Friday Five - The Pharma Week in Review

Strategic manoeuvres

Having acquired a controlling stake in Foundation Medicine three years ago, Roche announced this week it will acquire the diagnostics company outright in a deal that values the former at $5.3 billion.

This shows unwavering commitment by Roche to its drug development strategy in oncology, which is firmly centred on personalised medicines; and data from a number of Foundation Medicine's assays featured heavily in clinical presentations recently made by the company at the ASCO annual meeting.

The most important question, ask analysts at Credit Suisse, is why Roche has chosen to buy Foundation Medicine outright now and "what in practice it can do as a full owner that it couldn't do as a majority owner." See ViewPoints: Roche gets possessive about Foundation Medicine

Simultaneously, Roche has committed to Foundation Medicine operating as a separate legal entity; an important consideration given the numerous collaborations it is operating with other pharma companies. The aim, they conclude, is for Foundation Medicine tests to become standardised as the oncology market enters a new era of personalised medicine; one trend to watch will be whether Foundation Medicine can add to its impressive roster of collaborative agreements with rivals to Roche.  

From the clinic

Offering a first peek at biomarker data for its Duchenne muscular dystrophy gene therapy, Sarepta Therapeutics "hit it out the park," writes FirstWord's Becky Simon; the caveat being these results are from the first three patients treated, though Sarepta's shares soared on the news.

The data also add some long-sought legitimacy to Sarepta's pipeline; CEO Doug Ingram joked that the company had to tweak some of its dystrophin assays to account for the higher levels of expression the company was now seeing. He called it "a bit of a challenge" to rework its standards to quantify an 80 percent increase, from the sub-4 percent it had been detecting with its Exondys 51 programme, which barely squeaked by US regulators with a controversial approval two years ago.

Novo Nordisk continues to accumulate clinical evidence in favour of its oral GLP-1 analogue semaglutide; announcing this week superior efficacy and weight loss over its injectable GLP-1 Victoza and Merck & Co.'s DPP-4 inhibitor Januvia.

Most have been looking towards gene therapy as the biggest threat to Biogen's leadership in the spinal muscular atrophy (SMA) market, but Roche and PTC Therapeutics' oral candidate risdiplam may represent a more real and present danger, writes FirstWord's Michael Flanagan.

Data accumulates for new targets and dual targets in CAR-T - see ViewPoints: CD22 emerging as a good backup plan in ALL and ViewPoints: Dual-targeted CAR-Ts indirectly boosted by more CD22 success

Physician Intelligence

Mylan has been talking up proposed price discounting for its biosimilar version of Neulasta, which was approved by the FDA earlier this month and is expected to reach the US market in a matter of weeks. Focus should arguably sharpen on pricing more (and Amgen's inevitable response) with a large proportion of physicians snap-polled by FirstWord this week suggesting they are more than comfortable to prescribe Mylan and Biocon's product, which will be branded as Fulphila.

How comfortable are you with the notion of using a biosimilar Neulasta product?

To gauge sentiment to Novo Nordisk's new data for oral semaglutide (see above), we are also snap-polling US and EU5-based endocrinologists to gauge reaction to head-to-head results versus Victoza and Januvia, and how adoption could evolve as a result.

Recently announced top-line data suggest that Allergan's oral CGRP inhibitor atogepant could represent a significant commercial threat to injectable migraine prevention therapies utilising a similar mechanism, a leading key opinion leader told FirstWord this week; analysts have pegged peak sales for injectable products at billions of dollars, while atogepant has flown somewhat under the radar until now;

"One challenge with running placebo-controlled migraine trials is that more treatment arms increase the risk of losing the ability to differentiate a therapy from placebo, so in all honesty I thought Allergan's study may fail because it was testing five active arms. It turns out quite the opposite is true. Overall, I am impressed that so many treatment arms separated from placebo in a trial that used a rather modest sample size. The magnitude of the difference was about one migraine day per month when adjusted for placebo, which is really good and is more or less in the same ballpark as the antibodies." More here.

               See also ViewPoints: Teva misses an opportunity to make its mark in CGRP space

Digging a little deeper

AbbVie got something of a pleasant surprise when ICER published its provisional value assessment for Elagolix; which is pending US approval for the treatment of moderate-to-severe endometriosis. ICER's cost effectiveness threshold for Elagolix appears to be somewhat higher than analysts were expecting AbbVie to price the drug at launch.

               See also ViewPoints: ObsEva's linzagolix looks to join the GnRH party

Intellia Therapeutics weighs in on the recent CRISPR scare.

Momentum grows in US lawsuits aimed at eliminating exclusionary tactics blocking formulary access for biosimilars.

Can an amyloid-targeting vaccine bring hope in the field of Alzheimer's disease development? United Neuroscience lays out its plan.

Regulatory recon

The FDA slapped a clinical hold on Ziopharm's latest bid to disrupt the CAR-T space. What do key opinion leaders make of its 'Sleeping Beauty' platform? - Which the company says can manufacture CAR-T cells in just two days.

Bristol-Myers Squibb's Opdivo became the first PD-1 or PD-L1 inhibitor to be approved in China.

The FDA rejected approval of Valeant Pharmaceuticals' Duobrii for plaque psoriasis over pharmacokinetic data.

Continuing on a streak of market-based solutions to problems under the FDA umbrella, Commissioner Scott Gottlieb previewed a new licensing system to incentivise development of antibiotics, particularly for those targeting multidrug-resistant pathogens. But while every new policy change and incentive is likely to help, it may take a resurgence of M&A interest from pharma to get investment back on track for the sector.

Alexion has used a priority review voucher to speed up the US review process for ALXN1210; its follow-up to Soliris

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