• Companies focusing on white blood cells in severe asthma
  • Astra to present late-stage data on benralizumab at conference

If AstraZeneca Plc and GlaxoSmithKline Plc have their way, doctors and patients may someday talk about eosinophils the way they talk about cholesterol.

Eosinophils, a type of white blood cell, are often found in higher-than-normal numbers in asthma patients’ blood and lungs. In healthy people, they release toxins intended to kill invading germs -- but in some, they also cause the inflammation associated with asthma.

AstraZeneca and Glaxo are studying therapies that reduce eosinophil levels to see whether they can change the trajectory of respiratory disease, similar to cholesterol-cutting statins prescribed to prevent heart attacks. The potential market is huge: While severe asthma affects about 35 million people globally, about 600 million people suffer from asthma and the lung conditions known collectively as chronic obstructive pulmonary disease, or COPD, according to AstraZeneca.  

“The dream for the long-term is that you intervene in asthma earlier with a medicine that could fundamentally change the disease course, or even prevent someone at risk from developing disease at all,” said Tom Keith-Roach, global vice president of respiratory at AstraZeneca.

Stalling Sales

Widening use of their existing medicines and developing new ones for severe asthma is key for the British drugmakers amid patent expirations on their blockbuster inhalers. Glaxo’s Advair has generic competitors in Europe, with a possible copycat version in the U.S. next year. At 3.68 billion pounds ($4.83 billion), it was the company’s top seller last year.

Revenue from AstraZeneca’s Symbicort lung treatment has been under pressure since 2014, when its patent was revoked in the U.K. and a copy of the inhaler from Teva Pharmaceutical Industries Ltd. won backing from European regulators. Symbicort brought in $3.4 billion last year, making it the company’s best-selling medicine after cholesterol-lowering pill Crestor.

AstraZeneca will present data from two late-stage tests of its injectable drug benralizumab at the European Respiratory Society meeting starting Saturday. The drug curbs severe asthma by depleting eosinophils. AstraZeneca aims to file for regulatory approval for benralizumab for severe asthma patients in the U.S. and Europe this year, and present data that looks at the medicine as a treatment for COPD in 2018.

Earlier Treatment

Benralizumab would compete with Glaxo’s Nucala, which also reduces eosinophils and is approved in the U.S., Europe and Japan. Glaxo is studying whether eosinophils can be used as a trait to identify people who would benefit from earlier treatment, much like high cholesterol is used to identify candidates for statin therapy to avert heart disease, said Neil Barnes, medical head at the global respiratory franchise.

“At the moment the evidence about the beneficial effects of lowering cholesterol is really strong,’’ Barnes said. In patients with COPD, which includes emphysema and chronic bronchitis, evidence is growing that if people with high eosinophil counts are given inhaled steroids, they have fewer attacks, he said.

Glaxo-funded research has also identified a potential pitfall of lowering eosinophil levels too much: a slightly higher risk of pneumonia. Further studies are needed, the researchers wrote in the Lancet Respiratory Medicine journal in July.

Smoker’s Cough

Glaxo is conducting a three-year study of how well three of its inhalers reduce lung exacerbations in 10,000 people with COPD, also known as smoker’s cough. That study, which will conclude next year, is also looking at whether treating patients with high eosinophil counts also reduces the number of annual lung exacerbations.

Most people who have COPD are at least 40 when symptoms begin and have had long-term exposure to cigarette smoke or other lung irritants like air pollution. Unlike asthma patients, people with COPD get progressively worse and account for more hospital admissions, according to Glaxo’s Barnes.

COPD flare-ups and asthma attacks are expensive for health-care systems. In the European Union, the annual costs from treatment, hospitalizations and lost productivity due to lung diseases are around 82 billion euros ($92 billion), according to the European Respiratory Society.

Taming Costs

New treatments that curb flare-ups in severe, uncontrolled asthma and COPD patients may be key to taming the costs of emergency hospitalization. The prices of such drugs, however, restrict their use for the time being. The cost of Glaxo’s Nucala is $2,575 per monthly injection, according to data compiled by Bloomberg.

AstraZeneca is studying benralizumab dosing once every four weeks and also once every eight weeks. The Cambridge, England-based drugmaker is studying two more injectable respiratory medicines in humans, targeting different biomarkers, including the proteins periostin and DPP4, both linked to asthma.

“The more we understand what’s driving the inflammation of an individual patient, the better we can then engineer specific medicines to suppress that disease activity," said AstraZeneca’s Keith-Roach. “It’s a completely different philosophy from saying everyone with asthma should get an inhaled steroid.”

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