Friday Five - This week's key news stories

From bad to worse for Celgene

Celgene announced on Tuesday it received a refuse-to-file letter from the FDA in response to its marketing application for the experimental multiple sclerosis treatment Ozanimod.

At best, this is an embarrassing outcome for a company of its stature, and with the experience of Celgene; at worst it puts management under further scrutiny following a number of setbacks late last year.

Analysis - ViewPoints: Big questions about ozanimod raise bigger questions about Celgene and ViewPoints: Piecing together what went gone wrong with Celgene's ozanimod.

And what of the impact this could have on the broader MS market? Somewhat ironically, while Ozanimod has been identified by analysts and investors as Celgene's key near-term growth driver, key opinion leaders (KOLs) in the MS market remain largely ambivalent to its potential disruption of the treatment landscape.

Critically, even assuming Ozanimod reaches the market, it may now do so just prior to, or after, generic versions of Novartis' Gilenya become available. This could significantly curtail its commercial opportunity, argue KOLs.

Oral semaglutide makes strong initial showing 

2018 is poised to be a critical year for Novo Nordisk's ambitions to bring a first oral GLP-1 agonist to market for the treatment of diabetes. Things got off to a positive start late last week when the company announced positive data for semaglutide from the first of 10 pivotal-stage studies.

The PIONEER1 trial assessed oral semaglutide against placebo rather than active comparator drugs (data versus the Jardiance and Januvia brands will read out later this year), but nevertheless provides compelling evidence to support Novo Nordisk's ambitions. While efficacy data were impressive, analysts were particularly pleased with the demonstration of a clean safety profile for semaglutide, which bodes well for subsequent trial readouts.

Analysis - ViewPoints: Novo Nordisk passes first oral GLP-1 test with flying colours

Assuming positive data for semaglutide accumulates over the next 12 months, focus will shift increasingly to commercial considerations, likely centred around pricing on par with injectable GLP-1s rather than other oral agents; as per prior management commentary. This could prove problematic where payers are concerned, argue analysts at Barclays.  

See also - KOL Views: How have PIONEER-1 results affected expectations for Novo Nordisk’s oral semaglutide?

Gilead gets in on the gene-editing game

Following its acquisition of Kite Pharma last year, Gilead Sciences has been looking to use further collaborations to develop next-generation CAR-T products. A gene-editing partnership therefore comes as no surprise, though its choice of Sangamo Therapeutics' older – and some would argue, outmoded- zinc finger nuclease (ZFN) platform - can be viewed as a massive endorsement for the modality. In recent years, Sangamo has found itself quickly usurped by newer, flashier tech in the form of CRISPR/Cas9, which has supported lucrative initial public offerings for Editas Medicine, CRISPR Therapeutics and Intellia Therapeutics.

Analysis - ViewPoints: Once a gene-editing wallflower, Sangamo is now Gilead's surprise pick.

Pharma's growth drivers

With fourth-quarter earnings season now largely in the rear view mirror, we took a look at pharma's 50 fastest growing products in 2017; a closer look at the top 10 and give an in-depth analysis of Merck & Co.'s Keytruda - which outgrew all other drugs last year.

Pharma's fastest growing drugs - the top 50

Pharma's fastest growing drugs - a closer look at the top 10

ViewPoints: King Keytruda the apple of Merck & Co.'s eye

AstraZeneca hopes independence will allow inflammation, autoimmune assets to flourish

AstraZeneca announced that its MedImmune unit will spin out six molecules from its early-stage inflammation and autoimmunity programmes into a new company called Viela Bio. The compounds include the anti-CD19 monoclonal antibody inebilizumab, which is currently in mid-stage development for the treatment of neuromyelitis optica.

Analysis - ViewPoints: Viela gets rolling with an autoimmune pipeline from AstraZeneca

Viela Bio is the third new company to be spun out of AstraZeneca over the past decade, following Albireo Pharma in 2008 (which is focused on liver and gastrointestinal diseases) and more recently Entasis Therapeutics, spun out in 2015 with a focus on antibacterials.

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