TARRYTOWN, N.Y. and
JERUSALEM, Oct. 17, 2016 /PRNewswire/ -- 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 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 (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
IR Contact at Regeneron:
Manisha Narasimhan, Ph.D., Tel.
914.847.5126
E-Mail: manisha.narasimhan@regeneron.com
Media Contact at Regeneron:
Hala Mirza, Tel.
914.847.3422
E-Mail hala.mirza@regeneron.com
Teva IR
Contacts:
|
Kevin C.
Mannix
|
United
States
|
(215)
591-8912
|
|
Ran
Meir
|
United
States
|
(215)
591-3033
|
|
Tomer
Amitai
|
Israel
|
972 (3)
926-7656
|
Teva PR
Contacts:
|
Iris Beck
Codner
|
Israel
|
972 (3)
926-7687
|
|
Denise
Bradley
|
United
States
|
(215)
591-8974
|
|
Nancy
Leone
|
United
States
|
(215)
284-0213
|
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SOURCE Regeneron Pharmaceuticals, Inc.