Friday Five - the pharma week in review (21 Mar 2019)

Blockbuster debate surges around Amarin's Vascepa

New data presented this week at the annual meeting of the American College of Cardiology (ACC) has spurred further debate around Amarin's purified fish oil drug Vascepa as a potential blockbuster drug; and inevitable speculation that the company could be acquired by Big Pharma.

In data presented last year, Vascepa was shown to reduce the risk of initial cardiovascular events by 25 percent in patients who remain high risk despite treatment with a statin. New results show that Vascepa reduces the risk of all cardiovascular events by 30 percent.

Analysis - ViewPoints: New cut of REDUCE-IT reinforces Vascepa as a breakthrough

Amarin plans to submit an application by the end of the month to have these results added to Vascepa's current label.

Cardiologists we snap-polled this week have indicated that the drug could be used significantly, based on these data, while concerns about the use of mineral oil as the placebo in Amarin's study appear to have rescinded.

See - Physician Views Results - Cardiologist confidence in Vascepa grows as Amarin readies regulatory filing

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Sage comes of age with Zulresso nod

The FDA approved Sage Therapeutics' Zulresso this week as the first ever specific treatment for post-partum depression; a condition thought to affect one in nine women after childbirth.

Approval may not translate into rapid and sustained commercial success, however. The biggest stumbling block will likely be the requirement of receiving Zulresso through infusion; a means of administration that does facilitate a rapid onset of action (versus the older antidepressants that are currently used to treat PPD), but which takes 60 hours to complete.

Analysis - ViewPoints: Sage comes face to face with Zulresso’s commercial realities

There will, nevertheless, be important lessons for Sage to learn, particularly as Zulresso will become its first marketed product when it launches in June. The company has shared impressive Phase II data for an oral compound, which it is developing for both PPD and major depressive disorder; the latter indication being a much larger commercial opportunity.

Our next Physician Views poll will be asking US psychiatrists to share their views on the potential adoption of Zulresso - it will be in field early next week. 

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Dermira takes on Dupixent

In its two years on the market, Sanofi and Regeneron Pharmaceuticals' Dupixent has quickly become established as the go-to therapy for moderate-to-severe atopic dermatitis in adults. Its recent approval in adolescent patients should meaningfully enhance its profile, say dermatologists, but executives at Dermira believe they may have a superior product.

They presented promising Phase IIb data for their IL-13 inhibitor lebrikizumab this week and were not backwards in coming forwards by suggesting the biologic could emerge as a 'best in disease' treatment option.

Analysis - ViewPoints: Little Dermira has Dupixent in its sights

In its favour, lebrikizumab's efficacy when dosed less frequently than Dupixent (once, rather than twice, monthly) looks comparable, though with these results yet to be confirmed in a pivotal-stage study, a number of analysts said it was too soon to describe Dermira's product as a 'Dupi-killer.'

We asked dermatologists what they think about lebrikizumab’s potential; theoretically Dermira’s drug could disrupt the market, if Phase III data are similar, they suggest. Full results from our snap-poll will be published shortly.   

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Another regulatory first for Tecentriq

Roche's PD-L1 inhibitor Tecentriq may have so far failed to light up the immunotherapy market as some of the Swiss company's investors may have anticipated, but it continues to rack up approval in some sizeable indications where more prominent therapies in the same class have yet to demonstrate efficacy.

The FDA this week approved Tecentriq, in combination with chemotherapy, as a first-line treatment for extensive stage small cell lung cancer (SCLC). This comes quickly on the heels of approval for triple negative breast cancer (TNBC) in patients who are PD-L1 positive earlier this month.

Analysis - ViewPoints: A timely approval for Tecentriq in SCLC as Roche looks to lead from the front

Onus now will be on Roche to maximise its first-to-market status in these indications before the potential approval of other PD-(L)1 inhibitors.

See also - Physician Views Results - Tecentriq poised for rapid adoption in TNBC, suggest oncologists

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Better late than never - GlaxoSmithKline turns up for the PD-1 party

The latest company hoping to join the PD-(L)1 party is GlaxoSmithKline, which this week presented Phase I/II data for the PD-1 inhibitor dostarlimab in second-line endometrial cancer. Results were described as clinically meaningful and showing durable response rates, particularly in microsatellite instability-high (MSI-H) patients.

Approval in the niche indication of endometrial cancer could offer dostarlimab a quick route to market, though both Bristol-Myers Squibb's Opdivo and Merck & Co.'s Keytruda are approved for treating MSI-H tumours, irrespective of cancer type.

GlaxoSmithKline's bid to reintegrate into the oncology market remains, nevertheless, one of the more intriguing strategies within the Big Pharma peer set.

Analysis - ViewPoints: GlaxoSmithKline buys into Merck KGaA's post-Keytruda vision

Analysts at Jefferies were quick to suggest that impressive data for dostarlimab, integrated into GlaxoSmithKline's pipeline through last year's acquisition of Tesaro, should "provide confidence" the UK pharma giant can rebuild its presence in oncology.

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