BLOG: More AzaSite drama
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Seriously, you can’t make this stuff up.
Akorn, the most recent company making AzaSite (azithromycin ophthalmic solution), has filed for bankruptcy. That’s right, another company that owns the rights to the most snake-bitten medicine in all of eye care is having some sort of financial something or other. It’s probably just a coincidence, right? I mean, it can’t really have anything to do with AzaSite, right? Just because Inspire missed its endpoint on its next drug (diquafosol) and ended up being sold to Merck in a fire sale, that’s not because their first drug was AzaSite. And surely all of the legal issues that Merck had weren’t affected by the FTC’s interest in legacy AzaSite marketing. Surely AzaSite had nothing to do with Merck’s exit from eye care.
Akorn bought AzaSite (and two highly effective glaucoma products) from Merck, adding three branded products to a very strong lineup of generic products (and TheraTears, the first “good” artificial tear). It promptly ran into a buzz saw in the marketplace trying to sell an expensive branded drug within a culture more geared toward the “race to the bottom” pricing of the generic markets. Akorn’s numbers looked good, though. Good enough to attract a buyer that absorbed the Akorn product lines and pretty much axed everything else in the company, including nearly the entire management team and all but a relatively small number of sales staff. Somehow this deal was jinxed, too: The buyer tried to un-buy Akorn even after firing all those employees.
Frankly, I’m as confused as everyone else right now. Which Akorn is filing for bankruptcy? Is it the original company that bought out the Merck assets? The new merged company? Some other entity they snuck in while no one was watching?
In everyone’s defense, AzaSite is a terrifically difficult drug to market and sell now that we are no longer in the “approve and move” world where you get a very narrow indication for a drug and then shadow market all kinds of other uses. While it is actually a brilliant drug for its on-label indication, treating bacterial conjunctivitis, 95+% of AzaSite scripts are for meibomian gland dysfunction treatment. Tough sell, even for a drug that works so well in such a common entity. Without a change in label, AzaSite is likely to languish in the wings as it has been doing for the last 6 or 7 years at least. Which is a shame because, as I’ve oft written, it works great in the dry eye disease/ocular surface disease world.
I really don’t think AzaSite is jinxed or that it is like that Bermuda Triangle location where every business that occupies the address ends up failing. At least I hope not. I’m still waiting and hoping that somebody with a little cash picks up this tiny gem and keeps it in our quiver to treat MGD. Even though it is probably approaching the end of its patent life, the unique delivery vehicle will likely inoculate it against generic competition (see: Restasis).
AzaSite could use a break.
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