Friday Five – The pharma week in review (8 May 2020)

Alexion and Menarini acquire to diversify

Suggesting perhaps that the pharmaceutical industry in adapting to a new-normal shaped by the COVID-19 pandemic, two acquisitions were announced this week.

Menarini will acquire Stemline Therapeutics for $677 million to strengthen its presence in the US oncology market. Elsewhere, Alexion announced a deal to purchase Portola Pharmaceuticals for approximately $1.4 billion.

The success of this deal will depend on Alexion’s ability to accelerate the launch of Andexxa, a medication designed to reverse uncontrolled bleeding resulting from treatment with a Factor Xa inhibitor. Portola’s ability to market Andexxa has no doubt been hindered in recent weeks by social distancing measures, though US drug prescription trends show that use of novel anticoagulants has so far been largely unaffected, despite a notable decline in surgical procedures – a positive sign for Alexion.

See ViewPoints: Alexion now Portola's port in a storm

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Oncologists and neurologists predict a steady return to normality for cancer and MS patients

With lockdowns being eased in some parts of the world our latest Physician Views snap-poll data indicates that oncologists and neurologists expect cancer and multiple sclerosis patient-load numbers which have been disrupted by social-distancing measures to return to normal or near-normal levels at a slow-to-moderate pace.

FirstWord Pharma PLUS subscribers can read more detailed feedback from oncologists and neurologists here and here.

We will continue to publish feedback about the impact of social de-distancing measures on patient access from physicians in other specialty areas next week.

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Quoted – Regeneron’s chief scientific officer George Yancopoulos

…speaking on the company’s first quarter earnings call about an antibody cocktail drug Regeneron plans to advance into clinical testing for the treatment of COVID-19 next month…

“So I think that the history of antiviral antibodies, our experience the way they work our own antibodies and other programs most notably in Ebola, we think that there's a very significant chance that these specifically designed, very potent neutralizing antibodies will have a significant impact on the disease (COVID-19). We think that there's a great chance that they can be very powerful prophylactic and preventive agents. But we also think that they can treat patients who are already symptomatic with disease.”

Elsewhere the FDA granted emergency use authorisation to Gilead Sciences’ remdesivir for the treatment of severe COVID-19.

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Remember when NASH (and not COVID-19) was the hottest indication in pharma?

Alongside its first quarter results Novo Nordisk announced early (Phase II) but promising data for its GLP-1 agonist semaglutide for the treatment of non-alcoholic steatohepatitis (NASH). Novo confirmed that three separate doses of the drug, which is already approved for the treatment of diabetes, were more effective than placebo at resolving NASH without worsening liver scaring.

These data fell short of a home run as semaglutide was shown not to meet a secondary endpoint of resolving fibrosis, though efficacy here trended in the right direction. In the longer term, approval could be secured if Phase III studies show NASH resolution and no worsening of fibrosis, the company believes. When pivotal trials will start remains unclear at this point but they will likely evaluate a once-weekly dose of semaglutide, Novo said.

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Farxiga first to heart failure approval

AstraZeneca has secured expanded US approval for its diabetes treatment Farxiga to include the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with and without type 2 diabetes.

Heart failure is typically treated with a variety of cheaper generic drugs, though Novartis’ Entresto – prior to Farxiga, the newest approval in the field – generated global sales of $569 million in the first quarter of 2020.

A number of analysts have suggested that Farxiga could also generate peak sales upwards of a billion dollars in this indication alone, depending in part whether cardiologists prescribe it before or after Entresto. Combination use with Novartis’ drug, though possibly prohibitive as a result of cost, could be another option.

Approval of Farxiga is based on impressive Phase III data which was announced last year. Other drugs which use the same mechanism of action as Farxiga (it inhibits SGLT-2) are expected to show similar efficacy, experts argue, putting onus on AstraZeneca to maximise its first-to-market status.

Cardiologists snap-polled by FirstWord last year were enthused by data for Farxiga, noting that the drug meets unmet clinical need and hinting that adoption could be rapid once launched.

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