Auxilium Pharmaceuticals, Inc. and Bentley Pharmaceuticals, Inc. Announce Issuance of Patent Covering Testim(R)

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Tue Jan 22, 2008 8:47am EST

  MALVERN, PA and EXETER, NH, Jan 22 (MARKET WIRE) -- 
 Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Bentley Pharmaceuticals,
Inc. (NYSE: BNT) today announced that the United States Patent and Trademark
Office ("USPTO")  has issued U.S. Patent No. 7,320,968 covering Testim(R), 1%
testosterone gel, marketed by Auxilium under license from Bentley.  The patent
will expire in January 2025.  Auxilium plans to list the patent promptly in
Approved Drug Products with Therapeutic Equivalence Evaluations (commonly
known as the Orange Book), published by the U.S. Food and Drug
Administration.  The companies also announced that Bentley has filed a
divisional application and continuations with the USPTO, which, if granted, may
expand the scope of patent claims covering Testim.

    "We are very pleased that Testim now has patent protection through January
2025,"
said Mr. Armando Anido, Chief Executive Officer and President of Auxilium
Pharmaceuticals.  "Testim is a great product that continues to take market
share and grow at a high rate, so extending our patent protection through
January 2025 is an important accomplishment."

    "Receiving extended U.S. patent protection for Testim is an exciting
milestone for
Bentley and our newly formed CPEX Pharmaceuticals drug delivery subsidiary,"
said Mr. James R. Murphy, Chairman and CEO of Bentley Pharmaceuticals.  "As
announced last month, we plan to spin off our drug delivery business as an
independent, publicly traded company, CPEX Pharmaceuticals, subject to Board
and SEC approval of our recently filed Form 10.  The royalties on the rising
sales of Testim, both in the United States and in Europe, will contribute to the
growth of this business in the years ahead."

    About Testim

    Testim is a proprietary, clear, topical gel containing 1% testosterone,
thesame 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
prescribinginformation 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(R) 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. 
XIAFLEX(TM) 
(clostridialcollagenase 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 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.  Auxilium also has
options to all indications using XIAFLEX for non-topical formulations.  For
additional information, visit http://www.auxilium.com.

    About Bentley and CPEX Pharmaceuticals

    Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company
focusedon advanced drug delivery technologies and generic pharmaceutical
products.Bentley's proprietary drug delivery technologies enhance the absorption
of
pharmaceutical compounds across various membranes. Bentley plans to spin off
its drug delivery business as an independent, publicly traded company. Its newly
formed subsidiary, CPEX Pharmaceuticals, Inc., has filed an initial
registration statement on Form 10 with the Securities and Exchange Commission
(SEC) in furtherance of this plan. Completion of the proposed spin-off is
subject
to numerous conditions, including final approval by Bentley's Board of
Directors and the effectiveness of the registration statement on Form 10, which
is
subject to review by the SEC. Bentley's generic pharmaceuticals business
manufactures and markets a growing portfolio of generic and branded generic
products in Europe for the treatment of cardiovascular, gastrointestinal,
infectious and central nervous system diseases through its subsidiaries --
Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley
PharmaceuticalsIreland. Bentley also manufactures and markets active
pharmaceutical ingredients through
its subsidiary, Bentley API. Additional information regarding Bentley
Pharmaceuticals
may be obtained through Bentley's website at www.bentleypharm.com.

    SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995

    Auxilium

    This release contains "forward-looking-statements" made by Auxilium
Pharmaceuticals, Inc. ("Auxilium") within the meaning of The Private Securities
Litigation Reform Act of 1995, including statements regarding the listing of
U.S.
Patent No. 7,320,968 with the U.S. Food and Drug Administration in the Orange
Book, the protection for Testim afforded by U.S. Patent No. 7,320,968, the
value of extending patent protection for Testim through January 2025, the
value and likelihood that patents will be granted from the continuations and
divisional filed by Bentley, future sales and market share of Testim, and
products in development for Dupuytren's contracture, Peyronie's disease,
Frozen Shoulder syndrome, overactive bladder, 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
futureexpectations, plans and prospects for Auxilium, 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
Auxilium, 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 Auxilium's Annual Report on Form 10-K for the year ended
December 31, 2006 and in Auxilium's Quarterly Report on Form 10-Q for the
period ended September 30, 2007 under the heading "Risk Factors," which are on
file with the Securities and Exchange Commission (the "SEC") and may be
accessedelectronically by means of the SEC's home page on the Internet at
http://www.sec.gov or by means of Auxilium's home page on the Internet at
http://www.auxilium.com under the heading "Investor Relations -- SEC
Filings." There may be additional risks that Auxilium does not presently know or
that Auxilium 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 Auxilium's expectations,
plans or
forecasts of future events and views as of the date of this release. Auxilium
anticipates that subsequent events and developments will cause its assessments
to change. However, while Auxilium may elect to update these forward-looking
statements at some point in the future, Auxilium specifically disclaims any
obligation to do so. These forward-looking statements should not be relied upon
as representing Auxilium's assessments as of any date subsequent to the date of
this
release.  Auxilium disclaims responsibility for statements made by
Bentley.Auxilium specifically disclaims responsibility for information
describing Bentley
that was provided to Auxilium by Bentley for inclusion in this release.

    Bentley

    This press release contains certain forward-looking statements about Bentley
and its current businesses, which are based on management's good faith
expectations and beliefs concerning future developments in Bentley and CPEX
Pharmaceuticals.  Forward-looking statements can be identified by the use of
words such as "in the future," "will," "may," "believe," "expect," "plans,"
"strategy," "intends," and "estimate." Statements that refer to Bentley's or
CPEX Pharmaceuticals' plans for executing the spin-off and future prospects
of the companies as independent companies, and the like, are forward-looking
statements that reflect Bentley's current analysis of existing trends,
information and current plans.  Actual results may differ from current
expectations based on a number of factors affecting Bentley's businesses,
including
changing competitive, regulatory and market conditions; inherent uncertainty
associated with financial projections, which cannot be predicted with certainty;
unpredictability associated with the timing and the results of both the
research and development and

    regulatory processes; domestic and foreign health care and cost
containmentreforms; technological advances and patents obtained by competitors;
approval,
introduction and consumer acceptance of new products and continuing
acceptance of currently marketed products; timely and successful implementation
of
strategic alternatives; uncertainty associated with the identification of and
successful execution of external corporate development transactions and
strategic
alliance partners; each company's ability to obtain and maintain a sufficient
supply of its products to meet market demand in a timely manner; matters
affecting the economy in general, such as changes in interest and currency
exchange rates; the uncertainties associated with effecting a spin-off of a
separate
public company; the discretion of Bentley's Board of Directors to delay or
cancel the spin-off prior to execution; and other uncertainties detailed in
Bentley's most recent Annual Report on Form 10-K and its other subsequent
periodic reports filed with the Securities and Exchange Commission, as well as
the risks set forth in the "Risk Factors" section of the CPEX Form 10
registrationstatement.  Bentley disclaims any intent or obligation to update
these
forward-looking statements, and it disclaims responsibility for statements made
by
Auxilium.  Bentley specifically disclaims responsibility for information
describing Auxilium that was provided to Bentley by Auxilium for inclusion in
this
release.

    

For More Information, Contact:

James E. Fickenscher
Chief Financial Officer
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
Email Contact

Fern Lazar
Lazar Partners, Ltd.
(212) 867-1762
Email Contact

Robert Hebert
Controller
Bentley Pharmaceuticals, Inc.
(603) 658-6100
Email Contact

Jim Buckley
Sharon Merrill Associates, Inc.
(617) 542-5300
Email Contact

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