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Optimer to Tackle Hospital Bug With New Treatment

As Methicillin-resistant Staphylococcus aureus, known as MRSA, continues to cause concern for health care professionals, another potentially deadly bug has crept through hospitals and nursing homes, wreaking havoc on the human gastrointestinal tract.

Often associated with the overuse of broad-spectrum antibiotics, Clostridium difficile-associated disease flourishes in the intestinal tract, producing a toxin that causes a watery diarrhea.

The bacteria killed 1,270 people in Quebec between April 1, 2003, and March 31, 2004, a year that marked the height of an outbreak in hospitals of an especially powerful strain of the disease.

The U.S. Centers for Disease Control and Prevention lists C. difficile as an emerging infectious disease, responsible for as many as 500,000 cases a year in the United States.

Recent studies have suggested the incidence and severity of the disease may be increasing, although heath care agencies lack a national surveillance system to track rates.


Optimer To The Rescue?

Sorrento Valley biotechnology firm Optimer Pharmaceuticals Inc. says it has the next potential treatment for the bug. The publicly traded company, which develops drug candidates for treating a variety of gastrointestinal infections, is conducting late-stage human trials under fast track status from the FDA on a drug candidate called OPT-80.

If approved by the FDA, OPT-80 would be the first new drug on the market for C. difficile since the 1960s.

This month, the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, sponsored an initiative aimed at supporting new approaches to treat the disease. It awarded Optimer a $1 million grant to fund the project. The grant is renewable each year until August 2010 for a maximum amount of $3 million.

“It has been always an obscure hospital infection,” said Michael Chang, president and chief executive officer of Optimer. But recent outbreaks, he says, have pushed federal agencies to look into different treatment options.

Since its inception, Optimer has raised $154.7 million, including $49 million as a result of going public in February. The company reported a 2006 net loss of $11.9 million on revenues of $933,000.

The company says it is focusing on niche markets as a means of staying competitive.

“For a company like us, it’s best to focus on hospital infection, which is a reasonable size sales force,” said Chang, whose company’s stock is traded under the symbol OPTR on Nasdaq.

Last year, it bought back marketing rights it had sold to New Jersey-based Par Pharmaceutical Cos. Inc. in a deal worth more than $25 million.


Competition

The company will face competition from larger drug manufacturers as it moves forward with its treatment.

C. difficile is commonly treated with either metronidazole, sold under the name Flagyl, or vancomycin, sold as Vancocin, as a last resort.

But Chang says recurrences are common, leading him to believe the drug would offer a better option for current treatments. Approximately 20 percent of treated patients develop single or multiple recurrences of C. difficile, which may require repeated hospitalization for symptoms that persist for years.

“Treatment has become somewhat more a problem in severe cases and with the more virulent strain, which requires more vancomycin use,” said Dr. Julio Figueroa, associate professor of clinical medicine at Louisiana State University in Baton Rouge.

Hospital-acquired, C. difficile-associated diarrhea adds between $3,700 and $13,000 to the cost of the average hospital stay, and the total attributable annual cost in the United States is estimated between $1.1 billion and $3.2 billion, according to Figueroa.

Medicare’s refusal to pay for certain “preventable” complications under its pay-for-performance system may also have big impacts, according to Dr. Josh Fierer, a medicine and pathology professor at UC San Diego.

“Although improved antibiotic treatment for CDAD should be an important advance in these severe cases and in recurrent cases, I feel that the major emphasis needs to be on prevention,” Fierer said.

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