Bentley Pharmaceuticals Announces Agreement with Cardinal Health for Scale-Up and Manufacture of Clinical Supplies for Bentley's Intranasal Insulin Program

EXETER, N.H., Sept. 19 /PRNewswire-FirstCall/ -- Bentley Pharmaceuticals, Inc. , a specialty pharmaceutical company, announced today that it has secured capacity at Cardinal Health's new North Raleigh facility for the scale-up and manufacture of clinical supplies of Bentley's intranasal insulin product candidate, facilitating the expansion of clinical trials.

The product candidate utilizes Bentley's proprietary CPE-215(R) drug delivery technology to deliver insulin directly through diabetic patients' nasal mucosa using a small, discreet nasal spray. The conventional treatment requires intramuscular injections several times a day.

Cardinal Health, a leading provider of products and services supporting the health-care industry, will manufacture clinical supplies of Bentley Pharmaceuticals' intranasal insulin product under Current Good Manufacturing Practices (cGMP) at its new, sterile manufacturing facility in North Raleigh, N.C.

"This agreement with Cardinal Health is another important step forward in our intranasal insulin program and the CPE-215(R) delivery platform," said John A. Sedor, president of Bentley Pharmaceuticals. "Early results for the intranasal insulin product have been promising and there is growing interest in alternative insulin delivery methods that are less intrusive than injection. We are excited to be working with Cardinal Health to continue to advance this program through global Phase II trials this year."

This agreement builds on an existing drug development relationship with Cardinal Health's manufacturing and analytical services facility in Research Triangle Park, N.C., where Cardinal Health pulmonary and nasal experts worked with Bentley Pharmaceuticals to characterize the product.

"Bentley Pharmaceuticals leveraged multiple capabilities within Cardinal Health's development and manufacturing segment to prepare its intranasal insulin candidate for global clinical trials," said Shawn Gallagher, vice president and general manager of Cardinal Health's North Raleigh facility. "By using Cardinal Health's full range of solutions -- from development to manufacturing to packaging and distribution -- Bentley Pharmaceuticals maximizes its efficiency and relies on the same high-quality services through the entire drug development and commercialization cycle."

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 potential benefits of the 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 efficacy and safety of Bentley's intranasal insulin product candidate, the timing and nature of regulatory approvals, development and commercialization of the intranasal insulin product candidate, competition from other manufacturers of new insulin products, intellectual property litigation, our relationships with our strategic partners, the unpredictability of patent protection, risks associated with international clinical trials and operations, 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.

Contacts: Bentley Pharmaceuticals, Inc. Jean DeRoche 603.658.6136