Key themes for 2021/Democrats take back control in the senate
Earlier this week we published our industry outlook for the year but 2021 is proving to be almost as unpredictable as its predecessor.
Against a backdrop of troubling events on Capitol Hill this week, it is the Democrat’s newly gained control of the senate which could have notable implications for the pharmaceutical industry, which looked set to benefit from the prospect of a split Congress after November’s Presidential election.
Once the dust has settled on Wednesday’s ugly scenes, analysts at Barclays believe democratic control of both the house of senate will boost President-elect Biden’s legislative agenda and healthcare reform plans, specifically expansion of the Affordable Care Act (ACA) and direct negotiation with Medicare over drug prices. Both of which were previously seen as ‘non-starters’ in a divided congress.
However, narrow control of the senate and prioritisation of a domestic response to the COVID-19 pandemic are likely to at least limit healthcare reform momentum, analysts believe.
COVID-19 vaccination programmes under scrutiny
Echoing the situation in a number of other countries, focus on the US response to the pandemic is currently sharpened on the speed of the government-led vaccination programme. Despite growing criticism that the number of COVID-19 inoculations in the US is not accruing as quickly as possible, the FDA indicated this week that it has no plans to make any dosing or scheduling changes to the two mRNA-based COVID-19 vaccines currently authorised in the US, saying doing so at this time would be "premature and not rooted solidly in the available evidence."
The statement came in response to various proposals that call for adjusting the original vaccine regimens tested in clinical trials in order to stretch out supply and give more people at least some protection against COVID-19 rather than none at all. UK health authorities are pursuing such an approach with the two vaccines its regulatory agency has approved on an emergency basis (those developed by BioNTech/Pfizer and AstraZeneca and the University of Oxford).
Elsewhere, Moderna’s vaccine mRNA-1273 (approved in the US last month) this week became the second COVID-19 vaccine to be granted conditional marketing authorisation by the European Commission.
Hopes remain high for Johnson & Johnson’s COVID-19 vaccine, with Phase III data expected this month. Like AstraZeneca and Oxford’s vaccine AZD1222 it used an adenovirus vector and can be stored for long periods at normal refrigeration temperatures. Most significantly, it is designed to be administered with a single shot and if efficacious enough will be the first approved vaccine to use this dosing regimen.
A JP Morgan conference like no other
In a typical year many in the pharmaceutical and biotech sectors would be descending on San Francisco this coming weekend for the annual JP Morgan Healthcare Conference, which starts on Monday (January 11) but naturally will be taking place this year on a virtual basis.
This means that the conference itself – comprising four days of company presentations and Q&A sessions – can take place relatively uninterrupted. However, those who attend JP Morgan on a regular or frequent basis will know that the COVID-19 pandemic has robbed the industry of its premier face-to-face networking and deal-making event.
It also remains to be seen if the start of the conference is used as a backdrop for the announcement of any sizeable acquisitions or licensing deals as it is typically associated with, although in reality the value of deals announced varies considerably each year.
Particularly in these unusual times, a lack of M&A announcements next week will not necessarily set the tone for the year ahead. As we discuss here there were notably fewer acquisitions in the first half of 2020 due to the pandemic but activity picked up during the second half of the year and culminated with AstraZeneca’s $39 billion acquisition of Alexion (the biggest deal of the year) in December. Investors will be hoping this momentum now continues into 2021.
An early deal…Angelini acquires Arvelle
Those with a vested interest in M&A will have been pleased to see a deal announced in the first week of the year, with Angelini Pharma entering into a definitive agreement to acquire Arvelle Therapeutics for up to $960 million, in doing so gaining certain rights to the epilepsy therapy cenobamate. Angelini will pay $610 million up-front upon regulatory clearance of the transaction, while a further payment to Arvelle of $350 million is linked to cenobamate reaching certain revenue targets.
Arvelle previously gained exclusive European rights to cenobamate from SK Biopharmaceuticals in 2019, with a marketing application currently under review in the region. Following the purchase of Arvelle, Angelini will hold an exclusive license to commercialise cenobamate in the EU, where approval is expected later this year, and certain other countries in the region, including Switzerland and the UK.
The small-molecule drug was authorised last year in the US, where it is sold by SK Biopharmaceuticals under the name Xcopri to treat partial-onset seizures in adults. Cenobamate has a dual complementary mechanism of action, positively modulating the gamma-aminobutyric acid (GABAA) ion channel and inhibiting voltage-gated sodium currents.
The drugs that will shape 2021
Looking at the year ahead, the outlook for biopharma will also be shaped by headline grabbing drugs. We have produced our annual review of the drugs that will ‘shape’ 2021 which this year focuses on a key product for 14 of the largest industry players.
It is therefore not an exhaustive list but one which highlights some of the important drugs (comprising recently launched products and late stage pipeline assets) which we anticipate will shape industry news flow over the next 12 months, such as Sanofi’s amcenestrant for breast cancer.
One of three oral selective estrogen receptor degrader (SERD) in late-stage testing, amcenestrant has been touted as potentially the safest but least active among a group that also includes compounds from AstraZeneca and Roche. Findings from a Phase III trial in advanced breast cancer slated for this half should be an important step in determining whether the programme – thanks in part to its first-in-class potential – can live up to projections of $2 billion in peak sales.
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