Friday Five - This week's key news stories

Bristol goes big on Nektar deal

Bristol-Myers Squibb's billion dollar deal to co-develop Nektar Therapeutics' cancer drug NKTR-214 suggests that biotech valuations, particularly where immuno-oncology is concerned, are overcooked.

Including an equity stake in Nektar, Bristol-Myers Squibb's initial outlay will near $2 billion, a new benchmark in pharma licensing, and total value could rise to $3.6 billion. For this, Bristol-Myers Squibb has secured 35 percent of future profits in up to 20 cancer indications where NKTR-214 could be approved. There is also scope for Nektar to collaborate with other third parties and it has shifted a lot of R&D cost onto its new partner.

Analysis - ViewPoints: Is Bristol-Myers Squibb’s mega-deal for NKTR-214 a steal?

The alternative would be to acquire Nektar outright; but the biotech's market capitalisation has swelled from around $2 billion to $14 billion over the past 12 months; optimism has been driven by promising data for NKTR-214 - which could facilitate use of immuno-oncology treatment combinations in PD-L1-negative patients - albeit from a relatively small study.

Now approved, can Erleada carve out market share?

FDA approval of Johnson & Johnson's Erleada (apalutamide) represents another rapid fire decision from the US agency, but the jury remains out on whether this product can carve out anything more substantial than a small niche in the prostate cancer market.

Approved in non-metastatic castrate-resistant prostate cancer, questions have been asked of the decision to run pivotal-stage studies versus placebo and the potential size of this particular setting. At the very least, however, Johnson & Johnson will get an opportunity to establish Erleada in non-metastatic patients before Pfizer and Astellas' Xtandi is approved in the same indication.

Analysis -

KOL Views Results: Apalutamide, Xtandi will transform nmCRPC, but may find less riches up for grabs than expected

Physician Views Poll Results: Breaking down new prostate cancer data with treatment prescribers

Another setback in the pursuit for an Alzheimer’s treatment

More shade has been cast on efforts to develop treatments for Alzheimer's disease, following confirmation that Merck & Co. is to halt full development of the BACE inhibitor verubecestat.

Analysis - ViewPoints: Merck & Co. shelves verubecestat – is writing on wall for Biogen, Eli Lilly?

Furthermore, Biogen added to the uncertainty by confirming it has added 510 patients to its two ongoing, pivotal-stage studies for aducanumab; prompting the company's shares to drop 9 percent on Wednesday.

The concern is that any efficacy difference versus the control arm will be so small, a larger cohort is necessary to show statistical significance.

Vertex doubles up with cystic fibrosis approval

Vertex Pharmaceuticals secured FDA approval for the combination of Kalydeco and tezacaftor for the treatment of certain patients with cystic fibrosis. It will be sold as Symdeko and priced at $292 000 per year, specifically in patients aged 12 and over who have two copies of the F508del mutation in the CFTR gene or who have at least one mutation that is responsive to the drug combination.

Analysis - ViewPoints: Does a fresh approval for Vertex point to sky-high costs ahead?

Focus is already sharpening on triple-combination products being developed by Vertex, which would potentially broaden the CF population who can be treated. Furthermore, Symdeko has been priced higher in the US than analysts were expecting; is Vertex testing the waters for its triple combination, which also appears to offer improved efficacy versus its current CF therapies?  

Roche’s eyes a place in next-gen ophthalmology race

Hot on the heels of Novartis, Roche is staking a claim for a next-generation ophthalmology therapy - the bispecific VEGF/Ang-2 antibody RG7716 - with Phase II results in treatment-naïve diabetic macular oedema patients unveiled last weekend.

Roche has been bullish about RG7716's chances and it looks a superior therapy to Lucentis (which is co-marketed globally by Roche and Novartis), though it is unclear - based on Phase II data - whether RG7716 is clearly superior to Regeneron Pharmaceuticals and Bayer's Eylea franchise; ophthalmologists we surveyed this week largely came to the same conclusion - see Physician Views Poll Results: Significant opportunity for RG7716 but ophthalmologists will need more convincing it’s not another Eylea

Other recent Physician Views polls -

Physician Views Poll Results: Up-front Tagrisso use occurring already, but US oncologists less familiar with FLAURA

Physician Views Poll Results: Expectations high for Gilead's Biktarvy

Physician Views Poll Results: Data for Allergan’s oral migraine treatment is promising, say prescribers; but it could be a slow-burner

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