TARRYTOWN, N.Y. and
PARIS, May
18, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today shared positive results from
an interim analysis of a pivotal Phase 2b study of dupilumab in
adult patients with moderate-to-severe asthma, who are uncontrolled
despite treatment with inhaled corticosteroids and long-acting beta
agonists (ICS/LABA). As previously reported, the study met its
primary endpoint of improving lung function in asthma patients with
high blood eosinophil counts (HEos, greater than or equal to 300
eosinophilic cells/microliter). Such high counts are thought to be
a marker for patients more likely to have "atopic" or "allergic"
asthma. New data presented on secondary endpoints at the American
Thoracic Society 2015 International Conference included positive
results in study patients with low blood eosinophil counts (LEos,
less than 300 eosinophilic cells/microliter), who are thought to be
less likely to suffer from "allergic" asthma and thus less likely
to respond to TH2 targeted therapies. Dupilumab is an
investigational therapy that inhibits signaling of IL-4 and IL-13,
two cytokines required for the TH2 (or Type 2) immune response.
Based on discussions with the U.S. Food and Drug Administration
(FDA), this Phase 2b study may be considered one of two pivotal
efficacy studies required for a potential dupilumab biologics
license application (BLA) in asthma. The companies also announced
the initiation of a Phase 3 clinical trial of dupilumab in patients
with uncontrolled persistent asthma, known as LIBERTY ASTHMA QUEST,
which will serve as the second required pivotal efficacy study. The
global, placebo-controlled Phase 3 study will enroll more than
1,600 patients with uncontrolled persistent asthma and will
evaluate two doses of dupilumab, 200 milligrams (mg) and 300 mg,
subcutaneously administered every other week (Q2W).
The new results focused on LEos asthma patients. In this
population, patients treated with either 200 mg or 300 mg Q2W doses
of dupilumab showed a greater than 8 percent improvement in forced
expiratory volume over one second (FEV1, a standard measure of lung
function) at Week 12 (p less than 0.001), in comparison to
placebo, both in combination with ICS/LABA. Additionally, the 200
mg and 300 mg Q2W doses of dupilumab in combination with ICS/LABA
showed 68 percent and 62 percent reductions, respectively, in
adjusted annualized rate of severe exacerbations in the LEos
population (p less than 0.01 and p less than 0.05), in comparison
to placebo in combination with ICS/LABA.
These results are consistent with previously reported positive
results in HEos asthma patients and the overall patient population,
in which the two Q2W doses (200 mg and 300 mg) of dupilumab in
combination with ICS/LABA demonstrated a statistically significant
12 to 15 percent improvement in FEV1 over placebo at Week 12 and a
64 to 75 percent improvement in annualized rate of severe
exacerbations over placebo.
Dupilumab also significantly reduced mean fractional exhaled
nitric oxide (FeNO) across both Q2W doses tested (200 and 300 mg)
and the three patient populations (overall, LEos and HEos), in a
roughly dose-dependent manner. FeNO is recommended by the American
Thoracic Society clinical practice guidelines to assess airway
inflammation, since higher than normal levels of nitric oxide may
be released when a patient has a chronic airway disease, such as
asthma.
The most common adverse event was injection site reaction, which
was more frequent in the dupilumab dose groups (13 to 25 percent)
compared to placebo (12 percent). Other common adverse events
in the study included upper respiratory tract infection (10 to 13
percent dupilumab; 13 percent placebo), headache (5 to 10
percent dupilumab; 8 percent placebo), nasopharyngitis (3 to 10
percent dupilumab; 6 percent placebo) and bronchitis (5 to 8
percent dupilumab; 8 percent placebo). The incidence of infections
was balanced across treatment groups (42 to 45 percent dupilumab;
46 percent placebo), as was the incidence of serious adverse events
(3 to 7 percent dupilumab; 5 percent placebo).
"Despite available treatments, many patients with asthma
continue to have symptoms and recurring attacks, which have a
serious and detrimental impact on their daily lives," said
Sally Wenzel, M.D., lead
investigator from The University of
Pittsburgh, Division of Pulmonary, Allergy and Critical Care
Medicine. "In the study, dupilumab added to standard-of-care
therapy demonstrated fewer exacerbations and improved lung function
across both the high and low baseline eosinophil groups. We look
forward to the continued clinical development of dupilumab as a
potential option for a broad population of patients with
uncontrolled asthma."
The slide set presented at ATS can be found on Regeneron's
website here. Dupilumab is an investigational agent under clinical
development and its safety and efficacy have not been fully
evaluated by any regulatory agency.
