Bentley Pharmaceuticals Announces Product Approvals in Europe
13 Febbraio 2008 - 2:30PM
Business Wire
Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty
pharmaceutical company, today announced that its European
subsidiaries have received approvals to market their omeprazole
capsule products, through their licensees, in various territories
in Europe. The approvals are for 10 mg. 20 mg. and 40 mg. dosage
levels of omeprazole capsules under a Mutual Recognition Procedure
(MRP) that grants simultaneous authorizations throughout the EU.
Bentley�s subsidiaries expect to supply omeprazole to their
licensees in the major markets of Germany and Italy, as well as
other EU countries. Omeprazole is marketed in the United States
under the trade name Prilosec� by AstraZeneca and under the trade
name Losec� in Europe. The manufacture and supply of the finished
products will be through Bentley�s subsidiary, Laboratorios Belmac.
The Company plans to begin supplying omeprazole to licensees during
the first quarter of 2008. Jim Murphy, Chairman & Chief
Executive Officer of Bentley Pharmaceuticals said, �Representing
our first product entry into the major European markets of Germany
and Italy, these approvals follow the November 2007 announcement of
our entrance into France by way of similar agreements to distribute
lansoprazole. We expect that these MRP approvals, together with
other MRP registrations pending, will grow our specialty generic
revenues outside of Spain by approximately 25% in 2008.� Murphy
continued, �We have made the expansion of our products into major
European markets beyond Spain a primary objective over the past few
years, and receiving these multiple approvals is a milestone in
that initiative. We look forward to further enhancing the value of
our European operations by capitalizing on additional opportunities
in these larger EU markets.� 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 Statement under the Private
Securities Litigation Reform Act of 1995: This press release
contains certain forward-looking statements about Bentley
Pharmaceuticals, Inc. and its current and future business, which
are based on management�s good faith expectations and beliefs
concerning the prospects for Bentley to expand its generic
pharmaceutical business in European markets outside of Spain, and
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 the future prospects of Bentley or CPEX Pharmaceuticals
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; approval,
introduction and consumer acceptance of new products and continuing
acceptance of currently marketed products; unpredictability
associated with the timing and the results of both the research and
development and regulatory processes; inherent uncertainty
associated with financial projections, which cannot be predicted
with certainty; technological advances and patents obtained by
competitors; uncertainty associated with the identification of and
successful execution of external corporate development transactions
and strategic alliance partners; 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 Bentley Form 10-K.
Bentley disclaims any intent or obligation to update these
forward-looking statements.
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