Regeneron and Teva Provide Update on Fasinumab Clinical Development Programs

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Regeneron Pharmaceuticals and Teva Pharmaceutical Industries today provided an update on fasinumab, triggered by a recent development in a Phase 2b fasinumab study in patients with chronic low back pain.

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.
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performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the
“Company”), and actual events or results may differ materially from
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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
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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
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product candidates in patients, including fasinumab; serious
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and contemplated global clinical development programs evaluating
fasinumab for osteoarthritis pain, chronic low back pain, or other
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