Bentley Pharmaceuticals Comments on Spain's Plan to Suspend the Current Reference-Price System and Support Generic Substitution.

EXETER, N.H. -- New Regulations Should Accelerate Product Pricing and Launches; Government Seeks to Triple Use of Generics

Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company focused on advanced drug delivery technologies, which also manufactures and markets a growing branded and generic product line in Europe, announced today that it expects to benefit from a strategic plan recently unveiled by Spain's health minister to provisionally suspend the current reference-price system and encourage greater use of generic drugs in the country's socialized healthcare system.

The announced 67-point plan is expected to take effect in early 2005 and replace the current reference- price system implemented by the Spanish government in late 2003, which reduced Bentley's 2004 revenue growth by more than 20%. The new plan is expected to introduce a 4% price reduction in 2005 (and an additional 2% reduction in 2006) on only those drugs that have been on the market in Spain for over one year and were not already subject to the previous reference-price reductions for 2004. Consequently, the price reductions are expected to reduce Bentley's 2005 revenues by an estimated $200,000 to $400,000, subject to final pricing decisions by the Spanish Ministry of Health.

Under the proposed system, if a marketer of generic products submits a price request that is at least 30% below the product's reference price, approval is expected to be automatic, which should also accelerate the launch of new generic products. The government is also expected to conduct educational campaigns about generics, targeting both healthcare professionals and consumers, in efforts to promote generic competition. The Spanish government seeks to gradually increase the percentage of prescriptions filled by generic drugs -- one of Bentley subsidiaries' core competencies -- from the current rate of approximately 6% to a target of 20%.

James R. Murphy, Bentley's Chairman and CEO, said, "The proposed plan would accelerate the regulatory approval process used to get generic drugs into the hands of patients in Spain, reduce the rate of governmental healthcare spending, and increase the demand for our generic products. We are hopeful that this new plan will alleviate some of the pressure the previous system placed on us as a result of its multi-level initiatives. We expect that the benefits of the proposed plan will far outweigh the projected $200,000 to $400,000 reduction in 2005 revenues.

Murphy continued, "Historically, the regulatory process in Spain has been lengthy and has resulted in the accumulation of an extensive pipeline of products pending approval. We are hopeful that this new plan will contribute to the government's ambitious goal of issuing regulatory approvals within a period of four to seven months after submission, permitting us to introduce even more products in the year 2005.

"Although the proposed system would not eliminate price controls, we anticipate that our gross margins would continue to gradually increase as we further develop and implement our growth strategy of expansion throughout geographical Europe and into the US and benefit from manufacturing efficiencies and economies of scale," concluded Murphy.

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.

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 ability of Bentley's subsidiaries to capitalize on increased generic competition, receive accelerated pricing approvals, and accelerate product launches as a result of the Spanish government's proposed plan and the ability of its subsidiaries to achieve economies of scale through growth of their businesses. 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 implementation of the new plan by the Spanish government, the timing and nature of regulatory approvals, expanding generic operations, further changes in third-party reimbursement and government mandates which impact pharmaceutical pricing, competition from other manufacturers of generic and proprietary pharmaceuticals, the effects of economic conditions, risks associated with international operations, 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.