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Pharma Stock Roundup: JNJ to Spin Off Consumer Unit, PFE Eyes EUA for COVID Pill
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This week, J&J (JNJ - Free Report) announced plans to separate its Consumer Health segment into a new publicly-traded company. While Pfizer (PFE - Free Report) filed for FDA’s emergency approval for its COVID-19 antiviral pill, the European Commission approved new indications for Glaxo’s(GSK - Free Report) Nucala and AbbVie’s (ABBV - Free Report) Skyrizi. AstraZeneca’s (AZN - Free Report) study on its mRNA-based heart failure candidate met its primary endpoint of safety and tolerability.
Recap of the Week’s Most Important Stories
J&J to Split Into Two Companies: J&J announced plans to divide itself into two publicly traded companies. It will separate its Consumer Health segment into a new publicly-traded company, leaving behind a new J&J with its higher-growth, higher-margin Pharmaceuticals and Medical Device units. The separation of the Consumer Health unit is expected to be completed in the next 18 to 24 months, pending necessary board and regulatory approval.
J&J’s Pharmaceutical and Medical Devices units are expected to generate revenues of $77 billion in 2021 and remain one of the strongest drugmakers in the world. The Consumer Health segment is expected to generate approximately $15 billion in sales in 2021.
Pfizer Seeks EUA for COVID Antiviral Pill: Pfizer filed an application to the FDA seeking Emergency Use Authorization (EUA) for its promising oral antiviral candidate for COVID-19, Paxlovid for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalizations or death. The regulatory application was based on clinical data from an interim analysis of a phase II/III study, EPIC-HR, which showed that Paxlovid substantially reduced hospitalizations and deaths in the above patient group. Pfizer has begun rolling submissions in several countries including in the United Kingdom, Australia, New Zealand and South Korea.
Pfizer also announced that its chief financial officer (CFO), Frank D’Amelio, is retiring. He also holds the position of executive vice president of Global Supply, which is being filled by Mike McDermott. Pfizer has begun an external search for a new CFO.
AstraZeneca’s Heart Failure Study Meets Goal: AstraZeneca and partner Moderna’s phase II study — EPICCURE — evaluating the mRNA-based pipeline candidate, AZD8601, in patients with heart failure met its primary endpoint of safety and tolerability. The candidate was injected directly into the myocardium of patients undergoing coronary artery bypass grafting surgery. Data from the study demonstrated the potential of the mRNA therapeutic in stimulating VEGF-A production to provide reparative and disease-modifying options for heart-failure patients.
Glaxo, Vir Biotech Get U.S Government Order for COVID Drug: Glaxo and partner Vir Biotech have signed contracts worth approximately $1 billion with the U.S. government to supply their monoclonal antibody treatment for COVID-19, sotrovimab. The FDA granted EUA to sotrovimab in May. Glaxo will supply these doses to the government by December 17 while the government has an option to purchase additional doses through March 2022. Including the latest agreement, Glaxo and Vir have received orders for the sale of more than 750,000 doses of sotrovimab worldwide.
The European Commission granted approval to Glaxo’s Nucala (mepolizumab) for three additional eosinophil-driven diseases. While Nucala, an anti-IL5 biologic, was already approved for treating severe eosinophilic asthma in Europe, it is now approved for hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps. Nucala has become the only medicine in Europe approved for four eosinophil-driven diseases, which are inflammatory conditions associated with elevated levels of eosinophils, a type of white blood cell.
In the United States and some other countries, Nucala is already approved for the four eosinophil-driven diseases.
European Commission Approves AbbVie’s Skyrizi for New Indication: The European Commission granted approval to AbbVie’s Skyrizi (alone or in combination with methotrexate) for treating active psoriatic arthritis in the European Union. The approval was based on data from two phase III studies, KEEPsAKE-1 and KEEPsAKE-2.
Active psoriatic arthritis is the second indication for Skyrizi in Europe. This AbbVie drug is already approved to treat plaque psoriasis. A regulatory application seeking approval of Skyrizi for active psoriatic arthritis indication is under review in the United States. Skyrizi is under review for Crohn’s disease and is being evaluated in late-stage studies for ulcerative colitis.
The NYSE ARCA Pharmaceutical Index declined 0.5% in the last five trading sessions.
Image: Shutterstock
Pharma Stock Roundup: JNJ to Spin Off Consumer Unit, PFE Eyes EUA for COVID Pill
This week, J&J (JNJ - Free Report) announced plans to separate its Consumer Health segment into a new publicly-traded company. While Pfizer (PFE - Free Report) filed for FDA’s emergency approval for its COVID-19 antiviral pill, the European Commission approved new indications for Glaxo’s(GSK - Free Report) Nucala and AbbVie’s (ABBV - Free Report) Skyrizi. AstraZeneca’s (AZN - Free Report) study on its mRNA-based heart failure candidate met its primary endpoint of safety and tolerability.
Recap of the Week’s Most Important Stories
J&J to Split Into Two Companies: J&J announced plans to divide itself into two publicly traded companies. It will separate its Consumer Health segment into a new publicly-traded company, leaving behind a new J&J with its higher-growth, higher-margin Pharmaceuticals and Medical Device units. The separation of the Consumer Health unit is expected to be completed in the next 18 to 24 months, pending necessary board and regulatory approval.
J&J’s Pharmaceutical and Medical Devices units are expected to generate revenues of $77 billion in 2021 and remain one of the strongest drugmakers in the world. The Consumer Health segment is expected to generate approximately $15 billion in sales in 2021.
Pfizer Seeks EUA for COVID Antiviral Pill: Pfizer filed an application to the FDA seeking Emergency Use Authorization (EUA) for its promising oral antiviral candidate for COVID-19, Paxlovid for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalizations or death. The regulatory application was based on clinical data from an interim analysis of a phase II/III study, EPIC-HR, which showed that Paxlovid substantially reduced hospitalizations and deaths in the above patient group. Pfizer has begun rolling submissions in several countries including in the United Kingdom, Australia, New Zealand and South Korea.
Pfizer also announced that its chief financial officer (CFO), Frank D’Amelio, is retiring. He also holds the position of executive vice president of Global Supply, which is being filled by Mike McDermott. Pfizer has begun an external search for a new CFO.
AstraZeneca’s Heart Failure Study Meets Goal: AstraZeneca and partner Moderna’s phase II study — EPICCURE — evaluating the mRNA-based pipeline candidate, AZD8601, in patients with heart failure met its primary endpoint of safety and tolerability. The candidate was injected directly into the myocardium of patients undergoing coronary artery bypass grafting surgery. Data from the study demonstrated the potential of the mRNA therapeutic in stimulating VEGF-A production to provide reparative and disease-modifying options for heart-failure patients.
Glaxo, Vir Biotech Get U.S Government Order for COVID Drug: Glaxo and partner Vir Biotech have signed contracts worth approximately $1 billion with the U.S. government to supply their monoclonal antibody treatment for COVID-19, sotrovimab. The FDA granted EUA to sotrovimab in May. Glaxo will supply these doses to the government by December 17 while the government has an option to purchase additional doses through March 2022. Including the latest agreement, Glaxo and Vir have received orders for the sale of more than 750,000 doses of sotrovimab worldwide.
The European Commission granted approval to Glaxo’s Nucala (mepolizumab) for three additional eosinophil-driven diseases. While Nucala, an anti-IL5 biologic, was already approved for treating severe eosinophilic asthma in Europe, it is now approved for hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and chronic rhinosinusitis with nasal polyps. Nucala has become the only medicine in Europe approved for four eosinophil-driven diseases, which are inflammatory conditions associated with elevated levels of eosinophils, a type of white blood cell.
In the United States and some other countries, Nucala is already approved for the four eosinophil-driven diseases.
European Commission Approves AbbVie’s Skyrizi for New Indication: The European Commission granted approval to AbbVie’s Skyrizi (alone or in combination with methotrexate) for treating active psoriatic arthritis in the European Union. The approval was based on data from two phase III studies, KEEPsAKE-1 and KEEPsAKE-2.
Active psoriatic arthritis is the second indication for Skyrizi in Europe. This AbbVie drug is already approved to treat plaque psoriasis. A regulatory application seeking approval of Skyrizi for active psoriatic arthritis indication is under review in the United States. Skyrizi is under review for Crohn’s disease and is being evaluated in late-stage studies for ulcerative colitis.
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.
In the last five trading sessions, Pfizer rose the most (3.9%) while AstraZeneca declined the most (8.6%)
In the past six months, Lilly recorded the maximum gain (32.9%) while Novartis declined the most (6.6%)
(See the last pharma stock roundup here: AZN, BAYRY Q3 Results, PFE COVID Pill’s Strong Efficacy)
What's Next in the Pharma World?
Watch out for the results of Pfizer and the regular pipeline and regulatory updates next week.