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| |  Covera-HS for Hypertension and Angina Now Available SKOKIE, Ill., June 3, 1996 -- Searle, the pharmaceutical unit of Monsanto Company (NYSE: MTC), today announced that Covera-HS (verapamil hydrochloride) -- the first and only chronotherapeutic to treat hypertension and angina -- is now available to physicians and their patients through pharmacies across the United States. Covera-HS was approved by the U.S. Food and Drug Administration in February this year. Available in 180 mg and 240 mg tablets, it is the first once-a-day formulation of an antihypertensive/anti-anginal agent that uses advanced tablet coatings and a novel drug delivery system to mimic the body's typical 24-hour circadian variations in blood pressure and heart rate. The product, which incorporates this unique delivery technology called COER-24(TM) (Controlled-Onset Extended-Release), was developed in conjunction with ALZA Corporation. "We at Searle are very excited about the introduction of Covera-HS. The inquiries we have received from physicians, pharmacists and consumers about this unique new product are extremely encouraging," said Searle Chairman and CEO Richard U. De Schutter. "This level of interest reinforces our confidence that a once-daily formulation which follows the body's circadian rhythms will offer physicians and their patients a significant treatment option that is not being filled by existing antihypertensive therapies." Covera-HS is designed for oral dosing at bedtime. Peak concentration of Covera-HS is delivered in the early waking hours when blood pressure and heart rate are rising at their highest rate. There is minimal, but adequate concentration of drug during sleep, when blood pressure and heart rate are at their physiologic lowest, while continuing to provide appropriate coverage over the entire 24-hour dosing period. Blood pressure and heart rate -- physiologic processes which affect vital cardiovascular functions -- are influenced by these natural, 24-hour circadian rhythm patterns. The science of treating diseases that follow these circadian patterns is known as "chronotherapeutics" and is a well-established practice in medicine for the management of certain medical conditions including asthma, sleep, gastric and peptic ulcer diseases, arthritis and now, hypertension and angina. CONVINCE TRIAL PLANNED The unique features of Covera-HS will be further compared to the first-line "standard of care" regimen (diuretic, beta blocker) for hypertension in Searle's $50 million, 15,000-patient, prospective, randomized hypertension study called CONVINCE (Controlled ONset Verapamil Investigation of Cardiovascular Endpoints). More than 300 institutions worldwide will follow patients for a four-to-six year period to compare Covera-HS with the current standard care therapies, as recommended by the Joint National Committee on the Detection, Evaluation, and Treatment of Hypertension (JNC V) in preventing heart attacks, strokes and death. CONVINCE will also evaluate the ability of Covera-HS and its advanced COER-24 delivery system to effectively reduce the incidence of these adverse cardiovascular events in the early waking, or morning, hours when patients are considered to be at highest risk due to rapid rises in blood pressure and heart rate. Searle, a wholly owned subsidiary of Monsanto Company, is a research-based corporation that develops, manufactures and markets pharmaceutical products and other health care solutions worldwide. ALZA Corporation, headquartered in Palo Alto, Calif., is a leader in the development and commercialization of innovative pharmaceutical products using advanced drug delivery technologies to add medical and economic value to drug therapies. Note: Verapamil should be administered cautiously to patients with impaired renal function. The clinical significance of blunting an early morning rise in blood pressure and heart rate has not been established. For complete prescribing information for Covera-HS, including contraindications and adverse side effects, please call 1-800-323-4204.
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