Optimer Pharmaceuticals, Inc.

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Msg  36 of 79  at  4/1/2011 4:31:54 PM  by

mlkrborn


EARLY GREEN LIGHT! Good news!

Optimer stock rises on positive FDA review
Optimer Pharmaceuticals rises after FDA says drug prevents digestive system infection

Symbol Price Change
OPTR 13.13 +1.30

On Friday April 1, 2011, 2:26 pm EDT

WASHINGTON (AP) -- Shares of Optimer Pharmaceuticals Inc. jumped Friday after the Food and Drug Administration gave a positive review to the company's experimental antibiotic to prevent infection of the digestive tract.

The FDA said in an online memo that the company's data support the use of its antibiotic fidaxomicin to treat infections caused by bacteria called Clostridium difficile, which causes diarrhea and potentially life-threatening inflammation of the colon.

Shares of the drugmaker, based in San Diego, climbed $1.28, or 10.8 percent, to $13.11 in trading.

Regulators said company data show that patients taking the antibiotic experienced significantly fewer recurrences of infection than those taking another antibiotic currently on the market.

On Tuesday an outside panel of FDA advisers will vote on the benefits and risks of Optimer's drug. The FDA is not required to follow the group's advice, though it often does.

Clostridium difficile is one of the most common hospital-acquired bacterial infections, particularly among the elderly.

The FDA also agreed to give the drug priority review because it fulfills an unmet need. Optimer expects an FDA decision by May 30.


 
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