sanofi-aventis and UCB, a leading global biopharmaceutical company, announced that they have entered into an agreement to co-promote in the United States the prescription antihistamine medicine, Xyzal (levocetirizine dihydrochloride).
In July 2006, UCB submitted a New Drug Application for Xyzal, seeking FDA (US Food and Drug Administration) approval for the following indications: Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis, and Chronic Idiopathic Urticaria.
Under the terms of the agreement with UCB: sanofi-aventis will co-promote Xyzal with UCB in the United States; sanofi-aventis will book the sales; sanofi-aventis will make an upfront payment to UCB and milestones payments at certain stages in the development and commercialization of the drug, associated with regulatory approvals and sales milestones; Profits will be shared between sanofi-aventis and UCB.
Xyzal is a once-daily antihistamine indicated for the symptomatic treatment of Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis, and Chronic Idiopathic Urticaria in adults and children six years of age and older. Xyzal was first launched in Europe in 2001 and is currently marketed in 49 countries around the world.
Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment. This can lead to symptoms that affect their respiratory system, eyes, or skin. Estimates from a skin test survey suggest that allergies affect as many as 40 to 50 million people in the United States - more than 20 per cent of the US population.
Seasonal Allergic Rhinitis (SAR), commonly referred to as "hay fever"or "outdoor allergies," is the most common form of allergic rhinitis. By definition, SAR includes allergies to seasonal pollens like grass, trees, fungal molds, and weeds. Perennial Allergic Rhinitis (PAR) is sometimes referred to as "year round"or "indoor allergies"and is characterized by allergies that last longer than four weeks. House dust mites, animal dander, and mold most commonly trigger PAR. Chronic Idiopathic Urticaria (CIU) is most commonly known as "hives of unknown origin" and is defined as the occurrence of daily, or almost daily, wheals and itching for at least six weeks with no obvious causes.