TARRYTOWN, N.Y., June
11, 2020 /PRNewswire/ --
Dupixent meets early efficacy threshold for continuation in
ongoing Phase 3 trial of patients with COPD; second confirmatory
trial will commence in third quarter of 2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
announced updates related to the Dupixent®
(dupilumab) collaboration programs with Sanofi, which will be
highlighted today during Sanofi's Dupixent R&D investor
event.
Regeneron and Sanofi have commenced potentially registrational
trials investigating Dupixent in a number of diseases driven in
part by type 2 inflammation, including:
- Chronic obstructive pulmonary disease (COPD) – COPD
is a common, progressive lung disease that obstructs airflow and
makes it difficult to breathe. An ongoing Phase 3 trial in
approximately 900 COPD patients with evidence of type 2
inflammation recently met a blinded, stringent early efficacy
threshold for continuation, and based on this result a second
confirmatory trial will commence in the third quarter of 2020.
Regulatory submissions are expected to be submitted in the 2024
timeframe.
- Eosinophilic esophagitis (EoE) – EoE is a chronic and
progressive disease that damages the esophagus and prevents it from
working properly, leading to difficulties swallowing. The companies
recently announced that Part A of the Dupixent EoE
pivotal Phase 3 trial met both co-primary endpoints, as well as all
key secondary endpoints. Dupixent demonstrated significant clinical
and anatomic improvements, including the ability to swallow. Part B
of the Phase 3 trial is ongoing, and regulatory submissions are
expected to be submitted by 2022. The U.S. Food and Drug
Administration (FDA) has granted orphan drug designation to
Dupixent for the treatment of EoE.
- Prurigo nodularis (PN) – There are currently no approved
treatments for PN, which causes hard, intensely itchy nodules
(lumps) on the skin that impact patients' quality of life, with
many developing anxiety and depression. The companies have
initiated two Phase 3 Dupixent trials in PN, each designed to
enroll approximately 150 patients. Topline trial results are
expected in the second half of 2021, which could support regulatory
filings at the end of 2021.
- Chronic spontaneous urticaria (CSU) – CSU is a common
condition characterized by the recurrent appearance of highly itchy
wheals (hives) with or without angioedema (swelling) persisting for
more than six weeks without a specific known cause. Earlier this
year, the companies initiated a 240-patient registrational trial in
this patient group, with potential regulatory filings planned in
2022.
- Bullous pemphigoid (BP) – BP is a rare autoimmune
disease with type 2 inflammatory features, including itchy plaques
and large fluid-filled blisters, and is most common in adults older
than 60 years. The pivotal Phase 3 trial has been initiated, and
regulatory filings are planned for 2023+. The FDA has granted
orphan drug designation to Dupixent for the treatment of BP.
In addition, in moderate-to-severe asthma Dupixent
has been shown to provide rapid and sustained improvement in lung
function, and a marked reduction in exacerbations. This efficacy is
sustained out to almost three years. Furthermore, the safety
profile was consistent with previously reported data.
The use of Dupixent in EoE, COPD, PN, CSU and BP are
investigational and efficacy and safety in these diseases have not
yet been fully evaluated by any regulatory authority.
About Dupixent
Dupixent is approved in the U.S. to
treat patients aged 6 years and older with moderate-to-severe
atopic dermatitis that is not well controlled with prescription
therapies used on the skin (topical), or who cannot use topical
therapies; for use with other asthma medicines for the maintenance
treatment of moderate-to-severe eosinophilic or oral steroid
dependent asthma in patients aged 12 years and older whose asthma
is not controlled with their current asthma medicines; and for use
with other medicines for the maintenance treatment of CRSwNP in
adults whose disease is not controlled. In adolescents 12 years of
age or older, it is recommended that Dupixent be administered by or
under the supervision of an adult. In children younger than 12
years of age, Dupixent should be administered by a caregiver.
Outside of the U.S., Dupixent is approved for specific patients
with moderate-to-severe atopic dermatitis and certain patients with
asthma in a number of other countries around the world, including
the EU and Japan. Dupixent is also
approved in the EU and Japan to
treat certain adults with severe CRSwNP. The 200 mg and 300 mg
pre-filled pens are currently approved in the EU.
Dupilumab Development Program
To date, dupilumab has
been studied in more than 10,000 patients across 50 clinical trials
in various chronic diseases driven by type 2 inflammation. In
addition to the currently approved indications, Regeneron and
Sanofi are also studying dupilumab in a broad range of clinical
development programs for diseases driven by allergic and other type
2 inflammation, including pediatric asthma (6 to 11 years of age,
Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 2/3), eosinophilic esophagitis (Phase 3), chronic obstructive
pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo
nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and
food and environmental allergies (Phase 2). These potential uses
are investigational, and the safety and efficacy have not been
evaluated by any regulatory authority. Dupilumab is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
Dupilumab was invented using Regeneron's proprietary
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been
used to create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Ebola virus
infection, which is currently under review by the FDA, and is now
being used in efforts to create prophylactic and treatment
medicines for COVID-19.
U.S. Indications
DUPIXENT is
a prescription medicine used:
- to treat people aged 6 years and older with
moderate-to-severe atopic dermatitis (eczema) that
is not well controlled with
prescription therapies used on the skin
(topical), or who cannot use topical
therapies. DUPIXENT can be used with or without topical
corticosteroids. It is not known
if DUPIXENT is safe and effective in
children with atopic dermatitis under 6 years
of age.
