New data on Vesicare show significant improvements in urgency for patients with overactive bladder

As with other anticholinergic agents, VESIcare is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product.

As with other anticholinergic agents, VESIcare should be administered with caution to patients with bladder outflow obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function.

Doses of VESIcare higher than 5 mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients with severe hepatic impairment is not recommended.

The most common adverse events reported by patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%, 1.8%) and dyspepsia (1.4%, 3.9%, 1.0%) with VESIcare 5mg, 10mg, and placebo, respectively.

The overall rate of serious adverse events was 2%. For the 10 mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction and one intestinal obstruction). For the 5 mg dose, one case of angioneurotic edema was reported.

For complete prescribing information for VESIcare, go to www.vesicare.com.

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.com/us.

About GlaxoSmithKline

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For more information, please visit the company's Web site at www.gsk.com.

For more information or full prescribing information, contact:

GlaxoSmithKline:
Marc Meachem, Product Communications: 919-483-8756

Astellas:
Maribeth Landwehr, Corporate Communications: 847-317-8988