Expectation retained for COVID-19 vaccines
It is a race that the whole world is watching and pursuit of a COVID-19 vaccine took a positive turn this week with partners BioNTech and Pfizer announcing early, but promising, data for their mRNA-based candidate BNT162b1.
There was less positive news for the biotech company Inovio Pharmaceuticals, which saw its share price tumble in response to a press release that declared provisional success for its vaccine candidate INO-4800, but provided no material data to validate these claims.
Elsewhere, chair of the UK vaccine taskforce Kate Bingham told MPs this week that the vaccine being developed by the University of Oxford and AstraZeneca has the best chance of becoming available later this year. She cautioned that first-generation vaccines may not provide full protection against COVID-19, but should work to reduce the severity of symptoms.
Could US surge facilitate late-stage studies?
Disparities in how various countries of the developed world are handling the COVID-19 pandemic may be the cause of some alarm, but they do at least provide an opportunity to enrol patients into the larger studies required before vaccines can be approved. Speaking about the next stage of development for BNT162b1, for example, Pfizer executives suggested a surge in COVID-19 cases in the US would help to accelerate late-stage testing.
The University of Oxford and AstraZeneca have moved their vaccine into a Phase II/III study in the UK, but concerned at declining infection rates have also initiated Phase III trials in Brazil and South Africa. A US study that will enrol 30,000 patients is also planned.
Physicians seeking to re-engage patients face-to-face
Similar country-level trends are apparent in our most recent Physician Views analysis, which looks at the impact of COVID-19 on patient engagement based on a recent survey of 1139 physicians across 10 countries and compares these results to data from the same survey fielded in May.
Results show that physicians are interacting with more patients face-to-face compared to a month earlier, with telehealth engagement concurrently in decline, though the magnitude of these changes varies considerably by country.
On a global basis, the number of physicians conducting video consultations with patients for the first time fell dramatically in May and June versus March and April, casting doubt on whether the pandemic will prove to be a long-term driver of telemedicine expansion.
Remdesivir price revealed
Gilead Sciences announced long-awaited pricing of its COVID-19 treatment remdesivir this week, its strategy appearing designed to thread the needle by pricing the drug high enough to offer value to shareholders, but low enough to deflect most criticism.
Indeed, it was the US government that bore the brunt of any ire when it was confirmed that the country had secured more than 500,000 treatment courses of remdesivir through to September. This represents all of Gilead's projected production in July and 90% of output in August and September.
A number of other countries including Germany and the UK were quick to suggest that they have enough supplies of remdesivir for the time being. Matters have no doubt been helped by positive data favouring the use of the cheaply produced steroid dexamethasone to treat COVID-19 patients who require ventilation. In this setting, dexamethasone has shown a mortality benefit, a benchmark remdesivir is notably not yet to match.
Intercept knocked back at final hurdle
Away from COVID-19, Intercept Pharmaceuticals announced this week that the FDA has rejected its regulatory application for obeticholic acid (OCA) as a treatment for non-alcoholic steatohepatitis (NASH). The company was scathing in its assessment, suggesting to investors that when it received the FDA's complete response letter (CRL) it had instead been expecting to receive clarification when a twice-delayed AdCom meeting to evaluate its filing had been rescheduled for. Intercept added that it has been left unclear what data the FDA now requires to support approval of OCA in this indication.
Beyond Intercept's own route to market, its receipt of a CRL could pose bigger questions for the NASH field and whether the FDA has raised the bar for all potential treatment candidates, laced with some irony that the compound that kick-started the race to market six years ago has been kicked to the curb on the eve of a long awaited regulatory breakthrough.
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