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For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail. Douglas er ultram squires, Chief Executive Officer of Biovail Corporation. 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. Ortho-McNeil anticipates Er ultram launching Ultram(R) ODT early in the second quarter of 2006. Ultram(R) ER, which is indicated for moderate to moderately severe chronic pain, received FDA approval in September 2005 and will be available in 100mg, 200mg and 300mg er ultram dosage strengths.
Tramadol is currently sold in the United States under the brand name Ultram(R) with approximately 11 million prescriptions dispensed during for the twelve months ended December 31, 2003 including generics. Further, Biovail will benefit competitively from a first-to-market advantage in the once-daily tramadol market. TORONTO -- Biovail Corporation (NYSE:BVF)(TSX: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. Ultram(R) ODT, which is indicated for moderate to moderately severe pain, received FDA approval in May 2005, and er ultram will be available in a 50mg dosage strength.
The combined intellectual property of Biovail, Ortho-McNeil and Purdue provides patent protection through 2014 for Biovail's formulation, which may extend the branded market opportunity for Ultram(R) ER. Researchers wrote in The Health Care Manager (25:1) that an analysis of studies of mandatory continuing education (MCE) in medicine and other healthcare fields found no substantial evidence that MCE er ultram has changed practice behaviors in ways that improve patient care. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
Under the agreement, which has a 10-year term, Biovail will manufacture, supply and sell Ultram(R) ER to Ortho-McNeil for distribution at contractually determined prices, which will be based on Ortho-McNeil's net selling price. We have based these forward-looking statements on our current expectations and projections about future events. Food er ultram and Drug Administration and Health Canada in the first quarter of 2006. 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. Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. Biovail will manufacture, supply and sell Ultram(R) ODT to Ortho-McNeil for distribution at prices approximately equal to 30% of Ortho-McNeil's net selling price. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Er ultram tramadol's minimal propensity to induce adverse effects is an advantage over morphine-like agents.Upon closing of the transaction, Ortho-McNeil will pay to Biovail a supply prepayment of Er ultram $60 million to be credited against product purchases of Ultram(R) ER.
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Comments (14)john | Friday 13th March 2009 09:43:24 AM
Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the er ultram company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel.ch01 | Saturday 28th February 2009 12:37:25 PM
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies.olaf | Friday 27th February 2009 11:11:40 PM
Subject to FDA approval, er ultram ralivia(tm) FlashDose(R) will be available in 50mg, tablets by prescription only.ch01 | Tuesday 24th February 2009 08:41:36 PM
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.
Integrated Communications, a unit of Lowe Healthcare Worldwide, won a prelaunch med-ed assignment for Ultram ER, a chronic pain drug from J&J's PriCara unit, the agency's third PriCara hospital antibiotic win.
tara | Wednesday 25th February 2009 06:27:32 AM
"Our tramadol products will leverage the strong primary-care presence of a strategic partner, while providing Biovail an opportunity to focus its detailing efforts on certain specialist physicians. " Intellectual Property Position Pursuant to an agreement between Ortho-McNeil and Purdue Pharma L.
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domi | Saturday 7th March 2009 01:08:27 PM
Subject to FDA acceptance for filing, Cipher expects the review to Er ultram be completed by October 2008.