Optimer Shares Rise on FDA Panel Vote
Shares of Optimer Pharmaceuticals Inc. rose in pre-market trading today after a government panel recommended approval of Optimer's antibiotic Dificid.
On Tuesday, an FDA panel recommended approval for Dificid, which is intended to treat Clostridium difficile, a bacterium that can cause diarrhea and dangerous inflammation of the colon.
Shares rose 25 cents, or 1.8 percent, to $14.05 in pre-market trading. Optimer shares have traded between $7.68 and $16.30 in the last year.
Jefferies & Co. analyst Eun Yang said it's not a guarantee the FDA will approve the drug on May 30. The panel found Dificid was safe and effective, and panelists voted that it was more effective than the drug Vancocin in preventing recurrent infections. But she said the FDA and Optimer may need to hold discussions about the drug's label and how it will reflect information about recurrent infections.
Yang said she is conservatively assuming Dificid will reach the market in the fourth quarter. She kept a "Buy" rating on Optimer shares, and said she expects worldwide sales of Dificid to reach $240 million in 2015. She said Optimer should become profitable in 2014.