AstraZeneca gears up for benralizumab filing with latest asthma data

AstraZeneca, already some way behind Teva ($TEVA) and GlaxoSmithKline ($GSK) in the injectable mAb asthma drug market, is one step closer to making good on its blockbuster estimates after posting positive data for benralizumab.

The London-headquartered Big Pharma ($AZN) released more detailed results from its pivotal late-stage test at the European Respiratory Society International Congress this week, showing that adding its mAb benralizumab to standard-of-care medicine “significantly reduced exacerbations and improved lung function and asthma symptoms” in severe asthma patients with an eosinophilic phenotype.

Both the SIROCCO and CALIMA trials looked at the effect of two dosing regimens of benralizumab given in 4-week and 8-week regimens as an add-on therapy to standard-of-care medicine across primary and key secondary endpoints.

The data showed reductions in the annual rate of asthma exacerbations of up to 51% and improvement in lung function (change in FEV1 of up to 159 mL), which was seen at 4 weeks after the first benralizumab dose and sustained throughout the treatment period.

It also saw improvement in asthma symptoms, such as wheeze, cough, chest tightness and shortness of breath, according to the company.

While outcomes were shown for the 8-week dosing regimen, there was no additional benefit observed with 4-week dosing, something “which may support less-frequent dosing,” AZ said in a statement.

AZ believes its data are now strong enough for talks with the EMA and the FDA this year, with firm plans to submit the drug for review before the end of 2016 now in play.

Sean Bohen, EVP, global medicines development and CMO of the Big Pharma, said: “Severe asthma affects the lives of millions of patients around the world and can be life threatening. The SIROCCO and CALIMA Phase III trials have shown that benralizumab can offer a meaningful treatment option for patients as evidenced by reductions in exacerbations, improvement in lung function and symptoms, with the promise of fewer doses a year.

“Benralizumab has a unique way of working in patients with severe asthma with an eosinophilic phenotype and reflects AstraZeneca’s progress in bringing the next generation of respiratory medicines to patients.”

Asthma is, however, a well-catered-for market, and it may need to be besting marketed rivals if it is to gain a major share in a space in which it's already falling behind.

Alongside AZ, GlaxoSmithKline has been one of the biggest players in asthma for many years, with major blockbuster Seretide/Advair (which also has a license in COPD) being one of the biggest drugs in the space. But its sales have been dropping as pricing pressures increase, with the threat of biosimilars also emerging.

The bad news for AstraZeneca is that GSK has already been given approval for its asthma mAb Nucala (mepolizumab), which recently gained an EMA and FDA green light for severe eosinophilic asthma--the exact license AstraZeneca is gunning for. Analysts have estimated that Nucala should see sales in excess of $500 million a year, and potentially $1 billion-plus at peak.

Israeli generic giant Teva is also ahead in the game, and back in March gained FDA approval for its IL-5 inhibitor mAb Cinqair (reslizumab), also for the maintenance of severe asthma in patients with the eosinophilic phenotype.

This is also a fairly narrow subpopulation of asthma patients who struggle to control their asthma even when taking high doses of medicine to help stop attacks. There had been no specific treatment for eosinophilic asthma other than the inhaled corticosteroids, as well as other controller medications or the beta 2 adrenoceptor agonists already in use for milder forms of the disease.

But with three companies all set to be competing for market space from next year, and GSK the first to market in this new area with its mAb, a third-place AstraZeneca may struggle to gain a firm foothold.

The company previously touted benralizumab sales as being $2 billion at peak, but this may well depend on whether it can add to its license with a COPD indication, which it has slated for 2018. (Although it has endured several midstage hiccoughs for its COPD trials.) Current analysts’ forecasts are a much lower $450 million to $550 million for peak sales.

Benralizumab was not originally developed by AstraZeneca, but from an in-licensing deal the company made with BioWa--a subsidiary of Kyowa Hakko Kirin--which holds certain rights to sell the drug in Japan and other Asian markets, as well as being able to receive milestone payments rights.