Pain Therapeutics, Inc. (NASDAQ:PTIE) put out a fourth-quarter business update, and alongside it, gave us some insight into the possible future of the company’s long suffering abuse deterrent asset, Remoxy. This is one that we have covered in the past on a number of occasions here Market Exclusive, yet one that remains on an as-yet unresolved path.
Here is a look at the latest update, what it means for the drug, and what we expect going forward.
Many reading will already be familiar with Remoxy, Pain’s abuse deterrent oxycodone candidate, but for those that are new to the asset, here is a brief introduction. We will warn you ahead of time, it has a pretty convoluted history, but one that is well worth catching up on for anyone considering an allocation to the drug going forward.
in 2002, a company called DURECT Corporation (NASDAQ:DRRX) licensed a technology called Oradur to Pain Therapeutics. Shortly after, Pain did a deal with the then King Pharma, a company which Pfizer Inc. (NYSE:PFE) acquired in 2012, that saw a large portion of the Oradur rights (by this point it had been rebranded as Remoxy) transfer to King. As part of the acquisition, and reported as being one of the driving assets behind Pfizer’s decision, the rights transferred to the latter.
Pfizer basically carried the drug to NDA, but for reasons unknown, dropped it ahead of submission. Rights returned to Pain on the back of the drop, and markets sold of on the drug unreservedly. We speculated last year that Pfizer may have dropped the drug because it wanted to pursue its own in-house developed abuse deterrent asset, as opposed to one that it would end up having to pay royalties on if commercialized. This remains speculation, however. Anyway, what happened was, on April 12, 2016, Pain submitted an NDA and picked up a PDUFA of September 25, 2016. At this date, however, the FDA issued a complete response letter (CRL) and the company pretty much collapsed.
The fears that Pfizer had dropped the drug due to some degree of inadequacy that it had uncovered during the development process, as opposed to any alternative reasoning rooted in competition between an in-house and an externally developed asset, seemed validated, and it looked as though this was the end of Remoxy’s development pathway.
Fast-forward to the latest business update, however, and things have changed yet again.
Pain reported the following as part of the update:
“Pain Therapeutics recently met with the U.S. Food and Drug Administration (FDA) regarding REMOXY ER (oxycodone extended-release capsules). During this meeting, the FDA and the Company reached agreement on a roadmap to resubmit the New Drug Application (NDA) for REMOXY ER.”
So apparently, there is a renewed pathway to commercialization, and one that both the FDA and Pain agree on. The company has gained a few percentage points on the back of the news, but nothing substantial, so it seems that markets remain unsure as to what this development actually means.
So what is our take?
Well, that the asset is still alive is a bonus in our eyes, and one that certainly supports the current valuation of the company. This is a drug that – if approved – would be targeting a multibillion-dollar market, and a successful commercialization run would likely translate to a rapid forgetting of the trials and tribulations experienced by all companies involved during the pathway to development.
With that said, we don’t know any details as to what this pathway involves, and – more importantly – whether it runs towards a commercialization for the drug based on abuse deterrence, or purely based on pain management qualities. The latter would basically reduce it to a generic opioid, something that the market is already flooded with, and would devalue the asset considerably (likely almost to zero).
So, what is next?
It’s all about the details. The company has reported that the meeting’s minutes will be collated and released at some point over the next three weeks, and it is in these minutes that we should be able to pick up information with which we can form a more solid bias on the stock. As things stand, while the news is positive, it is a little flaky.
We will keep an eye out for the reports and update as and when we get it.