Specialty pharmaceutical company - therapeutic area of central nervous system (CNS) disorders..
Biovail Corporation, Mississauga, Ontario, NYSE & TSX : BVF, .is Canada's largest publicly traded pharmaceutical company.
Biovail Corporation is a specialty pharmaceutical company that applies advanced drug-delivery technologies to improve the clinical effectiveness of medicines.
In May 2008, the Company announced a New Strategic Focus – one in which the Company would concentrate its research-and-development and business-development efforts on specialty markets within the therapeutic area of central nervous system (CNS) disorders.
Biovail will target high-growth, niche markets within CNS disorders, which are characterized by an attractive commercial, regulatory and reimbursement environment.
At the end of September 2008, Biovail had $219 million in cash and $23 million in marketable securities. In addition, the Company has no long-term debt and no outstanding borrowings under its credit facility. This solid financial foundation provides the Company with the flexibility to invest in its research and development pipeline, to return capital to shareholders and to pursue external growth opportunities.
Biovail currently drives business growth by commercializing its pipeline products both directly through its own sales-and-marketing division in Canada and/or through strategic partners in the United States and other geographies.
Biovail has an impressive track record in the development and large-scale manufacturing of pharmaceutical products incorporating oral drug-delivery technologies. The Company’s current commercial portfolio includes Zovirax® Ointment, Zovirax® Cream, Wellbutrin XL®, Ultram® ER, Cardizem® LA and a number of Legacy and generic pharmaceutical products.
Biovail currently operates facilities in Barbados, Canada, the United States, Ireland and Puerto Rico.
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.).
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).
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 Ovation Pharmaceuticals, Inc.’s 48-member sales force. Pursuant to a supply-and-distribution agreement, Biovail supplies Xenazine® tablets to Ovation for a variable percentage of the product’s annual net sales. For net sales up to $125 million, Biovail's supply price will be 72% of net sales. Beyond $125 million, the supply price is 65% of net sales. At both tiers, Biovail will pay a supply price of 50% of net sales to Cambridge Laboratories (Ireland) Ltd., the worldwide license holder of tetrabenazine.
On November 24, 2008, Biovail announced the U.S. commercial availability of Xenazine®.
Launched in the U.S. by GlaxoSmithKline (GSK), in September 2003, Wellbutrin XL®, an extended-release formulation of bupropion indicated as first-line therapy 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 receives a tiered supply price that is based on GSK’s net sales of Wellbutrin XL® in any given year. In 2007, given the late-2006 launch of a generic formulation of the 300mg strength of Wellbutrin XL®, Biovail did not reach the second tier supply price until the fourth quarter – where it remained through year-end. Given the late-May 2008 launch of a generic formulation of the 150mg strength of Wellbutrin XL®, Biovail will likely remain in the lowest tier of pricing going forward.
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, which are substantially lower than the supply price the Company receives on sales of Wellbutrin XL® in the U.S.
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. As at January 2009, Ultram® ER is the only once-daily tramadol formulation marketed in the U.S. Pursuant to Biovail’s November 2005 agreement with OMI, the Company manufactures and supplies Ultram® ER to OMI for distribution at contractually determined prices, which range from 27.5% to 37.5% of OMI’s net selling price for Ultram® ER, depending on the year of sale.
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.
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 47% share of total prescriptions in the U.S. for topical anti-herpes products in 2007.
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 26% share of the total prescriptions in the U.S. for topical anti-herpes products at the end of 2007.
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. Cardizem® LA is 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 responsibility for Cardizem® LA in the U.S.