TARRYTOWN, N.Y. and
PARIS, June
27, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today announced that the
European Commission (EC) has granted marketing authorization for
Kevzara® (sarilumab) in combination with methotrexate
(MTX) for the treatment of moderately to severely active rheumatoid
arthritis (RA) in adult patients who have responded inadequately
to, or who are intolerant to one or more disease modifying
anti-rheumatic drugs (DMARDs), such as MTX. Kevzara may be used as
monotherapy in case of intolerance to MTX or when treatment with
methotrexate is inappropriate.
Kevzara is a human monoclonal antibody that binds to the
interleukin-6 receptor (IL-6R), and blocks pro-inflammatory IL-6
mediated signaling. Elevated levels of IL-6 are found in the
synovial fluid of patients with RA and play an important role in
both the pathologic inflammation and joint destruction which are
hallmarks of RA. Kevzara was developed using Regeneron's
proprietary VelocImmune® technology that yields
optimized fully-human antibodies.
"RA is a difficult-to-treat, lifelong disease and many
healthcare providers are challenged with finding a treatment that
works for their patients," said Elias
Zerhouni, M.D., President, Global R&D, Sanofi. "Kevzara
works differently from some of the other most commonly used
biologics, and its approval is good news for the many patients
where a high unmet need remains."
RA affects approximately 2.9 million people in Europe alone. In RA, the immune system attacks
the tissues of the joints, causing inflammation, joint pain,
swelling, stiffness, fatigue and eventually joint damage and
disability. RA is most common in those aged 35-50 years old.
"We are pleased to bring Kevzara to European patients who may
not be responding to the most commonly used biologics such as TNF
inhibitors, or who may be seeking an effective monotherapy to reach
their treatment goals," said George D.
Yancopoulos, M.D., Ph.D., Founding Scientist, President, and
Chief Scientific Officer, Regeneron. "This approval was made
possible through the hard work of our innovative scientists, as
well as thousands of dedicated investigators and patients around
the world who participated in the SARIL-RA clinical trial
program."
The EC approval is based upon receipt of a positive opinion by
European Medicine Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP), which evaluated results from seven Phase 3
trials in the global SARIL-RA clinical development program. These
studies incorporate data from more than 3,300 adults with
moderately to severely active RA who have had an inadequate
response or intolerance to one or more biologic or non-biologic
DMARDs.
The program includes the Phase 3 MONARCH study, in which
treatment with Kevzara 200 mg monotherapy was superior to
adalimumab 40 mg (marketed by AbbVie as HUMIRA®)
monotherapy in reducing disease activity and improving physical
function, with more patients achieving clinical remission over 24
weeks.
- At 24 weeks, patients treated with Kevzara demonstrated greater
reduction in disease activity as measured by change from baseline
in the Disease Activity Score with 28 joint count and erythrocyte
sedimentation rate (DAS28-ESR), the primary endpoint of the study
(Kevzara, -3.28; adalimumab, -2.20; p less than 0.0001)
- At 24 weeks, patients treated with Kevzara demonstrated greater
improvement from baseline in physical function as measured by the
Health Assessment Questionnaire - Disability Index (HAQ-DI), a
secondary endpoint of the study (Kevzara, -0.61; adalimumab, -0.43;
p=0.0036)
- At 24 weeks, patients treated with Kevzara achieved higher
rates of DAS28-ESR remission (score<2.6), a secondary endpoint
of the study (Kevzara, 26.6 percent; adalimumab, 7.0 percent; p
less than 0.0001)
- At 24 weeks, patients treated with Kevzara demonstrated a
greater improvement in signs and symptoms of RA as measured by the
proportion of patients achieving a 20 percent improvement in the
ACR criteria (ACR20) (Kevzara, 71.7 percent; adalimumab, 58.4
percent; p=0.0074). The proportion of patients achieving ACR50 was
also higher with Kevzara (Kevzara, 45.7 percent; adalimumab, 29.7
percent; p=0.0017) as well as for ACR70 (Kevzara, 23.4 percent;
adalimumab, 11.9 percent; p=0.0036). ACR20, ACR50, and ACR70
response at week 24 were secondary endpoints of the study.
