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Biovail
Biovail Biovail

加拿大Biovail
Biovail公司是加拿大最大的上市制藥公司。自20世紀(jì)90年代初, Biovail的策略是運(yùn)用先進(jìn)的藥物釋放技術(shù) , 以提高臨床療效的藥物。 自那時(shí)以來,一直從事Biovail的制定,臨床試驗(yàn),注冊(cè),生產(chǎn)和商業(yè)化的醫(yī)藥產(chǎn)品。  該公司的主要市場(chǎng)是美國(guó)和加拿大。
Biovail Corporation is Canada's largest publicly traded pharmaceutical company. Beginning in the early 1990s, Biovail strategy was to apply advanced drug-delivery technologies to improve the clinical effectiveness of medicines. Since that time, Biovail has been engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products. The Company's primary markets are the U.S. and Canada.

Biovail's business growth since the 1990s was driven by the development and large?scale manufacturing of pharmaceutical products incorporating oral drug-delivery technologies. The application of these technologies to existing orally administered medications provided Biovail, together with its partners, with the opportunity to extend product lifecycles through the development of novel formulations. The Company's successes in this regard include Wellbutrin XL?, Ultram? ER and Cardizem? LA. Today, while Biovail maintains a broad portfolio of proprietary drug-delivery technologies (including controlled release, enhanced absorption, taste masking and oral disintegration technologies), these technologies no longer represent the core of the Company's business model.

The change to Biovail's business strategy was a result of various changes in the environment for oral controlled-release products, including increased generic sophistication and competition, a slowdown of new drug approvals and increasing financial pressures from third-party payors. Accordingly, in 2008 Biovail undertook a comprehensive review of all aspects of the Company’s businesses, in an effort to identify and evaluate alternatives to enhance shareholder value. The result of that review was the development of Biovail's New Strategic Focus (described here) – one that targets the development of pharmaceuticals that address unmet medical needs in specialty central nervous system, or CNS disorders. Biovail believes it is well-positioned to enter this area due to the Company's financial strength and its expertise in clinical development, regulatory affairs and manufacturing.


BTA PHARMACEUTICALS, INC.

In the U.S., Biovail’s wholly owned subsidiary, BTA Pharmaceuticals, Inc. (BTA), distributes a number of pharmaceutical products. These Include Zovirax ? Ointment and Zovirax ? Cream (topical anti-viral drugs) and Cardizem ? LA (hypertension), which are marketed by commercialization partners (described below). In addition, BTA distributes a number of branded off-patent products, which Biovail refers to as “Legacy products”. The Company's Legacy products portfolio includes the well-known brands Cardizem? CD, Ativan?, Vasotec?, Vaseretic?, and Isordil? . These are products for which patent protection has expired, and that are not actively promoted by Biovail. While the products remain well respected by the medical community, their prescription volumes are in decline due to the availability of several competing generic formulations.

BIOVAIL PHARMACEUTICALS CANADA

In Canada, where the market dynamics are much different than in the U.S., Biovail maintains a direct-selling commercial presence through Biovail Pharmaceuticals Canada (BPC) that successfully targets both specialist and primary-care physicians across the country. BPC has established itself as a leading pharmaceutical marketing and sales operation in Canada. Market research indicates that BPC is the largest independent pharmaceutical Company that markets to physicians in Canada. BPC currently promotes a portfolio of products to approximately 11,000 physicians across the country. Products include Tiazac? XC, Wellbutrin XL? , Glumetza?, Ralivia? (Biovail’s once-daily formulation of tramadol, which was launched to Canadian physicians in November 2007) and more recently, Nitoman? (through the acquisition of Prestwick Pharmaceuticals, Inc.).


GENERIC PHARMACEUTICALS

Through it relationships with distribution partners, Biovail has a presence in generic pharmaceuticals in the U.S. The Company's focus in this segment has been on the development of generic formulations of branded controlled-release products (which are typically more difficult to manufacture) where the competitiveness and price discounting is significantly less than in the immediate-release generic market. Biovail’s generic pharmaceuticals, with the exception of generic Tiazac? (which is supplied to Forest Labs in the U.S.), are distributed in the U.S. by a subsidiary of Teva, pursuant to an agreement originally signed in 1997, and extended in 2004.

In Canada, Biovail's generic versions of Cardizem? CD and Tiazac? are distributed by Novopharm, a subsidiary of Teva.

In 2008, Biovail submitted three abbreviated new drug applications (ANDAs) to the FDA – for generic formulations of Effexor XR (extended-release venlafaxine tablets), Tricor (fenofibrate tablets) and Seroquel XR (extended-release quetiapine tablets).

 

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