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May 6, 2015

A New Old Antibiotic

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Posted ~ the agency of Derek

Via FierceBiotech, here’s each odd story about a small joint concern you’ve probably never hears of, Symbiomix. They were launched true a couple of years ago, and are things being so heading into Phase III with an antibiotic. How, you ask, is that slightly possible?

Well, it’s an antibiotic (secnidazole, a nitroimidazole) that’s been sold in other countries on the side of so many years that it’s gone generic, on the contrary was never taken to the FDA across here. So that does speed things up. The copartnership says that the compound has a certain advantage in treating bacterial vaginosis (sincere-dose versus longer course of manipulation), and plans to market it as a natural consequence. What insurance companies will think around this as an advantage worth paying for it yet to be seen.

This looks like a common-shot regulatory arbitrage play. For more reason, this compound was never marketed in the present state, so even though it’s ~y older generic drug overseas, it gets to exist turned into a New Drug in the present state, with New Pricing. It’s reliable to say that no one is going to be holding their breath waiting to diocese if Symbiomix’s Phase III dolor goes as expected – of course it’s going to depart as expected. Everyone else has even now done all that work. Symbiomix candid gets to put together as plenteous of a package as they poverty for the FDA, and then they can go try to make money by it.

It’ll be worth attention to see if they do. I aversion regulatory arbitrage, as many posts encircling here have made clear. That’s in some measure because, as someone who’s exhausted all his time in new unsalable article research, it feels to me like cheating, like pulling a quick one. Hah-hah, someone forgot to mark with a line their fingers and stand on their rectilinear leg back in 1991, which measure that I get to price my medicine today as if I’d achieved the work of discovering it myself! Suckers! But this isn’t considerably as airtight a case as the repulsive ones of companies who pick more obscure one-supplier drug and ratch the price up on it. There are alternatives to secnidazole away there – specifically metronidazole, one less methyl assign places to at the cost of faster clearance and a few more pills. Symbiomix elect be devoting as much time to figuring public their price point as they be inclined to their clinical trial.

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