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 Britain's GlaxoSmithKline, the leader in asthma
treatments since launching its Ventolin inhaler in 1969, is in the
vanguard but faces competition from the likes of Roche, AstraZeneca,
Sanofi and Teva.
Despite treatment advances in recent decades, asthma is still not
well controlled in up to 20 percent of patients on standard therapy,
which consists of inhaled steroids and long-acting beta agonists
that are designed to open the airways.
This patient group includes many with severe disease, thought to
number around 2 million in leading industrialized nations, according
to consultancy Decision Resources.
Novel antibody-based drugs now nearing the market offer a way to get
to the root of the problem by targeting key inflammatory chemicals
made in the body that drive asthma. They are already being hailed by
doctors as a major advance.
"I'm very optimistic about the new drugs," said Elisabeth Bel,
president-elect of the European Respiratory Society and head of
respiratory medicine at the Academic Medical Center in Amsterdam.
"We have participated in several trials with the new biological
agents and have seen some amazing results."
In particular, the new injectable medicines have led to reductions
in serious asthma attacks, known as exacerbations, of around 40 to
60 percent in clinical trials.
The threat of such attacks — which may require hospital treatment
and can sometimes be life-threatening — dominate the lives of people
with severe asthma and represent a big financial burden to
healthcare systems providing emergency care.
WHAT PRICE PERSONALISED MEDICINE?
Significantly, the new drugs offer a more personalized approach to
asthma care, with patients undergoing so-called "biomarker" blood
tests to check if they are likely to respond to the medicines.
This targeted approach is gaining traction in many medical fields,
most notably cancer. It is attractive to governments and insurers
who pay for healthcare, since it means drugs should only go to
patients who are likely to benefit.
"Severe asthma patients represent the majority of the (asthma)
burden on healthcare systems and budgets," said Bahija Jallal, head
of AstraZeneca's MedImmune biotech unit, which is investing in a
broad portfolio of medicines for the condition.
"We will be working to convince payers this is something that brings
value."
Coupled with the money hospitals could save from a big drop in
exacerbations, this leads many analysts to argue that companies will
be able to charge a high price for the new drugs.
Barclays analysts, for example, assume a price of around $15,000 a
year for GSK's new drug mepolizumab, which is set to be submitted
for regulatory approval later this year following positive
late-stage study results last week.
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Seamus Fernandez of Leerink, who predicts the market for severe
asthma biotech drugs could exceed $7.5 billion a year in the United
States and Europe alone, is more cautious and expects a price tag of
something under $10,000, reflecting an increasingly competitive
landscape.
That would be a modest discount to the price of Xolair, from
Novartis and Roche, which is the only biotech asthma drug sold at
present, but which works in a different way to the new batch of
products and is only indicated for allergic asthma.
Some doctors are wary about the pricing environment.
"I think cost is going to be a hurdle. Payers are going to have to
figure out whether they are going to allow multiple patients to be
on multiple biologics," said Michael Wechsler, an asthma specialist
at National Jewish Health in Denver.
DISEASE SUB-TYPES
Although the number of patients with severe asthma is small, there
are at least five known disease sub-types, depending on which
precise biological pathways are driving the condition.
Working out the right drug for the right patient is therefore going
to be a challenge, according to Wechsler, who believes there is
still more work to be done on tests, since biomarker signals can be
transient within individual patients, depending on their condition
and medicines they are taking.
Analysts reckon GSK is two years ahead of rivals with its drug to
block the action of inflammatory chemical interleukin-5 (IL-5), with
competition coming from AstraZeneca and Teva.
But IL-5 is not the only game in town. Experimental products from
Sanofi, working with Regeneron, and Roche target two chemicals known
as IL-4 and IL-13, which might have an even greater impact.
GSK hopes to get a commercial edge by being ahead of the pack, but
the company acknowledges that picking the right drug for the right
patient will not be straightforward.
"There will be some overlap where some patients could be effectively
treated with one or more drug, but there are likely to be others who
are only effectively treated with one type. It's still early days to
sort through all of that," said Steve Yancy, GSK's development
leader for mepolizumab.
(Editing by Will Waterman)
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