TARRYTOWN, N.Y., June 24, 2020 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today stated
there is no merit to the civil complaint filed by the U.S. Attorney
for the District of Massachusetts.
It is unfortunate that a misguided lawsuit is attempting to assign
wrongful intent to entirely legal conduct. Regeneron has fully
cooperated with the government's investigation and will vigorously
defend the Company's case.
In 2017, Regeneron disclosed it was among a large number of
companies that received subpoenas in connection with a government
inquiry related to charitable organizations that provide financial
assistance to patients. Regeneron has not settled the case because
the Company did not engage in illegal or wrongful conduct.
The complaint relates to lawful, charitable donations Regeneron
made in 2013 and early 2014 to an independent charitable patient
assistance foundation to assist financially disadvantaged elderly
patients with wet age-related macular degeneration ("wet AMD") gain
access to treatments designed to prevent blindness. Many wet AMD
patients who could not afford their medicines historically turned
to repackaged, off-label medicines in the hope of maintaining their
vision.
Regeneron is proud of the Company's legacy of supporting
patients in need through donations to charitable foundations to
help ensure elderly patients are able to access the medicines
prescribed by their physician. Advanced age-related macular
degeneration is a leading cause of irreversible blindness and
vision impairment around the world. As many as 11 million people in
the U.S. have some form of age-related macular degeneration. Wet
AMD accounts for approximately 10 percent of cases, but results in
90 percent of legal blindness.
"It is unfortunate that the government chose to bring these
baseless allegations related to our 2013 and early 2014 patient
assistance donations at a time when Regeneron employees have been
coming to work in the epicenter of the COVID-19 pandemic with the
goal of providing an effective treatment. We look forward to having
our case heard and will file a motion to dismiss," said
Joseph LaRosa, Executive Vice
President, General Counsel and Secretary, Regeneron. "We believe
our actions are legal and have helped preserve and restore the
vision of elderly patients. Regeneron's donations to independent
charity foundations help elderly patients access medicines that are
prescribed by their physicians."
EYLEA® (aflibercept) Injection is a vascular
endothelial growth factor (VEGF) inhibitor formulated as an
injection for the eye. It is designed to block the growth of new
blood vessels and decrease the ability of fluid to pass through
blood vessels (vascular permeability) in the eye by blocking VEGF-A
and placental growth factor ("PLGF"), two growth factors involved
in angiogenesis. In the U.S., EYLEA is the market-leading,
FDA-approved anti-VEGF treatment for its approved indications and
is supported by a robust body of research that includes eight
pivotal Phase 3 trials.
IMPORTANT SAFETY INFORMATION FOR EYLEA®
(aflibercept) INJECTION
- EYLEA (aflibercept) Injection is contraindicated in patients
with ocular or periocular infections, active intraocular
inflammation, or known hypersensitivity to aflibercept or to any of
the excipients in EYLEA.
- Intravitreal injections, including those with EYLEA, have been
associated with endophthalmitis and retinal detachments. Proper
aseptic injection technique must always be used when administering
EYLEA. Patients should be instructed to report any symptoms
suggestive of endophthalmitis or retinal detachment without delay
and should be managed appropriately. Intraocular inflammation has
been reported with the use of EYLEA.
- Acute increases in intraocular pressure have been seen within
60 minutes of intravitreal injection, including with EYLEA.
Sustained increases in intraocular pressure have also been reported
after repeated intravitreal dosing with VEGF inhibitors.
Intraocular pressure and the perfusion of the optic nerve head
should be monitored and managed appropriately.
- There is a potential risk of arterial thromboembolic events
(ATEs) following intravitreal use of VEGF inhibitors, including
EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial
infarction, or vascular death (including deaths of unknown cause).
