Analysis Showed Oral Ozanimod Reduced Brain Volume Loss Across All Age Subgroups in Adults with Relapsing Multiple Sclerosis

Patients across all age subgroups treated with ozanimod lost less
cortical grey matter volume than did those treated with interferon
beta-1a over 24 months

Data from new analysis of pivotal ozanimod trial will be presented at
2019 AAN Annual Meeting

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced the results of a
post-hoc analysis of data from the Phase 3 RADIANCE™ Part B trial
showing that ozanimod reduced cortical grey matter volume loss versus
first-line treatment, Avonex^® (interferon beta-1a), in adults
with relapsing multiple sclerosis (RMS) across all age groups, including
patients ages 18 to 25. The analysis will be presented at the 2019
American Academy of Neurology (AAN) Annual Meeting in Philadelphia, May
4-10, 2019.

“Brain volume loss is associated with long-term physical disability and
cognitive issues in multiple sclerosis,” said Bruce Cree, M.D., Ph.D.,
M.A.S., Professor of Neurology at the University of California San
Francisco (UCSF) Weill Institute for Neurosciences, Clinical Research
Director at the UCSF MS Center, and an author of the analysis. “Ozanimod
reduced the loss of cortical grey matter volume across all age groups in
this study.”

RADIANCE evaluated two doses of oral ozanimod (0.92 mg and 0.46 mg,
equivalent to 1 mg and 0.5 mg ozanimod HCI respectively) compared with
interferon beta-1a in 1,313 patients with RMS between the ages of 18 and
55 years old. In this post-hoc analysis of 874 patients, treatment
effect on serial brain volume, including thalamic volume and cortical
grey matter, was evaluated by patient age (18 to 25, n=146; 26 to 34,
n=265; 35 and older, n=463) at baseline, 12 months and 24 months.

Patients in the 18 to 25 age group tended to have greater brain volume
at baseline but more active disease as measured by gadolinium-enhancing
MRI lesions. There was also a trend for this age group to experience
greater whole brain volume loss at both 12 and 24 months compared with
the older groups.

Patients across all age groups treated with ozanimod lost less cortical
grey matter volume than did those treated with interferon beta-1a over
24 months, including patients in the 18 to 25 age group.

In the RADIANCE Part B trial, the most common adverse reactions (≥ 5
percent) that were higher with ozanimod than with interferon beta-1a
were upper respiratory tract infections, urinary tract infections,
increases of alanine aminotransferase and increases of gamma-glutamyl
transferase.

“Since loss of brain volume can be associated with disease progression,
there is a need for early diagnosis and treatment in multiple
sclerosis,” said Alise Reicin, M.D., President, Global Clinical
Development for Celgene. “This analysis adds to growing evidence
supporting the potential use of ozanimod to treat adults with relapsing
multiple sclerosis, including the youngest patients studied, who also
showed the most rapid loss in brain volume in this study.”

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 is an investigational compound that is
not approved for any use in any country.

Celgene submitted a New Drug Application to the U.S. Food and Drug
Administration and a Marketing Authorization Application to the European
Medicines Agency in March 2019 for ozanimod for the treatment of adults
with RMS.

About RADIANCE™ Part B

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 1,313 people living
with RMS across 150 sites in 21 countries.

The primary endpoint of the trial was annualized relapse rates (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.
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