Thursday, November 30, 2017 4:38:27 PM
The major impediments in the US for probuphine sales thus far seem to be (1) Braeburn didn't have their act together, and it's possible don't have the proper incentives to market probuphine, possibly sand-bagging it and promoting their own implant instead (if it gets approved); (2) insurance companies are taking forever for pre-approval, and making it very difficult; (3) patients needed to be stabilized first, and FDA label only for maintenance treatment.
One interesting thing I didn't see Zacks or anyone else mention is that Titan is applying for approval in the EU starting at initial treatment, not just for maintenance like approved in the US:
That combined with socialized medicine / state payors, might actually streamline things and EU could be a bigger market for probuphine vs. the US (with FDA restrictions and insurance reimbursement difficulties).
It would be great if Titan / Braeburn could petition the FDA to allow for initial treatment, especially if the new implants are allowed to do that (without even running any active comparator trials).
Who knows, maybe the insurance companies will stop making it so difficult to get reimbursed for probuphine in the US, with all the media and public awareness of the issue.
The launch is extremely disappointing, and things almost HAVE to improve - just not sure how much.
Regarding Braeburn and Titan's relationship and if Braeburn is really all-in on probuphine, doesn't Titan have some recourse there, such as (1) they are getting a cut of any other competing Braeburn OUD treatment sales - is that still true with modified license after first CRL?, or (2) Titan could cut a deal with a competitor of Braeburn, for instance for antagonist implant (or alternative pain / OUD implant). It seemed like the EU partner was prohibited from marketing any competing products for 5 years (unlike Braeburn?), and that Titan could get a cut of anything after that (IIRC).
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