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Bentley Pharmaceuticals Announces Initiation of Phase III Clinical Study of Topical Testosterone Gel.


Business Editors

NORTH HAMPTON, N.H.--(BUSINESS WIRE)--March 20, 2001

Signs a Letter of Intent With Auxilium A2 for Additional

Licenses for Osteoporosis and Pain Management;

Anticipates Filing NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  in 2001

Bentley Pharmaceuticals, Inc. (AMEX AMEX

See: American Stock Exchange
: BNT BNT Bentley Pharmaceuticals, Inc. (stock symbol)
BNT Boston Naming Test (psychology)
BNT Bermuda National Trust
BNT Bulgarian National TV
BNT Broadband Network Termination
BNT Binary File Transfer
), a drug delivery company with a commercial presence in Europe, announced today that Auxilium A2, Inc. has initiated a Phase III clinical evaluation of a new topical gel formulation of testosterone based upon Bentley's drug delivery technology and anticipates filing an NDA in 2001. A Phase III evaluation is the final stage of testing required prior to submission of a product to the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for approval.

Auxilium A2, Inc. licensed the worldwide rights to testosterone as well as the ability to sublicense in various global territories; Bentley maintained its commercial rights in Spain where commercialization is anticipated through its subsidiaries, Laboratorios Belmac and Laboratorios Davur. Bentley will receive payments based upon the completion of specific milestones plus royalties on net sales. As a result of these first studies, Auxilium and Bentley have signed a letter of intent to develop and license two additional products: transdermal delivery of dihydrotestosterone dihydrotestosterone /di·hy·dro·tes·tos·te·rone/ (DHT) (-tes-tos´te-ron) an androgenic hormone formed in peripheral tissue by the action of 5 on testosterone; thought to be the androgen responsible for development of male primary sex  (DHT (Distributed Hash Table) A method for storing hash tables in geographically distributed locations in order to provide a failsafe lookup mechanism for distributed computing. ) and the intranasal in·tra·na·sal
adj.
Within the nose.
 delivery of oxycodone oxycodone /oxy·co·done/ (-ko´don) an opioid analgesic derived from morphine; used in the form of the hydrochloride and terephthalate salts.

ox·y·co·done
n.
. The terms and conditions of these licenses will be modeled after the previous agreements with Auxilium A2.

DHT is a metabolic steroid that regulates most androgenic actions in the adult male and may have significant benefits in treating osteoporosis in men. Oxycodone is a powerful opiate opiate /opi·ate/ (o´pe-it)
1. any drug derived from opium.

2. hypnotic (2).


o·pi·ate
n.
1.
 used in the management of severe pain in acute and chronic conditions.

James R. Murphy, Bentley's Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  said, "We are pleased to announce this step toward the commercialization of the first product based upon our patented transdermal technology. Since signing our agreement in May 2000, Auxilium has pursued the development in a very timely manner, exceeding our initial expectations with regard to the schedule. Our formulation technology, combined with testosterone, will provide patients the convenience of a self-administered, simple topical application. We are also pleased to have our first partner in the development of an intranasal delivered product that could lead to a less invasive and highly effective treatment in pain management."

Murphy continued, "We are especially excited about this transaction because it is based on an expansion of an existing relationship with a pharmaceutical company whose staff is highly experienced in drug development and has performed Phase II trials involving our delivery technology."

Bentley Pharmaceuticals, Inc. is a drug delivery company focused upon improving the absorption of a wide range of drugs and peptides through proprietary drug delivery technologies, which it intends to commercialize in the U.S. and other major markets by licensing to other pharmaceutical companies. Bentley also manufactures and commercializes branded and generic products in Europe for the treatment of cardiovascular, gastrointestinal, neurological and infectious diseases through its subsidiaries, Laboratorios Belmac and Laboratorios Davur.

Safe Harbor Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, the ability to find effective market distribution channels, development of new products, regulatory approval processes, the impact of competitive products or pricing, unpredictability of patent protection, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

Copies of the Company's press releases and other information may be obtained through Bentley's web site at www.bentleypharm.com 2001
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Mar 20, 2001
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