Bentley Announces Its First Product Approval in France
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Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical
company focused on advanced drug delivery technologies and generic
pharmaceutical products, today announced its European subsidiaries have
received their first product approval in France, which is for
Lansoprazole, a generic version of Prevacid®.
Lansoprazole is used to treat gastrointestinal diseases including acid
reflux and ulcers and is marketed under the trade name, Prevacid®,
in the US by TAP and in Europe by Takeda Pharmaceuticals. Lansoprazole
is under patent protection in France until December 11, 2007. Bentley
subsidiaries plan to be in the French market, through partners and
licensees, at the time of market formation upon patent expiration. Firm
orders have been received under long-term supply agreements and the
finished products will be supplied in the fourth quarter from Bentley’s
subsidiary manufacturing facilities in Spain. According to the IMS, the
market size for Lansoprazole in France is approximately $220 million.
Bentley’s Irish subsidiary also received
approvals for marketing a generic version of a once weekly dosage form
of alendronate in Ireland. Alendronate is used in the treatment of
osteoporosis and bone loss, and is the generic version of Fosamax®,
which is currently marketed by Merck & Company, Inc.
John Sedor, president of Bentley Pharmaceuticals, said, "These
recent approvals not only open additional major markets for the
continued growth of our European business outside of Spain, but also
enhance the value of our European operations. We expect to be filling
orders for these products in France and Ireland in the fourth quarter.
We are also expecting similar approvals in other major European markets
in the near future.”
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 manufactures
and markets a growing portfolio of generic and branded generic
pharmaceuticals 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 forward looking statements,
including without limitation, statements regarding Bentley’s
new product approvals in France and Ireland, the potential impact of
these approvals on Bentley’s results of
operations and Bentley’s opportunities in the
European generics market. 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 timing and nature of regulatory
approvals, changes in third party reimbursement and government mandates
which impact pharmaceutical pricing, competition from other
manufacturers of generic and proprietary pharmaceuticals, 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. Bentley
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 Bentley undertakes no obligation to
update or revise the statements, except as may be required by law.