Biovail, Ortho-McNeil Partnership Receives Hart-Scott-Rodino Regulatory Clearance.TORONTO -- 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) today announced that the Company and its partner, Ortho McNeil, Inc., a Johnson & Johnson company, have received Hart-Scott-Rodino regulatory clearance in the United States for their supply agreement for the marketing and distribution of a once-daily extended-release formulation and an orally disintegrating, immediate-release tablet formulation of tramadol in the United States and Puerto Rico. Both formulations have already been approved by 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. ). Subject to final FDA approval for the trade names, the extended-release and immediate-release formulations of tramadol will be marketed in the U.S. and Puerto Rico under the brand names Ultram(R) ER and Ultram(R) ODT See SCO Open Desktop. ODT - Open Desktop , respectively. "The Ultram(R) brand name is well known and highly respected by physicians and health-care practitioners," said Dr. Douglas Squires, Chief Executive Officer of Biovail Corporation. "The ability to leverage the Ultram(R) name is a competitive advantage that should provide Ortho-McNeil's world-class sales force, and Biovail's specialty sales force, an opportunity to quickly establish a significant market position for Ultram(R) ER." Ultram(R) ER, which is indicated for moderate to moderately severe chronic pain, received FDA approval on September 8, 2005, and will be available in 100mg, 200mg and 300mg dosage strengths. Ortho-McNeil expects to launch Ultram(R) ER early in the first quarter of 2006. Ultram(R) ODT, which is indicated for moderate to moderately severe pain, received FDA approval on May 5, 2005, and will be available in a 50mg dosage strength. Ortho-McNeil anticipates launching Ultram(R) ODT early in the second quarter of 2006. About Tramadol Tramadol is a centrally acting synthetic opioid analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs , effective in the treatment of pain. Tramadol is currently available under the brand name Ultram(R), and in several generic formulations. Branded and generic formulations of tramadol are indicated for the management of moderate to moderately severe pain, and may be dosed up to six times per day. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " 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 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 Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. 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 The Ontario Securities Commission (OSC) is a regulatory agency which administers and enforces securities legislation in the Canadian province of Ontario. The OSC is an Ontario Crown corporation which reports to the Ontario legislature through the Minister of Finance. . Biovail undertakes no obligation to update or revise any forward-looking statement. |
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