TARRYTOWN, N.Y., Feb. 15, 2019 /PRNewswire/ --
Today the European Patent Office invalidated Immunex's
European patent claiming antibodies that target human IL-4
receptors (IL-4R)
Decision follows yesterday's ruling by the U.S. Patent
& Trademark Office invalidating a similar Immunex patent
claiming antibodies that target human IL-4R
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced two important legal developments invalidating Immunex
patents with functional claims to antibodies that target human
interleukin-4 receptors (IL-4R). Earlier today, the Opposition
Division of the European Patent Office (EPO) revoked Immunex's
European Patent No. 2,990,420 in its entirety because the claims
were invalid for insufficiency of disclosure. This follows a
decision yesterday by the Patent Trial and Appeal Board (PTAB) of
the U.S. Patent & Trademark Office (USPTO) to invalidate all 17
claims of Immunex's U.S. Patent No. 8,679,487 as obvious.
These decisions are subject to appeal by Immunex.
The patents in question are owned by Immunex Corporation, which
is wholly-owned by Amgen.
"We applaud decisions by the U.S. and European patent offices
this week, which invalidate Immunex's functional patent claims to
antibodies that target human IL-4 receptors," said Joseph LaRosa, Executive Vice President, General
Counsel and Secretary, Regeneron. "It is our position that
Immunex's functional claims unfairly attempt to claim ownership far
beyond the molecules developed, and stifle innovation within the
broader scientific community."
Dupixent® (dupilumab), jointly developed by Regeneron
and Sanofi, has been used to treat nearly 50,000 patients in the
U.S. alone since it was first approved in 2017. Dupixent is a
targeted biologic therapy that binds to IL-4R and inhibits
signaling of IL-4 and IL-13, two key proteins that play a central
role in Type 2 inflammation that underlies a number of allergic
diseases, including atopic dermatitis and asthma.
Today's EPO decision follows a ruling in November 2017 (published in January 2018), invalidating a similar Immunex
European patent also claiming antibodies that target human
IL-4R.
About Dupixent
Dupixent comes in two doses (200 mg
and 300 mg), each as a pre-filled syringe. Dupixent is intended for
injection under the skin (subcutaneous injection) and is given
every other week at different injection sites after an initial
loading dose. It can be given in a clinic or, for convenience, at
home by self-administration after training by a healthcare
professional.
Dupixent is approved in the U.S. as a treatment for adults with
moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with topical prescription therapies or when
those therapies are not advisable; and as add-on maintenance
treatment for patients 12 years and older with moderate-to-severe
asthma with an eosinophilic phenotype or with oral
corticosteroid-dependent asthma.
In the EU, Dupixent is approved for use in adults with
moderate-to-severe atopic dermatitis who are candidates for
systemic therapy.
Dupilumab Development Program
Regeneron, in
collaboration with Sanofi, is also studying dupilumab in a broad
range of clinical development programs for diseases driven by
allergic and other Type 2 inflammation, including chronic
rhinosinusitis with nasal polyps (Phase 3 completed),
adolescent (12 to 17 years of age) atopic dermatitis (Phase 3
completed), pediatric (6 to 11 years of age) atopic
dermatitis (Phase 3), pediatric (6 months to 5 years of age) atopic
dermatitis (Phase 2/3), pediatric (6 to 11 years of age) asthma
(Phase 3), eosinophilic esophagitis (Phase 3) and food and
environment allergies (Phase 2). A future trial is planned for
chronic obstructive pulmonary disease. Dupilumab is also being
studied in combination with REGN3500, which targets IL-33. These
potential uses are investigational and the safety and efficacy have
not been evaluated by any regulatory authority. Dupilumab and
REGN3500 were discovered using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully human antibodies, and are being jointly developed by
Regeneron and Sanofi under a global collaboration agreement.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults 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 18 years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe 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.
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 (if you also have atopic dermatitis)
- have a parasitic (helminth) infection
- are taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- 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. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
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. If you have atopic dermatitis, tell your
healthcare provider if you have any new or worsening eye problems,
including eye pain or changes in vision.
- Inflammation in 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 injection site reactions, pain in the
throat (oropharyngeal pain) and cold sores in your mouth or on your
lips. Eye and eyelid inflammation, including redness,
swelling and itching have been seen in patients who have atopic
dermatitis.
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. 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 adolescents with asthma 12 years of age and
older, it is recommended that DUPIXENT be administered by or under
supervision of an adult.
Please see accompanying full Prescribing Information
including Patient Information.
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 for 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, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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.
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 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 Dupixent® (dupilumab) Injection;
risks associated with intellectual property of other parties and
pending or future litigation and other proceedings relating
thereto, including without limitation the patent litigation and
other proceedings relating to Dupixent (such as the proceedings
relating to U.S. Patent No. 8,679,487 and EP Patent No. 2,990,420
discussed in this press release), EYLEA® (aflibercept)
Injection, and Praluent® (alirocumab) Injection, the
ultimate outcome of any such proceedings, and the impact any of the
foregoing may have on Regeneron's business, prospects, operating
results, and financial condition; the likelihood of success of any
appeal of the decisions relating to U.S. Patent No.
8,679,487 and EP Patent No. 2,990,420 discussed in this press
release; the likelihood, timing, and scope of possible regulatory
approval and commercial launch of Regeneron's late-stage product
candidates and new indications for marketed products, such as
dupilumab for the treatment of pediatric atopic dermatitis,
pediatric asthma, chronic rhinosinusitis with nasal polyps,
eosinophilic esophagitis, food and environment allergies, chronic
obstructive pulmonary disease, and other potential indications (as
well as in combination with REGN3500); unforeseen safety issues
resulting from the administration of products and product
candidates (such as dupilumab) in patients, including serious
complications or side effects in connection with the use of
Regeneron's product candidates in clinical trials; ongoing
regulatory obligations and oversight impacting Regeneron's marketed
products (such as Dupixent), research and clinical programs, and
business, including those relating to patient privacy;
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, including without limitation dupilumab; the
availability and extent of reimbursement of the Company'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; uncertainty of market acceptance
and commercial success of Regeneron's products and product
candidates (such as Dupixent) and the impact of studies (whether
conducted by Regeneron or others and whether mandated or voluntary)
on the commercial success of any such products and product
candidates; 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 or its collaborators may be replicated in
other studies and lead to 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 to perform
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; and 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. 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, 2018. 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).
Regeneron
Contacts:
|
|
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Media
Relations
|
Investor
Relations
|
Sarah
Cornhill
|
Mark
Hudson
|
Tel: +1 (914)
847-5018
|
Tel: +1 (914)
847-3482
|
Sarah.Cornhill@regeneron.com
|
Mark.Hudson@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.