Business Editors/Health/Medical Writers
TORONTO--(BUSINESS WIRE)--June 2, 2003
-- Anxiety treatment Ativan complements Biovail's growing CNS
-- Isordil further expands Biovail's cardiovascular product line
Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has acquired U.S. rights to the Ativan(R) (lorazepam) and Isordil(R) (isosorbide dinitrate) oral product lines from Wyeth (NYSE:WYE) for $130 million and annual payments pursuant to a three year supply agreement. Sales of Ativan and Isordil in the U.S. were in excess of $50 million in 2002.
Ativan is a benzodiazepine, indicated for the management of anxiety disorders or for the short-term relief of anxiety or anxiety associated with depressive symptoms. The market for anxiety treatments was in excess of $11 billion for the 12 months ended December 2002. Isordil is a nitrate indicated for the prevention of angina pectoris due to coronary artery disease. Sales of nitrate products were in excess of $360 million for the 12 months ended December 2002.
Biovail believes there are significant market opportunities to expand the Ativan brand in the U.S. with an already formulated sublingual formulation as well as other line extension products and potential new indications for this well-respected medication. Biovail has also licensed data and technical know-how for the manufacturing and marketing in the U.S. of a sublingual formulation of Ativan, which is currently marketed in Canada. Wyeth will receive a milestone payment on the development by Biovail of an Ativan product line extension and royalties on the future sales of any Ativan product line extensions developed and marketed by Biovail in the U.S.
"The acquisition of Ativan and Isordil is another example of the execution of Biovail's business model," commented Eugene Melnyk, Chairman and Chief Executive Officer of Biovail. "These products have tremendous brand equity and strategically complement two of the Company's target therapeutic areas. Isordil complements and enhances the current offerings of our cardiovascular portfolio and Ativan is one of the most well respected brand names amongst anxiety treatments. The acquisition of Ativan provides Biovail with several future life cycle product opportunities including a sublingual product or other orally disintegrating tablet (ODT) formulations. Furthermore, Biovail is considering new indications for Ativan. We believe that an ODT such as the sublingual or a FlashDose(R) formulation will provide patients with the convenience of a medication that can be easily administered and may be more ideally suited for certain additional clinical uses of Ativan."
Anxiety-related disorders are among the most prevalent of all mental disorders occurring in as much as 16% of the population. It is estimated that approximately 19 million adults (age 18-54) in the U.S. suffer from anxiety disorders. Unlike the relatively mild, brief anxiety caused by a stressful event such as a business presentation, anxiety disorders are chronic, relentless, and can grow progressively worse if not treated. Anxiety disorders frequently co-exist with other disorders such as depressive disorders, eating disorders, and substance abuse. With the exception of obsessive-compulsive disorders, which appear to effect men and women equally, women are more likely than men (2:1) to have an anxiety disorder.
Anxiety disorders are serious medical illnesses characterized by overwhelming anxiety and fear of a chronic nature and can grow progressively worse if not treated. Several types of anxiety disorders exist, and each anxiety disorder has its own distinct features. However, they are all bound by the common theme of excessive irrational fear and dread.
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) recognizes a number of anxiety disorders. Among the most important are:
-- General Anxiety Disorder (GAD)
-- Panic Disorder
-- Obsessive-Compulsive Disorder (OCD)
-- Post-Traumatic Stress Disorder (PTSD)
-- Phobias (social and other specific phobias)
Total market prescriptions for orally administered benzodiazepines in 2002 were in excess of 70 million, having grown 3% over 2001. Benzodiazepines, as a class of anti-anxiety agents, continue to record strong prescription volumes, as their value to the treatment of anxiety is maintained even with the approval of products such as Paxil(R) and Effexor XR(R) for Generalized and Social Anxiety Disorders. Total lorazepam represents the second most widely prescribed benzodiazepine, with approximately 21 million prescriptions, or 30% market share, for the twelve months ended December 2002 and growing at 3% per year.
Isordil (isosorbide dinitrate) (ISDN), 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. Oxygen flow improves as the vessels relax, and chest pain subsides.
Isordil helps to increase the amount of exercise prior to the onset of chest pain and can help relieve chest pain that has already started or prevent pain expected from a strenuous activity such as walking up a hill or climbing stairs.
Total market prescriptions for orally administered nitrates were in excess of 21 million in 2002. ISDN (brand and bioequivalent) represented nearly 3 million of these, or 13% market share, for the 12 months ended December 2002.
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.
For further information, please contact Ken Howling at 905-286-3000 or send inquiries to email@example.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.
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