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Amgen, AstraZeneca's Asthma Drug Tezepelumab Gets FDA Nod
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Amgen (AMGN - Free Report) along with its partner AstraZeneca (AZN - Free Report) announced that the FDA has granted approval to their monoclonal antibody, tezepelumab, for the treatment of severe asthma. The medicine will be marketed by the trade name of Tezspire and can be prescribed as an add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
The approval for Amgen and AstraZeneca’s Tezspire was based on data from the PATHFINDER clinical program and included the pivotal phase III NAVIGATOR study. Data from these studies showed that treatment with Tezspire led to superior results across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy. In the studies, which included a broad population of severe asthma patients, Tezspire consistently and significantly reduced exacerbations. It is the only biologic medicine approved by the FDA to treat severe asthma with no phenotype limitation and irrespective of biomarker levels.
Regulatory applications seeking approval of Tezspire are under regulatory review in the EU and Japan.
AstraZeneca and Amgen are jointly developing Tezspire. While AstraZeneca leads the development of the drug, Amgen leads manufacturing. Amgen and AstraZeneca will jointly commercialize Tezspire in North America. While Amgen will record product sales in the United States, AstraZeneca will record its share of profits in the United States as collaboration revenue. AstraZeneca will record product sales outside the United States while Amgen will record profit share.
Amgen’s stock has declined 0.3% this year so far compared with a decrease of 18.4% for the industry.
Image Source: Zacks Investment Research
So far this year, AstraZeneca’s shares have gained 15% compared with an increase of 22.9% for the industry.
Image Source: Zacks Investment Research
Competitive pressure in the overall asthma market has intensified over the years. Tezspire is likely to face stiff competition from Glaxo’s (GSK - Free Report) Nucala, and Regeneron (REGN - Free Report) and Sanofi’s blockbuster medicine Dupixent, which are approved for treating patients with severe asthma and some other indications as well.
Other than severe asthma, Glaxo’s Nucala is approved for eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Nucala is a key top-line driver for Glaxo. It is being studied in late-stage studies for chronic obstructive pulmonary disease (COPD).
Sanofi and Regeneron’s Dupixent is now approved in the United States and the EU for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis.
With outside U.S. revenues accelerating and multiple approvals for new indications expected in the near future, Dupixent’s sales are expected to be higher. Sanofi and Regeneron’s Dupixent is in late-stage development for bullous pemphigoid, chronic spontaneous urticaria, prurigo nodularis, eosinophilic esophagitis and COPD.
Image: Bigstock
Amgen, AstraZeneca's Asthma Drug Tezepelumab Gets FDA Nod
Amgen (AMGN - Free Report) along with its partner AstraZeneca (AZN - Free Report) announced that the FDA has granted approval to their monoclonal antibody, tezepelumab, for the treatment of severe asthma. The medicine will be marketed by the trade name of Tezspire and can be prescribed as an add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
The approval for Amgen and AstraZeneca’s Tezspire was based on data from the PATHFINDER clinical program and included the pivotal phase III NAVIGATOR study. Data from these studies showed that treatment with Tezspire led to superior results across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy. In the studies, which included a broad population of severe asthma patients, Tezspire consistently and significantly reduced exacerbations. It is the only biologic medicine approved by the FDA to treat severe asthma with no phenotype limitation and irrespective of biomarker levels.
Regulatory applications seeking approval of Tezspire are under regulatory review in the EU and Japan.
AstraZeneca and Amgen are jointly developing Tezspire. While AstraZeneca leads the development of the drug, Amgen leads manufacturing. Amgen and AstraZeneca will jointly commercialize Tezspire in North America. While Amgen will record product sales in the United States, AstraZeneca will record its share of profits in the United States as collaboration revenue. AstraZeneca will record product sales outside the United States while Amgen will record profit share.
Amgen’s stock has declined 0.3% this year so far compared with a decrease of 18.4% for the industry.
So far this year, AstraZeneca’s shares have gained 15% compared with an increase of 22.9% for the industry.
Competitive pressure in the overall asthma market has intensified over the years. Tezspire is likely to face stiff competition from Glaxo’s (GSK - Free Report) Nucala, and Regeneron (REGN - Free Report) and Sanofi’s blockbuster medicine Dupixent, which are approved for treating patients with severe asthma and some other indications as well.
Other than severe asthma, Glaxo’s Nucala is approved for eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Nucala is a key top-line driver for Glaxo. It is being studied in late-stage studies for chronic obstructive pulmonary disease (COPD).
Sanofi and Regeneron’s Dupixent is now approved in the United States and the EU for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis.
With outside U.S. revenues accelerating and multiple approvals for new indications expected in the near future, Dupixent’s sales are expected to be higher. Sanofi and Regeneron’s Dupixent is in late-stage development for bullous pemphigoid, chronic spontaneous urticaria, prurigo nodularis, eosinophilic esophagitis and COPD.
AstraZeneca currently carries a Zacks Rank #4 (Sell). Amgen has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.