Friday Five - The pharma week in review (28 Mar 2019)

Aducan'tumab - another setback in Alzheimer's disease

The beta amyloid hypothesis has taken a significant - though apparently not fatal - blow, with confirmation of aducanumab's failure in two pivotal-stage Alzheimer's disease studies.

The setback did not deter its co-developer Eisai from announcing that another of its beta amyloid-targeting antibodies will move into a large Phase III study, though partner Biogen has been conspicuous by its absence where communication of this decision is concerned.

Analysis - ViewPoints: Biogen sends mixed messages about Alzheimer's drug

Without aducanumab, Biogen's late-stage pipeline looks sparse; its market cap some 25 percent lower; and management credibility under investor scrutiny.

Analysis - ViewPoints: Aducanumab setback asks questions of Biogen's future strategy

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Tau's turn next?

So what comes next if the beta amyloid hypothesis looks increasingly desperate?  

A closer look at Big Pharma's licensing deals in the Alzheimer's disease space over the past five years reveals that recent investment is broadening the R&D scope.

Tau remains a popular target, and one which has yet to be investigated nearly as thoroughly as beta amyloid, whilst Denali Therapeutics has attracted notable upfront investment related to both its RIP1K inhibitor and proprietary ATV platform.

Further reading…

ViewPoints: AC Immune CEO ruminates on fate of the amyloid hypothesis

ViewPoints: Probiodrug warns not to throw baby out with the Abeta bathwater

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Mayzent offers something different in multiple sclerosis

Novartis hopes to secure approval of three new drugs this year. Its gene therapy for spinal muscular atrophy - Zolgensma, due to be approved by the FDA by May - will likely attract the biggest focus, but Mayzent, approved on Tuesday, should make the biggest near-term revenue impact.

Mayzent has received a broad label in multiple sclerosis, including the underserved secondary progressive MS population.

Experts describe clinical data supporting use in SPMS as modest, but nevertheless think uptake of Mayzent will occur quickly, particularly if Novartis can effectively support more effective diagnosis of these patients.

Analysis - ViewPoints: Mayzent - everything you need to know about Novartis' new multiple sclerosis treatment

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Naughty, nice in NASH

A handful of competitors vying for a share of the potentially lucrative non-alcoholic steatohepatitis (NASH) market, which included a pair of very different clinical readouts.

Conatus Pharmaceuticals got things started off with a whimper on March 22 when the company said emricasan failed yet another Phase IIb trial, this one in NASH patients with liver fibrosis. The setback begs serious questions about whether Novartis, which exercised an option to partner up on the pan-caspase inhibitor in 2017, will remain involved going forward – though there is one additional readout still to come later this year.

Analysis - ViewPoints: Emricasan’s latest ENCORE performance looks definitive

The news was decidedly more upbeat from Viking Therapeutics, which revealed Phase II data for VK2809 suggesting the thyroid hormone receptor (THR) beta agonist may provide an impressively wide therapeutic window in the related indication of non-alcoholic fatty liver disease (NAFLD).

Analysis - ViewPoints: More momentum for Viking Therapeutics as EASL moves into focus

Finally, while not a clinical update, NGM Biopharmaceuticals offered up the latest reminder that investors are champing at the bit to get in on the NASH action, as the company upsized its fundraising plans and now anticipates raising up to $123 million in an initial public offering (IPO). The biotech's lead programme, NGM282, is in Phase II testing for NAFLD and NASH.

Analysis - ViewPoints: NGM scales up its IPO plans

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FirstWord from the frontlines

Our latest Physician Views snap-polls provide prescriber feedback on a recent new drug approval in depression and promising Phase II data in atopic dermatitis.

We asked 100 psychiatrists five key questions about Sage Therapeutics' recently approved postpartum depression (PPD) therapy Zulresso, with feedback supporting the view that uptake will be slowed by a less than straightforward means of administration.

Analysts were quick to dismiss Dermira's new Phase II data for lebrikizumab as being worthy of 'Dupixent killer' status, but dermatologists we polled (n=133) are, at the very least, intrigued by results that suggest lebrikizumab could offer similar efficacy to Sanofi and Regeneron Pharmaceuticals' treatment with less frequent dosing.

Reacting to recently announced head-to-head clinical data in favour of Takeda's Entyvio versus AbbVie's Humira in ulcerative colitis, a leading expert told FirstWord this week the results will likely boost usage of the former among community physicians.  

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