This week, J&J JNJ and Novartis NVS announced their fourth-quarter 2020 results. The European Commission granted approvals to Merck’s MRK Keytruda, AbbVie’s ABBV Rinvoq and Pfizer’s PFE Bavencio for expanded use. Merck ended the development of its COVID-19 vaccine candidates while Lilly LLY announced promising data from a study evaluating the combination of its COVID-19 antibodies.
Recap of the Week’s Most Important Stories
Earnings Update: J&J beat fourth-quarter estimates for earnings as well as sales. Its Pharmaceuticals unit continued to do well. Meanwhile, increasing demand for its Consumer Health products and continued procedure recovery in Medical Devices provided top-line support. Importantly, J&J’s guidance for 2021 topped investor expectations.
Novartis’ earnings and sales missed the Zacks Consensus Estimate. Sales in the Innovative Medicines division rose 1% at constant currency while that in the Sandoz division were flat. The company issued a grim outlook for 2021, warning of challenges ahead in the first half of the year due to the ongoing coronavirus pandemic.
Merck Ends COVID-19 Vaccine Development: Merck said it is discontinuing development of its two COVID-19 vaccine candidates, V590 and V591, which were in early-stage studies. Merck took the decision due to inferior immune responses observed for patients given the two vaccines in phase I studies compared to those seen in patients who were infected naturally and those reported for other COVID-19 vaccines. V590 was being developed in collaboration with International AIDS Vaccine Initiative.
Merck will however continue to develop its two therapeutics for COVID-19, its oral antiviral candidate molnupiravir/MK-4482 (phase II/III) and biological therapeutic, MK-7110 (phase III). MK-4482 is being developed in collaboration with Ridgeback Bio. Two pivotal studies are evaluating the candidate in non-hospitalized adult COVID-19 patients or hospitalized adult COVID-19 patients. For MK-7110, Merck has a supply agreement with the U.S. government to advance its manufacturing and initial distribution.
The European Commission granted approval to Keytruda as first-line treatment for metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Keytruda is already approved to treat MSI-H or dMMR colorectal cancer in patients whose cancer has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. The FDA had granted approval for first line-setting for MSI-H or dMMR colorectal cancer in June
EU Approval to AbbVie’s Rinvoq for Two New Indications: The European Commission granted approval to AbbVie’s JAK inhibitorRinvoq for expanded use in two additional rheumatic indications, active psoriatic arthritis and active ankylosing spondylitis. Rinvoq is presently approved to treat rheumatoid arthritis in Europe. Regulatory applications seeking approval of Rinvoq for these two indications as well as atopic dermatitis are under review in the United States.
Promising Data on Lilly’s COVID-19 Antibody Combo: Lilly announced new data from the phase III BLAZE-1 study, which showed that a combination of its COVID-19 antibodies, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) reduced risk of COVID-19 hospitalizations and death by 70% in high-risk patients recently diagnosed with COVID-19. The study, thus, met its primary endpoint. The antibody combination (both at doses of 2,800 mg) also demonstrated statistically significant improvements on all key secondary endpoints, indicating that the combination reduced viral load and accelerated symptom resolution.
Bamlanivimab was granted Emergency Use Authorization (EUA) by the FDA in November for the treatment of patients at high risk for progressing to severe COVID-19 illness or hospitalization based on data from the BLAZE-1 study. A request to grant EUA to bamlanivimab/etesevimab combination to treat mild-to-moderate COVID-19 in high-risk patients is also under review with the FDA.
Meanwhile, Lilly announced a deal with Vir Biotech and Glaxo to expand its ongoing BLAZE-4 study to evaluate bamlanivimab (700mg) with Vir Biotech/Glaxo’s investigational COVID-19 antibody, VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19. A phase II/III study is ongoing on VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization.
Lilly in-licensed exclusive rights for chronic pain drug candidate, AK1780 from Japan’s Asahi Kasei Pharma for an upfront payment of $20 million. Per the terms of the deal, Lilly will take care of future global development and regulatory activities for AK1780 while Asahi Kasei Pharma will just retain the right to promote the candidate in Japan and China. Meanwhile, Asahi Kasei Pharma will be eligible to receive up to $210 million in potential development and regulatory milestones
Pfizer’s Bavencio Gets EU Approval for Expanded Use: The European Commission approved Pfizer’s PD-L1 inhibitor Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC). Bavencio was approved in the United States for first-line maintenance treatment of advanced UC in June last year. Bavencio is already approved for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy. The approval for first-line use was based on positive data from the phase III JAVELIN Bladder 100 study.
Pfizer announced co-primary endpoint results from a post-marketing required safety study on Xeljanz in patients with rheumatoid arthritis (RA). The study failed to meet the co-primary endpoints of showing non-inferiority of Xeljanz to a TNF inhibitor with regard to major adverse cardiovascular events (MACE) and malignancies. Xeljanz is presently approved for four indications, RA, active psoriatic arthritis, moderately to severely active ulcerative colitis and active polyarticular course juvenile idiopathic arthritis
Pfizer & BioNTech signed an advance purchase agreement with COVAX to supply the latter with up to 40 million doses of its COVID-19 vaccine in 2021. The doses will be delivered throughout the year with the first deliveries taking place in the first quarter.
AstraZeneca’s Calquence Shows Superiority to Imbruvica in CLL Study: AstraZeneca’s (AZN) leukemia drug, Calquence met the primary efficacy endpoint in a head-to-head phase III study (ELEVATE-RR) evaluating it against AbbVie/J&J’s Imbruvica (ibrutinib) for previously treated chronic lymphocytic leukemia patients. The data demonstrated that treatment with Calquence led non-inferior progression-free survival (PFS), the primary endpoint, in such patients compared to Imbruvica. The study also met a key secondary endpoint for safety by showing that treatment with Calquence led to statistically significantly lower incidence of atrial fibrillation compared to Imbruvica.
The NYSE ARCA Pharmaceutical Index declined 0.5% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Last week, J&J recorded the maximum gain (4.6%) while AbbVie declined the most (6.3%).
In the past six months, Lilly recorded the maximum gain (37.3%) while AstraZeneca declined the most (10.1%).
(See the last pharma stock roundup here: FDA Nod to MRK, (AZN), JNJ, GSK Drugs, LLY’s New Antibody Deal)
What’s Next in the Pharma World?
Watch out for fourth-quarter and full-year 2020 earnings of Merck, Pfizer, Abbvie and others and pipeline and regulatory updates next week.
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