Bentley Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the European Patent Office has issued patent number 1425019 entitled "Pharmaceutical Composition." This patent provides coverage for the pharmaceutical composition process and method of use of testosterone as a gel as well as other androgens, incorporating Bentley's CPE-215 drug delivery technology. Issued from an application submitted on April 21, 2003, the new European patent provides proprietary protection to Bentley for 20 years from the date of filing.
Bentley's licensee Auxilium Pharmaceuticals, Inc successfully launched this testosterone gel in the United States in early 2003 under the brand name Testim, and the product now commands nearly 20 per cent of the US market for topical testosterone replacement therapy. Testim has been approved for marketing in Canada and 15 EU countries including Belgium, Germany, Greece, Ireland, Portugal, Spain, Sweden and the United Kingdom, and has received scientific approval in Italy.
"This European patent significantly strengthens and extends the intellectual property franchise protecting Bentley's drug delivery technology," said John Sedor, president of Bentley Pharmaceuticals, Inc. "We anticipate further strengthening of this IP portfolio beyond Europe in the year ahead". The testosterone replacement market has increased as more baby-boomers enter middle age and more attention is focused on male hormonal deficiencies.
The US Food and Drug Administration estimates that about 4-5 million Americans suffer from male hypogonadism a condition where insufficient amounts of testosterone are produced and that male hypogonadism affects about 5 in every 1,000 men. It is believed that male hypogonadism affects one out of every 5 men over age 50. Symptoms associated with low testosterone levels in men include depression, decreased libido, erectile dysfunction, muscular atrophy, loss of energy, mood alterations, increased body fat and reduced bone density. The condition is significantly under-treated. Growing patient awareness and education continue to spur demand for testosterone replacement therapy.
Currently, marketed hormone replacement therapies deliver hormones through injections, transdermal patches and gels. Injection therapy has limitations, including pain, which can lead to decreased patient acceptance and decreased compliance. Although patches have alleviated many of the side effects associated with other methods of delivery of hormones, patches are often conspicuous and may result in skin irritation or even inaccurate dosing should the patch fall off. The transdermal delivery of hormones through gels, creams and lotions provides commercially attractive and efficacious alternatives. Testim delivers 30 per cent more testosterone transdermally than its leading competitor.
Bentley's CPE-215 drug delivery technology has the potential to enhance the absorption of drugs across a variety of biological membranes, including not only the skin, but also the nasal mucosa. The company is developing an intranasal drug delivery technology based on CPE-215. This technology has the potential to improve drug delivery of more complex molecules, especially injectable therapeutic peptides for treatment of chronic diseases.
Bentley's first patented product candidate for intranasal drug delivery is Nasulin, an insulin formulation currently in global phase II clinical trials for the treatment for diabetes. Bentley is continuing to expand its drug delivery technology intellectual property portfolio and was awarded a broad patent on July 19, 2007, for delivery of other peptides, peptidomimetics and proteins via Bentley's drug delivery technology utilizing CPE-215.
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.