Bentley Pharmaceuticals Announces Product Approvals in Europe
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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.