FDA APPROVES EXPANDED USE OF LAP-BAND®

“As a surgeon, I see patients every day who have been obese for years and have tried several diet and exercise programs without success,” said Robert Michaelson, M.D., Ph.D., Northwest Surgical Weight Loss Surgery, Everett, Washington, and Clinical Trial Investigator. “These patients frequently feel judged by their weight, as obesity is often viewed as a lack of will power, which it is not. Obesity is a disease, which requires medical treatment, but unfortunately diet and exercise alone do not work for everyone. The LAP-BAND® System meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss.”

The approval to expand the use of the LAP-BAND® Adjustable Gastric Banding System is based on a review of full 12-month data and available 24-month data from a prospective, single-arm, non-randomized, multi-center five year-study and the more than 17-year safety and effectiveness record of the LAP-BAND® System. Following approval, the patients in the trial will continue to be followed for a total of five years. In addition, there will be an analysis of the outcomes of patients with BMI of 30 to 40 recorded in the Bariatric Outcomes Longitudinal DatabaseSM (BOLDSM). Established in 2007 by the Surgical Review Corporation, BOLD is now the world’s largest and most comprehensive repository of clinical bariatric surgery patient information. The database currently contains more than 300,000 patients and 12,000 new patients are added monthly. The BOLD analysis will consist of examining the explant rates, adverse events, weight loss, and changes in the status of obesity related comorbid conditions observed in LAP-BAND® System patients over the course of 10 years.

About the LBMI-001 Clinical Study

The LAP-BAND® System study, initiated by Allergan, Inc., is a prospective, single-arm, non- randomized, multi-center five year-study conducted under an FDA-approved Investigational Device Exemption (IDE G070039; registered at www.clinicaltrials.gov, registration
# NCT00570505). The study was conducted to determine the safety and effectiveness of the LAP-BAND® System as a treatment for obesity in adult patients with a BMI of ≥ 30 and < 40, with and without comorbid conditions. The study was initiated in 2007, and included 149 patients, who had a mean excess weight of 62.8 lbs and had been obese on average for 17 years and who underwent the LAP-BAND® System procedure.

The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month timepoint, where clinically meaningful weight loss was defined as at least 30% Excess Weight Loss (EWL). Percent excess weight loss (%EWL) is defined as the percent of “excess weight” – i.e., the weight above ideal weight – that is lost. Results from the 12-month dataset demonstrate clinically significant weight loss in this patient group with a low risk of serious complications. Specifically, 83.9% of the patients lost at least 30% of their excess weight at the one-year timepoint, more than twice the percentage required for success. More

than 65% of the patients in the trial were no longer obese after one year. Weight loss was maintained in the second year of the study. This level of weight loss exceeds what is typically seen with more conservative treatment, such as diet and exercise.

The secondary endpoints for the trial were improvement in obesity related comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension and improvement in Quality of Life (QoL). Eighty five percent of subjects in the trial had at least one comorbid condition. In terms of improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension, 22- 33% of patients with those conditions, saw their conditions resolved after one year. In addition, approximately 60% of patients, who had a comorbidity at baseline, had improvement of at least one comorbid condition by month 12. Also, there was a statistically significant improvement in QoL at months six and 12.

During the 12-month study period, the types of Adverse Events (AEs) reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease (GERD). Most AEs were mild to moderate in severity and resolved in less than four weeks.

About the LAP-BAND® System
The LAP-BAND® System was originally approved by the FDA in 2001 for use in severely obese adults, individuals with a BMI of 35 with at least one severe comorbid condition or a BMI of 40, or those who are at least 100 pounds or more overweight. In addition, the LAP-BAND® System has been approved internationally since 1993. The LAP-BAND® System is now the first and only FDA-approved device for bariatric surgery in patients with a BMI of 30-35. Over the past 18 years, more than 650,000 procedures have been performed, leading to over two million patient years of exposure for the device.

Important LAP-BAND® Safety Information

Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the

required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.

Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.

Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure and the patient’s ability to tolerate a foreign object implanted in the body.

Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection or nausea and vomiting may occur. Reoperation may be required.

Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

Important: For full safety information, please visit www.lapband.com, talk with your doctor or call Allergan Product Support at 1-800-624-4261.

CAUTION: Rx only.

Forward-Looking Statements

This press release contains “forward-looking statements,” including, but not limited to, the statements by Dr. Beddingfield and Dr. Michaelson, and other statements regarding the safety, effectiveness, adverse reactions, product availability and market potential of the LAP-BAND® System. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan’s expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Allergan’s public periodic