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Biovail Receives Canadian Approval for Ralivia(TM).


Company to Launch Once-Daily Tramadol Product Shortly

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 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.  (TPD TPD Tons Per Day
TPD Therapeutic Products Directorate
TPD Total and Permanent Disablement (insurance)
TPD Temperature Programmed Desorption
TPD Temporary Partial Disability (insurance) 
) Canada has issued a Notice of Compliance (NOC (Network Operations Center) A central or regional location for monitoring a large network. Also called a "network management center" (NMC), "service management center" (SMC) or "network control center" (NCC), a NOC may be used to manage a large enterprise network, ) for 100mg, 200mg and 300mg tablet strengths of Ralivia[TM], the Company's once-daily, extended-release formulation of tramadol hydrochloride indicated for the management of pain of moderate severity in patients who require continuous treatment for several days or more.

Biovail Pharmaceuticals Canada (BPC BPC British Potato Council
BPC Brewton-Parker College (Mt Vernon, GA)
BPC Bible Presbyterian Church
BPC Bangladesh Petroleum Corporation (Chittagong, Bangladesh)
BPC British Pharmaceutical Codex
), Biovail's Canadian sales and marketing division, will introduce the features and benefits of Ralivia[TM] to health-care professionals throughout Canada. BPC anticipates launching Ralivia[TM] shortly.

"The receipt of a Notice of Compliance for once-daily Ralivia[TM] is the first important pillar in the establishment of Biovail's family of pain-management medicines in Canada," said Scott Smith, Vice-President and General Manager of BPC. "Ralivia[TM] is formulated using Biovail's proprietary Smartcoat[TM] technology to provide 24-hour delivery for more constant plasma concentration and clinical effects with less peak-to-trough fluctuation. Therefore, Biovail believes that the availability of Ralivia[TM] will offer health-care practitioners another compelling treatment option for their patients who suffer from pain of moderate severity."

The Ralivia[TM] formulation approved by the TPD is identical to Biovail's once-daily formulation of tramadol that received approval from 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.
) in September 2005. The product, Ultram[R] ER, was launched in the U.S. and Puerto Rico by Ortho-McNeil, Inc., a Johnson & Johnson company, and is the only once-daily, extended-release formulation of tramadol available in the United States.

Comprehensive Clinical Package

Ralivia[TM] was approved based on clinical and safety data obtained from four original adequate and well-controlled trials involving more than 3,000 patients who received doses of up to 400mg once daily. Biovail's NDS See eDirectory.

NDS - Netware Directory Services
 submission also included 12 definitive and five supportive pharmacokinetic studies.

Significant Market Opportunity

A significant market opportunity exists for once-daily formulations of tramadol hydrochloride in the Canadian pain market. Statistics from IMS Health show that sales for the 12 months ended June 30, 2007 for pain products in Canada were $872.2 million on 27.3 million total prescriptions.

Safety Precautions

As with all medications, patients who are prescribed Ralivia[TM] may experience side effects, which are most likely to present shortly after the commencement of treatment. The most common side effects identified by patients taking tramadol include: dizziness, nausea, constipation and headache.

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 has two complementary mechanisms of action: binding to opioid receptors and inhibition of the reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance.

re·up·take
n.
 of norepinephrine norepinephrine (nôr'ĕpīnĕf`rən), a neurotransmitter in the catecholamine family that mediates chemical communication in the sympathetic nervous system, a branch of the autonomic nervous system.  and serotonin.

Caution Regarding Forward-Looking Information and "Safe Harbor" 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 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 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.  ("OSC O.S.C. n. short for Order to Show Cause. (See: Order to Show Cause) "), 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, 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 Nelson F. Isabel at 905-286-3000 or send inquiries to ir@biovail.com.
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Date:Sep 4, 2007
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