Friday Five – The pharma week in review (15 May 2020)

Hudson’s COVID-19 vaccine claim stirs controversy in France

Sanofi CEO Paul Hudson has been in the job less than a year but has managed to get investors largely on side in a short period of time. He had some explaining to do on Wednesday, however, after telling Bloomberg that the US was likely to be the first recipient of a potential COVID-19 vaccine the company is developing with GlaxoSmithKline. Why? – Because the US has contributed more funding to the programme than other governments. The French government subsequently dismissed the claim as “unacceptable.”

Elsewhere in pharma’s race to tackle COVID-19, Gilead signed non-exclusive licensing agreements to expand the global supply of its drug remdesivir; the US National Institute of Allergy and Infectious Diseases (NIAID) will enrol hospitalised adults with COVID-19 into a study evaluating the combination of remdesivir with Eli Lilly and Incyte's JAK inhibitor Olumiant; and the FDA granted fast track status to Moderna’s mRNA vaccine.

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Cautious approach to re-engaging with physicians will serve pharma well

Big Pharma may have placated investors during first-quarter earnings season by suggesting that a temporary hit to sales caused by COVID-19 will be felt in Q2 before a return to relative normality during the second half of 2020, but feedback from physicians suggests that companies will need to take a steady approach when re-engaging with healthcare professionals to promote the use of medicines as lockdowns are eased.

Our snap-poll of 815 physicians across multiple markets and specialties also indicates that despite pre-lockdown stockpiling and the use of telemedicine, around a quarter of patients still struggled to retain normal access to branded, specialty drugs during periods of social distancing.

In other (unrelated to COVID-19) Physician Views content, our latest snap-poll indicates that AstraZeneca’s Farxiga should enjoy relatively rapid adoption as a treatment for heart failure.

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ASCO –a-go-go

Abstracts have dropped ahead of this year’s full virtual annual meeting of the American Society of Clinical Oncology (ASCO), which will be held between May 29 and June 2.

The standout data was provided by Roche for the anti-TIGIT antibody tiragolumab in non-small cell lung cancer. TIGIT looks increasingly well positioned to emerge as a complementary mechanism of action in immuno-oncology.

FirstWord Pharma PLUS users can read our overview of the key trends from the ASCO abstract dump here.

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Ide-cel delay puts ex-Celgene shareholders on edge

Refuse-to-file letters are never a good look, especially if the recipient is part of the Big Pharma club. On Wednesday, Bristol Myers Squibb said that the FDA has rejected its application for ide-cel, the experimental myeloma CAR-T treatment which has been co-developed with bluebird bio. The FDA requires further detail regarding the chemistry, manufacturing and control (CMC) module of the filing. BMS hopes to resubmit its application by late July.

With the race to bring new treatments to market for multiple myeloma a particularly competitive one (Johnson & Johnson will present impressive data for a similar BCMA-targeting CAR-T at ASCO), this delay – though relatively short – could raise further question marks over Bristol’s $74 billion acquisition of Celgene, through which the inherited the ide-cel programme.

The news is more material for Celgene shareholders who were issued a contingent value right (CVR) as part of the takeout. The CVR will pay out if three products, including ide-cel, are approved by specific dates. Two of these, ide-cel and liso-cel – a CAR-T therapy targeted against CD19 for the treatment of lymphoma – are still in play and Bristol Myers Squibb also said last week that the US PDUFA date for liso-cel has been delayed from August to November.

Assuming there are no more setbacks CVR holders should get their money still, but deadlines are being cut tight.  

Analysis – ViewPoints: Bristol Myers Squibb, bluebird stung by RTF bug

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Perseverance wins the day for MyoKardia

MyoKardia announced on Monday that a Phase III study of its experimental drug mavacamten for the treatment of patients with symptomatic, obstructive hypertrophic cardiomyopathy (oHCM) met its primary endpoint and all secondary goals. The company, whose shares jumped as much as 84% on the news, said that based on the results of the EXPLORER-HCM trial, it plans to submit a marketing application to the FDA in the first quarter of 2021.

Results would appear to be reward for the company’s perseverance. MyoKardia’s work looked interesting enough for Sanofi to partner up on it in 2014 to the tune of investment worth $230 million before pulling the plug on the collaboration in early 2019.

Undeterred, MyoKardia forged ahead despite the loss of Big Pharma backing and pledged to shoulder the responsibility for funding the continued development of mavacamten, which was the focus of the Phase III EXPLORER trial in oHCM that at the time had only recently gotten underway.

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