Healthcare Industry News: Biovail
News Release - May 19, 2006
Biovail to Promote Novartis' Lescol(R) Franchise in Canada; Lescol(R) Provides Treatment Option for Patients Who Need a Statin to Reduce Cardiovascular RiskTORONTO, May 19 (Healthcare Sales & Marketing Network) - Biovail Corporation (NYSE:BVF ; TSX:BVF ) today announced that Biovail Pharmaceuticals Canada (BPC), the Company's Canadian sales and marketing division, has entered into an agreement with Novartis Pharmaceuticals Canada Inc., a wholly owned subsidiary of Novartis AG, to market and promote cholesterol medicines Lescol(R), fluvastatin sodium capsules, and once-daily Lescol(R) XL, fluvastatin sodium extended-release tablets, to Canadian specialists and primary-care physicians.
Lescol(R) and Lescol(R) XL are indicated for the treatment of hypercholesterolemia and mixed hyperlipidemia in conjunction with a diet low in saturated fat and cholesterol. Lescol(R) is also indicated for the secondary prevention of cardiovascular events in patients with coronary heart diseases who have undergone a percutaneous coronary intervention (PCI) procedure.
Under the terms of the agreement - which will run through 2008 - Biovail will promote Lescol(R), 20mg and 40mg capsules and once-daily Lescol(R) XL, 80mg extended-release tablets, for a fee based on a percentage of Novartis' net selling price over mutually determined performance baselines. In addition, Biovail has certain performance obligations related to marketing and promotional activities for these products.
Doug Herman, Vice-President and General Manager of BPC, says that the excellent safety profile and low risk of drug interactions with Lescol(R) and Lescol(R) XL make it a compelling treatment option for patients who require a statin to reduce their cardiovascular risk, such as patients with Type II diabetes. For example, the Canadian Diabetes Association (CDA) recommends statin therapy for all patients with Type II diabetes - regardless of their cholesterol levels.
"Lescol(R) reduces 'bad' LDL cholesterol and increases 'good' HDL cholesterol in the blood which, in turn, can help to lower the risk of atherosclerosis and heart disease," Mr. Herman said. "Lescol(R) provides proven reductions in cardiovascular morbidity and mortality, and has been shown to significantly reduce major adverse cardiac events. In the LIPS(1) study, Lescol(R) 80mg significantly reduced the risk of major adverse cardiac events by 22%, compared with placebo, and by 47% among patients with diabetes, thus equalizing the long-term complications in diabetic patients down to that of non-diabetic patients.
"As such, Lescol(R) and Lescol(R) XL are important additions to BPC's cardiovascular portfolio which includes Tiazac(R) XC and Glumetza(TM), a new once-daily formulation of metformin."
Lescol(R) and Lescol(R) XL compete in the C$1.4-billion statin market, the largest prescription drug market in Canada. Statistics from IMS Health for the 12 months ended March 31, 2006, show that almost 19.8 million prescriptions were written for statins to manage cholesterol-related illness.
According to the Heart and Stroke Foundation of Canada, about 40% of adult Canadians have high cholesterol. Cardiovascular disease remains the leading cause of death in Canada, accounting for 37% of total deaths. Approximately $7.3 billion (17%) of total direct health-care costs and $12.3 billion (14.5%) of total indirect health-care costs for all disease categories can be attributed to cardiovascular disease. Failure to treat elevated cholesterol levels can lead to coronary artery disease, which can cause a heart attack or stroke.
About Lescol(R)/Lescol(R) XL
Lescol(R) and Lescol(R) XL are indicated for the treatment of hypercholesterolemia (high levels of cholesterol) and mixed hyperlipidemia (high levels of cholesterol and triglycerides) in conjunction with a diet low in saturated fat and cholesterol. Lescol(R) is also indicated for the secondary prevention of cardiovascular events in patients with coronary heart diseases who have undergone a percutaneous coronary intervention (PCI) procedure. Despite the overwhelming benefit of statins, their use may be limited by concerns about drug interactions and risk of significant adverse events including myopathy and rhabdomyolysis. The low risk of drug interactions with Lescol(R) XL and its excellent safety and tolerability profile may improve use of statins in these patient populations.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
To the extent any statements made in this press 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, and within the meaning of the "safe harbor" provisions of applicable Canadian securities legislation. These forward-looking statements relate to, among other things, our objectives, goals, strategies, intentions, plans estimates and outlook, and can generally be identified by the use of 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.
Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, regulatory matters including compliance with pharmaceutical regulations, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, consolidated tax-rate assumptions, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), the Ontario Securities Commission ("OSC"), and other securities regulatory authorities in Canada. Additional information about these factors and about the material factors or assumptions underlying any such forward-looking statements may be found in our current Annual Report on Form 20-F, filed March 31, 2006, and in particular under the heading "Risk Factors" under Item 3, Sub-Part D. Biovail cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization 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 ir(at)Biovail.com.
(1) Serruys P et al. JAMA 2002;287:3215-3222 (LIPS)
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