologics Ltd. Under the amended agreement, Cobra will complete only one BLA (Biologics License Application) batch of the active ingredient for AA4500, the Company's injectable enzyme. The amendment reflects Auxilium's decision to move forward with its facility in Horsham, Pennsylvania to support the BLA submission and as a primary source of the commercial supply of AA4500. As previously announced, Auxilium will use the materials produced by Cobra in its ongoing and potential future clinical trials for AA4500 for the treatment of Dupuytren's contracture and other indications. The companies agreed to continue their collaboration related to the technology transfer, ongoing stability programs and other services provided by Cobra.
"This amendment allows our Manufacturing, Quality Assurance and Development teams to focus on getting the Horsham facility ready for the BLA submission expected at the end of 2007," said Mr. Armando Anido, Auxilium's Chief Executive Officer and President. "The amendment also ensures that Cobra will continue to provide technology support and be involved as a development partner for this critical asset. We look forward to continuing our collaboration with the Cobra team."
About Auxilium
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 quality of the AA4500 produced and the work performed pursuant to the amended agreement with Cobra, the performance of Cobra under the amended agreement, the timing of the filing of the BLA submission for AA4500 for the treatment of Dupuytren's contracture, the timing for the commencement of various clinical trials for Auxilium's product candidates, including AA4500. 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.