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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 Second Quarter Profitability On 65% Revenue Growth; Second Quarter Revenue Reaches a Record $10.1 Million
From Business Wire, 8/6/02

Business Editors

NORTH HAMPTON, N.H.--(BUSINESS WIRE)--Aug. 6, 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 second quarter ended June 30, 2002.

Total revenue for the second quarter of 2002 increased 65% to $10,133,000 from $6,125,000 in the prior-year second 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. Including a non-recurring pre-tax gain of $520,000 related to the disposition of a gastrointestinal product, operating income in the second quarter of 2002 improved to $1,395,000 compared with an operating loss of ($468,000) in the second quarter of 2001. Including the non-recurring gain, net income in the 2002 second quarter totaled $519,000, or $0.03 per basic and diluted common share, compared with a net loss of ($569,000), or ($0.04) per basic and diluted common share, in the comparable period of the prior year.

Total revenue for the six months ended June 30, 2002 increased 64% to $19,556,000 from $11,939,000 in the same period of the prior year. Net income for the six months ended June 30, 2002 totaled $654,000, or $0.04 per basic common share, $0.03 per diluted common share, compared with $2,073,000, or $0.15 per basic common share, $0.13 per diluted common share, in the comparable period of the prior year. The 2001 six-month results included a $4,977,000 pre-tax gain on the sale of a drug license during the first quarter of 2001.

James Murphy, president and CEO, stated, "This quarter's strong performance, marked by strong top-line growth and our second consecutive quarter of profitability, primarily reflects our increasing share of Spain's rapidly emerging generic drug market. Our balance sheet is particularly strong, with cash and short-term liquid investments of more than $26 million and essentially no long-term debt. During the quarter, our two Spanish subsidiaries were granted approvals from the Ministry of Health to market generic 5-mg and 10-mg strength tablets of zolpidem, which is marketed as Ambien(R) in the U.S. Bentley is the only company to obtain generic approval for the 5-mg strength of this popular orally administered sedative in Spain. We are on schedule to launch both dosage forms of this product during the fourth quarter of 2002.

"During the second quarter we successfully launched our generic trimetazidine product in Spain, which we expect will spur revenue growth beginning in the fourth quarter of this year. In addition to obtaining generic approval for this widely used product, which controls chest pain associated with angina, our Spanish subsidiaries were also granted branded approval for the product, and will market 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. Going forward, our goal remains to capture an increasing percentage of the vast market in this region to position us for sustainable, long-term growth.

"We continue to make strides in advancing our drug-delivery technologies, and are progressing nicely with plans to expand our clinical programs toward achieving commercialization. Recently, 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.

"Clinical trials for evaluating our topical nail lacquer for treating nail-fungal infections remain on track at the University of Alabama-Birmingham. We recently announced successful results of our fingernail onychomycosis pilot study, which showed improvement in over 80% of patients who used a clotrimazole lacquer formulation containing 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 a strong first half behind us, we look forward to the rest of the year, and expect to generate total revenues of approximately $35-37 million in 2002," concluded Mr. Murphy.

The company will host a conference call on Wednesday, August 7 at 8:30 a.m. EDT to discuss results. Those who wish to participate in the conference call may call (888) 335-6674 fifteen minutes before the 8:30 a.m. starting time. A replay will be available by telephone for 30 days 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 # 3407491.

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.

--30--af/md/ny*

COPYRIGHT 2002 Business Wire
COPYRIGHT 2002 Gale Group

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