Biovail Receives Canadian Approval for Wellbutrin XL for the Prevention of Seasonal Major Depressive Illness

Feb 15, 2008 - Biovail Corporation (NYSE: BVF) (TSX: BVF) today announced that it has received a Notice of Compliance from the Therapeutic Products Directorate (TPD) for its supplemental New Drug Submission (sNDS) for a new indication for Wellbutrin(R) XL in Canada - the prevention of major depressive illness with an autumn-winter seasonal pattern.

The approval of Wellbutrin(R) XL for this indication represents a significant milestone for Biovail and for Canadian healthcare, as it represents the first time in Canada that a medication has received an indication for the prevention of this type of major depressive illness. Many patients with major depressive disorder have a seasonal pattern to their disease. For the first time, their physicians will have the option to prescribe an agent specifically indicated to prevent their seasonal major depressive episodes.

"Seasonal major depressive illness is a serious and often under-diagnosed type of depression," says Scott Smith, Vice-President and General Manager of Biovail Pharmaceuticals Canada (BPC), the Canadian sales and marketing division of the Company, that will introduce this new indication to Canadian health care professionals in 2008. "The approval of Wellbutrin(R) XL as a prevention for this type of depression offers new hope to patients who dread the onset of winter, and the episodes of major depression that often come with it."
"Physicians who already appreciate the unique combination of first-line efficacy with low incidence of sexual dysfunction and weight gain offered by Wellbutrin(R) XL, will have a new reason to choose it for their patients."
The approval of Wellbutrin(R) XL in seasonal major depressive illness represents Biovail's third Notice of Compliance in the past six months.
The efficacy of Wellbutrin(R) XL for the prevention of seasonal major depressive episodes was established in three, double-blind, placebo-controlled trials in adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria.