Pharma Stock Roundup: EU Nod for J&J COVID-19 Vaccine, Updates From LLY, GSK, MRK
This week J&J’s JNJ single dose COVID-19 vaccine was granted conditional authorization in Europe, making it the fourth vaccine to be authorized in the country. Eli Lilly LLY, Merck MRK and Glaxo GSK/Vir Biotech announced positive data from clinical studies on their COVID-19 antibody/antiviral drugs. Roche RHHBY announced withdrawal of its U.S. bladder cancer indication forPD-L1 inhibitor, Tecentriq.
Recap of the Week’s Most Important Stories
EU Grants Conditional Nod to J&J’s COVID-19 Vaccine: The European Commission granted Conditional Marketing Authorization (CMA) to J&J’s single shot COVID-19 vaccine for individuals 18 years of age and older. The approval followed a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) the same day. J&J is committed to supply 200 million doses to the EU, beginning delivery in the second half of April.
The vaccine was granted Emergency Use Authorization (EUA) in the United States by the FDA late last month. The approval of J&J’s vaccine was based on interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. The company has also begun rolling filings in other countries. It has also filed for Emergency Use Listing with the World Health Organization for its vaccine.
CHMP Recommends Approval of Lilly’s Bamlanivimab: The CHMP recommended approving Lilly’s COVID-19 antibody drug, bamlanivimab, as a monotherapy as well as in combination with another antibody therapy, etesevimab for the treatment of confirmed COVID-19 in Europe. The CHMP nod was based on phase II and III data from theBLAZE-1 study. Bamlanivimab has already been granted EUA, both alone as well as in combination with etesevimab, for the treatment of mild-to-moderate COVID-19 in high-risk patients.
Meanwhile, the bamlanivimab/etesevimab cocktail reduced hospitalizations and death, per new data announced from another cohort from the BLAZE-1 study, evaluating the combination in high-risk patients recently diagnosed with COVID-19. The data from the new cohort showed that the bamlanivimab/etesevimab cocktail reduced risk of hospitalizations and death by 87% in the said patient group.
Lilly announced a research collaboration with Biolojic Design to leverage its AI-based multibody platform to discover and develop antibody therapies to treat diabetes.
Glaxo/Vir Biotech’s COVID-19 Antibody Shows Promising Data: Glaxo and Vir Biotech’s COVID-19 antibody VIR-7831 reduced hospitalization and risk of death by 85%, per interim data from the phase II COMET-ICE study evaluating the candidate for the early treatment of COVID-19 in adults at high risk of hospitalization. An Independent Data Monitoring Committee (IDMC) recommended that the study be stopped early as there was evidence of profound efficacy. The companies immediately plan to seek EUA in the United States and authorizations in other countries based on the interim data.
Additionally, the companies also announced data from a new in-vitro study, which indicated that VIR-7831 maintains activity against major circulating COVID-19 variants including the UK, South African and Brazilian variants.
Merck’s First Phase II Data on COVID-19 Antiviral Therapy: Merck and its partner, Ridgeback Biotherapeutics announced promising preliminary data from the ongoing phase IIa study on their oral antiviral candidate, molnupiravir in patients infected with SARS-CoV-2 or COVID-19. Data on one secondary objective from the study showed a quicker reduction in infectious virus, as measured by Vero cell line culture, in patients with symptomatic COVID-19.
Roche Withdraws U.S. Bladder Cancer Indication for Tecentriq: Roche announced voluntary withdrawal of the U.S. second-line bladder cancer indication for its PD-L1 inhibitor, Tecentriq. The drug was granted accelerated approval in 2016 for the bladder cancer indication based on data of the IMvigor210 study. The continued approval was dependent on results of IMvigor211 study. However, the IMvigor211 study failed to meet its primary endpoint of overall survival in the PD-L1 high patient population, which prompted Roche to take the decision in consultation with the FDA. The decision does not impact the other approved indications of Tecentriq like non-small cell lung cancer, small cell lung cancer, a PD-L1-positive triple negative breast cancer, and for hepatocellular carcinoma. In February, AstraZeneca announced a similar decision for its PD-L1 inhibitor, Imfinzi.
Meanwhile, Roche’s REMDACTA study evaluating Actemra/RoActemra plus Veklury in patients with severe COVID-19 pneumonia did not meet the primary endpoint of improved time to hospital discharge for such patients. The study also did not meet its key secondary endpoints like likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status.
Pfizer Begins Phase II Study on Lyme Disease Vaccine Candidate: Pfizer PFE and its France-based partner Valneva’s vaccine candidate for Lyme disease entered phase II development. Pfizer announced the collaboration with Valneva to co-develop and commercialize VLA15 in April last year. The aim of the study is to see if VLA15 can be used in populations that are at risk of contracting Lyme disease, potentially including children aged five years and older.
Meanwhile, real world data gathered by the Israel Ministry of Health showed that Pfizer/BioNTech’s COVID-19 vaccine dramatically lowers COVID-19 disease incidence rates observed in individuals fully vaccinated. Meanwhile the data suggested that the vaccine prevented asymptomatic SARS-CoV-2 infection.
Novartis’ Lung Cancer Study on Canakinumab Fails: Novartis’ NVS phase III study evaluating its investigational candidate, canakinumab (acz885) as second or third-line treatment in non-small cell lung cancer (NSCLC) failed to meet its primary endpoint of overall survival. However, two phase III NSCLC studies in first-line and adjuvant settings continue.
The NYSE ARCA Pharmaceutical Index rose 2.9% 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, all the stocks were in the green with J&J recording the maximum gain (4%).
In the past six months, Lilly recorded the maximum gain (37.81%) while Merck declined the most (11.3%).
(See the last pharma stock roundup here: SNY/GSK & PFE COVID-19 Vaccine Update, MRK’s Pandion Buyout)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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