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| |  Extra Strength Cardizem CD (Diltiazem HCl) Available In US For Hypertension And Angina MONTREAL, QC and KANSAS CITY, MO -- February 22, 2000 -- Ethypharm, a European leader in the Drug Delivery Systems field, announced the U.S. launch of a new, exclusive 360 mg extra strength formulation of the well-established cardiovascular drug, Cardizem(R) CD (diltiazem HCl), manufactured and marketed by Hoechst Marion Roussel (Aventis). This new once-a-day diltiazem dosage, formulated as capsules of microgranules, uses the Multicaps SR HD (high density) system developed by Ethypharm. It reinforces the Cardizem CD product line, which was already available in the strengths of 120, 180, 240 and 300 mg. "The launch of the extra strength Cardizem product represents a significant technological achievement for Ethypharm. Until now, high doses of Cardizem needed to be administered in two doses which causes some compliance problems," noted Pierre Lapalme, CEO of Ethypharm (North America). "Using our proprietary Multicaps technology, we developed this new product to circumvents these issues, which at the same time ensures that patients are covered with their medication for 24 hours." Aimed at the treatment of hypertension and angina, diltiazem must often be prescribed at high therapeutic strength for a subset of the patient population suffering from severe heart conditions. Because of acceptability and compliance problems, heart specialists until now needed to prescribe two capsules of 180 mg per dose, because no technology had succeeded in obtaining the 360 mg strength in one capsule of a size acceptable by patients. Another restriction was the need to respect the pharmacokinetic profile specific to Cardizem CD that is necessary for efficient and reliable patient care over 24 hours. The formulation of this new strength, which could not be simply transposed from the previous formulations, was faced with two specific technical challenges: -- pharmacokinetics capable of ensuring efficient therapeutic coverage of patients over a 24 hour period, and;
The pharmacokinetics of the 360 mg strength also had to be a continuation of the existing strengths so that the product would be considered as a line extension (ANDA). In order to meet these requirements for rapid launch, Ethypharm used its Multicaps SR HD (High Density) system. This multiparticular system is made of hundreds of tiny microgranules highly charged in active ingredient and coated by a polymeric membrane through an automated process that does not require any organic solvent. Ethypharm, the European leader in Drug Delivery Systems, offers a wide portfolio of mind-to-market products, proprietary technologies, US Food and Drug Administration (FDA)-approved manufacturing facilities and full product development services to its customers, the major companies in human healthcare, for both chemical entities as well as biotech drugs. Founded in 1977 by Patrice Debregeas, President, and Gerard Leduc, CEO, Ethypharm, employs 700 people worldwide. The Group, whose products are sold in more than 80 countries in Europe, Asia and North America is now orienting its strategy towards the US and Japanese markets. In these territories, Ethypharm is already engaged in several product development contracts with major pharmaceutical companies. Ethypharm is also developing several internal projects based on its proprietary delivery systems including, several forms of morphine, in particular using the Multicaps SR technology aimed at a twice-a-day oral administration. At present, Multicaps SR morphine is in phase III clinical development in the U.S. and Japan. Outside the U.S. and Japan, Ethypharm already has developed and launched its twice-daily formulation of morphine in numerous countries, including France, Germany, the UK and Canada. Hoechst Marion Roussel (Aventis), a world leader in pharmaceutical-based healthcare, is dedicated to extending and enhancing human life through the discovery, development, manufacture and sale of innovative pharmaceutical products. Related Links: Cardizem CD (diltiazem HCl) and Hoechst Marion Roussel (Aventis).
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