In the Phase 3 MOBILITY study, treatment with Kevzara plus MTX
reduced signs and symptoms, improved physical function, and at week
52, inhibited the progression of structural damage by 91 percent
for the Kevzara 200 mg dose and 68 percent for the Kevzara 150 mg
dose, compared to placebo plus MTX. In the Phase 3 TARGET study,
treatment with Kevzara plus DMARD reduced signs and symptoms and
improved physical function, compared to placebo plus DMARD.
Detailed results from the MOBILITY and TARGET studies are available
in the Kevzara (sarilumab) FDA approval press release here.
The recommended dose of Kevzara is 200 mg once every 2 weeks
administered as a subcutaneous injection with a prefilled syringe
or prefilled pen.1 If necessary, reduction of dose from
200 mg once every 2 weeks to 150 mg once every 2 weeks is
recommended to help manage certain laboratory abnormalities
(neutropenia, thrombocytopenia, and liver enzyme
elevations).
The most frequent adverse reactions observed with Kevzara in
clinical studies as indicated were neutropenia, increased alanine
aminotransferase, injection site erythema, upper respiratory
infections, and urinary tract infections. The most common serious
adverse reactions were infections. Treatment with Kevzara should be
withheld in patients who develop a serious infection until the
infection is controlled. Initiating treatment with Kevzara is not
recommended in patients with a low neutrophil count, i.e., absolute
neutrophil count (ANC) < 2 x 109/L and in patients
with a platelet count below 150 x 103/μL.
Kevzara is also approved in the United
States and Canada. The
companies are also seeking approvals in a number of other countries
globally.
Important Safety Information for U.S.
Kevzara can cause serious side effects including:
- SERIOUS INFECTIONS: Kevzara is a medicine that
affects your immune system. Kevzara can lower the ability of your
immune system to fight infections. Some people have serious
infections while using Kevzara, including tuberculosis (TB), and
infections caused by bacteria, fungi, or viruses that can spread
throughout the body. Some people have died from these
infections.
-
- Before starting Kevzara, tell your healthcare provider if
you:
-
- think you have an infection or have symptoms of an infection,
with or without a fever, such as sweats or chills, muscle aches,
cough, shortness of breath, blood in phlegm, weight loss, warm, red
or painful skin or sores on your body, diarrhea or stomach pain,
burning when you urinate or urinating more often than normal or
feel very tired; or are being treated for an infection, get a lot
of infections or have repeated infections
- have diabetes, HIV, or a weakened immune system.
- have TB, or have been in close contact with someone with
TB
- live or have lived, or have traveled to certain parts of the
country (such as the Ohio and
Mississippi River valleys and the Southwest) where there is an
increased chance of getting certain fungal infections
(histoplasmosis, coccidioidomycosis, or blastomycosis)
- have or have had hepatitis
- After starting Kevzara, call your healthcare provider right
away if you have any symptoms of an infection.
- CHANGES IN CERTAIN LABORATORY TEST RESULTS: Your
healthcare provider should do blood tests before and after starting
Kevzara to check for low neutrophil (white blood cells that help
the body fight off bacterial infections) counts, low platelet
(blood cells that help with blood clotting and stop bleeding)
counts, and an increase in certain liver function tests. Changes in
test results are common with Kevzara and can be severe. You
may also have changes in other laboratory tests, such as your blood
cholesterol levels.
- TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: Some
people using Kevzara get tears in their stomach or intestine. Call
your healthcare provider right away if you have fever and stomach
(abdominal) pain that does not go away.
- CANCER: Kevzara may increase your risk of certain
cancers by changing the way your immune system works. Tell
your healthcare provider if you have ever had any type of
cancer.
- SERIOUS ALLERGIC REACTIONS: Serious allergic reactions
can happen with Kevzara. Get medical attention right away if
you have any of the following signs: shortness of breath or trouble
breathing; feeling dizzy or faint; swelling of the lips, tongue or
face; moderate to severe stomach (abdominal) pain or vomiting; or
chest pain.
- Do not use Kevzara if you are allergic to Sarilumab or any of
the ingredients of Kevzara.
- Before using Kevzara, tell your healthcare provider if
you:
-
- have an infection
- have liver problems
- have had stomach (abdominal) pain or a condition known as
diverticulitis (inflammation in parts of the large intestine) or
ulcers in your stomach or intestines
- recently received or are scheduled to receive a vaccine. People
who take Kevzara should not receive live vaccines.
