Celgene Corporation (NASDAQ:CELG) today announced that the U.S.
Food and Drug Administration (FDA) has accepted for review the New
Drug Application for ozanimod for the treatment of people with
relapsing forms of multiple sclerosis (RMS) in the United States.
The European Medicines Agency (EMA) also accepted for review the
Marketing Authorization Application for ozanimod for the treatment
of adults with relapsing-remitting multiple sclerosis (RRMS) in the
European Union. Ozanimod is an oral, sphingosine 1-phosphate (S1P)
receptor modulator that binds with high affinity selectively to S1P
subtypes 1 (S1P1) and 5 (S1P5). Under the Prescription Drug User
Fee Act, the FDA has set its action date as March 25, 2020. A
regulatory decision from the EMA is expected in the first half of
2020.
Both applications are based primarily on ozanimod data from the
SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized,
double-blind, double-dummy, active-controlled trials.
“The U.S. Food and Drug Administration and European Medicines
Agency acceptances of our applications represent a crucial step
forward in our efforts to bring ozanimod to people with multiple
sclerosis,” said Jay Backstrom, M.D., Chief Medical Officer for
Celgene. “We believe that ozanimod has the potential to be an
important option early in the treatment of relapsing forms of MS
and a best-in-class S1P receptor modulator.”
Ozanimod is an investigational compound that is not approved for
any use in any country.
About SUNBEAM™
SUNBEAM is a pivotal, phase 3, multicenter, randomized,
double-blind, double-dummy, active-controlled trial evaluating the
efficacy, safety and tolerability of two doses of oral ozanimod
(0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI
respectively) against weekly intramuscular interferon beta-1a
(Avonex®) for at least a 12-month treatment period. The study
included 1,346 people living with RMS across 152 sites in 20
countries.
The primary endpoint of the trial was annualized relapse rates
(ARR) during the treatment period. The secondary MRI endpoints
included the number of new or enlarging hyperintense T2-weighted
brain MRI lesions over 12 months, number of gadolinium-enhanced
brain MRI lesions at month 12 and percent change from baseline in
whole brain volume at month 12. Cortical grey and thalamic volume
changes were also prospectively assessed versus active
comparator.
An analysis of the time to onset of 3-month confirmed disability
progression was pre-specified using pooled data from both the
SUNBEAM and RADIANCE Part B phase 3 trials.
About RADIANCE™
RADIANCE Part B is a pivotal, phase 3, multicenter, randomized,
double-blind, double-dummy, active-controlled trial evaluating the
efficacy, safety and tolerability of two doses of oral ozanimod
(0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI
respectively) against weekly intramuscular interferon beta-1a
(Avonex®) over a 24-month treatment period. The study included
1,320 people living with RMS across 150 sites in 21 countries.
The primary endpoint of the trial was ARR over 24 months. The
secondary MRI endpoints included the number of new or enlarging
hyperintense T2-weighted brain MRI lesions over 24 months, number
of gadolinium-enhanced brain MRI lesions at month 24 and percent
change from baseline in whole brain volume at month 24. Cortical
grey and thalamic volume changes were also prospectively assessed
versus active comparator.
An analysis of the time to onset of 3-month confirmed disability
progression was pre-specified using pooled data from both the
SUNBEAM and RADIANCE Part B phase 3 trials.
About Ozanimod
Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor
modulator that binds with high affinity selectively to S1P subtypes
1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in
lymphoid tissues. The mechanism by which ozanimod exerts
therapeutic effects in multiple sclerosis is unknown, but may
involve the reduction of lymphocyte migration into the central
nervous system.
Ozanimod is in development for immune-inflammatory indications
including RMS, ulcerative colitis and Crohn's disease.
About Multiple Sclerosis
Multiple sclerosis (MS) is a disease in which the immune system
attacks the protective myelin sheath that covers the nerves. The
myelin damage disrupts communication between the brain and the rest
of the body. Ultimately, the nerves themselves may deteriorate — a
process that's currently irreversible. Signs and symptoms vary
widely, depending on the amount of damage and the nerves affected.
Some people living with MS may lose the ability to walk
independently, while others experience long periods of remission
during which they develop no new symptoms. MS affects approximately
400,000 people in the U.S. and approximately 2.5 million people
worldwide.
RMS is characterized by clearly defined attacks of worsening
neurologic function. These attacks — often called relapses,
flare-ups or exacerbations — are followed by partial or complete
recovery periods (remissions), during which symptoms improve
partially or completely with no apparent progression of disease.
RMS is the most common disease course at the time of diagnosis.
Approximately 85 percent of patients are initially diagnosed with
RMS, compared with 10-15 percent with progressive forms of the
disease.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next‐generation solutions in protein homeostasis,
immuno‐oncology, epigenetics, immunology and neuro‐inflammation.
For more information, please visit www.celgene.com. Follow
Celgene on Social Media: @Celgene, Pinterest, LinkedIn,
Facebook and YouTube.
Forward-Looking Statements
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are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking
statements are based on management's current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. We undertake no obligation to update any forward-looking
statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to
predict and are generally beyond our control. Actual results or
outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual
Report on Form 10-K and our other reports filed with the U.S.
Securities and Exchange Commission, including factors related to
the proposed transaction between Bristol-Myers Squibb and Celgene,
such as, but not limited to, the risks that: management’s time and
attention is diverted on transaction related issues; disruption
from the transaction make it more difficult to maintain business,
contractual and operational relationships; any legal proceedings
are instituted against Bristol-Myers Squibb, Celgene or the
combined company that could delay or prevent the proposed
transaction; and Bristol-Myers Squibb, Celgene or the combined
company is unable to retain key personnel.
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