- AstraZeneca's respiratory pipeline received a lift on Tuesday with the company announcing positive data from two Phase 3 studies of its asthma drug benralizumab. The drug met its primary endpoint in both trials for significantly reducing annual asthma exacerbation rates.
- Designed to target special cells which drive inflammation in airways, benralizumab is intended as an add-on therapy for adult and adolescent patients with severe uncontrolled asthma.
- AstraZeneca expects to file for approval in both the U.S. and E.U. sometime in the second half of 2016. The company will face stiff competition from GlaxoSmithKline's Nucala and Teva's Cinqair, notes Reuters.
Severe uncontrolled asthma affects as many as 13 million people worldwide, and has significantly higher risk of mortality. Patients are typically treated with high-dose inhaled corticosterioids.
Unlike some other treatments, benralizumab targets eosinophils, effector cells which cause inflammation in 50% of asthma patients. The drug reduces eosinophils levels by activating natural killer cells to attack the cells, leading to "near complete" depletion of eosinophils in the bone marrow, blood, and targeted tissue, according to the company.
"Benralizumab is AstraZeneca’s first respiratory biologic and its development underscores our commitment to transform the treatment of asthma and chronic respiratory disease with our next generation of respiratory medicines," said Sean Bohen, chief medical officer at AstraZeneca.
AstraZeneca reported lower core operating profits in the first quarter as it continued to invest heavily in R&D. Several major older AstraZeneca drugs, such as Crestor and Nexium are beginning to feel the effects of generic competition - potentially threatening the attainability of the company's loft $45 billion revenue goal by 2023.
Chief executive Pascal Soriot recently announced plans to cut $1.1 billion in costs at the same time as the company redoubles its focus on oncology (as evidenced by its recent acquisition of Acerta Pharma).
AstraZeneca previously estimated peak sales of $2 billion for benralizumab, but forecasts have dropped considerably lately, according to Reuters. If benralizumab approaches original estimates, the company's respiratory portfolio would receive a major boost just as revenues from category-leader Symbicort decline.