Bentley Receives Broad U.S. Patent Protection for Its Intranasal Drug Delivery Technology
2007年7月19日 - 11:05PM
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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.
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