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A New Old Antibiotic

Via FierceBiotech, here’s an odd story about a small company you’ve probably never hears of, Symbiomix. They were launched just a couple of years ago, and are now heading into Phase III with an antibiotic. How, you ask, is that remotely possible?
Well, it’s an antibiotic (secnidazole, a nitroimidazole) that’s been sold in other countries for so many years that it’s gone generic, but was never taken to the FDA over here. So that does speed things up. The company says that the compound has a real advantage in treating bacterial vaginosis (single-dose versus longer course of treatment), and plans to market it accordingly. What insurance companies will think about this as an advantage worth paying for it yet to be seen.
This looks like a one-shot regulatory arbitrage play. For some reason, this compound was never marketed here, so even though it’s an older generic drug overseas, it gets to be turned into a New Drug here, with New Pricing. It’s safe to say that no one is going to be holding their breath waiting to see if Symbiomix’s Phase III trial goes as expected – of course it’s going to go as expected. Everyone else has already done all that work. Symbiomix just gets to put together as much of a package as they need for the FDA, and then they can go try to make money with it.
It’ll be worth watching to see if they do. I dislike regulatory arbitrage, as many posts around here have made clear. That’s partly because, as someone who’s spent all his time in new drug research, it feels to me like cheating, like pulling a fast one. Hah-hah, someone forgot to cross their fingers and stand on their right leg back in 1991, which means that I get to price my drug today as if I’d done the work of discovering it myself! Suckers! But this isn’t quite as airtight a case as the odious ones of companies who pick some obscure one-supplier drug and ratchet the price up on it. There are alternatives to secnidazole out there – specifically metronidazole, one less methyl group at the cost of faster clearance and a few more pills. Symbiomix will be devoting as much time to figuring out their price point as they will to their clinical trial.

19 comments on “A New Old Antibiotic”

  1. petros says:

    If it avoids the nasty alcohol interaction of metronidazole then it might have another advantage over the standard drug

  2. A Nonny Mouse says:

    Same thing was done with metformin some years ago as this, too, had never been launched in the US.

  3. Biotech Capitalist says:

    I think a bit less knee jerking is due to regulatory arbitrage plays. Critically, there are strong payer-driven market forces at play today which, even if secnidazole is safe and effective and passes NDA, may make it unprofitable if it is not much more effective than competitors which may be cheaper. And what if there is a surprise and secnidazole is much much better than expected and better than competitors? Then their PhIII gamble did something productive for medicine and higher drug prices can be justified.

  4. Gordon Gekko says:

    What she said ^^^^^^^

  5. biotechtoreador says:

    ” as someone who’s spent all his time in new drug research, it feels to me like cheating, like pulling a fast one”
    Cheating would be stealing a $100 bill from someone, this is like finding it on the sidewalk. Symbiomix didn’t find this asset by accident, they looked hard for it, and when they found it did a lot of diligence to make sure it was the real deal (which maybe it will be). These guys worked, I’m sure, pretty hard to get this done just not by making it themselves in the lab.

  6. Academic111 says:

    In today’s BioWorld Symbiomix acknowledges that no composition of matter patents are attainable, but they do say they have generated new IP around manufacturing and other areas. So there may be more to the story.

  7. Another Annonymous says:

    @5 That’s an awfully charitable assessment…
    Facts like it has “…been sold in other countries for so many years that it’s gone generic…” and “There are alternatives to secnidazole out there – specifically metronidazole, one less methyl group…” make it sound like no one at Symbiomix had to work too hard in order to make sure secnidazole was “the real deal”.
    In the absence of a surprise contribution like @3 stated, this is quintessentially pulling a fast one.

  8. Andy II says:

    A good example is Salix’s Xifaxan. They licensed in the old antibiotic from Italy for travelers’ diarrhea. When they received the FDA approval, the composition of matter patent expired in the US. They did very well to expand the label that includes HE, IBD.

  9. HT says:

    Gd luck trying to make money with it. Maybe they have a great marketing team that can prevent doctors from prescribing tinidazole …

  10. I don’t usually disagree with Derek, but I do on this one.
    Market exclusivity is an incentive for drug makers to spend money to get drugs approved. It works fantastically well if you look at the money risked on things like Alzheimer’s disease.
    If Symbiomix’s drug has value (physicians and patients want it), they do quite well with this investment. If there is little value there, then the price will follow and Symbiomix will regret ever investing in the drug’s approval.