These results were based on a pre-specified interim analysis,
which occurred when all patients had reached Week 12 of the 24-week
treatment period; the average treatment duration at the time of the
analysis was 21.4 weeks. The primary endpoint of the study was
improvement from baseline in FEV1 at Week 12 in the HEos group.
Final analyses on exacerbations and safety will be conducted after
24 weeks of treatment and a 16-week follow-up period.
About the Phase 2b Study
The double-blind,
placebo-controlled, 24-week, dose-ranging study enrolled 776 adult
patients with moderate-to-severe uncontrolled asthma, as defined by
the Global Initiative for Asthma 2014 Guidelines. Trial
participants were randomized to receive one of four doses of
dupilumab (300 mg every other week, 200 mg every other week, 300 mg
monthly, 200 mg monthly) or placebo. Approximately 42 percent of
patients had high eosinophils across the dose groups. During the
treatment period, patients continued their stable medium- or
high-dose inhaled corticosteroid and long-acting beta agonist
(ICS/LABA) combination product. Patients could have administered
inhaled rescue medication as needed during the study. A severe
exacerbation event during the study was defined as a deterioration
of asthma requiring the use of systemic corticosteroids for three
or more days, or hospitalization or an emergency room visit.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in the field of
healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets,
animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron is a
leading science-based biopharmaceutical company based in
Tarrytown, New York that
discovers, invents, develops, manufactures, and commercializes
medicines for the treatment of serious medical conditions.
Regeneron markets medicines for eye diseases and a rare
inflammatory condition and has product candidates in development in
other areas of high unmet medical need, including
hypercholesterolemia, oncology, rheumatoid arthritis, allergic
asthma, and atopic dermatitis. Several Regeneron programs are based
on human genetics findings. For additional information about the
company, please visit www.regeneron.com.
Sanofi Forward-Looking Statements
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press release contains forward-looking statements as defined in the
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things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
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product candidates if approved will be commercially successful, the
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Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2014. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron Forward-Looking Statements
This
news release includes forward-looking statements that involve risks
and uncertainties relating to future events and the future
performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"), and
actual events or results may differ materially from these
forward-looking statements. Words such as "anticipate,"
"expect," "intend," "plan," "believe," "seek," "estimate,"
variations of such words, and similar expressions are intended to
identify such forward-looking statements, although not all
forward-looking statements contain these identifying words. These
statements concern, and these risks and uncertainties include,
among others, the nature, timing, and possible success and
therapeutic applications of Regeneron's products, product
candidates, and research and clinical programs now underway or
planned, including without limitation dupilumab; ongoing regulatory
obligations and oversight impacting Regeneron's marketed products,
research and clinical programs, and business, including those
relating to patient privacy; unforeseen safety issues resulting
from the administration of products and product candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's product candidates in
clinical trials, such as the Phase 3 LIBERTY ASTHMA QUEST clinical
trial evaluating dupilumab in patients with uncontrolled persistent
asthma; the likelihood and timing of possible regulatory approval
and commercial launch of Regeneron's late-stage product candidates,
including without limitation dupilumab; determinations by
regulatory and administrative governmental authorities which may
delay or restrict Regeneron's ability to continue to develop or
commercialize Regeneron's products and product candidates;
competing drugs and product candidates that may be superior to
Regeneron's products and product candidates; uncertainty of market
acceptance and commercial success of Regeneron's products and
product candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's products and product candidates;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; coverage and
reimbursement determinations by third-party payers, including
Medicare and Medicaid; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its sales or other financial projections
or guidance and changes to the assumptions underlying those
projections or guidance; the potential for any license or
collaboration agreement, including Regeneron's agreements with
Sanofi and Bayer HealthCare LLC, to be cancelled or terminated
without any further product success; and risks associated with
intellectual property of other parties and pending or future
litigation relating thereto. A more complete description of these
and other material risks can be found in Regeneron's filings with
the United States Securities and Exchange Commission, including its
Form 10-K for the year ended December 31,
2014 and its Form 10-Q for the quarter ended March 31, 2015. Any forward-looking statements
are made based on management's current beliefs and judgment, and
the reader is cautioned not to rely on any forward-looking
statements made by Regeneron. Regeneron does not undertake any
obligation to update publicly any forward-looking statement,
including without limitation any financial projection or guidance,
whether as a result of new information, future events, or
otherwise.
Contacts
Sanofi:
Media
Relations
Jack
Cox
Tel: +33 (0)1 53 77
94 74
jack.cox@sanofi.com
|
Investor
Relations
Sebastien
Martel
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
|
|
Contacts
Regeneron:
Media
Relations
Alexandra
Bowie
Tel: 1 (914)
847-3407
alexandra.bowie@regeneron.com
|
Investor
Relations
Manisha
Narasimhan, Ph.D.
Tel: 1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.