AstraZeneca plc (NYSE:AZN) announced that it has received positive phase 3 results on benralizumab, its candidate for severe asthma.
AstraZeneca announced that the drug had performed better than placebo at paring down annual asthma exacerbation rate in patients who are taking ICS/LABA combos. The company hopes to add this medication into its respiratory biologic portfolio as an add-on therapy.
The positive news on benralizumab creates a new level of competition between AstraZeneca and GlaxoSmithKline plc (NYSE:GSK). The two companies have been longtime rivals.
Last year, GSK took the lead with what is expected to be a multibillion dollar market for biological respiratory drugs after winning regulatory approval for its Nucala.
AstraZeneca is on track to filing benralizumab in European and US regulators in the second half of this year. Beralizumab will still have to compete with the likes of Xolair that is shared by Roche’s Genentech and Novartis AG (NYSE:NVS) in the market.
Tom Keith-Roach, head of AstraZeneca’s respiratory wing, noted that the arrival of injectable biological medicine like benralizumab is a revolution in the treatment of severe asthma. He further pointed out that older products treat the symptoms of the disease with new ones treating the underlying biology.
In the meantime, GSK is working hard to ensure it creates as big a lead as possible since it needs its new respiratory therapies to make up for declining blockbuster drug Advair. CEO Andrew Witty told investors that Nucala has started very well in every country that it has launched, even exceeding the company’s expectations. He noted that GSK had already recorded 3,500 patient enrolments and visited nearly all referring physicians.
Witty pointed out that the company feels good about the profile of the drug versus any up and coming competition. He indicated that the dosage and specific claim they have are unique, and obviously the six-month head start doesn’t hurt.