AstraZeneca plc (ADR) (NYSE:AZN) portfolio of drugs could receive a major boost this year after the company posted positive results in a phase III trial for its asthma treatment. The drug maker says benralizumab achieved its primary endpoint in two registrational trials.
Positive Phase III Trials
According to the British drug maker, benralizumab demonstrated significant reductions in annual asthma exacerbation rate compared to placebo. The two trials evaluated the drug’s efficacy and safety regimens as an add-on therapy for asthma in adult and children above the age of 12.
AstraZeneca says it will present the drug for regulatory approval in the US and Europe in the second half of 2016. The drug will target patients with a history of severe attacks even after using approved drugs. Benralizumab could reach the market next year. AstraZeneca believes the drug has the potential to generate $2 billion in revenues annually.
If approved, the drug will have to compete for market share in a field that is not short of alternatives. GlaxoSmithKline plc (ADR) (NYSE:GSK) Nucala and Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) Cinqair are some of the drugs that benralizumab will have to compete against for market share.
Analysts have already raised doubts about the drug’s potential given the $2 billion sales forecast. Given the level of competition in the space, analysts expect the drug sales to stand at just $450 million by 2021.
Amidst the concerns, AstraZeneca’s head of respiratory inflammation and autoimmune disorders Tom Keith remains bullish about benralizumab prospects. According to Keith, the drug’s unique mechanism of action should give it an edge in the highly competitive industry.
Even though attention has in the recent past switched to the oncology drug portfolio, the drug maker continues to bet big on respiratory drugs.
AstraZeneca badly needs new drugs to drive sales having suffered a major setback on the expiry of patent protection for its blockbuster drugs. Sales for cholesterol fighter Crestor and stomach acid pill Nexium have been on a decline in the recent past as alternatives continue to disrupt the marketplace.