UPDATE 4-Allergan stomach band works in less obese group

* FDA reviewers have questions on studied population

* Advisory panel to make recommendations Friday

* Allergan shares gain 0.3 percent
(Updates shares; adds details on patient groups)

By Lisa Richwine

WASHINGTON, Dec 1 (BestGrowthStock) – Allergan Inc’s (AGN.N: )
already approved stomach band was effective for reducing weight
in a broader group of obese patients, U.S. reviewers said in
documents released on Wednesday.

The maker of Botox, breast implants and other cosmetic
products wants approval to promote the surgically implanted
Lap-Band device to people with lower body mass indexes who are
still considered obese. Wider approval could boost sales.

Allergan shares gained 0.3 percent to close at $66.46 on
the New York Stock Exchange.

In an Allergan study, “there was significant decrease in
all measures of weight loss,” Food and Drug Administration
reviewers wrote in a summary prepared for outside advisers who
will consider the wider use on Friday.

The company is seeking FDA approval to promote the Lap-Band
for adults with a BMI of 35 or higher, or at least 30 plus one
weight-related health problem such as diabetes or high blood
pressure. A person 6 feet (1.8 meters) tall would need to weigh
about 225 pounds (102 kilograms) to have a BMI of at least 30.

The Lap-Band is approved for adults with a BMI of at least
40, or at least 35 plus one other health problem. About 15
million Americans are candidates under the currently approved
definition and about 27 million more fit under the broader
group, Allergan said.

The company studied 149 patients in the less obese group.
Nearly 81 percent of them had lost at least 30 percent of their
weight at one year, FDA reviewers said.

No unexpected complications were reported. About 2 percent
of device-related problems were considered severe, FDA staff
said. One patient’s band had eroded and was removed, while
another’s was repositioned in a new operation after it
slipped.

The FDA reviewers said they had some questions about
Allergan’s data, including whether the people who were studied
represented the types of U.S. patients who would be eligible if
wider use is approved. Most patients studied were white women,
and nonwhite men were underrepresented, they said.

Collins Stewart analyst Louise Chen said she conservatively
estimates Lap-Band sales could rise to $390 million by 2016.
The device, which is placed around the upper part of the
stomach to create a small pouch and limit food intake, already
commands two-thirds of the $300 million to $400 million gastric
band market.

Wider approval would be positive for Allergan, Chen said,
but “uptake may be slow given the high unemployment rate” as
many patients pay out of pocket for the device.

The surgery costs between $12,000 and $20,000, Allergan
said.

More than 72 million U.S. adults are obese, which raises
the risk of heart disease, stroke, diabetes and some types of
cancer. Efforts to fight fat with a pill have fallen short,
leading some patients to consider surgical options.
[ID:nN24231336]

Allergan dominates other markets with products such as
wrinkle smoother Botox and dermal filler Juvederm, making it an
attractive takeover target for large drugmakers.
[ID:nN2096505]

The FDA cleared the Lap-Band for sale in 2001. The device
can be implanted through a small “keyhole” incision. The
procedure is less invasive than stomach stapling or gastric
bypass, which involves cutting and rerouting the stomach.
Johnson & Johnson (JNJ.N: ) sells a rival device called Realize.

The FDA panel is set to vote on Friday afternoon on whether
to recommend approval for the less-obese patients. The agency
usually follows panel recommendations.

Doctors are free to implant the Lap-Band now in any patient
they consider appropriate, but Allergan needs FDA approval to
market the device for the wider group.

In a summary also released by the FDA, Allergan said its
study findings “make it clear that the benefits of the weight
loss exceed the risk of surgery and the risk of failure to
treat” obesity.

Allergan also is studying the Lap-Band in teens ages 14 to
17.
(Reporting by Lisa Richwine; editing by Lisa Von Ahn and Tim
Dobbyn)

UPDATE 4-Allergan stomach band works in less obese group