AbbVie (NYSE:ABBV) took center stage in yesterday’s biotechnology news arena with its potentially groundbreaking Alzheimer’s partnership but the company isn’t stopping there. As we head into the end of the week, news has hit press that a partnership between AbbVie and Neurocrine Biosciences, Inc. (NASDAQ:NBIX) has just produced some trial data and both companies are gaining strength (at least, did so initially) on the back of the development.
The data is rooted in the first of two planned pivotal trials set up to investigate the safety and efficacy of a drug called elagolix, which AbbVie and Neurocrine are investigating in combination with low dose hormone therapy as a potential treatment for patients with uterine fibroids (benign tumors in the uterus basically) and the resulting heavy menstrual bleeding.
As per the results, the trial met its primary endpoint, with 68.5% (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (8.7%).
This drug is already at application stage in another indication, endometriosis, and is one of a number of drugs in AbbVie’s advanced pipeline that has the potential to command blockbuster (i.e., billion dollars plus) revenues if and when it hits shelves in its various target indications.
Of course, as relates to the indication that’s in focus here, Neurocrine also stands to benefit from an approval and any potential sales revenues going forward.
So, what’s next?
To get the second trial underway. Markets will probably look for a topline readout at some point during 2019.
The market response to the development has been somewhat muted, with AbbVie initially jumping during after-hours trading towards and above $120 a share but looking likely to enter today’s session in and around $117 apiece. Neurocrine registered a similar response, picking up some after-hours strength before returning to trade pre-market today in and around yesterday’s close.
We expect to see a bit of early strength as the bell rings for the Thursday session.
GW Pharmaceuticals plc (NASDAQ:GWPH) also put out data on Wednesday, with the company reporting results from a Phase 2a trial there that was set up to investigate an asset called GWP42006 as a potential treatment in adult patients with focal seizures.
Unfortunately for the company and its shareholders, however, the news on this occasion wasn’t positive.
As per the release, the trial failed to hit its primary endpoint, and shares are trading down approximately 5% to $125.49 ahead of the market open on Thursday.
Alongside the data announcement (which was admittedly brief), GW also reported to markets that it is set to meet with the Peripheral and Central Nervous System Drugs Advisory Committee on April 19, 2018 to discuss the New Drug Application (NDA) of one of its potentially blockbuster assets, Epidiolex, which is currently at application stage with the FDA for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.
This is an incredibly debilitating form of epilepsy that basically has no cure at the moment and, perhaps more importantly, doesn’t really have any sort of treatment that’s available for symptoms (which are, for the most part, frequent seizures).
It primarily affects children (again, for the most part, this is because it’s early onset and life expectancy is dramatically reduced) and the idea is that, with Epidiolex, a patient can lead an improved quality of life with seizure control on the back of regular treatment.
And there’s some pretty strong data that supports this thesis, with said data currently at the root of the application that’s with the NDA right now. This will form the basis of the company’s discussion with the above-mentioned panel come April 19.
So, the market response to the latest news hasn’t been great but it’s also not too significant. The real catalyst is the agency response to the NDA, meaning shareholders are likely to hold on to their exposures in anticipation of a positive result as opposed to selling out at this stage on the back of the trial endpoint miss.
We’ll be keeping a close eye on this one moving forward as GW is a closely watched stock and can move significantly this year if catalysts go its way.
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