Teva and Regeneron Announce Global Collaboration to Develop and Commercialize Fasinumab, an Investigational NGF Antibody for Chronic Pain

JERUSALEM & TARRYTOWN, N.Y.–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) 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 milestones 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 the U.S. In countries outside the
U.S.¹ 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).

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

View source version on businesswire.com: http://www.businesswire.com/news/home/20160920005827/en/