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Trimetazidine

A drug for vertigo sometimes called Vastarel. Usually 0.020g per tablet.

Trimetazidine is an anti-ischemic (anti-anginal) metabolic agent, improves myocardial glucose utilization through inhibition of fatty acid oxidation.

It improves left ventricular function in diabetic patients with coronary artery disease.

It is described as the first cytoprotective anti-ischemic agent, acts by directly counteracting all the major metabolic disorders occurring within the ischemic cell. The actions of trimetazidine include limitation of intracellular acidosis, correction of disturbances of transmembrane ion exchanges, and prevention of excessive production of free radicals.

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Bentley Pharmaceuticals Reports Third Quarter Profitability On 37% Revenue Growth; Raises 2002 Revenue Guidance to $37 - $38 Million
From Business Wire, 10/30/02

Business Editors & Health Writers

NORTH HAMPTON, N.H.--(BUSINESS WIRE)--Oct. 30, 2002

Bentley Pharmaceuticals, Inc. (AMEX: BNT), a specialty pharmaceutical company focused on advanced drug-delivery technologies, which also manufactures and markets generic and branded products in Europe, today announced financial results for the third quarter and nine months ended September 30, 2002.

Total revenue for the third quarter of 2002 increased 37% to $8,664,000 from $6,316,000 in the prior-year third quarter. Revenue growth during the quarter primarily reflects the company's success in gaining additional market share of the growing generic drug market in Spain. Third quarter operating income improved to $692,000 compared with $120,000 in the comparable quarter in 2001. Net income in the 2002 third quarter totaled $291,000, which is $0.02 per basic common share or $0.01 per diluted common share, compared with a net loss of $149,000, or ($0.01) per basic and diluted common share, in the comparable period of the prior year.

Total revenue for the nine months ended September 30, 2002 increased 55% to $28,220,000 from $18,255,000 in the same period of the prior year. Net income for the nine-month period totaled $945,000, which is $0.06 per basic common share, or $0.05 per diluted common share, compared with $1,924,000, which is $0.14 per basic common share or $0.12 per diluted common share, in the comparable period of the prior year. The 2001 nine-month results included a $5,090,000 pre-tax gain on the sale of certain drug licenses.

James Murphy, president and CEO, stated, "This quarter's strong performance, marked by impressive top-line growth and our third consecutive quarter of profitability, primarily reflects our increasing share of Spain's rapidly emerging generic drug market. During the quarter we successfully launched our generic trimetazidine product in Spain. In addition to obtaining generic approval for this widely used angina product, our Spanish subsidiaries were also granted branded approval for the product, and are marketing the drug under the tradename Vaso Rimal(R). Moreover, our Spanish subsidiaries were granted branded product approval in Spain to market the lipid-lowering cholesterol drug, simvastatin, which is marketed as Zocor(R) in the U.S. by Merck & Co. Furthermore, earlier this month, our Spanish subsidiaries were granted approval to market the generic version of paroxetine, the popular antidepressant that is marketed as Paxil(R) in the U.S. Going forward, our strategy is to expand our product lines in targeted areas, such as cardiovascular, anti-infective, gastrointestinal and CNS, and be among the first to market in this region in order to capture an increasing percentage of the vast market and position us for sustainable, long-term growth. The products from our collaboration with Teva continue to proceed through the Spanish regulatory process.

"We recently extended our research collaboration with Pfizer to evaluate the impact of Bentley's drug delivery technology on certain Pfizer compounds. We are also progressing nicely with other plans to expand clinical programs toward achieving commercialization. We successfully completed the development program for our improved acetaminophen product in Europe, which demonstrated that Bentley's new tablet product has a higher rate of absorption than Termalgin(R), a tablet popular among Europeans. Bentley's product reached maximum blood concentration in only 25 minutes versus Termalgin, which took 45 minutes.

"Our fingernail onychomycosis pilot study at the University of Alabama showed improvement in over 80% of patients who used a clotrimazole lacquer formulation enhanced by Bentley's CPE-215(R) drug delivery technology. Most patients reported that they experienced less discomfort, more pliable nails and the onset of clear nail growth. These encouraging results lead us to the next phase of development, evaluating our lacquer against placebos and other currently marketed therapies. Results of our toenail study are expected in early 2003. We are also progressing with our pre-clinical study at Dartmouth College for evaluating topical androgen therapy for women suffering from fibromyalgia syndrome and continue to gather valuable information for more advanced studies.

"The strategic investments we are making in the company continue to position us well for future growth. Looking ahead, we expect additional revenue growth and profits from both our generic products and our proprietary drug-delivery technologies. With continued momentum, we look forward to a strong year-end finish, and are confident that the company will generate total revenue of approximately $37-38 million in 2002," concluded Mr. Murphy.

The company will host a conference call on Wednesday, October 30 at 10:00 a.m. EDT to discuss results. Those who wish to participate in the conference call may call (888) 335-6674 fifteen minutes before the 10:00 a.m. starting time. A replay will be available by telephone for two weeks following the completion of the live call at (877) 519-4471 toll free in the U.S. or (973) 341-3080 for international callers, PIN # 3564061.

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 Spain for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries Laboratorios Belmac and Laboratorios Davur.

Copies of the company's 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: 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 identifying suitable drugs for drug delivery technologies, expanding generic and branded drug operations, development and commercialization of our products, relationships with our strategic partners, uncertainty of clinical trials, regulatory approval process, product sales concentration, unpredictability of patent protection, technological changes, the effect of economic conditions and other uncertainties detailed in Bentley's filings with the Securities and Exchange Commission.

COPYRIGHT 2002 Business Wire
COPYRIGHT 2002 Gale Group

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