Alkermes, Cephalon get FDA OK for alcoholism drug

NEW YORK (Reuters) – Alkermes Inc. and Cephalon Inc. said
on Thursday the U.S. Food and Drug Administration approved
their alcoholism drug, Vivitrol, sending shares of both
companies higher.

The drug is an injectable form of naltrexone administered
monthly to help control cravings for alcohol.

The companies expect Vivitrol to be available to doctors
and patients in the United States by the end of June in the
form of a single dose 380-milligram intramuscular injection.

The FDA in December granted Vivitrol conditional approval
but said the companies had to provide more data before a final
decision could be made.

Under the terms of the agreement between the two companies,
Alkermes receives a milestone payment of $110 million for the
approval.

The drug was developed by Alkermes, which will manufacture
Vivitrol, while Cephalon takes on marketing and sales
responsibilities.

The drug is expected to be prescribed in conjunction with
therapy for patients who are able to abstain from drinking in
an outpatient setting and are not actively drinking when
initiating treatment, the companies said.

The once-a-month treatment frees patients battling
alcoholism from having to make a decision to take medicine on a
daily basis.

Shares of Alkermes rose 89 cents, or 4.2 percent, to close
at $21.96 on Nasdaq. They continued to climb after hours,
trading for $22.24 on Inet electronic brokerage.

Cephalon shares closed up 48 cents at $60.20 on Nasdaq, but
slipped to $60.15 in extended trading on Inet.