By Angela Chen
Bristol-Myers Squibb Co. said Tuesday that the U.S. Food and
Drug Administration has granted breakthrough designation for its
HIV treatment for users who have become accustomed to most other
treatment options.
Bristol's shares, which have increased 18% this year through
Monday's close, jumped 5.2% in premarket trading.
A breakthrough designation accelerates the development and
review of therapies that treat life-threatening or extremely
serious conditions.
The designation is based on data from a Phase 2 clinical study
that showed that the drug, under the name BMS-663068, showed
positive results on "treatment-experienced" patients, or those who
have used existing treatments long term and become somewhat
resistant to them. It is the first investigational antiretroviral
treatment designed to prevent HIV from attaching to and entering
certain T cells.
A Phase 3 study began in February and is ongoing.
"We are now 30-plus years into the AIDS epidemic, and there is
an ever-increasing number of long-term survivors of the condition,
many of whom are facing issues of drug resistance and are in need
of new treatment options," said Bristol's head of specialty
development, Douglas Manion.
The New York-based pharmaceutical company said in June that it
plans to close two sites, eliminate 100 positions and discontinue
discovery-research efforts in virology while it makes adjustments
for other expansions in research and development.
Write to Angela Chen at angela.chen@dowjones.com
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