Celgene Corporation (NASDAQ: CELG) today announced that the
GED-0301 (mongersen) phase III REVOLVE trial (CD-002) in Crohn’s
disease (CD) and the extension trial (SUSTAIN, CD-004) will
discontinue. Celgene has decided to stop the trials following an
October recommendation of the Data Monitoring Committee, which
assessed overall benefit/risk during a recent interim futility
analysis. There were no meaningful safety imbalances identified in
the analysis.
At this time, the phase III DEFINE trial (CD-003) in Crohn’s
disease will not be initiated. Celgene is waiting to review the
full dataset from the phase II trial with GED-0301 in ulcerative
colitis (UC) to determine next steps.
“We thank the patients and the investigators involved in the
REVOLVE trial,” said Scott Smith, President and Chief Operating
Officer for Celgene. “Crohn’s disease is a debilitating condition
with few effective long-term treatment options. While we are
disappointed with the results of REVOLVE, we remain committed to
advancing our portfolio of novel medicines for patients suffering
from this disease and other inflammatory bowel disorders.”
Celgene Inflammatory Bowel Disease Portfolio of Novel
Medicines Advances
Ozanimod: At the World Congress of Gastroenterology
meeting in October, two-year data from the phase II TOUCHSTONE
trial in UC and phase II data from the STEPSTONE trial in CD were
presented. The phase III TRUENORTH pivotal trial in UC is ongoing.
Celgene expects to initiate a phase III pivotal trial in CD in the
next few months.
OTEZLA®: A randomized, controlled, phase II
trial (UC-001) in UC is ongoing with data expected by year-end
2017. Pending positive results, a broad phase III UC program could
initiate in 2018.
About GED-0301 (mongersen)
The investigational oral antisense therapy GED-0301 (mongersen)
is an oligonucleotide that decreases Smad7 protein, thereby
potentially impacting TGF-β1 signaling. In patients with Crohn’s
disease, abnormally high levels of Smad7 interfere with TGF-β1
anti-inflammatory pathways in the gut, leading to increased
inflammation.
GED-0301 is an investigational compound that is not approved for
any use in any country.
About OzanimodOzanimod is a novel, oral, selective,
sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator
in development for immune-inflammatory indications including
relapsing multiple sclerosis, ulcerative colitis and Crohn's
disease. Selective binding with S1PR1 is believed to inhibit a
specific sub set of activated lymphocytes from migrating to sites
of inflammation. The result is a reduction of circulating T and B
lymphocytes that leads to anti-inflammatory activity. Importantly,
immune surveillance is maintained.
Selective binding with S1PR5 is thought to activate specific
cells within the CNS. This has the potential to enhance
remyelination and prevent synaptic defects. Ultimately,
neurological damage may be prevented.
Ozanimod is an investigational compound that is not approved for
any use in any country.
About OTEZLA®OTEZLA® (apremilast) 30 mg tablets is an
oral small-molecule inhibitor of phosphodiesterase 4 (PDE4)
specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition
results in increased intracellular cAMP levels which is thought to
indirectly modulate the production of inflammatory mediators. The
specific mechanism(s) by which OTEZLA® exerts its therapeutic
action in patients with psoriasis or psoriatic arthritis is not
well defined.
INDICATIONSOTEZLA® (apremilast) is indicated for the
treatment of patients with moderate to severe plaque psoriasis who
are candidates for phototherapy or systemic therapy.
OTEZLA® is indicated for the treatment of adult patients with
active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
ContraindicationsOTEZLA®
(apremilast) is contraindicated in patients with a known
hypersensitivity to apremilast or to any of the excipients in the
formulation.
Warnings and
PrecautionsDiarrhea, Nausea and Vomiting: Cases of
severe diarrhea, nausea, and vomiting were associated with the use
of OTEZLA®. Most events occurred within the first few weeks of
treatment. In some cases, patients were hospitalized. Patients 65
years of age or older and patients taking medications that can lead
to volume depletion or hypotension may be at a higher risk of
complications from severe diarrhea, nausea, or vomiting. Monitor
patients who are more susceptible to complications of diarrhea or
vomiting; advise patients to contact their healthcare provider.
