Auxilium Selects MODA-EM™ to Support Commerical Development Initiative
WAYNE, PA and MALVERN, PA – MAY 1, 2007 – MODA Technology Partners (MODA), a software company that provides mobile data acquisition solutions to the pharmaceutical manufacturing industry, and Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) announced today that Auxilium has selected MODA-EM™ to automate environmental monitoring processes at its new manufacturing facility in Horsham, PA.
MODA-EM is an innovative software and hardware solution that improves the performance of environmental monitoring (EM) operations by eliminating the inefficiencies and reducing error rates inherent with manual, paper-based systems. The system delivers a tangible return on investment by removing low value and redundant activities from EM processes while improving the quality and availability of EM data.
“The Horsham facility is a key component of the commercial development strategy for AA4500, our injectable collagenase enzyme,” stated Dr. Ben Del Tito, Jr., Auxilium’s Sr. Vice President of Quality and Regulatory Affairs. “MODA-EM will allow us to institute a comprehensive and efficient EM program in our facility from the outset – without the burden of EM paperwork.”
“We are very pleased to be part of Auxilium’s commercial development strategy,” stated David Lipson, MODA CEO and Chairman. “It is clear that Auxilium’s commitment to innovation is not just limited to R&D but extends into their commercial manufacturing operations as well.”
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 190-person sales and marketing team. Auxilium has four projects in clinical development. AA4500, an injectable collagenase 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 www.auxilium.com.
About MODA Technology Partners
MODA Technology Partners (MODA) is a commercial software company whose primary focus is addressing the growing need for effective automation and efficient regulatory compliance within pharmaceutical manufacturing. MODA's software leverages mobile computing technology to help their clients increase operational efficiency, improve quality and reduce manufacturing costs. Additional information is available at www.modatp.com.
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 environmental monitoring program of Auxilium Pharmaceuticals, Inc. (the "Company") and the Company’s products in development for the treatment of pain, hormone replacement and urologic disease. 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 Annual Report on Form 10-K for the year ended December 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.
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