In need of a few wins in its late-stage pipeline, AstraZeneca ($AZN) has announced positive top-line results for its licensed asthma biologic benralizumab, but is still far behind its rivals Teva ($TEVA) and GlaxoSmithKline ($GSK) in this new market.
The Anglo-Swedish drugmaker said its experimental, anti-eosinophil monoclonal antibody was “well tolerated and achieved the primary endpoint” in two pivotal Phase III registrational trials (SIROCCO and CALIMA).
Exact details are expected later this year, but AstraZeneca said its drug demonstrated “significant reductions in the annual asthma exacerbation rate compared to placebo.” Based on these late-stage results, the drugmaker said in a statement that it plans to submit the drug to the FDA and the EMA in the second half of the year.
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 reslizumab (Cinqair), 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 has said previously it thinks benralizumab could be worth as much as $2 billion at its 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 $500 million for peak sales.
Like GSK, AstraZeneca has a strong legacy respiratory portfolio consisting of drugs like Symbicort and Pulmicort, both targeting the asthma and COPD markets. It also acquired the rights to Allergan’s ($AGN) branded respiratory business in North America last year, so will have a strong sales and marketing knowledge in this area.
Benralizumab was not originally developed by AstraZeneca but rather from a biotech--and no, not its autoimmune and inflammatory biologics arm MedImmune, 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.
AstraZeneca’s trials were designed to see just how well--and how safely--two-dose regimens of benralizumab as an add-on therapy for severe, uncontrolled asthma with eosinophilic inflammation works.
In SIROCCO and CALIMA, the primary analysis population included patients on high-dose inhaled corticosteroids (ICS) plus long-acting β2-agonist (LABA).
Patients were randomized to receive 30 mg of benralizumab every 4 weeks; 30 mg every 4 weeks for the first three doses followed by 30 mg every 8 weeks; or placebo. Full details will be released at a “future medical conference,” according to a statement by AstraZeneca.
- check out the release