Consider OTEZLA® dose reduction or suspension if patients develop
severe diarrhea, nausea, or vomiting.
Depression: Carefully weigh the risks and benefits of treatment
with OTEZLA® for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on OTEZLA®. Patients, caregivers, and families
should be advised of the need to be alert for the emergence or
worsening of depression, suicidal thoughts or other mood changes,
and they should contact their healthcare provider if such changes
occur.
Psoriasis: Treatment with OTEZLA®
is associated with an increase in depression. During clinical
trials, 1.3% (12/920) of patients reported depression compared to
0.4% (2/506) on placebo; Depression was reported as serious in 0.1%
(1/1308) of patients exposed to OTEZLA®, compared to none in
placebo-treated patients (0/506). Suicidal behavior was observed in
0.1% (1/1308) of patients on OTEZLA®, compared to 0.2% (1/506) on
placebo. One patient treated with OTEZLA® attempted suicide; one
patient on placebo committed suicide.
Psoriatic Arthritis: Treatment with
OTEZLA® is associated with an increase in depression. During
clinical trials, 1.0% (10/998) reported depression or depressed
mood compared to 0.8% (4/495) treated with placebo. Suicidal
ideation and behavior was observed in 0.2% (3/1441) of patients on
OTEZLA®, compared to none in placebo treated patients. Depression
was reported as serious in 0.2% (3/1441) of patients exposed to
OTEZLA®, compared to none in placebo treated patients (0/495). Two
patients who received placebo committed suicide compared to none on
OTEZLA®.
Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of OTEZLA®.
Psoriasis: Body weight loss of
5-10% occurred in 12% (96/784) of patients treated with OTEZLA® and
in 5% (19/382) of patients treated with placebo. Body
weight loss of ≥10% occurred in 2% (16/784) of patients treated
with OTEZLA® compared to 1% (3/382) of patients treated with
placebo.
Psoriatic Arthritis: Body weight
loss of 5-10% was reported in 10% of patients taking OTEZLA® and in
3.3% of patients taking placebo.
Drug Interactions: Apremilast exposure was decreased when
OTEZLA® was co-administered with rifampin, a strong CYP450 enzyme
inducer; loss of OTEZLA® efficacy may occur. Concomitant use of
OTEZLA® with CYP450 enzyme inducers (e.g., rifampin, phenobarbital,
carbamazepine, phenytoin) is not recommended.
Adverse
ReactionsPsoriasis: Adverse
reactions reported in ≥5% of patients were
(OTEZLA®%, placebo%): diarrhea (17, 6), nausea (17, 7),
upper respiratory tract infection (9, 6), tension headache (8, 4),
and headache (6, 4).
Psoriatic Arthritis: Adverse
reactions reported in at least 2% of patients taking OTEZLA®, that
occurred at a frequency at least 1% higher than that observed
in patients taking placebo, for up to 16 weeks (after the initial
5-day titration), were (OTEZLA®%, placebo%): diarrhea (7.7,
1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory
tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis
(2.6, 1.6); upper abdominal pain (2.0, 0.2).
Use in Specific
PopulationsPregnancy and Nursing Mothers: OTEZLA® is
Pregnancy Category C; it has not been studied in pregnant women.
Use during pregnancy only if the potential benefit justifies the
potential risk to the fetus. It is not known whether apremilast or
its metabolites are present in human milk. Caution should be
exercised when OTEZLA® is administered to a nursing woman.
Renal Impairment: OTEZLA® dosage should be reduced in patients
with severe renal impairment (creatinine clearance less than 30
mL/min); for details, see Dosage and Administration,
Section 2, in the Full Prescribing Information.
Please click here for Full
Prescribing Information
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical 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
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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 Securities
and Exchange Commission.
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Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Corporate Vice President, Investor
RelationsorMedia:Catherine Cantone, 908-897-4256Senior Director,
Corporate Communications
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