Business Editors
TORONTO--(BUSINESS WIRE)--Feb. 26, 2004
Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today it has acquired the rights to a novel formulation of eprosartan (Teveten(R)) and a formulation for an enhanced version of carvedilol (Coreg(R)) through the acquisition of the remaining interest in BNC-PHARMAPASS, LLC. The novel eprosartan formulation (Teveten SB) was developed to improve the bioavailability of the currently marketed product and may provide better dosing flexibility. Teveten SB will enter Phase I studies this quarter. Coreg, marketed by GlaxoSmithKline (GSK), is indicated for the treatment of Congestive Heart Failure (CHF) and had sales of approximately $619 million in the United States in 2003.
In July 2003, a joint venture was established between BLI Pharmaceutical Development Ltd (BNC), a subsidiary of Biovail Laboratories Incorporated (49% ownership) and PharmaPass II, LLC (51% ownership) for the purpose of developing enhanced or Super-Bioavailable formulations of Coreg, Teveten and Flomax. The joint venture (BNC-PHARMAPASS, LLC) agreed to enter into an exclusive manufacturing and distribution agreement with Biovail for these products and BNC had an option to acquire PharmaPass II, LLC's interest in the joint venture.
BNC has acquired PharmaPass II, LLC's remaining ownership interest in the joint venture for total consideration of approximately $35 million. PharmaPass II, LLC retains a royalty interest on the future sales of enhanced carvedilol and Teveten SB while the Flomax developmental program has been terminated. As a result of these transactions, Biovail confirms that it does not have any remaining joint ventures.
Additional information
Carvedilol
GlaxoSmithKline (GSK) markets carvedilol in the United States under the brand name Coreg. Coreg is a beta-blocker and is prescribed to patients for the treatment of Congestive Heart Failure (CHF), among other things. The beta-blocker market in the United States is approximately $2.2 billion and grew approximately 21% in 2003 versus 2002. During 2003, Coreg prescriptions grew approximately 26% to 5.7 million. The product patent for Coreg expires in March 2007. Coreg is currently dosed twice per day and according to the package insert, must be carefully titrated up and should be taken with food to slow the rate of absorption when being used for the treatment of CHF. Biovail believes a once-daily carvedilol formulation should improve patient compliance and may enhance dosing flexibility.
Eprosartan (Teveten and Teveten HCT)
Teveten and Teveten HCT are marketed by Biovail in the United States and are Angiotensin II Receptor Blockers (ARB's) used for the treatment of hypertension. The ARB market in the United States is approximately $3.5 billion and is the fastest growing class of drugs (30%) in the cardiovascular category. During 2003, combined prescriptions for Teveten and Teveten HCT grew 110%. In the United States, the patent for Teveten expires in February 2010 and the patent for Teveten HCT expires in August 2014.
Biovail is committed to developing and commercializing product line extensions that offer meaningful clinical enhancements that provide product life cycle opportunities for Biovail or its partners. Biovail will finalize the accounting for this transaction and announce the treatment as part of its 2003 earnings release scheduled for March 3, 2004.
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 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 FDA 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.
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