Contact Information: For More Information, Contact: James E. Fickenscher Chief Financial Officer Auxilium Pharmaceuticals, Inc. (484) 321-5900 Fern Lazar Lazar Partners, Ltd. (212) 867-1762 Robert Hebert Controller Bentley Pharmaceuticals, Inc. (603) 658-6100 Jim Buckley Sharon Merrill Associates, Inc. (617) 542-5300
Auxilium Pharmaceuticals, Inc. and Bentley Pharmaceuticals, Inc. Announce Issuance of Patent Covering Testim(R)
| Source: Auxilium Pharmaceuticals, Inc.
MALVERN, PA and EXETER, NH--(Marketwire - January 22, 2008) - 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®, 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, 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 four projects in clinical development. XIAFLEX™ (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 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 focused
on 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 Pharmaceuticals
Ireland. 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 future
expectations, 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 accessed
electronically 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 containment
reforms; 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 registration
statement. 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.