Sanofi, Regeneron unveil 'blow-out' smoker's lung drug data
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[March 23, 2023]
By Ludwig Burger and Juby Babu
(Reuters) -Sanofi's asthma drug Dupixent met all targets in a trial to
treat "smoker's lung", potentially adding billions to the French
drugmaker's growth prospects, but also underscoring a heavy reliance on
its bestseller.
In a late stage trial Dupixent, jointly developed with Regeneron, led to
a 30% reduction in moderate or severe acute exacerbations of chronic
obstructive pulmonary disease (COPD), a potentially deadly disease
marked by progressive lung function decline.
Sanofi and Regeneron said in a statement on Thursday a Phase III trial
involving 939 current or former smokers also showed improvements in lung
function, quality of life and COPD respiratory symptoms.
The French group's stock was up 4.5% at 0818 GMT, reaching a seven-month
high and far outperforming a 0.5% decline in the STOXX Europe 600 Health
Care index.
"COPD is an urgent global health concern and a notoriously
difficult-to-treat disease due to its heterogeneity, with no novel
treatments approved in more than a decade," said Regeneron Chief
Scientific Officer George Yancopoulos.
Sanofi added its "bold" decision to go without earlier-stage clinical
COPD trials had shaved years off the development time.
![](http://archives.lincolndailynews.com/2015/May/02/images/ads/current/guzzardo_lda022609.png)
JP Morgan analyst Richard Vosser said the trial update had "blow-out
data" in store for investors, and that market consensus for 2027
Dupixent sales of 15.7 billion euros would likely be topped-up by
between 1 and 2 billion euros.
"We see Dupixent data in COPD exceeding any expectations in the market
for benefit," the analyst said.
Jefferies analysts said the update yielded "perhaps best case efficacy"
to treat the disease.
Sanofi previously forecast Dupixent would generate up to 13 billion
euros ($14.2 billion) in sales in its best year as it seeks to widen its
use across several inflammatory conditions, but it has excluded COPD
from its sales target.
Sanofi said on Thursday it was too early to update its sales estimate
for the product, which is also used to ease eczema.
The anti-inflammatory drug accounted for 8.3 billion euros, or more than
19% of the French group's overall sales of 43 billion euros, last year.
That was a currency-adjusted increase of 44% from a year earlier.
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![](../images/032323PIX/health85.jpg)
A logo on the Sanofi exhibition space at
the Viva Technology conference dedicated to innovation and startups
at Porte de Versailles exhibition center in Paris, France June 15,
2022. REUTERS/Benoit Tessier
![](http://archives.lincolndailynews.com/2023/Mar/23/images/ads/current/longview_lda_SFARM_2023.png) Sanofi reports combined global
Dupixent sales from its alliance with Regeneron.
The companies said that full efficacy and safety results would be
presented later. They added a second late-stage COPD Dupixent trial
was ongoing, with the first data read-out expected next year.
Overall rates of adverse events in the trial reporting results were
77% for Dupixent and 76% for placebo.
Sanofi shares have been battered following disappointing trial
results in August 2022 of a once-promising breast cancer drug
candidate.
Legal claims that heartburn drug Zantac caused cancer have also
weighed on the stock.
The group, led by British CEO Paul Hudson, this month struck a deal
to acquire Provention Bio Inc for $2.9 billion to bolster its work
on a U.S.-approved type 1 diabetes therapy.
Analysts have said that this year's expected market debut of two new
products, to balance out reliance on Dupixent, would be important
tests of the company's marketing and development prowess and a
chance to regain investor confidence.
These products are haemophilia A treatment Altuviiio, requiring
fewer injections than standard therapy, and Beyfortus from a
partnership with AstraZeneca, which is a preventive injection
against the common RSV airways infection in infants.
Sanofi and Regeneron on Tuesday announced the European Commission
had approved Dupixent to treat severe atopic dermatitis in young
children. Prior to that, the drug was also approved in Europe to
treat a type of esophagus inflammation.
![](http://archives.lincolndailynews.com/2023/Mar/23/images/ads/current/safetytip_sda_topflight_2023.png)
($1 = 0.9168 euros)
(Reporting by Ludwig Burger in Frankfurt and Juby Babu in Bengaluru;
editing by Mark Potter and Jason Neely)
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