TORONTO -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that the company's supplemental New Drug Submission (sNDS) for TIAZAC(R) XC, a once-daily extended-release formulation of diltiazem hydrochloride, for the treatment of angina, has been accepted for review by the Therapeutic Products Directorate (TPD).
In August 2004, TIAZAC(R) XC, which is available in 120mg-360mg dosages, received TPD approval for the treatment of hypertension. TIAZAC(R) XC, which builds on the success of Biovail's TIAZAC(R), Canada's leading once-daily diltiazem formulation, will be launched in Canada in the first quarter of 2005.
TIAZAC(R) XC, if approved for the treatment of angina, will represent a further advance in the management of this condition. TIAZAC(R) XC combines Biovail's advanced drug-delivery technology with the proven efficacy of diltiazem, a calcium channel blocker (CCB) that has been trusted by Canadian physicians for more than 20 years.
"The dual indication of TIAZAC(R) XC in hypertension and chronic stable angina, combined with its unique Diffusion Technology (DiTech(TM)) System, will make TIAZAC(R) XC an excellent choice for the physician in the management of two very important cardiovascular risk factors," says Suzanne Villeneuve, General Manager of Biovail Pharmaceuticals Canada, the Canadian sales and marketing division of Biovail Corporation in Mississauga, Ont.
Non-dihydropyridine calcium channel blockers (NDHP CCBs), like TIAZAC(R) XC, are often prescribed by physicians to treat angina because they improve cardiac blood flow and reduce heart rate. This combined effect balances the supply and demand of oxygen in the cardiac tissue, thereby reducing chest pain. TIAZAC(R) XC also lowers blood pressure which further reduces strain on the heart.
Angina - chest pain or discomfort that occurs when the heart muscle does not get enough blood - affects nearly one million Canadians. Angina is a symptom of coronary artery disease, the most common kind of heart disease, and occurs when vessels that carry blood to the heart become narrowed and blocked due to atherosclerosis.
The choice of drug to control angina is usually dependent on the acuity and severity of the symptoms, as well as the presence of other existing conditions. NDHP CCBs, including TIAZAC(R) XC, are a family of medications used primarily to lower blood pressure (hypertension) and to treat chest pain caused by coronary artery disease (angina). They are also sometimes used to treat arrhythmias (irregular heart rhythms) or diabetic nephropathy. NDHP CCBs are generally well tolerated.
About TIAZAC(R) XC
TIAZAC(R) XC (diltiazem HCl) is currently indicated for the treatment of high blood pressure (hypertension). TIAZAC(R) XC is a brand name for once-daily, extended-release tablet formulation for bedtime administration in dosages of 120 mg-360 mg per day. TIAZAC(R) XC works by slowing the heart rate, and by relaxing and widening blood vessels (arteries), which reduces blood pressure. Widening of the coronary arteries also increases the amount of blood reaching the heart, which can reduce the symptoms of angina.
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
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"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
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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