The incidence of reported thromboembolic events in wet AMD studies
during the first year was 1.8% (32 out of 1824) in the combined
group of patients treated with EYLEA compared with 1.5% (9 out of
595) in patients treated with ranibizumab; through 96 weeks, the
incidence was 3.3% (60 out of 1824) in the EYLEA group compared
with 3.2% (19 out of 595) in the ranibizumab group. The incidence
in the DME studies from baseline to week 52 was 3.3% (19 out of
578) in the combined group of patients treated with EYLEA compared
with 2.8% (8 out of 287) in the control group; from baseline to
week 100, the incidence was 6.4% (37 out of 578) in the combined
group of patients treated with EYLEA compared with 4.2% (12 out of
287) in the control group. There were no reported thromboembolic
events in the patients treated with EYLEA in the first six months
of the RVO studies.
- Serious adverse reactions related to the injection procedure
have occurred in <0.1% of intravitreal injections with EYLEA
including endophthalmitis and retinal detachment.
- The most common adverse reactions (≥5%) reported in patients
receiving EYLEA were conjunctival hemorrhage, eye pain, cataract,
vitreous detachment, vitreous floaters, and intraocular pressure
increased.
INDICATIONS
EYLEA (aflibercept) Injection 2 mg (0.05
mL) is indicated for the treatment of patients with Neovascular
(Wet) Age-related Macular Degeneration (AMD), Macular Edema
following Retinal Vein Occlusion (RVO), Diabetic Macular Edema
(DME), and Diabetic Retinopathy (DR).
DOSAGE AND ADMINISTRATION
Diabetic Macular Edema (DME) and Diabetic Retinopathy
(DR)
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered
by intravitreal injection every 4 weeks (approximately every 28
days, monthly) for the first 5 injections followed by 2 mg (0.05
mL) via intravitreal injection once every 8 weeks (2
months).
- Although EYLEA may be dosed as frequently as 2 mg every
4 weeks (approximately every 25 days, monthly), additional
efficacy was not demonstrated in most patients when EYLEA was dosed
every 4 weeks compared to every 8 weeks. Some patients
may need every 4 week (monthly) dosing after the first
20 weeks (5 months).
Neovascular (Wet) Age-Related Macular Degeneration
(AMD)
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered
by intravitreal injection every 4 weeks (approximately every 28
days, monthly) for the first 3 months, followed by 2 mg (0.05 mL)
via intravitreal injection once every 8 weeks
(2 months).
- Although EYLEA may be dosed as frequently as 2 mg every
4 weeks (approximately every 25 days, monthly), additional
efficacy was not demonstrated in most patients when EYLEA was dosed
every 4 weeks compared to every 8 weeks. Some patients may need
every 4 week (monthly) dosing after the first 12 weeks (3
months).
- Although not as effective as the recommended every 8 week
dosing regimen, patients may also be treated with one dose every 12
weeks after one year of effective therapy. Patients should be
assessed regularly.
Macular Edema Following Retinal Vein Occlusion (RVO)
- The recommended dose for EYLEA is 2 mg (0.05 mL) administered
by intravitreal injection once every 4 weeks (approximately every
25 days, monthly).
For more information, please see full Prescribing
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, risks associated
with pending or future litigation, including the proceedings
initiated by the U.S. Attorney for the District of Massachusetts discussed in this press release
(the "U.S. Civil Complaint"), as well as litigation concerning
intellectual property of other parties (including without
limitation the patent litigation and other related proceedings
relating to Dupixent® (dupilumab) 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
(including without limitation the U.S. Civil Complaint and whether
Regeneron will be able to successfully defend the U.S. Civil
Complaint) and investigations, and the impact any of the foregoing
may have on Regeneron's business, prospects, operating results, and
financial condition; 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; 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 likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron's product candidates and new
indications for Regeneron's Products; unforeseen safety issues
resulting from the administration of Regeneron's Products 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 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; 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,
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 (914) 847-5018
sarah.cornhill@regeneron.com
Investor Relations
Vesna
Tosic
Tel: +1 (914) 847-5443
Vesna.Tosic@regeneron.com
View original
content:http://www.prnewswire.com/news-releases/regeneron-to-vigorously-defend-allegations-related-to-contributions-to-a-patient-assistance-charity-in-2013-and-early-2014-301083161.html
SOURCE Regeneron Pharmaceuticals, Inc.