Sanofi addresses its mRNA FOMO
The existential threat of mRNA to traditional vaccine manufacturers has been apparent for some time.
Sanofi – which is at particular risk due to its large revenues from influenza vaccines, a segment of the market mRNA players are targeting next in-line after COVID-19 – moved this week to strengthen its position by agreeing to acquire Translate Bio for $3.2 billion.
The two companies have been working together for a number of years and have mRNA vaccines in early-stage development for COVID-19 and influenza, but are trailing rivals in both cases. Pfizer recently announced plans to push its mRNA flu vaccine into Phase III studies before the end of this quarter.
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Moderna advocates booster strategy
On the subject of mRNA COVID-19 vaccines, Moderna announced on Thursday that it generated sales worth $4.2 billion from their product during the second quarter and has purchase agreements for sales worth $20 billion this year.
Looking further ahead, Moderna has purchase agreements worth $12 billion for 2022, with a further $8 billion attached to options. The company said new data showed its vaccine was 92% effective at preventing COVID-19 infections six months-post second vaccination and did little to play down comparisons to the efficacy of BioNTech and Pfizer's rival mRNA vaccine at six months, reported to be 87%.
This did not, however, stop Moderna from suggesting that a third booster dose (of which it has a number in testing) will likely be necessary this winter for some patients who have already received their first two vaccinations, echoing recent claims by Pfizer.
Lilly loud on donanemab aspirations
During its second-quarter earnings call, Eli Lilly sounded increasingly bullish about bringing its investigational Alzheimer's disease therapy donanemab to the US market next year. Management reiterated its plans to file for accelerated approval largely on the basis of Phase II data by the end of 2021.
Then, Eli Lilly is confident that donanemab will become a preferred treatment to Biogen's controversial Aduhelm. The company says that its drug acts faster and deeper to remove beta-amyloid plaques and thus requires patients to be treated for up to 18 months rather than chronically for the rest of their lives.
Does it have the current best-in-sector R&D output?
Whilst heightened expectations for donanemab have largely driven the near doubling in Eli Lilly's share price this year, the company can point to other programmes responsible for this momentum. Eli Lilly is on track to launch a potentially game changing type 2 diabetes treatment next year in the form of its first-in-class GLP-1/GIP-1 receptor agonist tirzepatide.
It also recently confirmed that the SGLT-2 inhibitor Jardiance, which it co-markets with Boehringer Ingelheim, met its primary endpoint in a Phase III study evaluating use in hard-to-treat heart failure patients and said this week that its CDK4/6 inhibitor Verzenio appears to be a promising treatment for prostate cancer.
The potential hits for Eli Lilly are stacking up nicely.
AstraZeneca gets approval for SLE treatment
AstraZeneca announced FDA approval of Saphnelo for the treatment of adults with moderate-to-severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The company noted that this marks the first regulatory clearance for a type I interferon (type I IFN) receptor antagonist and the only new treatment approved for SLE in more than 10 years.
The path to approval for Saphnelo was not a particularly straightforward one, characterised by mixed clinical data readouts. However, a leading SLE expert we spoke to this week said AstraZeneca's drug appears to be particularly effective at treating lupus-related skin ulcerations and will help to address a key unmet need.
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