Pharma's election interest
At the time of writing, a winner in the US Presidential election has yet to be announced. With it abundantly clear, however, that the democrats have not swept back into power – or will control all of congress – a worst-case scenario for the pharmaceutical industry has been avoided, analysts have been quick to pronounce.
A democrat 'sweep' would have significantly raised concerns about drug pricing reform in the US market. Whilst President Trump has discussed his wish to lower prices for pharmaceuticals, concrete proposals designed to do so have been lacking detail or heavily diluted versus the rhetoric from democrats.
Former Vice President Joe Biden, who at this point retains more routes to the White House as ballot counting in just a few states continues, has shown some interest in a German-style drug pricing model, which could see value assessments for new therapeutics determined by perceived levels of innovation. However, with voting patterns indicating that the House will remain Democrat and the Senate likely Republican, this conflict of control will make it harder for any proposed legislation to be passed into law.
Biogen's boost ahead of AdCom
Investors have been gearing up this week for one of, if not, the biggest events in the biopharma sector this year – Friday's FDA advisory committee meeting to discuss Biogen and Eisai's US regulatory application for the investigational Alzheimer's disease treatment aducanumab.
Things got off to an inauspicious start with an analysis published in the journal Alzheimer's & Dementia at the beginning of the week calling for aducanumab to be evaluated in a third Phase III study before US approval is considered.
However, when the FDA's pre-meeting briefing documents were published on Wednesday, they provided a much more positive (some would argue overwhelmingly so) review of the data that has been submitted by Biogen to support its application, not to mention evidence of substantial cooperation between the company and the regulator over recent months.
Shares in Biogen surged more than 40% as a result, with investors buying into the view that the FDA is keen to approve aducanumab, despite its less than perfect clinical data package. The company has much riding on the outcome of Friday's panel and any subsequent decision by the FDA, which is set to be announced in the first quarter of 2021. Like investor expectations, the stakes have been raised further by the FDA's unexpected show of support.
What next for aducanumab if approved?
Should aducanumab successfully navigate a path to market, the next focal point for investors – not to mention other companies developing similar Alzheimer's disease treatments – will be assessing its potential commercial profile.
Approval would provide aducanumab the status of being the first new Alzheimer's disease treatment for two decades and this is not a rare condition. Furthermore, clinical data suggest effectiveness in patients with mild cognitive impairment and analysts at Cowen model 2.2 million US citizens as having mild dementia caused by Alzheimer's disease. They suggest that if priced at approximately $50,000 per patient per year and used in approximately a third of this population, aducanumab would generate peak annual sales of $36 billion in the US alone. For comparison, AbbVie's anti-TNF drug Humira is the world’s biggest selling pharmaceutical product and generates global sales just shy of $20 billion.
To what extent payers can manage patient expectations and the pressure exerted by availability of a new (though only moderately efficacious) Alzheimer's disease treatment remains to be seen. They may find an ally in neurologists, however. We are in the process of snap-polling US-based neurologists about aducanumab and though data at the time of publication are limited (to 26 respondents), results of our poll suggest that although almost all would prescribe Biogen's drug if approved, the majority would only to plan so occasionally (rather than frequently or very frequently).
Provisional data from our poll also show a near perfect split in opinion as to whether Friday's AdCom panel should vote in favour of approving aducanumab.
BMS's psoriasis hopeful produces positive data
This week, Bristol Myers Squibb announced top-line results from the first of two Phase III studies evaluating its investigational Tyk-2 inhibitor deucravacitinib for the treatment of moderate-to-severe plaque psoriasis. The company confirmed that against two co-primary endpoints measuring skin clearance, deucravacitinib was superior to placebo and, more notably, Amgen's marketed psoriasis treatment Otezla.
Analysts were quick to identify superiority versus an active comparator as key to supporting multi-billion dollar peak sales forecasts for deucravacitinib, though there is something of a disconnect between what Wall Street are focused on and what experts in the psoriasis field are looking for.
Key opinion leaders are not surprised that deucravacitinib has overcome Otezla, which has been chosen, as like Bristol Myers Squibb's drug, it is dosed orally, citing it as a relatively weak competitor. They are instead focused on the safety profile of deucravacitinib and whether higher selectively of Tyk-2 spares patients the side effects associated with the broader class of JAK inhibitors; something that analysts appear to be less concerned about at this point, but which could be critical in driving potential adoption of deucravacitinib at the expense of popular biologic therapies, say experts.
ASH abstract bonanza
Christmas came early for anyone eagerly awaiting abstracts from the American Society of Hematology (ASH) meeting, which dropped a day ahead of schedule. Key abstracts from the data deluge include disclosures from CRISPR Therapeutics and Vertex Pharmaceuticals, which are hoping to outmanoeuvre bluebird bio’s gene therapy in sickle cell disease- made easier by a newly-disclosed delay in the latter’s submission timelines as it contends with more stringent manufacturing requirements from the FDA.
The ASH abstracts also demonstrate that interest in BCMA as the target of choice in multiple myeloma hasn’t gone anywhere; the meeting looks primed to once again produce battles between bispecific antibodies- particularly those from Amgen and Johnsons & Johnson- against CAR-Ts developed by Bristol Myers Squibb and bluebird, as well as Johnson & Johnson and partner Legend Biotech.
The fun isn’t over yet; late-breaking abstracts for the ASH meeting drop on November 19.
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