TARRYTOWN, N.Y. and
JERUSALEM, Sept. 20, 2016 /PRNewswire/
-- Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) announced today a global1 agreement
to develop and commercialize fasinumab, Regeneron's investigational
NGF antibody in Phase 3 clinical development for osteoarthritis
pain and in Phase 2 development for chronic low back pain. Under
the terms of the agreement, Teva will pay Regeneron $250 million upfront and share equally in the
global1 commercial value, as well as ongoing research
and development costs of approximately $1
billion.
"This is a significant transaction for Teva, and we look forward
to our collaboration with Regeneron, a leader in the research and
development of innovative biologics, which aligns with our overall
corporate strategy. With our commercial footprint, we will be able
to widely educate healthcare providers about this new treatment
option when it becomes available," said Rob Koremans, M.D.,
President and Chief Executive Officer of Global Specialty Medicines
for Teva.
"The development of novel pain medicines, such as fasinumab, can
be one important step in combating the growing opioid epidemic,"
said George D. Yancopoulos, M.D.,
Ph.D., Chief Scientific Officer, Regeneron and President, Regeneron
Laboratories. "Fasinumab represents the culmination of more than 25
years of Regeneron scientific work in neurotrophic factors. We look
forward to working with Teva, a leading global pharmaceutical
company with an expertise in pain therapeutics, to advance this
program for patients in need."
Under the terms of the agreement, Regeneron is eligible to
receive development and regulatory milestone payments and
additional payments based on net sales. Regeneron will lead global
development and U.S. commercialization. The companies will share
U.S. commercialization efforts by utilizing sales teams and
marketing expertise from both companies, and split profit equally.
In countries outside the U.S., with the exception of those
covered by a previously announced collaboration agreement between
Regeneron and Mitsubishi, Teva will be responsible for development
and commercialization and pay Regeneron a purchase price, which
allows both companies to retain approximately equal shares of
fasinumab's global1 commercial value over time.
"Fasinumab has shown proof of concept in early clinical trials,
and represents an exciting, novel target for pain relief. Adding
the promise of fasinumab to our developing pipeline of pain
products also provides a strong, strategic cornerstone to our pain
franchise at Teva. It has the potential to provide a treatment
option without the concerns of abuse, addiction and misuse of
opioids. In the United States
alone, it is estimated that 30 million people suffer pain from
osteoarthritis and the same number with chronic low back pain,"
said Michael Hayden, President of
Teva Global R&D and Chief Scientific Officer.
Fasinumab is a fully human monoclonal antibody that targets NGF,
a protein that plays a central role in the regulation of pain
signaling. There is evidence that NGF levels are elevated in
patients with chronic pain conditions.
Under a previously announced collaboration agreement with
Regeneron, Mitsubishi Tanabe Pharma has exclusive development and
commercial rights to fasinumab in Japan, Korea and nine other Asian
countries.
About Osteoarthritis Pain and Chronic Low Back Pain
In
the U.S., more than 30 million people live with osteoarthritis
pain, and a similar number with chronic low back pain, with both
populations expected to grow in the low-single digit percentages
annually.2,3 Many patients experience pain at
moderate-to-severe levels with intolerance and/or inadequate
response to current analgesic therapies such as opioids and
NSAIDs.4,5 There is a great need for highly effective
analgesic medications to provide patient relief without the
toxicity and tolerability challenges of NSAIDs and
opioids.3 Opioid prescriptions account for 40 percent of
the chronic pain market and carry a well-known risk of abuse and
misuse, underscoring the need for alternative pain therapies
without the medical and societal challenges.3,6
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.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading science-based biopharmaceutical company
based in Tarrytown, New York 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.
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) and the collaboration agreement with Teva Pharmaceutical
Industries Ltd. discussed in this news release; 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 conducted pursuant to the collaboration
agreement discussed in this news release) 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 pain due to osteoarthritis and chronic low back pain
and other potential indications; unforeseen safety issues and
possible liability resulting from the administration of products
and product candidates in patients; 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; 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 collaboration agreement with Teva
Pharmaceutical Industries Ltd. discussed in this news release, 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:
Alexandra Bowie, Tel.
914.847.3407
E-Mail: alexandra.bowie@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
|
[1] Excludes Japan, Korea and nine other Asian countries,
which are part of a previously announced collaboration agreement
between Regeneron and Mitsubishi Tanabe Pharma.
[2]
Decisions Resources Group. Chronic Pain: Disease Landscape and
Forecast. 2016; 120
[3] Decisions Resources Group.
Chronic Pain: Disease Landscape and Forecast. 2016; 115
[4]
Decisions Resources Group. Chronic Pain: Disease Landscape and
Forecast. 2016; 148-149
[5] Decisions Resources Group.
Chronic Pain: Disease Landscape and Forecast. 2016; 147
[6]
Decisions Resources Group. Chronic Pain: Disease Landscape and
Forecast. 2016; 7
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/regeneron-and-teva-announce-global-collaboration-to-develop-and-commercialize-fasinumab-an-investigational-ngf-antibody-for-chronic-pain-300330606.html
SOURCE Regeneron Pharmaceuticals, Inc.