Biovail Announces FDA Approval of Teveten HCT for Hypertension - Promotional Activities for This Combination ARB/Diuretic Product Will Begin March 10, 2003 -.Business Editors/Health/Medical Writers TORONTO--(BUSINESS WIRE)--Feb. 20, 2003 Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency )(TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :BVF) announced today that the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved Teveten(R) HCT Hct abbr. hematocrit HCT Hematocrit, see there for the treatment of hypertension (high blood pressure). Teveten(R) HCT is a combination of the angiotensin II receptor blocker (ARB), eprosartan mesylate, and the diuretic diuretic (dī'yərĕt`ĭk), drug used to increase urine formation and output. Diuretics are prescribed for the treatment of edema (the accumulation of excess fluids in the tissues of the body), which is often the result of underlying , hydrochlorothiazide hydrochlorothiazide /hy·dro·chlo·ro·thi·a·zide/ (-klor?o-thi´ah-zid) a thiazide diuretic, used for treatment of hypertension and edema. hy·dro·chlo·ro·thi·a·zide n. Abbr. . Biovail will begin shipping Teveten(R) HCT to the trade and initiate promotional activities for the two dosage strengths of this combination ARB/diuretic product in early March 2003. "Most patients with high blood pressure, regardless of age, race, gender or severity of hypertension, respond to Teveten(R)," commented Eugene Melnyk, Chairman and Chief Executive Officer of Biovail. "With the availability of Teveten(R) HCT in two dosing strengths, Biovail is offering physicians the flexibility to provide their patients with additional control." Studies illustrate that approximately two thirds of hypertensive patients require the use of more than one therapeutic agent to bring their blood pressure to an acceptable target level. Teveten(R) HCT offers patients the convenience of a combination of a diuretic and an angiotensin receptor blocker (ARB) in one tablet. This product may be used alone or in conjunction with other antihypertension medications. The ARB market segment is the fastest growing class of antihyperintensive medications in the United States. The total value of the ARB market is approximately $2.6 billion in the United States and growing in excess of 34% annually. The value of the ARB/hydrochlorothiazide market, to which Teveten(R) HCT belongs, is approximately $1 billion per year and growing at an annual rate of 44%. Biovail acquired the United States marketing rights for Teveten(R) and Teveten(R) HCT from Solvay Pharmaceuticals in March of 2002. Under the terms of this agreement, Solvay manufactures and supplies both products to Biovail for U.S. distribution. The chemical compound, eprosartan mesylate, has patent protection until 2011. The Prescribing Information for Teveten(R) HCT states that this product should not be taken during the second and third trimesters of pregnancy. 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 further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA/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, 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. |
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