- plan to have surgery or a medical procedure
- are pregnant or plan to become pregnant. It is not known if
Kevzara will harm your unborn baby
- are breastfeeding or plan to breastfeed. Talk to your
healthcare provider about the best way to feed your baby if you use
Kevzara. It is not known if Kevzara passes into your
breastmilk.
- take any medicines, including prescription and nonprescription
medicines, vitamins, and herbal supplements. Especially tell your
healthcare provider if you use any other medicines to treat your
RA. Using Kevzara with these medicines may increase your risk of
infection.
- The most common side effects include:
-
- injection site redness
- upper respiratory tract infection
- urinary tract infection
- nasal congestion, sore throat, runny nose
These are not all the possible side effects of
Kevzara. Tell your doctor about any side effect that
bothers you or does not go away. You are encouraged to report side
effects of prescription drugs to the FDA at www.fda.gov/medwatch or
call 1-800-FDA-1088 or to Sanofi-Aventis at 1-800-633-1610.
To learn more, talk about Kevzara with your healthcare
provider or pharmacist. The FDA-approved Medication Guide and
Prescribing Information can be found at Kevzara.com or by calling
1-844-Kevzara (1-844-538-9272).
Please click here for full
prescribing information including risk of SERIOUS SIDE EFFECTS and
Medication Guide
About Sanofi
Sanofi, a global healthcare
leader, discovers, develops and distributes therapeutic solutions
focused on patients' needs. Sanofi is organized into five global
business units: Diabetes and Cardiovascular, General Medicines and
Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer
Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led by physician-scientists for nearly 30 years, our
unique ability to repeatedly and consistently translate science
into medicine has led to six FDA-approved treatments and over a
dozen product candidates, all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its unique VelociSuite®
technologies, including VelocImmune® which yields
optimized fully-human antibodies, and ambitious initiatives such as
the Regeneron Genetics Center, 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.
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2016. 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 and Use of Digital
Media
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" 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 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
Kevzara® (sarilumab) for the treatment of moderately to
severely active rheumatoid arthritis in adult patients who have
responded inadequately to, or who are intolerant to, one or more
disease modifying anti-rheumatic drugs or other potential
indications; the likelihood and timing of possible regulatory
approval and commercial launch of Regeneron's late-stage product
candidates, such as the possible regulatory approval and commercial
launch of Kevzara in additional jurisdictions; 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 Kevzara; 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, such as
Kevzara; ongoing regulatory obligations and oversight impacting
Regeneron's marketed products (such as Kevzara), research and
clinical programs, and business, including those relating to
patient privacy; 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, including without limitation
Kevzara; coverage and reimbursement determinations by third-party
payers, including Medicare and Medicaid; 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 to perform filling, finishing,
packaging, labelling, 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 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, 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 relating to Praluent®
(alirocumab) Injection, the permanent injunction granted by the
United States District Court for the District of Delaware that, if upheld on appeal, would
prohibit Regeneron and Sanofi from marketing, selling, or
commercially manufacturing Praluent in the United States, the outcome of any appeals
regarding such injunction, the ultimate outcome of such litigation,
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 United States Securities and
Exchange Commission, including its Form 10-K for the year ended
December 31, 2016 and its Form 10-Q
for the quarterly period ended March 31,
2017. 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
Regeneron:
|
|
|
|
Media
Relations Arleen
Goldenberg Tel: 1 (914)
847-3456 Mobile: +1 (914)
260-8788 arleen.goldenberg@regeneron.com
|
Investor
Relations Manisha
Narasimhan, Ph.D. Tel: 1
(914) 847-5126 Manisha.narasimhan@regeneron.com
|
Contacts
Sanofi:
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|
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Media
Relations Ashleigh
Koss Tel: +1 908 981
8745 ashleigh.koss@sanofi.com
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Investor
Relations George
Grofik Tel. +33 (0)1 53 77
45 45 ir@sanofi.com
|
|
|
Global
Communications Sarah
Connors Tel: +1 617 252
7639 Mobile: +1
781-697-5890 sarah.connors@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.