Cytokinetics data raises expectation for heart failure drug
Impressive Phase II data for Cytokinetics’ CK-274 – a potential treatment for hypertrophic cardiomyopathy – could have Bristol Myers Squibb looking over its shoulder.
The Big Pharma gained a similar drug called mavacamten when it acquired MyoKardia for $13.1 billion last year.
The important caveat is that mavacamten has already delivered compelling Phase III data and is on track for US approval in January. That said some analysts believe that CK-274 could be a superior drug, though it will need to replicate these results in a larger pivotal-stage study.
Pharma sales up in Q2
Early second quarter financial disclosures suggest that sales of established pharmaceutical products have rebounded strongly versus the comparative period in 2020. The fact that most major global markets were in lockdown during the second quarter of last year makes for favourable comparisons but revenue upturns appear to have exceeded expectations regardless.
Caution prevails, however, with the COVID-19 Delta variant – and its likely spread in the US and key European markets over the next six months – providing particular uncertainty. The message from pharma companies is that they are hopeful the second half of 2021 provides further return to normality.
But J&J’s COVID vaccine limps home
In Johnson & Johnson’s second quarter earnings the performance of its COVID-19 vaccine came in for close inspection. Revenues in the second quarter stood at $164 million but are expected to reach $2.5 billion for the full year, the company noted.
This figure will, of course, be dwarfed by revenues for the two mRNA vaccines, with Pfizer expected to reveal quarterly sales of around $8 billion for Comirnaty when it reports its results next week.
Despite its status as the only single-shot vaccine, Johnson & Johnson’s Ad26.COV2.S has run into multiple setbacks relating to manufacturing and safety concerns. Most recently doubts have been cast on its effectiveness against the Delta variant, albeit based on data from a small study.
Other notable updates
Aside from financial performance the first tranche of second quarter results delivered some notable disclosures from management.
Novartis confirmed that following its recent resubmission of inclisiran with the FDA the agency has set a new PDUFA date of January 1 2022. The company also played down any competitive threat to its flagship Entresto franchise shaped by recently announced positive top-line data for Boehringer Ingelheim and Eli Lilly’s Jardiance in heart failure.
Roche plays down early AD filing as Biogen comes out fighting
Biogen and Roche simultaneously held their second quarter earnings calls as the same time on Thursday and it feels inevitable that the fortunes of these two companies will become more entwined over time.
Most analysts wanted to know if Roche is planning on submitting its Alzheimer’s drug gantenerumab with the FDA on the strength of Phase II data. This would mirror the approach recently taken by Eli Lilly (with donanemab) with a potential faster route of approval made possible by the agency’s recent – and highly controversial – approval of Biogen’s Aduhelm.
Biogen used its own call to mount an aggressive pushback against the scrutiny and criticism Aduhelm has attracted blaming ‘misinformation’ about the drug which it claims has been amplified by the media.
Roche appears to have taken the pragmatic view that filing gantenerumab now runs the risk of diminishing its Phase III data which is due to read out in late 2022. Confident that these results could represent the best data for any Alzheimer’s drug developed so far, it may be prudent to let Biogen do the early commercial heavy lifting.
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