Novel Nerve Growth Factor (NGF) Antibody Has
Potential to Address Limitations of Current Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) and Opioid Therapies
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; 1203 Decisions
Resources Group. Chronic Pain: Disease Landscape and Forecast.
2016; 1154 Decisions Resources Group. Chronic Pain: Disease
Landscape and Forecast. 2016; 148-1495 Decisions Resources Group.
Chronic Pain: Disease Landscape and Forecast. 2016; 1476 Decisions
Resources Group. Chronic Pain: Disease Landscape and Forecast.
2016; 7
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version on businesswire.com: http://www.businesswire.com/news/home/20160920005827/en/
Teva IR:United StatesKevin C. Mannix, (215) 591-8912orRan Meir,
(215) 591-3033orIsraelTomer Amitai, 972 (3) 926-7656orRegeneron
IR:United StatesManisha Narasimhan, PhD, (914)
847-5126manisha.narasimhan@regeneron.comorTeva PR:IsraelIris Beck
Codner, 972 (3) 926-7687orUnited StatesDenise Bradley, (215)
591-8974orNancy Leone, (215) 284-0213orRegeneron PR:United
StatesAlexandra Bowie, (914)
847-3407alexandra.bowie@regeneron.com
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