Ins & outs on COVID-19 vaccines
One week after Moderna – among others – made headlines with encouraging preliminary data for a COVID-19 vaccine, China-based CanSino Biologics offered a useful reminder that the undertaking is challenging and success is not assured as the first look at peer-reviewed data from a Phase I trial raised questions about the vaccine’s risk/benefit profile.
Far from ducking the challenge, Merck & Co. showed that industry is seeking to meet it head on as the US drugmaker dove right in with two deals – an acquisition of Themis Bioscience and partnership with the International AIDS Vaccine Initiative (IAVI) – designed to generate COVID-19 vaccine candidates of its own. The company also diversified its portfolio by in-licensing an antiviral in Phase I testing from Ridgeback Bio.
Remdesivir revs up
Gilead Sciences disclosed that it has provided 200,000 of 1 million doses of remdesivir it has pledged to donate to the US government on the heels of this month’s emergency use authorisation, with rest coming shortly as it continues to ramp up its manufacturing capacity. The company has been tight-lipped about how it plans to transition to selling the drug, which is understandable given the sensitivity of the situation, but management indicated this would take place in the coming months.
In parallel, researchers published detailed results from the Phase III ACTT trial that supported licensure of remdesivir. The new data offered some positive signs, such as a slight improvement in the non-significant survival benefit and hints of stronger efficacy in less severe patients, but it remains clear that the drug is just a small step in the right direction.
Regeneron, Sanofi back on the prowl
Long-time associates Regeneron Pharmaceuticals and Sanofi all but wound down their relationship this week as the French drugmaker divested all but a tiny slice of the 20.5% stake it held in the US bellwether biotech. Regeneron sweetened the deal for its own shareholders by absorbing roughly $5 billion worth of the shares through a buyback.
The partnership has generated a number of notable commercial successes, led by Dupixent (dupilumab) and also including Praluent (alirocumab) and Kevzara (sarilumab). Whether the newly single companies – notably Sanofi – will be looking to mingle in the business development arena remains to be seen though the pharma is now thought to have $50 billion in dry powder to play with.
Alexion, argenx square up
Efgartigimod hit the mark in a Phase III trial to treat generalised myasthenia gravis (gMG) pushing argenx shares up 34% on May 26, and analysts inevitably began buzzing about a brewing battle with Alexion Pharmaceuticals, which markets the only drug approved for the indication in Soliris (eculizumab).
argenx argued that cross-study comparisons with Alexion’s anti-C5 complement mAb are fatally flawed, not that the Street is likely to listen, but the company will be more concerned with establishing a commercial beachhead for efgartigimod as several fast-following FcRN inhibitors are hot on its heels.
Medefield conducted a recent poll of 1424 physicians soliciting feedback on practice patterns in the wake of the COVID-19 pandemic that generated useful insights.
To read more Friday Five articles, click here.