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 But the British drugmaker's established Bydureon medicine for
diabetes failed to show a hoped-for benefit in reducing heart risks,
putting it at a disadvantage to Novo Nordisk's rival Victoza in the
so-called GLP-1 drug class.
Novo's next-generation GLP-1 drug semaglutide, currently awaiting
approval, has also shown such a heart benefit.
The mixed news left AstraZeneca's shares little changed in early
dealings on Tuesday.
While most investor focus is on AstraZeneca's cancer research,
particularly the immunotherapy drug durvalumab, the company also has
a long history in respiratory therapy and a significant presence in
diabetes.
It plans to build on the lung expertise with new asthma drug
benralizumab, which will compete with GlaxoSmithKline's Nucala and
Teva's Cinqair - two other recently approved antibody drugs for
severe asthma.
AstraZeneca hopes its product's potency and convenient dosing will
give it an edge, despite being third to market.
Data from the 28-week Phase III clinical trial presented at the
American Thoracic Society and published in the New England Journal
of Medicine on Monday showed the median reduction in oral steroid
dose was 75 percent for patients on benralizumab.
Overall, patients treated with benralizumab were more than four
times as likely to cut steroid use than those on placebo and there
was also a 70 percent reduction in the rate of serious asthma
attacks, known as exacerbations.
Tom Keith-Roach, head of AstraZeneca's respiratory, inflammation and
autoimmune business, said the results were good news for the sickest
patients, who currently rely on oral steroids that can cause weight
gain, mood changes and other side effects.
Data from the latest trial, along with results from two earlier
studies, were included in regulatory submissions for benralizumab in
various countries, including the United States, where an approval
decision is due in the fourth quarter.
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The picture was less favorable for Bydureon, where a separate
clinical trial showed that while the injectable drug did not raise
heart dangers, it failed to demonstrate a statistically significant
reduction in cardiovascular risks.
Consensus industry analyst forecasts point to annual benralizumab
sales of $915 million in 2023, while Bydureon is expected to sell
$854 million, according to data compiled by Thomson Reuters.
In addition to competition from GSK and Teva, benralizumab also
faces a potentially serious challenge from Sanofi and Regeneron,
whose drug dupilumab is being tested for severe asthma after winning
a green light in eczema.
Benralizumab works by directly killing off inflammatory cells found
in the lungs called eosinophils and, unlike the two existing drugs,
it is given only every eight weeks rather than monthly.
"There are around 2 million severe uncontrolled asthmatics worldwide
in our top 12 markets and I certainly think based on this profile we
would expect to have a really competitive share of that market,"
Keith-Roach said.
(Editing by Susan Thomas)
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