Biovail Corporation
NYSE : BVF
TSX : BVF

Biovail Corporation

September 09, 2005 07:30 ET

Biovail's Tramadol ER Receives FDA Approval

TORONTO--(CCNMatthews - Sep 9, 2005) -

Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that its New Drug Application (NDA) for a once-daily formulation of tramadol hydrochloride (Tramadol ER) has received final approval from the United States Food and Drug Administration (FDA).

Tramadol ER has been approved for the treatment of moderate to moderately severe chronic pain in once-daily 100mg, 200mg and 300mg dosage strengths. Biovail is the first and only company to submit an application to the FDA for review, and to receive an approval for a once-daily tramadol formulation.

Biovail is actively involved in negotiations related to the commercialization of Tramadol ER by a strategic marketing partner. The Company expects to conclude these negotiations soon, and anticipates the commercial launch of Tramadol ER to occur in early 2006.

As a trade name is currently being finalized for the product, the label, as approved by the FDA, refers to the product as "Tradename ER".

"This is an important milestone as it further demonstrates Biovail's technological and scientific capability in utilizing advanced drug-delivery technologies to add significant clinical benefits to medications," said Dr. Douglas Squires, Biovail's Chief Executive Officer. "The timing of the approval gives Biovail a significant competitive advantage, and allows us to further diversify our revenue base. The conditions of approval by the FDA for Tramadol ER support three years of exclusivity for the indication and doses approved."

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@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 U.S. Food and Drug Administration and Canadian Therapeutic Products Directorate 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, tax rate assumptions, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission. Biovail undertakes no obligation to update or revise any forward-looking statement.

Contact Information

  • Biovail Corporation
    Kenneth G. Howling, 905-286-3000