TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that a major cardiovascular study has shown that TEVETEN(R) (eprosartan), an angiotensin II receptor blocker (ARB) marketed in the United States by Biovail, offers protection against cerebrovascular and cardiovascular events in hypertensive patients with a previous stroke, over and above that offered by blood-pressure reduction alone.
The results of the MOSES(1) study (Morbidity and Mortality After Stroke - Eprosartan Compared with Nitrendipine in Secondary Prevention) in more than 1,400 patients were released late Monday at the European Society of Cardiology Congress in Munich. Initial results from the study showed that blood pressure was equally well controlled when hypertensive patients with a history of stroke were treated with either TEVETEN(R)-based or nitrendipine-based therapies. There was a 20% greater reduction in the primary endpoint (total mortality and total cardiovascular and cerebrovascular events), a 25% greater reduction in the recurrence of stroke and associated disease, and a 30% greater reduction in first-time cardiovascular events in the TEVETEN(R) group vs. the nitrendipine group. All of these differences were statistically significant.
Biovail acquired United States marketing rights for TEVETEN(R) and TEVETEN(R) HCT (eprosartan mesylate and hydrochlorothiazide combination), both of which are patent-protected through 2010, from Solvay Pharmaceuticals Marketing & Licensing AG in March 2002. TEVETEN(R) and TEVETEN(R) HCT compete in the US$4-billion angiotensin receptor blocker market, the fastest-growing class of anti-hypertensive drugs; for the 12 months ended June 30, 2004, the ARB market grew 27%. Approximately 62.6 million total prescriptions were written for ARBs during the same period. The TEVETEN(R) line provides Biovail with multiple treatment options for cardiovascular disease.
The MOSES study was designed to compare the efficacy of the two agents in secondary stroke prevention and reduction of cardiovascular and cerebrovascular morbidity and mortality. It is the first study to specifically compare the outcomes of alternative anti-hypertensive treatment in patients with a history of stroke. Nitrendipine was chosen as the comparator agent because of its success in the Syst-Eur study(2) where treatment reduced the risk of stroke by 42% in elderly patients with systolic hypertension. Although not marketed in the United States, nitrendipine is a member of the dihydropyridine calcium channel blocker class, which includes amlodipine, nifedipine and felodipine.
In the MOSES study, both nitrendipine and TEVETEN(R) produced impressive reductions in blood pressure, with approximately 75% of patients in each group reaching the target blood pressure as determined by ambulatory blood-pressure monitoring. Since both agents produced similar reductions in blood pressure, the reduced incidence of cerebrovascular and cardiovascular events in patients receiving TEVETEN(R) suggests that these benefits are achieved independently of blood-pressure reductions.
Stroke is the leading cause of disability and third leading cause of death(3) in the United States. Statistics show that 5%-14% of stroke survivors will suffer a second stroke, within one year(4). Approximately, 200,000 secondary strokes occur each year in the U.S(5). Within five years, 24% of women and 42% of men will suffer a second stroke(4). A second stroke may be truly devastating.
TEVETEN(R) (eprosartan) is an antihypertensive agent in the angiotensin II receptor blocker (ARB) class that treats hypertension in a broad range of patients, including older patients, African Americans, and individuals with severe hypertension. TEVETEN(R) and TEVETEN(R) HCT are indicated for the treatment of hypertension. TEVETEN(R) HCT is not indicated for initial therapy. TEVETEN(R) and TEVETEN(R) HCT are contraindicated in patients who are hypersensitive to any component of these products. Because of the hydrochlorothiazide component, TEVETEN(R) HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs; patients should be observed for clinical signs of fluid or electrolyte imbalance. Volume and/or salt depletion should be corrected in patients prior to administering TEVETEN(R) or TEVETEN(R) HCT to avoid symptomatic hypotension.
Adverse events were generally mild to moderate and similar to placebo. Upper respiratory infection, rhinitis, pharyngitis, and coughing were reported more frequently (greater than 2% and greater than placebo) with TEVETEN(R). Dizziness and back pain were most common (greater than 2% and greater than placebo) with TEVETEN(R) HCT.
USE IN PREGNANCY: When used in pregnancy during the second and third trimesters, drugs that act directly on the rennin angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, TEVETEN(R) and TEVETEN(R) HCT should be discontinued as soon as possible. Please see Prescribing Information, including WARNINGS: Fetal/Neonatal Morbidity and Mortality.
TEVETEN(R) and TEVETEN(R) HCT are marketed in the United States by Biovail Corporation.
For more information about TEVETEN(R), visit the Web site at www.teveten-us.com.
About Biovail Corporation
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the company's Web site at www.biovail.com
For further information, please contact Ken Howling at 905-286-3000 or send inquiries to email@example.com.
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To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration ("FDA") and Canadian Therapeutic Products Directorate ("TPD") approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, third parties, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission ("SEC") and the Ontario Securities Commission ("OSC").
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