TARRYTOWN, N.Y. and
JERUSALEM, Aug. 16, 2018 /PRNewswire/ --
Data include final primary efficacy results and an interim
safety analysis
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced positive topline results from a Phase 3, randomized,
double-blind, placebo-controlled study of fasinumab in patients
with chronic pain from osteoarthritis (OA) of the knee or hip. At
the week 16 primary efficacy analysis, the study met both
co-primary endpoints and all key secondary endpoints.
Fasinumab-treated patients experienced significantly less pain and
significantly improved functional ability from baseline compared to
placebo.
"We are encouraged by these data and look forward to advancing
our pivotal Phase 3 fasinumab program in patients with
osteoarthritis of the knee or hip, who currently have very limited
therapeutic choices to treat their chronic pain, other than with
non-steriodal anti-inflammatory drugs or opioids," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer of Regeneron.
The study compared two different fasinumab treatment arms
(subcutaneous 1 mg every four or eight weeks) with placebo. The
co-primary endpoint results are presented in Table 1.
Table 1: Topline Efficacy Results from Phase 3
Study1
|
Placebo
(n=214)
|
Fasinumab 1 mg
every 8 weeks
(n=215)
|
Fasinumab 1 mg
every 4 weeks
(n=217)
|
Change in pain at
week 16 vs. baseline (least squares [LS]
mean)2
|
-1.56
|
-2.25
(p=0.0019)
|
-2.78
(p<0.0001)
|
Change in physical
function at week 16 vs. baseline (LS
mean)3
|
-1.37
|
-2.10
(p=0.0011)
|
-2.57
(p<0.0001)
|
1. Approximately 85% of sub-study patients had OA of the
knee; 2. As measured by the Western Ontario and McMaster Universities
Osteorarthritis Index (WOMAC) pain subscale score (score range:
0-10); 3. As measured by the WOMAC physical function
subscale score (score range: 0-10)
After the primary efficacy assessment at week 16, patients
continue on therapy for an additional 36 weeks, followed by a
subsequent 20-week off study drug follow-up period for further
safety assessment.
Interim safety data indicate that fasinumab was generally well
tolerated, with similar adverse events (AEs) as those observed in
previous fasinumab trials. At week 16, treatment discontinuations
due to AEs had occurred in 6% of the placebo group patients, 5% of
the fasinumab 1 mg every eight weeks group patients and 6% of the
fasinumab 1 mg every four weeks group patients. The fasinumab
safety program was designed to capture all arthropathies (joint
damage), including those identified due to symptoms and those
identified by regularly-scheduled radiographic monitoring, the
first of which was scheduled at week 24. Among the approximately
65% of patients who had completed their first radiographic
assessment, the placebo-adjusted rate of adjudicated arthropathies
was approximately 2%. The majority of arthropathies were captured
by the regularly-scheduled radiographic monitoring and involved
isolated joint space narrowing, called RPOA-1 (rapid progressive OA
type 1). No cases of osteonecrosis have been identified to date in
this study.
The companies plan to present detailed results at an upcoming
medical congress.
Regeneron and Teva are jointly developing fasinumab as part of a
global collaboration agreement. In Japan and 10 other Asian countries, Mitsubishi
Tanabe Pharma Corporation holds exclusive development and
commercial rights for fasinumab.
About the Phase 3 Study
The Phase 3 study is a sub-study of a larger, long-term trial
that involves 52 weeks of active treatment, designed to determine
the safety and tolerability of fasinumab, including AEs of special
interest, in patients with pain due to radiographically-confirmed
OA of the knee or hip. Approximately 85% of sub-study patients had
OA of the knee. The primary efficacy data were assessed at 16
weeks; the primary safety analysis of the larger long-term trial
will occur at 72 weeks (52-week active treatment and 20-week
follow-up periods). The safety data presented today are interim
data and preliminary in nature. Earlier this year, an Independent
Data Monitoring Committee (IDMC) monitoring the safety and efficacy
of ongoing fasinumab trials recommended that the two higher dose
regimens (3 mg every four weeks and 6 mg every eight weeks) be
discontinued.
