EXETER, N.H., Sept. 26 /PRNewswire-FirstCall/ -- Bentley Pharmaceuticals, Inc. , a specialty pharmaceutical company, announced today that the U.S. Patent and Trademark Office has issued patent number 7,112,561 entitled “Pharmaceutical Compositions and Methods for Insulin Treatment”. This patent covers Bentley’s intranasal insulin delivery system containing its proprietary enhancer, CPE-215(R).
James R. Murphy, chairman and CEO, commented, “This is the first patent to issue from Bentley’s comprehensive filings around the world for protecting its intranasal insulin and peptide delivery platform. This patent also covers uses where the insulin formulation is administered in the form of a solution or a spray, and where the permeation enhancer works across the nasal mucosa. The patent, which issued from an application filed on December 2, 2004, provides proprietary protection to Bentley for 20 years from the date of filing.”
“While diabetes has reached epidemic levels worldwide, subcutaneous insulin injection has remained the standard method of delivery for the past 75 years, and it still has not resulted in widespread prophylactic care and control of Type II diabetes,” said John A. Sedor, president of Bentley. “The advance of our intranasal insulin program offers new hope to patients in need of a safer, more effective and more discreet delivery method.”
Bentley has developed an intranasal, stable-emulsion formulation of insulin, which incorporates Bentley’s platform delivery technology, CPE-215, as a physiological absorption enhancer. Extensive preclinical evaluation and toxicology has been completed, and this formulation was well tolerated and absorbed in preliminary clinical studies. Clinical supplies of intranasal insulin have been produced for the continuation of clinical development in Asia, Europe and North America.
The effectiveness of Bentley’s CPE-215 platform technology has been demonstrated in the marketed product, Testim(R), a testosterone replacement gel licensed to Auxilium Pharmaceuticals . Since its launch in 2003, Testim has captured 18% of the testosterone gel market.
The delivery of injectable therapeutic peptides by intranasal administration of stable emulsions without using irritating preservatives is a principal focus of Bentley Pharmaceuticals’ drug delivery platform for treating a variety of medical conditions.
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley’s proprietary drug technologies enhance or facilitate the absorption of pharmaceutical compounds across various membranes. Bentley also manufactures a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiary, Laboratorios Belmac, and markets these pharmaceutical products through its subsidiaries, Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland; and 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 http://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 intranasal insulin development program and the United States patent covering its intranasal insulin delivery system. 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 efficacy and safety of Bentley’s intranasal insulin product candidate, the unpredictability of patent protection, intellectual property litigation, competition from other manufacturers of new insulin products, 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.
Contact: Bentley Pharmaceuticals, Inc. Jean DeRoche 603.658.6136
Bentley Pharmaceuticals, Inc.