  11. Curt F. says:

    I think Derek’s position is logical, but if you want to consider this type of regulatory arbitrage as “cheating”, then the flip side of it is that you have to condemn the pharmaceutical industry of the 1980s and 1990s.
    If the regulatory arbitrage of today works, it means the America’s chemists and biologists of those days dropped the ball, and refused to do the best they could to help patients. They left unmet a very meetable medical need. That’s the only reason there is arbitrage today.
    I think the opposite position is also logical, i.e. you don’t consider this form of regulatory arbitrage to be “cheating”, and you don’t view the industry of yesteryear as a failure.

  12. bard says:

    Does it address the carcinogenesis and mutagenesis concerns of Metronidazole? I’ve ordered this from aldrich and its labeled as a carcinogen on the reagent bottle? I would say that would be a huge leap forward for metronidazole. I have a feeling that property is pretty closely tied to the whole nitroimidazole thing its got going on though.
    Anecdotal story : My wife was cultured for this during a recent pregnancy and there was no way I was filling a prescription for metronidazole for my pregnant wife, who was also asymptomatic. Suffice it to say at here next appointment she was cultured again and came back negative. So I’m glad we didn’t listen to the docs on that one.

  13. bard says:

    Does it address the carcinogenesis and mutagenesis concerns of Metronidazole? I’ve ordered this from aldrich and its labeled as a carcinogen on the reagent bottle? I would say that would be a huge leap forward for metronidazole. I have a feeling that property is pretty closely tied to the whole nitroimidazole thing its got going on though.
    Anecdotal story : My wife was cultured for this during a recent pregnancy and there was no way I was filling a prescription for metronidazole for my pregnant wife, who was also asymptomatic. Suffice it to say at here next appointment she was cultured again and came back negative. So I’m glad we didn’t listen to the docs on that one.

  14. Anonymous says:

    I don’t think it’s fair to compare this to, say, the situation with Colchicine and similar. This drug has never been available in the U.S. There are no patients who have been taking this for years at dirt-cheap prices who will now be forced to pay through their noses.
    Running tests and getting this drug approved will not hurt U.S. patients at all. It might not help them much, if the price point is too high or it is very similar to alternatives, but no one is going to have to pay more for a drug they were already taking.

  15. David Young, MD says:

    Most people tolerate Metronidazole just fine. But a few patients get neuropathy from it. It might be interesting to se if more or less people get neuropathy from Secnidazole. But if it costs a lot more, I seriously doubt that it will get much play. The drug reps will come in, beg us to use it, physicians will finally write prescriptions only to get calls from pharmacists indicating that the secnidazole is not covered by their insurances. After a few phone calls interferring with the doctor’s day, there will not longer be prescriptions written. If the advantage is just taking fewer pills, it won’t be use… won’t be seen as an advantage. If it ends up being a better drug to eradicate C. difficile from the gut (fewer relapses of pseudomembranous colitis) then they will have something. (The ID doctors will order it all the time… they love new antibiotics!).

  16. Chest Rockwell says:

    @9
    That’s right, tinidazole is already listed on the CDC treatment guidelines as an alternative regimen. Even a single higher dose of metronidazole seems to work:
    http://www.ncbi.nlm.nih.gov/pubmed/24983350
    @15
    For this disease intravaginal administration is an option so concerns about systemic tox are mitigated.

  17. Pete says:

    Metronidazole is so cheap, and common that it will take a herculean effort to get uptake amongst the medical profession. If the ‘new’ version ss priced high, I expect it not to be covered by insurance companies: the alternative in metronidazole is inexpensive, and a known quantity despite the side effects/interactions with alcohol. Given the new drug’s structure and mechanism of action, I doubt it will avoid the problems with metronidazole. If I had to bet, I doubt secnidazole will make much impact.

  18. Pete says:

    Metronidazole is so cheap, and common that it will take a herculean effort to get uptake amongst the medical profession. If the ‘new’ version ss priced high, I expect it not to be covered by insurance companies: the alternative in metronidazole is inexpensive, and a known quantity despite the side effects/interactions with alcohol. Given the new drug’s structure and mechanism of action, I doubt it will avoid the problems with metronidazole. If I had to bet, I doubt secnidazole will make much impact.

  19. Mfernflower says:

    @12 Just by glancing over the structure on the Wikipedia page I would say it would seem just as bad. And I do believe its from the nitro group being connected to a 5 membered ring that makes them misbehave.

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