Danish biotech Forward Pharma A/S (NASDAQ:FWP) just announced its full year and Q4 2015 financials, and alongside the numbers, gave us an update as to the progress of its late stage pipeline in psoriasis and multiple sclerosis. The company is trialing the same compound in both indications – the small molecule dimethylfumarate (DMF) – under the name FP187. DMF has had a pretty controversial half decade, with a number of companies (Forward Pharma being one) challenging patents picked up by Biogen Inc (NASDAQ:BIIB), and the exclusivity afforded by the FDA in the US and the EMA in Europe associated with a 2013 approval of the compound under the name Tecfidera, in an MS indication.
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The pharma giant had its patent 537 revoked in Europe last month, which could pave the way for a slashing of the expected 2028 exclusivity cutoff, and based on the latest pipeline update, Forward Pharma is ploughing ahead with FP187 in anticipation of a failed appeal by Biogen on the revocation.
So, what’s the update, and how might it impact both Biogen and Forward Pharma going forward? Let’s take a look.
As mentioned, the drug is a formulation of dimethylfumarate called FP187. It’s probably important to say straight off the bat that the exact MOA of DMF is unknown. All we really know about it is that it interacts with certain elements of our immune system – specifically T Cells and dendritic cells in our GI tract, and this interaction allows for an immunomodulary effect that is concurrently non-immunosuppressive.
In MS, again, the exact cause of the condition is not known. We do know, however, that the immune system seems to attack the coating of nerve cells, called the myelin sheath, and this causes a sort of short circuit effect. Through its immunomodulary effects, DMF seems to modulate the attacking of the myelin sheath, without impacting the efficacy of our natural immune system; or at least, without a significant reduction in efficacy.
So what did the update tell us? Well, Forward gave us plenty of information relating to the ongoing litigation between it and Biogen, and you can read the specifics here, but let’s focus on the drug and its progress to date for the purposes of this discussion. During the second half of 2016, Forward intends to kick of a phase III pivotal that will investigate the efficacy of FP187 in an MS indication. The trial will run concurrent to a number of ongoing phase I trials, which are looking at both safety and tolerability, in healthy patients. There’s a host of data to support the efficacy of DMF in this sort of indication, so the only thing that is likely to hamper the drug’s chances is, not surprisingly, the thing that differentiates it from Biogen’s Tecfidera – its release formulation. FP187 is designed as a slow release formulation through the company’s so called erosion matrix technology, while Tecfidera is immediate release. Chances are, however, there won’t be too much of an impact. What does this mean? That its all going to come down to litigation.
The European patent is already overturned, and while Biogen is appealing, the contest looks strong on Forward’s front. In the US, things remain uncertain, but Forward reported in its latest investor presentation some evidence that seems to suggest the filing of a patent relating to the exact dose it is contesting, a few years earlier than did Biogen. See below for an image taken directly from said presentation.
Priority statements have been filed, oral arguments are set for June, and oppositions to motions are set for November this year.
Needless to say, and as confirmed by its latest update, Forward is forging ahead with the development of FP187 in anticipation of the courts revoking the issued permit and allowing the company to bring its DMF formulation to market.
If it does, it could be looking at mounting a serious challenge to the close to $1 billion global revenues generated from Tecfidera quarterly. Of course, there’s also the potential for a royalty issue, which would see Biogen pay Forward a royalty on Tecfidera sales and Forward stop the development of FP187 as a result. Either way, it’s an interesting situation to keep an eye on as it plays out.