About Fasinumab
Fasinumab is an investigational therapy invented by Regeneron
using the company's proprietary VelocImmune®
technology that yields optimized fully-human antibodies. Fasinumab
targets nerve growth factor (NGF), a protein that plays a central
role in the regulation of pain signaling. There is evidence that
NGF levels are elevated in the synovial fluid of patients with
chronic pain conditions.
Regeneron and Teva are currently enrolling patients with chronic
pain caused by OA of the knee or hip in three Phase 3 clinical
trials including one assessing fasinumab long-term safety and two
trials comparing fasinumab to standard pain therapies. The safety
and efficacy of fasinumab have not been fully evaluated by any
regulatory authority.
About Regeneron
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 six 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 disease, heart disease, allergic and inflammatory
diseases, pain, cancer, 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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global leader in generic medicines, with innovative treatments in
select areas, including CNS, pain and respiratory. We deliver
high-quality generic products and medicines in nearly every
therapeutic area to address unmet patient needs. We have an
established presence in generics, specialty, OTC and API, building
on more than a century-old legacy, with a fully integrated R&D
function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally
responsible way. Headquartered in Israel, with production and research
facilities around the globe, we employ 45,000 professionals,
committed to improving the lives of millions of patients. Learn
more at www.tevapharm.com.
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 fasinumab; 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 clinical development
programs evaluating fasinumab; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates, such as fasinumab for
patients with chronic pain from osteoarthritis of the hip or knee
or other potential indications; 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 fasinumab; 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;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products, 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; 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; the
availability and extent of reimbursement of the Company'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;
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 (or their
respective affiliated companies, as applicable) and Regeneron's
agreements with Teva Pharmaceutical Industries Ltd. and Mitsubishi
Tanabe Pharma Corporation relating to fasinumab, 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 proceedings relating to EYLEA®
(aflibercept) Injection, Dupixent® (dupilumab)
Injection, and Praluent® (alirocumab) Injection, the
ultimate outcome of any such litigation proceedings, 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-Q for the quarterly period ended
June 30, 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).
Teva Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding fasinumab, which are based on management's current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- challenges inherent in product research and development,
including uncertainty of clinical success and obtaining regulatory
approvals;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; competition for our specialty products, especially
COPAXONE®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased indebtedness and significantly
decreased cash on hand, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make
new investments, may result in a further downgrade of our credit
ratings; and our inability to raise debt or borrow funds in amounts
or on terms that are favorable to us;
- our business and operations in general, including: failure
to effectively execute our restructuring plan announced in
December 2017; uncertainties related
to, and failure to achieve, the potential benefits and success of
our new senior management team and organizational structure; harm
to our pipeline of future products due to the ongoing review of our
R&D programs; our ability to develop and commercialize
additional pharmaceutical products; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; compliance with sanctions and other trade
control laws; manufacturing or quality control problems, which may
damage our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; our ability to successfully bid for suitable acquisition
targets or licensing opportunities, or to consummate and integrate
acquisitions; and our prospects and opportunities for growth if we
sell assets;
- compliance, regulatory and litigation matters, including:
costs and delays resulting from the extensive governmental
regulation to which we are subject; the effects of reforms in
healthcare regulation and reductions in pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales
and marketing practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and
payment obligations; and environmental risks;
- other financial and economic risks, including: our exposure
to currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2017,
including in the section captioned "Risk Factors," and in our other
filings with the U.S. Securities and Exchange Commission, which are
available at www.sec.gov and
www.tevapharm.com. Forward-looking statements speak only
as of the date on which they are made, and we assume no obligation
to update or revise any forward-looking statements or other
information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
Contacts Regeneron:
|
Contacts
Teva:
|
Media
Relations
Sarah
Cornhill
Tel: +1 (917)
297-1522
sarah.cornhill@regeneron.com
|
Media
Relations
Doris
Saltkill
Tel: +1 (913)
777-3343
doris.saltkill@tevapharm.com
|
Investor Relations
Manisha Narasimhan,
Ph.D.
Tel: +1 (914)
847-5126
manisha.narasimhan@regeneron.com
|
Investor
Relations
Kevin C.
Mannix
Tel: +1 (215)
591-8912
kevin.mannix@tevapharm.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.