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Friday, November 28, 2008
Life sciences firms struggle for support in fighting staph infections
By Marc Songini
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While the potentially deadly staphylococcus aureus bacteria seems nearly unstoppable, life sciences companies have yet to mount a comprehensive counterattack — in part because financial backers treat the anti-infection business as if it were under quarantine.
Local experts say there are too few treatments for staph infection, including so-called superbugs such as the methicillin-resistant variety, known as MRSA. These infections typically occur in medical facilities, killing thousands of patients a year.
“Over time, staph has become resistant to every single drug that’s been developed to defeat it,” said James Richards, president and CEO of BioCidePharma, based in Sudbury.
The company is one of a handful of local life sciences firms trying to combat drug-resistant infections — in BioCidePharma’s case by developing an iodine-based staph-prevention therapy. Coming up with other staph cures is “an imperative,” Richards said. “But right now, it’s not happening.”
So far, companies are focusing on niche areas, such as certain types of skin or blood infections, and most are not yet ready for the U.S. market.
In September, biotech Enanta Pharmaceuticals Inc. began a Phase 1 trial of its oral antibiotic EDP-322, a re-engineered macrolide agent called a bicyclolide. According to the Watertown-based company, the drug has seen positive signs in preclinical studies, which showed that it may be effective against hospital-acquired MRSA strains which are resistant to vancomycin, linezolid, and daptomycin.
One of the biggest problems is that anti-staph drugs aren’t as profitable as other types of drugs. “The economics have turned away from anti-infective drugs,” said Mark Leuchtenberger, CEO and president of Cambridge-based Targanta Therapeutics Corp. “It’s difficult to treat infection, and it’s never going to be a $10 billion market,” he noted.
Targanta is developing the anti-bacterial drug oritavancin, which is designed to heal complicated skin and skin structure infections. However, last week a U.S. Food and Drug Administration committee voted against advancing the drug. That caused the company’s stock to drop precipitously, but Targanta stands by its technology and is confident it will get approval, said Leuchtenberger.
Compounding the problem is the poor market overall for investment in life sciences, noted Richards. Making it an even harder sell to venture capitalists, doctors are hesitant to prescribe an anti-staph drug unless absolutely necessary. Some such drugs must be delivered intravenously and in a highly controlled environment to be effective.
Even a successful antibiotic drug will have a slow return on investment, said Eileen McIntyre, senior director of corporate communications at Lexington-based Cubist Pharmaceuticals Inc. Its product, Cubicin, is used to treat staph infections of the skin and blood, including MRSA.
In 1997, Cubist acquired rights to Cubicin from Eli Lilly & Co. and won FDA approval in 2003. Getting it to market cost a half-billion dollars and Cubist just turned a profit two years ago. By year’s end, the company will have spent about $800 million on the testing and development of Cubicin.
The problems aren’t just economic, according to Ania Knap, CEO of Beverly-based MaxThera Inc. “Some venture capital firms have noted that there is a wealth of new antibiotics in development and have suggested there is no further need,” she said. However, these drugs are mostly revised versions of old drugs, she noted.
MaxThera is developing drugs to fight antibiotic-resistant infections, and has been using federal grants to survive. The company is seeking $10 million in financing, which will allow it to file the investigational new drug application next year and to move through Phase 1 clinical trials.
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