MALVERN, Pa., July 17 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. , a specialty pharmaceutical company, today announced that it has signed an agreement with UK-based Cobra Biologics Ltd. to manufacture additional cGMP (current Good Manufacturing Practices) and BLA (Biologics License Application) batches for AA4500. Auxilium currently anticipates that this manufacturing activity will be completed by the end of 2006.
"The financial guidance for 2006 that we reported on June 21, 2006 anticipated the costs that we expect to incur under this agreement," said Mr. Jim Fickenscher, Auxilium's Chief Financial Officer.
The agreement does not cover long-term production of AA4500 for commercial sale, but the companies will be discussing a non-exclusive long-term supply agreement for AA4500 during the second half of 2006.
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. 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, the quality of the AA4500 produced pursuant to the agreement with Cobra, the performance of Cobra under the agreement, financial guidance for 2006, 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. 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.
Auxilium Pharmaceuticals, Inc.
CONTACT: James E. Fickenscher, CFO of Auxilium Pharmaceuticals, Inc.,+1-484-321-5900, email@example.com; or Gregory Gin of LazarPartners, Ltd., +1-212-867-1762, firstname.lastname@example.org, for AuxiliumPharmaceuticals, Inc.