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Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

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Data include final primary efficacy results and an interim safety
analysis

Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron
Pharmaceuticals, Inc. (NASDAQ:REGN) 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

  Fasinumab 1 mg   Fasinumab 1 mg

(n=214)

every 8 weeks every 4 weeks
       

(n=215)

 

(n=217)

Change in pain at week 16 vs. -1.56 -2.25 -2.78

baseline (least squares [LS] mean)2

      (p=0.0019)   (p0.0001)
Change in physical function at week -1.37 -2.10 -2.57

16 vs. baseline (LS mean)3

      (p=0.0011)   (p0.0001)

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 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.

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.

Teva Cautionary Note Regarding 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.

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).

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