Regeneron and Teva Provide Update on Fasinumab Clinical Development Programs

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today provided an update on fasinumab, triggered by a recent development in a Phase 2b fasinumab study in patients with chronic low back pain. Fasinumab is an investigational Nerve Growth Factor (NGF) antibody in clinical development for osteoarthritis pain and chronic low back pain.
Chronic Low Back Pain Program Update
The U.S. Food and Drug
Administration (FDA) has placed the Phase 2b study in chronic low back
pain on clinical hold and requested an amendment of the study protocol
after observing a case of adjudicated arthropathy in a patient receiving
high dose fasinumab who had advanced osteoarthritis at study entry. As a
result of the FDA decision, Regeneron completed an unplanned interim
review of results and has stopped dosing in the study. The unplanned
analysis showed clear evidence of efficacy with improvement in pain
scores in all fasinumab groups compared to placebo at the 8- and 12-week
time points (nominal p-value less than 0.01). Preliminary safety results
are generally consistent with what has been previously reported with the
class. The Phase 2b chronic low back pain study enrolled approximately
70 percent of the targeted 800 patients in four dose groups: placebo,
6mg subcutaneously monthly, 9mg subcutaneously monthly and 9mg
intravenously every two months. Regeneron has notified health
authorities and study investigators about the decision. Patients will
continue to be followed for up to 36 weeks.
Based on these results, Regeneron and Teva plan to design a pivotal
Phase 3 study in chronic low back pain that excludes patients with
advanced osteoarthritis. The companies plan to submit a pivotal program
plan for review with the FDA and other health authorities.
Osteoarthritis Pain Program Update
Sixteen week positive
results from the fasinumab Phase 2/3 osteoarthritis pain study in 421
patients were previously
reported. Patients received their last dose at 12 weeks and a
follow-up analysis occurred at 36 weeks. The study incorporated
extensive imaging and analyses at baseline and during the study of index
and non-index joints, with particular focus on arthropathies including
subchondral insufficiency fractures (SIF), osteonecrosis (ON) and
rapidly progressive osteoarthritis (RPOA). At the 36-week analysis, the
incidence of adjudicated arthropathies was found to be potentially
dose-dependent, with a higher rate of patients experiencing
arthropathies in the higher dose groups [12 percent (9mg), 7 percent
(6mg), 5 percent (3mg), 2 percent (1mg) and 1 percent (placebo)]. Based
on these data, the companies are planning to advance only lower doses in
the ongoing fasinumab osteoarthritis pivotal Phase 3 program, subject to
discussion with the FDA and other health authorities.
Updated data from the osteoarthritis pain Phase 2/3 study and the
chronic low back pain Phase 2b study will be presented at upcoming
medical congresses.
“We are making data-driven decisions on Phase 3 fasinumab dosing that we
believe will maximize potential benefit for patients in need, while
minimizing the likelihood of side effects,” said George D. Yancopoulos,
M.D., Ph.D., Chief Scientific Officer, Regeneron and President,
Regeneron Laboratories. “We look forward to working with global health
authorities to advance this important investigational therapy for
patients with often difficult-to-treat osteoarthritis pain and chronic
low back pain.”
“We believe fasinumab represents an important potential innovation for
patients with osteoarthritis pain and chronic low back pain who
currently have clear unmet need and limited treatment options,” said
Michael Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva. “We look forward to advancing clinical
development for this promising novel therapy.”
Regeneron and Teva are collaborating on the global development and
commercialization of fasinumab. Under a separate agreement with
Regeneron, Mitsubishi Tanabe Pharma has exclusive development and
commercial rights to fasinumab in Japan, Korea and nine other Asian
countries.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ:
REGN) is a leading science-based biopharmaceutical company that
discovers, invents, develops, manufactures and commercializes medicines
for the treatment of serious medical conditions. Regeneron
commercializes medicines for eye diseases, high LDL cholesterol and a
rare inflammatory condition and has product candidates in development in
other areas of high unmet medical need, including rheumatoid arthritis,
atopic dermatitis, asthma, pain, cancer and infectious diseases. 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 leading global pharmaceutical company that delivers
high-quality, patient-centric healthcare solutions used by millions of
patients every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva’s net
revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva’s Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains
forward-looking statements, which are based on management’s current
beliefs and expectations and involve a number of known and unknown risks
and uncertainties that could cause our future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such differences
include risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our specialty
products, especially Copaxone^® (which faces
competition from orally-administered alternatives and a generic
version); our ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of realizing
such benefits); the fact that following the consummation of the Actavis
Generics acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt incurred to finance the Actavis Generics acquisition; the fact that
for a period of time following the Actavis Generics acquisition, we will
have significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from investments in our pipeline of specialty
and other products; our ability to identify and successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; the extent to which any
manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions as
well as credit risks; the effectiveness of our patents, confidentiality
agreements and other measures to protect the intellectual property
rights of our specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
governmental investigations into sales and marketing practices,
particularly for our specialty pharmaceutical products; adverse effects
of political or economic instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; the impact of continuing consolidation of our distributors
and customers; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; our potential exposure to
product liability claims that are not covered by insurance; any failure
to recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare and
Medicaid reporting and payment obligations; significant impairment
charges relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting reliance
on access to the capital markets; potentially significant increases in
tax liabilities; 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; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 and in our other filings with the U.S. Securities and Exchange
Commission (the “SEC”). 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, whether as a
result of new information, future events or otherwise.
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 (REGN475) for
osteoarthritis pain, chronic low back pain, or other potential
indications; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
(including without limitation the development of fasinumab for
osteoarthritis pain and other potential indications pursuant to the
collaboration agreement with Teva Pharmaceutical Industries Ltd.) may
lead to therapeutic applications; 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 fasinumab
for osteoarthritis pain, chronic low back pain, or other potential
indications, as well as the potential fasinumab pivotal Phase 3 study in
patients with chronic low back pain and the fasinumab pivotal Phase 3
program in patients with osteoarthritis pain; unforeseen safety issues
and possible liability resulting from the administration of products and
product candidates in patients, including fasinumab; serious
complications or side effects in connection with the use of Regeneron’s
products and product candidates in clinical trials, such as the current
and contemplated global clinical development programs evaluating
fasinumab for osteoarthritis pain, chronic low back pain, or other
potential indications; ongoing regulatory obligations and oversight
impacting Regeneron’s marketed products, research and clinical programs,
and business, including those relating to the enrollment, completion,
and meeting of the relevant endpoints of post-approval studies; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron’s late-stage product candidates (such as
fasinumab) and new indications for marketed products; competing drugs
and product candidates that may be superior to Regeneron’s products and
product candidates; coverage and reimbursement determinations by
third-party payers, including Medicare, Medicaid, and pharmacy benefit
management companies; 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;
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 the respective collaboration agreements with Teva
Pharmaceutical Industries Ltd. and Mitsubishi Tanabe Pharma Corporation
relating to the development of fasinumab, to be cancelled or terminated
without any product success; and risks associated with intellectual
property of other parties and pending or future litigation relating
thereto. 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, 2015 and its Form 10-Q for the quarterly period ended June
30, 2016. 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 (https://newsroom.regeneron.com)
and its Twitter feed (https://twitter.com/regeneron).