Profile: Biovail Corporation (BVF)

Biovail Corporation (Biovail) is a specialty pharmaceutical company that applies advanced drug-delivery technologies to improve the clinical effectiveness of medicines. The Company is engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products. The Company has various research and development, clinical research, manufacturing and commercial operations located in Barbados, Canada, the United States and Puerto Rico. Its main therapeutic areas of focus are central nervous system (CNS) disorders, pain management and cardiovascular disease. The primary markets for its products are the United States and Canada. On September 16, 2008, Biovail acquired Prestwick Pharmaceuticals, Inc.

Xenazine (tetrabenazine)

Xenazine is indicated for the treatment of chorea associated with Huntington's disease. Xenazine is marketed to United States specialist physicians by Ovation Pharmaceuticals, Inc’s 48-member sales force.

Wellbutrin XL (bupropion hydrochloride extended-release tablets)

Wellbutrin XL is an extended-release formulation of bupropion indicated as first-line therapy for the treatment of depression in adults. Wellbutrin XR is launched in a number of countries, including Austria, Belgium, Estonia, Germany, Greece, Iceland, Italy, Lithuania, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and South Korea.

Ultram ER (tramadol hydrochloride extended-release tablets)

Ultram ER is an extended-release formulation of tramadol hydrochloride 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. During the year ended December 31, 2008, over 26 million prescriptions were dispensed for tramadol-based medicines in the United States. In January 2009, a second once-daily formulation of tramadol was approved for sale in the United States.

Zovirax Ointment/Zovirax Cream (acyclovir)

Zovirax Ointment is a topical formulation of a synthetic nucleoside analogue active against herpes viruses. Each gram of Zovirax Ointment contains 50milligram of acyclovir in a polyethylene glycol base. This product is indicated for the management of initial genital herpes and in limited non-life threatening mucocutaneous herpes simplex infections in immuno-compromised patients. Zovirax Cream is a topical antiviral medication used for the treatment of herpes labialis (cold sores).

Cardizem LA (diltiazem)

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 120 milligram to 540milligram. Cardizem LA is a diltiazem product labeled to allow administration in either the morning or evening.

Biovail Pharmaceuticals Canada

Tiazac is a calcium-channel blocker (CCB) used in the treatment of hypertension and angina. Tiazac is a once-daily formulation of diltiazem that delivers smooth blood pressure control over a 24-hour period. As a non-dihydropyridine CCB, Tiazac provides specific renal protective benefits, as well as blood pressure reduction, which is particularly important for diabetic hypertensive patients. Tiazac XC is a formulation of diltiazem taken at bedtime specifically formulated to provide peak drug-plasma levels during the early morning hours when cardiac events are most likely to occur. The Company’s generic version of Tiazac is distributed in Canada by Novopharm Limited (Novopharm), a subsidiary of Teva Pharmaceuticals Industries Ltd. (Teva).

Wellbutrin XL (extended-release bupropion hydrochloride) is a once-daily formulation of bupropion developed by the Company. In February 2008, Wellbutrin XL received Therapeutic Products Directorate (TPD) approval for a new indication of the prevention of seasonal major depressive illness. Wellbutrin SR (bupropion)/Zyban bupropion hydrochloride) is indicated as first-line therapy for the treatment of depression. Wellbutrin SR’s anti-depressant activity appears to be mediated by noradrenergic and dopaminergic mechanisms that differentiate it from serotonin reuptake inhibitors (SSRIs) and other known anti-depressant agents. In addition to anti-depressant efficacy, Wellbutrin SR has a low propensity to cause sexual dysfunction, a common side effect of some other anti-depressant therapies. Zyban, the same chemical entity as Wellbutrin SR, is indicated as an aid to smoking cessation treatment.

Monocor (bisoprolol fumarate) is a cardio selective beta-blocker indicated for the treatment of mild to moderate hypertension and congestive heart failure. Retavase (reteplase recombinant) is a tissue plasminogen activator used in thrombolytic therapy. Glumetza (extended-release metformin hydrochloride) is a once-daily formulation of metformin, indicated for the control of hyperglycemia in adult patients with type 2 (non-insulin dependent, mature onset) diabetes, as an adjunct to dietary management, exercise, and weight reduction, or when insulin therapy is not appropriate. Ralivia (extended-release tramadol hydrochloride) is produced using its Smartcoat technology, which provides 24-hour delivery for more constant plasma concentration and clinical effects with less peak-to-trough fluctuation. Nitoman (tetrabenazine) is indicated for the treatment of hyperkinetic movement disorders, such as Huntington's chorea, Hemiballismus, Senile Chorea, Tic and Gilles de la Tourette Syndrome, and Tardive Dyskinesia.

Legacy Products

This category includes products that Biovail distributes in the United States, but do not actively promote. The products in this category are Cardizem CD, Ativan, Tiazac, Vasotec, Vaseretic and Isordil. Cardizem CD (diltiazem) branded products fall under the CCB category of cardiovascular drugs. Ativan (lorazepam) is the benzodiazepine lorazepam, indicated for the management of anxiety disorders, or for the short-term relief of anxiety, or anxiety associated with symptoms of depression. Tiazac (diltiazem) belongs to the CCB class of drugs, used in the treatment of hypertension and angina.

Vasotec (enalapril maleate) and Vaseretic (enalapril maleate/hydrochlorothiazide) are used in the treatment of hypertension, symptomatic congestive heart failure and asymptomatic left ventricular dysfunction. Enalapril is a pro-drug, which is bio-activated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin converting enzyme (ACE) inhibitor. Vasotec is the maleate salt of enalapril. Vaseretic combines Vasotec and a diuretic, hydrochlorothiazide. The product is also indicated for the treatment of hypertension. Isordil (isosorbide dinitrate), a coronary vasodilator, is indicated for the prophylaxis of ischemic heart pain associated with coronary insufficiency (angina pectoris). Isordil dilates the blood vessels by relaxing the muscles in their walls.

Generic Products

As of December 31, 2008, Biovail’s generic product portfolio comprises products that are distributed in the United States for the Company by Teva, in addition to an authorized generic formulation of Tiazac, which is distributed ibn United States by Forest Laboratories, Inc. (Forest). During 2008, the products distributed by Teva included bioequivalent formulations of Cardizem CD, Adalat CC, Procardia XL, Tiazac, Voltaren XR and Trental.

Glumetza (United States Market)

Glumetza is a once-daily formulation of metformin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. In the United States, Santarus, Inc. promotes Glumetza to United States physicians for Depomed Inc.