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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controlled release, enhanced absorption, taste masking and oral disintegration technologies), these technologies no longer represent the core of the Company's business model.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 business strategy (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 and/or distributed 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 its 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).

STRATEGIC PARTNERSHIPS

Xenazine ® 

Approved by the FDA in August 2008, Xenazine® is indicated for the treatment of chorea associated with Huntington's disease (HD). Huntington’s disease is a rare, inherited neurological disorder that is passed from parent to child through a gene mutation. The disease causes a degeneration of specific brain cells that most frequently leads to problems associated with loss of motor control, psychiatric and behavioral symptoms, and cognitive impairment. Chorea, named from the Greek word 'dance', is the most visible and perhaps the most disabling of the symptoms faced by people with HD.

 

Xenazine® is marketed to U.S. specialist physicians through the sales force of Ovation Pharmaceuticals, Inc. (acquired by H. Lundbeck A/S in March 2009). Pursuant to a supply-and-distribution agreement, Biovail supplies Xenazine® tablets to Ovation for a variable percentage of the product's annual net sales, and pays a royalty to a third party that was acquired by H. Lundbeck A/S in July 2009.

 

On November 24, 2008, Biovail announced the U.S. commercial availability of Xenazine®.

In June 2009, Biovail acquired the worldwide development and commercialization rights to tetrabenazine from Cambridge Laboratories (Ireland) Limited. Tetrabenazine is marketed through distribution agreements in Australia, Denmark, France, Germany, Ireland, Israel, Italy, New Zealand, Portugal, Spain, Switzerland and the United Kingdom. Licence applications are pending in several other European territories.

Wellbutrin XL ®

Launched in the U.S. by GlaxoSmithKline (GSK), in September 2003, Wellbutrin XL®, an extended-release formulation of bupropion indicated for the treatment of depression in adults, was well received by U.S. physicians and by the end of 2006, had captured 59% of all bupropion prescriptions in the U.S. Pursuant to Biovail’s manufacturing and supply agreement with GSK, the Company received a tiered supply price that was based on GSK’s net sales of Wellbutrin XL® in any given year. However, as a result of the May 2009 acquisition of full U.S. rights to Wellbutrin XL® , Biovail will now record 100% of U.S. revenues from the product. 

In January 2007, GSK announced the first European approval for Wellbutrin XR® (the brand name that GSK will use in a number of countries for our once-daily formulation of bupropion hydrochloride) in The Netherlands for the treatment of adult patients with major depressive episodes. Since then, Wellbutrin XR® has been launched in a number of European countries, including Germany, Italy, Spain, Sweden, Netherlands, Norway, Austria, Iceland, Poland, Portugal and Greece. Biovail manufactures and supplies Wellbutrin XR® to GSK at fixed contractual supply prices.

Aplenzin

Launched in the U.S. by sanofi-aventis US in April 2009, Aplenzin is an extended-release formulation of bupropion hydrobromide developed and manufactured by Biovail. Aplenzin is available in dosage strengths of 174mg, 348mg and 522mg for the treatment of major depressive disorder. The 522mg strength represents the only FDA-approved single-tablet, once-daily treatment option equivalent to 450mg of bupropion hydrochloride therapy, which requires two or three tablets daily.

Ultram® ER

Launched in the U.S. in February 2006 by Ortho-McNeil, Inc. (OMI), a Johnson & Johnson company, Ultram® ER is an extended-release formulation of tramadol hydrochloride developed by Biovail and indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Pursuant to Biovail's November 2005 agreement with OMI, the Company manufactures and supplies Ultram® ER to OMI for distribution at contractually determined prices. In November 2009, a generic formulation of Ultram® ER was launched in the U.S. 

Zovirax® Ointment/Zovirax® Cream

In October 2001, Biovail acquired U.S. promotion and distribution rights for Zovirax® Ointment and Zovirax® Cream – topical formulations of acyclovir – from GSK. Zovirax® Ointment is a topical formulation of a synthetic nucleoside analogue active against herpes viruses. This product is indicated for the management of initial genital herpes and in limited non-life threatening mucocutaneous herpes simplex infections in immuno-compromisedpatients. Today, a contract sales organization details Zovirax® Ointment and Zovirax® Cream to U.S. physicians.

Zovirax® Ointment was originally launched in 1982 by Burroughs Wellcome and although it was not promoted by Glaxo Wellcome, and subsequently GSK, since 1997, Zovirax® Ointment remains the market leader with approximately 48% share* of total prescriptions in the U.S. for topical anti-herpes products in 2009.

Zovirax ® Cream was approved by the FDA in December 2002 and launched by BTA in July 2003. Zovirax ® Cream is a topical antiviral medication used for the treatment of herpes labialis (cold sores). Zovirax® Cream held a 28% share* of the total prescriptions in the U.S. for topical anti-herpes products in 2009. 

* Source: IMS Health, Inc.

Cardizem ® LA

Cardizem® branded products have been leading medications in the calcium channel blocker (CCB) category of cardiovascular drugs for more than 20 years. In April 2003, Biovail launched Cardizem® LA - a graded, extended-release formulation of diltiazem hydrochloride that provides 24-hour blood pressure control with a single daily dose and offers physicians a flexible dosing range from 120mg to 540mg. Cardizem® LA is the only diltiazem product labeled to allow administration in either the morning or evening.

Through the acquisition of Kos Pharmaceuticals, Inc., Abbott Laboratories now has marketing/distribution responsibility for Cardizem® LA in the U.S. In March 2010, a generic formulation of Cardizem® LA was approved by the U.S. Food and Drug Administration.  

Biovail operates facilities in Barbados, Canada, the United States , and Puerto Rico . Shares of Biovail Corporation, with approximately 1,300 employees worldwide, trade on the New York Stock Exchange (NYSE) and the Toronto Stock Exchange (TSX) under the symbol BVF.



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