- with other asthma medicines for the
maintenance treatment of moderate-to-severe
eosinophilic
or oral steroid dependent asthma in people
aged 12 years and older whose asthma is
not controlled with their current
asthma medicines. DUPIXENT helps
prevent severe asthma
attacks (exacerbations) and can improve your
breathing.
DUPIXENT may also help reduce the
amount of oral corticosteroids you need
while preventing severe asthma attacks
and improving your
breathing. DUPIXENT is not used
to treat sudden breathing problems.
It is not known if DUPIXENT is
safe and effective in children with asthma
under 12 years of age.
- with other medicines for the maintenance treatment
of chronic rhinosinusitis with nasal polyposis
(CRSwNP) in adults whose disease is
not controlled. It is not known
if DUPIXENT is safe and effective in
children with chronic rhinosinusitis with nasal polyposis
under 18 years of age.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
Do not use if you are allergic to dupilumab or to
any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the- counter medicines, vitamins
and herbal supplements.
Especially tell your healthcare provider if you are taking oral,
topical, or inhaled corticosteroid medicines; have asthma and use
an asthma medicine; and have atopic dermatitis or CRSwNP, and also
have asthma. Do not change or stop your corticosteroid
medicine or other asthma medicine without talking to your
healthcare provider. This may cause other symptoms that were
controlled by the corticosteroid medicine to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and
tell your healthcare provider or get emergency help right away if
you get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you
have any new or worsening eye problems, including eye pain or
changes in vision.
- Inflammation of your blood vessels. Rarely, this
can happen in people with asthma who receive DUPIXENT. This may
happen in people who also take a steroid medicine by mouth that is
being stopped or the dose is being lowered. It is not known whether
this is caused by DUPIXENT. Tell your healthcare provider right
away if you have: rash, shortness of breath, persistent fever,
chest pain, or a feeling of pins and needles or numbness of your
arms or legs.
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye
and eyelid inflammation, including redness, swelling, and itching,
and cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the
throat (oropharyngeal pain), and high count of a certain white
blood cell (eosinophilia).
- Chronic rhinosinusitis with nasal
polyposis: injection site reactions, eye and eyelid
inflammation, including redness, swelling, and itching, high count
of a certain white blood cell (eosinophilia), trouble sleeping
(insomnia), toothache, gastritis, and joint pain (arthralgia).
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. You are encouraged to report negative
side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. Your healthcare provider
will tell you how much DUPIXENT to inject and how often to inject
it. DUPIXENT is an injection given under the skin (subcutaneous
injection). If your healthcare provider decides that you or a
caregiver can give DUPIXENT injections, you or your caregiver
should receive training on the right way to prepare and inject
DUPIXENT. Do not try to inject DUPIXENT until you have been shown
the right way by your healthcare provider. In children 12 years of
age and older, it is recommended that DUPIXENT be administered by
or under supervision of an adult. In children younger than 12 years
of age, DUPIXENT should be given by a caregiver.
Please see full Prescribing Information including
Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes
forward-looking statements that involve risks and uncertainties
relating to future events and the future performance of Regeneron
Pharmaceuticals, Inc. ("Regeneron" or the "Company"), 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 impact of
SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on
Regeneron's business and its employees, collaborators, suppliers,
and other third parties on which Regeneron relies, Regeneron's and
its collaborators' ability to continue to conduct research and
clinical programs, Regeneron's ability to manage its supply chain,
net product sales of products marketed by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and Regeneron's
product candidates and research and clinical programs now underway
or planned, including without limitation Dupixent® (dupilumab); the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's product candidates and new
indications for Regeneron's Products, such as dupilumab for the
treatment of pediatric asthma, pediatric atopic dermatitis,
eosinophilic esophagitis, chronic obstructive pulmonary disease,
bullous pemphigoid, prurigo nodularis, chronic spontaneous
urticaria, food and environmental allergies, and other potential
indications; 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; unforeseen safety
issues resulting from the administration of Regeneron's Products
(such as Dupixent) and product candidates in patients, including
serious complications or side effects in connection with the use of
Regeneron's Products and product candidates in clinical trials;
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; ongoing regulatory obligations and oversight
impacting Regeneron's Products, research and clinical programs, and
business, including those relating to patient privacy; the
availability and extent of reimbursement of Regeneron's Products
(such as Dupixent) from third-party payers, including private payer
healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to Regeneron's Products and product
candidates; the extent to which the results from the research and
development programs conducted by Regeneron and/or its
collaborators may lead to advancement of product candidates to
clinical trials or therapeutic applications; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's Products and
product candidates; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its 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, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), 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 (including without limitation the patent litigation and
other related proceedings relating to Dupixent and Praluent®
(alirocumab)), other litigation and other proceedings and
government investigations relating to the Company and/or its
operations, the ultimate outcome of any such proceedings and
investigations, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron's filings with the U.S. Securities
and Exchange Commission, including its Form 10-K for the year ended
December 31, 2019 and its Form 10-Q
for the quarterly period ended March
31, 2020. 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.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Contacts:
Media Relations
Sarah Cornhill
Tel: +1 (917) 297-1522
Sarah.Cornhill@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
Mark.Hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.