Optimer Wins EU Approval for New Antibiotic

Xconomy San Diego — 

Optimer Pharmaceuticals got approval in the U.S. for its new antibiotic just in time for the Memorial Day weekend, and now it has closed out the year by getting clearance for the drug in Europe.

The San Diego-based biotech company (NASDAQ: OPTR) said today it has gotten clearance from the European Commission to start selling fidaxomicin (Dificlir) as a new treatment for C.difficile infections. Japan-based Astellas Pharma has the rights to market the drug in Europe, through a partnership agreement that paid Optimer $68 million upfront back in February.

Optimer and Astellas are hoping to capitalize on the opportunity to fight C. difficile, a hardy bug that causes diarrhea so severe it can be fatal. Optimer’s drug is designed to specifically kill this bug, while sparing most of the healthy bacteria in the gut. Optimer showed in clinical trials that its treatment cures patients about 90 percent of the time, offering a slight advantage over standard vancomycin. The trials, which followed patients for 30 days, showed that about half as many patients on the Optimer drug had a recurrence, when compared with those who got vancomycin. The drug generated $10.6 million in sales in its first quarter on the U.S. market.

“The European approval is a key step in making fidaxomicin more widely available to patients across the globe to treat this very serious disease,” said Pedro Lichtinger, Optimer’s CEO, in a statement.

The drug is marketed in the U.S. under the name Dificid.

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