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Celgene to Present New Data from Clinical Trials on Oral OTEZLA® (apremilast) at American Academy of Dermatology Congress

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Celgene Corporation (NASDAQ:CELG) today announced that findings from
ongoing clinical trials of OTEZLA® (apremilast), the
Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4),
conducted in patients with moderate or moderate to severe plaque
psoriasis, and in adult patients (18 years or older) with active
psoriatic arthritis, will be presented at the 75th Annual
Meeting of the American Academy of Dermatology (AAD) in Orlando,
Florida. Ten abstracts will be presented at the meeting.

Among the data that will be presented is an analysis of the phase 4
UNVEIL trial, which evaluates the clinical efficacy and safety of oral
OTEZLA 30 mg twice daily compared with placebo at week 16 in patients
with moderate plaque psoriasis [defined as a body surface area (BSA)
involvement of 5-10 percent and a static Physician's Global Assessment
(sPGA) of 3] who were naïve to systemic and biologic therapy. At
baseline, more than 80 percent of patients enrolled in the trial had
previously received topical therapy.

"We are excited to present new clinical research to the scientific
community at AAD showing the efficacy and safety of OTEZLA in a variety
of studies in patients with plaque psoriasis, including longer-term
data," said Scott Smith, President, Celgene Inflammation & Immunology.
"Furthermore, we are eager to share the results from UNVEIL, which is
the first trial to evaluate a systemic therapy in patients with moderate
plaque psoriasis who have not previously been treated with a systemic
therapy, including biologics."

The following abstracts will be presented at American Academy of
Dermatology as an exchange of scientific and clinical information (all
times, EST):

Abstracts at a Glance
UNVEIL
DATA

Abstract 4892; Sunday, March 5, 2017, 8:55 – 9:00 AM
Efficacy
and Safety of Apremilast in Patients With Moderate Plaque Psoriasis
(UNVEIL Phase 4 Study); Bruce Strober

Abstract 5432; Sunday, March 5, 2017, 10:30 – 10:35 AM
Efficacy of
Apremilast on Quality of Life Measures in Patients With Moderate Plaque
Psoriasis (UNVEIL Phase 4 Study); Jerry Bagel

LONG-TERM DATA
Abstract 4927;
Sunday, March 5, 2017, 8:40 – 8:45 AM
Long-term Safety of
Apremilast Treatment in Psoriasis and Psoriatic Arthritis Patients:
Pooled Analysis for 156 Weeks and Beyond in the ESTEEM 1 and 2 and
PALACE 1-3 Phase 3 Trials; Jeffrey Crowley

Abstract 5139; Sunday, March 5, 2017, 11:10 – 11:15 AM
Apremilast,
an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term
(104-Week) Improvement in Fatigue in Patients With Psoriatic Arthritis:
Pooled Results From 3 Phase III, Randomized, Controlled Trials; Arthur
Kavanaugh

Abstract 5390; Sunday, March 5, 2017, 3:45 – 3:50 PM
Low Serious
Infection Rates in Patients with Psoriasis and Psoriatic Arthritis
Treated With Apremilast for 156 Weeks and Beyond: Pooled Analysis of the
Phase 3 ESTEEM 1 and 2 and PALACE 1-3 Trials; David Pariser

Abstract 5436; Sunday, March 5, 2017, 8:25 – 8:30 AM
Safety and
Efficacy of Apremilast Through 104 Weeks in Patients With Moderate to
Severe Psoriasis Who Continued on Apremilast or Switched From Etanercept
Treatment in the LIBERATE Study; Kristian Reich

OTHER DATA
Abstract 5413;
Sunday, March 5, 2017, 10:25 – 10:30 AM
Apremilast Reduces IL-17F,
IL-17A, IL-22, and TNF-α Plasma Protein Levels in Patients With Moderate
to Severe Plaque Psoriasis: Pharmacodynamic and Correlative Results From
Phase 2/3 Studies; James G. Krueger

Abstract 5137; Sunday, March 5, 2017, 11:50 – 11:55 AM
First
"Real-World" Insights on Apremilast Therapy for Patients With Plaque
Psoriasis From the LAPIS-PSO Study: An Interim Analysis; Kristian Reich

Abstract 5437; Sunday, March 5, 2017, 1:00 – 1:05 PM
Real-World
Burden of Comorbidities in US Patients With Psoriasis; Kamal Shah

Abstract 5439; Sunday, March 5, 2017, 12:35 – 12:40 PM
Evaluation
of the PGAxBSA Composite Tool in Patients With Moderate vs. Moderate to
Severe Plaque Psoriasis; Kristina Callis Duffin

OTEZLA is not indicated for the treatment of plaque psoriasis patients
with BSA involvement of less than 10 percent or sPGA less than 3.

About UNVEIL

UNVEIL is the first prospective, randomized, controlled study to
evaluate the clinical efficacy and safety of OTEZLA in patients with
moderate plaque psoriasis (defined as a BSA involvement of 5-10 percent
and sPGA of 3 based on a 0 to 5 scale) who were naïve to systemic and
biologic therapies. Patients (n=221) were randomized 2:1 to receive
either OTEZLA 30 mg twice daily or placebo for 16 weeks, followed by an
open-label extension phase in which placebo patients were switched to
OTEZLA through week 52. All doses were titrated over the first week of
treatment. At baseline, more than 80 percent of patients had previously
received topical therapy. The primary endpoint was the mean percentage
change from baseline in the product of Physician's Global Assessment
(PGA) and BSA (%) at week 16.

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.

INDICATION

Otezla® (apremilast) is indicated for the treatment of
patients with moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy and for the treatment of adult patients
with active psoriatic arthritis.

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla (apremilast) is contraindicated in patients with a known
hypersensitivity to apremilast or to any of the excipients in the
formulation.

Warnings and Precautions

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 adverse reactions of depression. During
clinical trials, 1.3% (12/920) of patients treated with Otezla reported
depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of Otezla
patients discontinued treatment due to depression compared with none on
placebo (0/506). 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: During clinical
trials, 1.0% (10/998) of patients treated with Otezla reported
depression or depressed mood compared to 0.8% (4/495) treated with
placebo; 0.3% (4/1441) of patients treated with Otezla discontinued
treatment due to depression or depressed mood compared with none in
placebo treated patients (0/495). Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo
treated patients (0/495). Suicidal ideation and behavior were observed
in 0.2% (3/1441) of patients on Otezla, compared to none on placebo
(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. Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla.

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 Reactions

Psoriasis: 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 ≥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 Populations

Pregnancy 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: @CelgenePinterest,
LinkedInFaceBook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which 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 Securities and
Exchange Commission.

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