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Anti-MRSA Drug Fast-Tracked

by Paul Bass | Oct 11, 2012 10:39 am

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Posted to: Business/ Economic Development, Health

Paul Bass Photo Superbugs beware: a bunch of scientists in lab coats in downtown New Haven have your number.

The white-coated researchers gathered in their offices at the 300 George St. biotech complex Wednesday to mark a milestone: a decision by federal regulators to put a new antibiotic they’re developing on a fast track to approval.

They also gathered to thank a politician who helped them get there, Connecticut U.S. Sen. Dick Blumenthal.

The gathering took place in the third-floor suite belong to Rib-X (pronounced RYE-bex), an 11-year-old pharmaceutical company that employs 43 people to develop antibiotics to combat deadly “superbugs,” bacteria that have developed resistance to existing medicines.

The Food and Drug Administration has designated a Rib-X drug working its way toward approval, called radezolid, a “qualified infectious disease product.” That means it can get an extra five years of market exclusivity (no generic competitors allowed) if approved. And it will get a “priority review” and “fast-track status” from FDA regulators as it tries to speed its way toward approval. A Nobel Prize-winning Yale chemist named Thomas Steitz helped develop it.

Rib-X received the same FDA designation last month for another drug under development called delafoxacin. Both drugs treat a wide range of infections including MRSA (aka methicillin-resistant Staphylococcus aureus), a fast-growing virus that kills 17,000 Americans a year.

A new law called The GAIN (Generating Antibiotic Incentives Now), which passed earlier this year, created the FDA designation. Blumenthal cosponsored it. Rib-X was the first company to benefit from it.

Blumenthal sponsored the law to “streamline and fast-track the products that can save lives,” he said at Wednesday’s gathering. The “antiobiotic pipeline” has been drying up, he said, because unlike “blockbuster” drugs like cholesterol-fighting Lipitor—which patients buy their entire lives, thus ensuring its makers profits—antibiotics are designed for up to two weeks’ use. And that means less potential profit for potential investors in the development of new drugs. Blumenthal said the GAIN Act is meant to get new antibiotics flowing through that pipeline.

Blumenthal (pictured) was making a return visit to the 300 George biotech complex. He made it a campaign stop in 2010 to demonstrate the kind of new-economy jobs he hoped to help promote if elected to the Senate.

On Wednesday, Blumenthal said he learned some lessons about medicine in working on the GAIN Act. He also learned a political lesson: “Bipartisanship is possible for a good cause.” Republicans, most notably Tennessee’s Bob Corker, worked with Blumenthal on the bill.

Blumenthal was asked if these new medicines simply lead to newer super-bugs, requiring more and more antibiotics; and if it makes more sense to find new ways to stop people from getting infections in the first place.

His answer: We need to do both.

He advocated “exploring” cutting down on hospital-acquired infections through disposable equipment and more frequent hand-washing, for instance; and avoiding overusing antibiotics on, for instance, cattle and other factory-farmed animals.

At the same time, “people have these diseases now” and need antibiotics that work, he argued. Also, he said, drugs have wiped out some diseases in the past, and that remains a worthwhile quest.

“There will always be an arms race with the bugs,” added Rib-X Chief Scientific Officer Erin Duffy (at far left in the photo at the top of this story). “Some will be conquered. There will always be the evolution process” requiring that science “stay ahead. ... “To surrender is to say MRSA will spread and there’s nothing we can do” to stop it.

Click here to read one legal critique questioning the speed with which the GAIN Act passed and the benefits it offers pharmaceutical companies.

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