Allergan Inc.’s (NYSE:AGN) Lap-Band is now approved for use in less-obese patients.
The Food & Drug Administration approved the weight loss device for patients with a body mass index of at least 35, or a BMI greater than or equal to 30 along with at least one co-morbid condition, such as diabetes or hypertension.
The device, first approved by the FDA in 2001, was formerly indicated for use only in patients categorized as “severely obese,” with a BMI of 40 or 100 pounds or more over their estimated ideal weight.
The gastric banding system is permanently implanted around the upper portion of the stomach to reduce the amount of food than can be ingested. Gastric bands are considered less invasive than stomach stapling or gastric bypass surgery.
The Lap-Band represents "a potential treatment option for those patients with obesity and a related health condition, who have failed more conservative weight-loss therapies, such as diet and exercise and pharmacotherapy, and under consultation with their physician, have determined that weight-loss surgery is the next best treatment option," Allergan vice president of clinical research and development Dr. Frederick Beddingfield said in prepared remarks.
Today’s approval does not come as a surprise. An FDA advisory panel voted on Dec. 6 that the benefits of extending use of the device to healthier patients outweighed its risks. The agency concluded in a Dec. 3 report that Allergan had proved in clinical studies that the Lap-Band showed “a significant decrease in all measures of weight loss.”
A 299-patient study showed that 20 percent of patients lost at least 50 percent of their excess weight after three years. And while 89 percent of respondents reported some adverse events, the highest number of incidents were vomiting/nausea and GE reflux. A total of 26 patients required re-operation over the three-year study. Two subjects died during the study, although the FDA did not cite the procedure as contributing to their deaths.
Irvine, Calif.-based Allergan’s earnings will likely get a significant bump with the expanded indication, particularly by targeting the adolescent market, Collins Stewart LLC analyst Louise Chen told the Bloomberg news service. Chen estimated that sales could increase some 51 percent, to $390 million, by 2016, or $500 million if the economy improves. About 220,000 people in the U.S. underwent some form of weight-loss surgery in 2009, according to the American Society for Metabolic & Bariatric Surgery.
For 2010, the company reported profits of just $600,000, less than 1 cent per diluted share, on sales of $4.92 billion. That compares with a profit of $621.3 million, or $2.03 per diluted share, on sales of $4.50 billion in 2009. For the three months ended Dec. 31, the company reported net income of $263.1 million, or 85 cents per diluted share, on revenue of $1.31 billion. That compares with a profit of $221.5 million, or 72 cents per diluted share, on revenue of $1.22 billion during the same period last year.
The approval is also good news for the company’s stock price, which has been in recovery after the release of an FDA report linking some breast implants with a rare form of cancer in late January. The company’s Natrelle gel and saline breast implant line essentially controls the breast implant market, along with Johnson & Johnson (NYSE:JNJ) unit Mentor Corp.
AGN shares seemed to get wind of the Lap-Band announcement early. The company’s stock rose about 1.7 percent for the day, closing at $74.77.
Click here to calculate your BMI to see if you’d qualify for gastric band surgery under the new indications.
