* Co seeks OK for Vivitrol to treat painkiller addicts
* Alkermes drug already cleared for alcoholics
* Sales could reach $125 million with wider use - analyst
* Shares down 1.4 percent
* FDA panel to review Vivitrol on Thursday
(Adds detail from documents, analyst comment, byline, updates
By Susan Heavey
WASHINGTON, Sept 14 Alkermes Inc's (ALKS.O)
drug to help wean alcoholics from drinking appears to also help
treat people addicted to certain painkillers based on a small,
limited study, U.S. regulatory staff said in documents released
But the Food and Drug Administration staff said the data
was based on a single study in patients who were somewhat
different than the target ones and the agency would ask its
panel of outside experts on Thursday whether it was enough to
back wider use of the drug called Vivitrol.
Sales could reach $125 million by 2015 if it wins the
additional approval, said Steve Yoo, an analyst for Leerink
Although several analysts saw little harm in the FDA's
comments and expected a positive review by the agency's
advisers, Alkermes shares were down 20 cents, or 1.4 percent,
at $14.10 in early afternoon trading on the Nasdaq.
The once-monthly injection of the drug was approved in 2006
to treat alcohol dependency, but the biotechnology company is
now seeking clearance to market it for patients addicted to
On Thursday, an FDA panel of outside experts will recommend
whether to approve the new use and the FDA is expected to make
the final decision by Oct. 12.
Such an expansion could be a boost for Alkermes, which has
just one other product on the U.S. market.
Net sales from Vivitrol were $20.2 million for fiscal 2010,
compared with $16.9 million for 2009 for Alkermes and its
then-partner Cephalon Inc CEPH.O, according to Alkermes.
But it costs the company roughly $40 million to make and
sell the drug, said Leerink's Yoo.
"Therefore, the opioid dependence indication is critical
for commercial success," he added.
The Cambridge, Massachusetts biotech has seen its shares
rise more than 50 percent so far this year ahead of the
anticipated expansion. It is also awaiting an FDA decision on
its diabetes drug Bydureon.
Alkermes, in a separate document also released on Tuesday,
said approval of the drug was key to getting more opioid drug
addicts to receive treatment. Data showed the drug was
effective and well tolerated "with broad and substantial impact
on a devastating disorder," it wrote.
"We agree with Alkermes that the efficacy study provides
convincing evidence that Vivitrol prevents relapse to opioid
use in recently-detoxified opioid-dependent patients," FDA
staff wrote in documents released ahead of the meeting.
However, agency reviewers also noted the study was done in
people with "demographic, cultural, and societal differences
from the target population."
FDA staff also said that, while no new safety issues were
found with the drug, the company's most recent Russian-based
study turned up fewer reported problems than a U.S. study done
for the company's first approval, "perhaps due to cultural
Pricing and other issues have kept the drug from taking
hold so far among alcoholics, according to some analysts who
see a potentially better market with opioid addiction.
"We do not think investors are placing much weight in the
expansion of Vivitrol into opioid dependence and think a
positive panel recommendation could give a positive boost,"
said Jon LeCroy, a senior analyst for Hapoalim Securities USA
Inc, in a research note earlier this month.
While doctors are already free to prescribe FDA-approved
medications as they see fit, formal FDA approval allows the
drugmaker to legally market the new use to physicians and
patients without risking fines or other legal action.
Still, even if the company wins FDA approval, there are
risks. The drug is the first one the drugmaker has had to
market and sell by itself, having ended its partnership with
Cephalon in December 2008.
"We have very little sales and marketing experience," the
company wrote in its annual report filed in May.
(Reporting by Susan Heavey; editing by Dave Zimmerman and