UPDATED: FDA gives Optimer key antibiotic approval

There's going to be a lot of backslapping at barbeques in San Diego this weekend. The FDA sent out word this afternoon that it's approved San Diego-based Optimer Pharmaceuticals' ($OPTR) antibiotic Dificid for treating diarrhea linked to C. diff infections.

The FDA said that more patients who took Dificid showed "a sustained cure" three weeks after finishing treatment on the antibiotic than those who took an older and previously approved antibiotic, vancomycin. That acknowledgement of superiority should help Optimer ($OPTR) and the co-promoter of Dificid, Cubist Pharmaceuticals ($CBST), hit the ground running with their sales launch this summer. Yet Optimer says today that it's seeking a premium for its antibiotc, with a price of $2,800 for a 10-day course of treatment, compared with the $1,000 cost of similar treatment with vancomycin, according to Needham & Co. analyst Alan Carr.

In a note to investors this morning, Carr estimated that sales of Dificid would be just $10 million this year, but the marketing help of Cubist could provide better sales results during the launch of the drug. He projects worldwide sales of the antibiotic to eventually reach $300 million to $500 million.

For Optimer, the FDA approval of Dificid is a key first. With an approved drug, the company can now plan to do something that many biotechs have never done--generate product revenue. As Xconomy's Luke Timmerman pointed out in a story posted before the approval came in on the afternoon of May 27, the company has labored for 13 years and gone through more than $175 million to arrive at the finish line. What's more, for the first time in a quarter of a century, there's now a newly approved weapon against C. diff, which can often spread in hospitals and nursing homes and lead to potentially deadly infections.

"In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a (C. diff) infection," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in the FDA's press release about the approval. "Dificid is an effective new treatment option for patients who develop (C. diff-associated) diarrhea."

Editor's Note: This story was updated to include pricing information and sales forecasts on Optimer's Dificid.

- here's the FDA's release

- check out Bloomberg's report

- read the story in the New York Times

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