Bentley Pharmaceuticals, Inc, a specialty pharmaceutical company, announced that the US 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 US 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.

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.

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.