Auxilium Pharm. : Auxilium Selects MODA-EM(TM) to Support Commercial Development Initiative
05/01/2007| 09:30am US/Eastern
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
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
?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.?
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.
© Business Wire 2007