Bentley Pharmaceuticals and Dong Sung Pharmaceuticals Enter into a Lic

    Business Editors

    EXETER, N.H.--(BUSINESS WIRE)--April 25, 2005--Bentley Pharmaceuticals, Inc. (NYSE: BNT), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, today announced that it has entered into an agreement with Dong Sung Pharm. Co. Ltd. for the development of an intranasal spray formulation of insulin for the South Korean market and possibly additional territories. The agreement is Bentley's first to develop and license its intranasal spray formulation of insulin.
    Under the agreement, the two companies have agreed to conduct Phase II and Phase III studies designed to comply with international standards that would be applicable for regulatory submissions in South Korea and possibly in other countries. A joint working team consisting of Bentley and Dong Sung employees, as well as consultants, will guide the development process in Korea. Dong Sung will fund the appropriate studies and submit the regulatory documents required for their licensed territory. Bentley will provide clinical and commercial supplies of insulin formulations, as well as metered administration devices.
    James R. Murphy, Chairman and CEO of Bentley Pharmaceuticals, Inc., commented, "We are very pleased to sign our first agreement for developing and licensing our intranasal delivery of insulin. The generation of more advanced clinical data through this collaboration could be very valuable in assisting and supporting our other developmental strategies for Asia, the EU and the US. The development of this product has also given us encouragement that our platform technology may be used to deliver other peptides."
    Y.S. Kim, Vice Chairman, Dong Sung Pharm. Co. Ltd., commented, "Since 1997, when we opened our factory in A-San city, we have been working on the development of non-parenteral administration of insulin and other therapeutic agents. The intranasal delivery method developed by Bentley is by far the most promising of the approaches we have studied, including oral administration of insulin. We believe that Bentley has overcome the challenges to this method of insulin delivery with its proprietary technology. We are very happy to be working with them in the development of this technology."
    Yang-Gu Lee, President of Dong Sung went on further to comment, "We are very hopeful that we will successfully complete Phase III clinical trials of Bentley Pharmaceuticals' breakthrough technology here in Korea. We are excited by the prospect of undertaking the work that has the potential to bring this intranasal insulin product to those suffering from Type I diabetes. If the study lives up to our expectations, and the evidence Bentley has gathered so far suggests that it will, then the product will receive the regulatory clearances needed, not just in the Republic of Korea, but in other countries in Asia, Europe and the Americas."
    Bentley previously announced that it will report the results of its initial Phase II clinical trial in an abstract, entitled "Intranasal Insulin Administration in Type I Diabetic Patients Utilizing CPE-215 Technology" at the American Diabetes Association 65th Scientific Sessions, June 10-14, 2005, in San Diego, California. Previous reports of Bentley's intranasal insulin development program were published in Diabetes Technology and Therapeutics, Vol. 7 (1): 124-130, 2005 and previously presented at the Diabetes Technology Society Meeting in October, 2004 in Philadelphia, Pennsylvania.

    Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and pharmaceutical products. Bentley's proprietary drug technologies enhance or facilitate the absorption of pharmaceutical compounds across various membranes. Bentley also manufactures and markets a growing portfolio of generic and branded pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar; and manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.

    Dong Sung is a publicly traded company based in Seoul, South Korea, founded in 1957 engaged in the development, manufacture and sale of pharmaceuticals, cosmetics and nutritional and health products.
    Additional information about Dong Sung Pharmaceuticals may be obtained through their web site at www.dongsung-pharm.co.kr.

    Copies of Bentley Pharmaceuticals' press releases and other information may be obtained through Bentley's web site at 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 the potential of Bentley's intranasal insulin formulation and the prospects for its collaboration with Dong Sung Pharmaceuticals. 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 timing and results of clinical trials, efficacy and safety of our products, the timing and nature of regulatory approvals, development and commercialization of our products, the unpredictability of patent protection, technological changes, and other uncertainties detailed in Bentley's most recent Annual Report on Form 10-K and its other 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.

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CONTACT: Bentley Pharmaceuticals, Inc. Michael D. Price, 603-658-6100 www.bentleypharm.com or Investor Relations Contacts: Porter, Le Vay & Rose, Inc. Investor Relations: Linda Decker, 212-564-4700 Editorial: Jeff Myhre, 212-564-4700 Media Relations: Tom Gibson, 201-476-0322

KEYWORD: NEW HAMPSHIRE SOUTH KOREA INTERNATIONAL ASIA PACIFIC INDUSTRY KEYWORD: PHARMACEUTICAL MARKETING AGREEMENTS SOURCE: Bentley Pharmaceuticals, Inc.

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