Bentley Announces Research, Licensing Deals for Topical Testosterone Products
Formulation License a First for Bentley's CPE-215 Permeation Technology
Bentley Pharmaceuticals Inc. (North Hampton, NH), which specializes in drug delivery, has entered into an agreement with Auxilium A2 Inc. (Philadelphia) to license a new topical gel formulation of testosterone in combination with Bentley's permeation facilitator, CPE-215. Auxilium A2 focuses on products for maintaining normal function among the aging population. Auxilium's management have a pretty good track record for getting products through regulatory approval, but proving efficacy for topical testosterone might prove challenging.
The collaboration will begin with a research agreement to characterize Bentley's formulation, presumably to be followed by issuance of a worldwide license to Auxilium A2 (except in Spain, where Bentley will maintain commercial rights). Bentley will receive payments based upon the completion of specific milestones plus, upon effectiveness of the license, royalties on net sales. Specific terms were not disclosed.
Bentley is eager to proceed with this collaboration, and the studies it will entail, to see if its CPE-215 permeation enhancement technology can indeed improve adsorption of topical drugs. "Our initial evaluation of this product indicates we have an impressive formulation that enhances the topical absorption of testosterone over non-enhanced formulations, which will facilitate the use of a small quantity of fast drying gel," according to James Murphy, chairman and CEO of Bentley. "Our CPE-215 technology combined with testosterone will provide patients the convenience of a self-administered, simple topical application rather than a more aggressive therapy involving injections."
Murphy continued, "It is becoming more apparent that men undergo mid-life changes similar to those experienced by post-menopausal women, who can be treated with estrogen and progesterone therapy. It is believed that as much as 25% of the male population over the age of 50 have low levels of testosterone and approximately 5 million men suffer hypogonadism. The symptoms associated with low testosterone levels can include depression, decreased libido, erectile dysfunction, muscular atrophy, loss of energy, mood alterations, gain in body fat, and loss of bone density. Researchers have also concluded that testosterone helps protect aging men from osteoporosis. Although the worldwide market for testosterone products during 1999 approached $150 million, as baby-boomers approach middle age and more attention becomes focused on male hormonal deficiencies, the market could evolve to a very sizable level. Research has indicated that some women can also benefit from testosterone therapy where it has shown to be useful in treating sexual dysfunction and conditions such as fibromyalgia syndrome (FMS)."
For more information: Michael D. Price, VP and Chief Financial Officer, Bentley Pharmaceuticals, Inc., 65 Lafayette Rd., 3rd Floor, North Hampton, NH 03862-2403. Tel: 603-964-8006. Fax: 603-964-6889.