Moderna's turn in the regulatory spotlight
Having issued emergency-use authorisation (EUA) for BioNTech and Pfizer's COVID-19 vaccine BNT162b2 last week, the FDA looks poised to make a similar decision for Moderna's mRNA-1273 imminently. An FDA advisory panel meeting to discuss the application will take place on Thursday, December 17.
FDA briefing documents released earlier this week confirm a high level of efficacy for mRNA-1273, which is similar to that of BioNTech and Pfizer's vaccine, though reviewers did note that its effectiveness among people 65 years and older "appears to be lower" than in younger adults 18 to 64, with rates of 86.4% and 95.6%, respectively.
Moderna also disclosed new data that was not available at the time of its EUA application, which potentially supports the efficacy of mRNA-1273 against asymptomatic infection.
The company said it collected nasopharyngeal swabs for SARS-CoV-2 prior to the second injection, finding that 14 study volunteers in the vaccine group and 38 in the placebo group had evidence of infection at the second dose, but no COVID-19 symptoms. These data suggest that "some asymptomatic infections start to be prevented after the first dose," Moderna said.
Elsewhere, and seemingly under pressure from a number of member states, the European Medicines Agency (EMA) on Tuesday said it has pushed forward the date for a meeting to discuss Pfizer and BioNTech's COVID-19 vaccine BNT162b2 to December 21. This should allow vaccinations to begin before the end of the year.
AstraZeneca acquires Alexion
AstraZeneca is to acquire Alexion Pharmaceuticals for $39 billion, the UK drugmaker announced last weekend, pushing it into the market for rare diseases in the field of immunology.
Investors have not unanimously welcomed the deal, despite the apparent strategic rationale of moving into the orphan drug space.
Whether it is viewed more positively in the long term will largely depend on whether AstraZeneca can grow revenues for Alexion's core complement inhibitor franchise at a faster rate than analysts currently model, in light of an anticipated increase in competition from other brands.
If it can't, the concern for shareholders is that integration of Alexion will dilute AstraZeneca's impressive revenue outlook through to 2025 and beyond.
Other M&A activity
The past week has also seen a number of smaller acquisitions announced.
Gilead Sciences has been the industry's most active M&A player in 2020 with an almost exclusive focus on deals to build out its oncology portfolio and pipeline. Its latest move, the acquisition of MYR Pharmaceuticals for $1.4 billion, is in the more familiar territory of infectious diseases and builds on Gilead's legacy in viral hepatitis.
In oncology, Boehringer Ingelheim announced the acquisition of NBE Therapeutics in a deal potentially worth $1.5 billion. It provides Boehringer access to the antibody-drug conjugate (ADC) NBE-002, which is in early-stage testing in multiple solid tumour types. It is also the second Big Pharma deal in recent weeks focused on a cancer asset directed against the target ROR1, following Merck & Co.'s acquisition of VelosBio for $2.75 billion last month.
Early data subsequently presented for VelosBio's own ROR1-targeted ADC VLS-101 impressed at the annual American Society of Hematology (ASH) meeting earlier this month and this may have prompted Boehringer into pulling the trigger for a promising rival asset.
On Wednesday, Eli Lilly said it will acquire the gene therapy specialist Prevail Therapeutics for around $880 million and a contingent value right (CVR) worth up to $160 million. Prevail is developing AAV9-based gene therapies for the treatment of neurodegenerative diseases. This deal illustrates Big Pharma's continued interest in gene therapies and Eli Lilly has notably moved ahead of a number of important, potentially validating, clinical readouts for Prevail's gene therapy programmes in dementia, Gaucher's disease and Parkinson's disease next year.
Keep an eye out for our review of this year's biggest pharma M&A deals in the next few days.
Regulatory updates of note
A number of notable products were recommended for approval or expanded labelling in the European Union this week, including Merck KGaA and Pfizer's PD-L1 inhibitor Bavencio for the first-line maintenance treatment of bladder cancer.
Conditional marketing authorisation was granted for AstraZeneca and Daiichi Sankyo's antibody-drug conjugate (ADC) Enhertu for the treatment of HER2-breast cancer patients who have received two or more prior anti-HER2 based regimens, and for Seagen's targeted therapy Tukysa (in combination with Herceptin and capecitabine) for the same indication.
Novartis also announced that its RNAi-based PCSK9 inhibitor Leqvio has been approved in Europe for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, with approval pending in the US.
Providing further momentum for Novartis' cardiovascular portfolio, an FDA advisory committee panel this week voted near unanimously in favour of expanding approval for Entresto to include some heart failure patients with preserved ejection fraction (HFpEF). Analysts believe that if the FDA follows this advice – and dependent on labelling – use in HFpEF could add $1 billion to peak sales of Entresto.
A number of leading pharmaceutical companies announced notable corporate updates this week, including Gilead, which has confirmed that it is no longer seeking US regulatory approval of the JAK inhibitor filgotinib for rheumatoid arthritis (RA). The decision is part of a broader renegotiation of the collaboration Gilead formed with Galapagos for filgotinib back in 2015, which will see the Belgian company retain full marketing rights in Europe, where approval in RA has been secured.
At an investor event to discuss its immunology portfolio, AbbVie increased its combined sales forecast for the Rinvoq and Skyrizi brands from around $11.5 billion to "more than" $15 billion by 2025 (split $8 billion and $7 billion by franchise, respectively).
Promising new data has recently been announced for Rinvoq in ulcerative colitis and atopic dermatitis (AD). In the latter indication, Rinvoq demonstrated superior efficacy to the established standard-of-care Dupixent, but safety concerns remain an issue. It was notable therefore, that AbbVie said this week that most Rinvoq use in AD will occur in the second-line setting among patients who have an inadequate response to Dupixent. This echoes our feedback from physician surveys and KOL interviews.
Elsewhere, Eli Lilly lifted its annual revenue and earnings guidance for 2020, saying it expects higher sales of its COVID-19 antibody therapy bamlanivimab due to a recent additional purchase agreement with the US government. As a result, Eli Lilly said it now forecasts 2020 revenue of between $24.2 billion and $24.7 billion, with both ends of its prior guidance lifted by $500 million.
Management also highlighted a number of forthcoming events for 2021 including further disclosures for the cancer drug LOXO-305, additional Phase III readouts for tirzepatide in diabetes and Phase II data for donanemab in Alzheimer's disease.
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