Bentley Receives Broad U.S. Patent Protection for Its Intranasal Drug Delivery Technology
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Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical
company, announced today that the U.S. Patent and Trademark Office has
issued patent number 7,244,703 entitled "Pharmaceutical
Compositions and Methods for Peptide Treatment.”
This patent extends coverage for Bentley’s
current intranasal drug delivery technology utilizing CPE-215®
beyond insulin to include delivery of other therapeutically effective,
pharmaceutically active peptides, peptidomimetics and proteins. Many
such molecules are already in commercial use in chronic clinical
indications employing injections that could benefit patients through
enabling of nasal administration formats. In September 2006, Bentley
received a U.S. patent covering Bentley’s
intranasal delivery spray for insulin.
"This patent is a critical milestone for
Bentley as it provides us with broad protection for our intranasal drug
delivery technology and for future applications,”
said John Sedor, president of Bentley Pharmaceuticals, Inc. "These
applications have the potential to be far-reaching. We believe our
CPE-215 intranasal delivery technology can provide therapeutic and
commercial advantages for the delivery of a number of complex molecules
that address a wide variety of metabolic, neurological and other serious
medical conditions. In particular, intranasal drug delivery has the
potential to be beneficial to patients, including children and the
elderly, who are resistant to treatments with injectable
pharmaceuticals. Our intranasal drug delivery technology also has the
potential to create significant opportunities for life-cycle extension
of existing marketed products.”
This new patent, which was issued from an application filed on March 5,
2004, provides proprietary protection to Bentley for 20 years from the
date of filing.
About Bentley’s Permeation Enhancement
Technology
Bentley’s CPE-215 drug delivery technology
has the potential to enhance the absorption of drugs across a variety of
biological membranes, including the skin, mouth, nose and eye. The
effectiveness of Bentley’s patented
permeation technology was validated in the product Testim®,
a testosterone replacement gel licensed to Auxilium Pharmaceuticals
(NASDQ: AUXL). Since its launch in 2003, Testim has gained a leadership
position in the testosterone gel market.
Bentley determined that its intranasal technology could be extended to
improve drug delivery of more complex molecules, especially injectable
therapeutic peptides for treatment of chronic diseases. Bentley’s
development work led it to incorporate its drug delivery technology,
employing the key excipient CPE-215, into Nasulin™,
Bentley’s patented product candidate for the
intranasal administration of insulin. In addition to studies reported
previously, positive initial clinical results for Nasulin in three other
Company-sponsored studies were presented at the American Diabetes
Association’s 67th
Scientific Sessions in late June 2007. Nasulin is currently in global
Phase II clinical trials.
About Bentley 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 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 web site 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 the potential for
development of pharmaceutical product candidates employing active
peptides, peptidomimetics and proteins using intranasal delivery methods
covered by Bentley’s intranasal technology
patent, the potential advantages of such products and the potential of
Bentley’s Nasulin product candidate. 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 unpredictability of patent protection and technological changes, risks associated with further studies of the safety and efficacy of
Bentley’s intranasal insulin product
candidate and its drug delivery technology, risks inherent in the
conduct of international clinical trials and regulatory review of a
pharmaceutical product, and other risks detailed under Item 1A "Risk
Factors” in Bentley’s
most recent Annual Report on Form 10-K and its 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.