Contact Information: For More Information, Contact: James E. Fickenscher Chief Financial Officer Auxilium Pharmaceuticals, Inc. +1-484-321-5900 or William Q. Sargent Jr. Vice-President, Investor Relations and Corporate Communications Auxilium Pharmaceuticals, Inc. +1-484-321-5900 or Robert P. Hebert Chief Financial Officer CPEX Pharmaceuticals, Inc. +1-603-658-6100 or Laura Okpala The Trout Group +1-617-583-1306
Auxilium Pharmaceuticals, Inc. and CPEX Pharmaceuticals, Inc. Receive Paragraph IV Certification Notice From Upsher-Smith Laboratories for Testim(R)
| Source: Auxilium Pharmaceuticals, Inc.
MALVERN, PA and EXETER, NH--(Marketwire - October 24, 2008) - Auxilium Pharmaceuticals, Inc.
(NASDAQ : AUXL ) and CPEX Pharmaceuticals, Inc. (NASDAQ : CPEX ) today
announced that they have received a notice from Upsher-Smith Laboratories,
Inc. advising of the filing by Upsher-Smith Laboratories, Inc. of an
Abbreviated New Drug Application (ANDA) containing a Paragraph IV
certification under 21 U.S.C. Section 355(j) for testosterone gel. This
Paragraph IV certification notice refers to CPEX's U.S. Patent No.
7,320,968 ("the '968 Patent"), which covers Testim®, 1% testosterone gel.
The Paragraph IV certification notice also states that Upsher-Smith
Laboratories, Inc. does not believe that the product for which it is
seeking approval infringes the '968 Patent. The '968 Patent is listed in
Approved Drug Products with Therapeutic Equivalence Evaluations (commonly
known as the Orange Book), published by the U.S. Food and Drug
Administration, and will expire in January 2025.
Auxilium and CPEX are currently reviewing the details of this notice from
Upsher-Smith Laboratories, Inc. Auxilium and CPEX intend to pursue all
available legal and regulatory options in defense of Testim, including
enforcement of their intellectual property rights and approved labeling.
About Testim
Testim is a proprietary, clear, topical gel containing 1% testosterone, the
same type of hormone that is produced by the human body. When applied
once-daily to the upper arms and shoulders, clinical studies have shown
that Testim will restore and maintain testosterone levels. Once Testim is
absorbed through the skin, it enters the bloodstream and helps return
testosterone to normal levels. The efficacy of Testim has been demonstrated
in 16 clinical studies involving approximately 1,800 patients, including
the largest placebo-controlled study ever conducted to evaluate the
benefits and risks of testosterone replacement therapy. For information
regarding the safety and use of Testim, please see the prescribing
information at http://www.testim.com.
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 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
http://www.auxilium.com.
About CPEX Pharmaceuticals
CPEX Pharmaceuticals, Inc. (NASDAQ : CPEX ) is an emerging specialty
pharmaceutical company focused on the development, licensing and
commercialization of pharmaceutical products utilizing CPEX's validated
drug delivery platform technology. CPEX has U.S. and international patents
and other proprietary rights to technologies that facilitate the absorption
of drugs. CPEX has licensed applications of its proprietary CPE-215®
drug delivery technology to Auxilium Pharmaceuticals, Inc., which launched
Testim®, a topical testosterone gel, in 2003. CPEX also is developing an
intranasal insulin product candidate, Nasulin™, which is in Phase II
clinical trials. CPEX maintains its headquarters in Exeter, NH. For more
information about CPEX, please visit www.cpexpharm.com.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995
Auxilium
In addition to historical facts or statements of current condition, this
press release contains forward-looking statements within the meaning of the
"Safe Harbor" provisions of The Private Securities Litigation Reform Act of
1995, including without limitation, statements regarding the legal and
regulatory options available to defend U.S. Patent No. 7,320,968 and Testim
and Auxilium's intentions regarding such options. These forward-looking
statements are subject to a number of risks and uncertainties that could
cause actual results to differ materially from future results expressed or
implied by such statements. Factors that may cause such differences
include, but are not limited to, risks associated with the following:
intellectual property litigation, the unpredictability of patent
protection, competition from other products, and other risks and
uncertainties detailed under "Risk Factors" in Auxilium's Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 which is on file with
the Securities and Exchange Commission. Given these risks and
uncertainties, any or all of the forward-looking statements contained in
this press release may prove to be incorrect. Therefore, you should not
rely on any such factors or forward-looking statements. Forward-looking
statements contained in this press release speak only as of the date of
this document, and Auxilium undertakes no obligation to update or revise
such statements.
Auxilium disclaims responsibility for statements above in "About CPEX",
which were provided by CPEX for inclusion in this press release.
CPEX
This press release contains forward-looking statements, including, without
limitation, statements regarding the legal and regulatory options available
to defend U.S. Patent No. 7,320,968 and Testim and CPEX's intentions
regarding such options. These forward-looking statements are subject to a
number of risks and uncertainties that could cause actual results to differ
materially from future results expressed or implied by such statements.
Factors that may cause such differences include, but are not limited to,
risks associated with the following: intellectual property litigation, the
unpredictability of patent protection, competition from other products, and
other uncertainties detailed under "Risk Factors" in CPEX's Registration
Statement on Form 10 dated June 17, 2008 in connection with the
distribution of CPEX's common stock to stockholders of Bentley
Pharmaceuticals, Inc. CPEX cautions investors not to place undue reliance
on the forward-looking statements contained in this release. These
statements speak only as of the date of this document, and CPEX undertakes
no obligation to update or revise the statements, except as may be required
by law.
CPEX disclaims responsibility for statements above in "About Auxilium",
which were provided by Auxilium for inclusion in this release.