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New Long-Term Apremilast Data to Be Presented at American College of Rheumatology Annual Meeting

  New Long-Term Apremilast Data to Be Presented at American College of
  Rheumatology Annual Meeting

 New analyses of PALACE clinical trial program assess long-term efficacy and
    safety profiles of apremilast for the treatment of psoriatic arthritis

Phase II trial results evaluate apremilast in Behçet’s disease—a rare disease
                 with limited therapies in the U.S. or Europe

Business Wire

BOUDRY, Switzerland -- September 26, 2013

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation
(NASDAQ: CELG), today announced that the latest research findings on
apremilast, the Company’s novel, oral small-molecule selective inhibitor of
phosphodiesterase 4 (PDE4), will be presented at the 2013 American College of
Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP)
annual meeting in San Diego, October 25-31.

Data to be presented include long-term (52-week) results from two Phase III
investigational trials evaluating the treatment with apremilast for patients
with psoriatic arthritis (PALACE 2) and in patients with psoriatic arthritis
with skin involvement (PALACE 3). Additional analyses from the PALACE program
will be presented demonstrating the effect of apremilast treatment on the
signs and symptoms characteristic of psoriatic arthritis, including swollen
joints, painful/tender joints, enthesitis (inflammation at sites where
tendons, ligaments or joint capsule fibers insert into bone), dactylitis
(inflammatory swelling of a finger or toe) and impairments of physical
function. Scheduled presentations will include long-term safety findings from
three PALACE trials.

Results will also be presented from BCT-001, a Phase II trial evaluating
apremilast in patients with Behçet’s Disease with active oral ulcers. No
therapies have been approved in the U.S. or in Europe to treat this rare,
chronic inflammatory disorder of unknown cause. The approved treatment options
depend largely on the manifestations of the different organ systems involved.

“There is a clear need for new treatment options for both psoriatic arthritis
and Behçet’s disease, and the apremilast data being presented at the upcoming
ACR meeting reinforces Celgene’s commitment to the development of options for
people living with these diseases,” said Peter Callegari, M.D., Global Medical
Affairs Vice President of Inflammation and Immunology for Celgene Corporation.
“We are pleased by the continued success of the clinical development program
for apremilast in both more common inflammatory as well as orphan diseases.”

The following abstracts on apremilast will be presented in oral and/or poster
sessions as an exchange of scientific and clinical information by clinical
investigators (all times, PDT):

Plenary Presentation
Abstract 761; Oral; Sunday, October 27, 11:15 AM
Location: Hall B1
Apremilast for the Treatment of Behçet’s Syndrome: A Phase II Randomized,
Placebo-Controlled, Double-Blind Study; Hatemi, et al.

Oral Presentations
Abstract 815; Sunday, October 27; 2:45 PM
Location: Room 33A
Long-term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic
Arthritis (PALACE 2); Cutolo, et al.

Abstract 816; Oral; Sunday, October 27, 3:00 PM
Location: Room 33 A
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With
Long-term (52-Week) Improvements in Enthesitis and Dactylitis in Patients with
Psoriatic Arthritis: Pooled Results From Three Phase 3, Randomized, Controlled
Trials; Gladman, et al.

Posters
Abstract 311; Sunday, October 27, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Long-term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic
Arthritis and Current Skin Involvement (PALACE 3); Edwards, et al.

Abstract 310; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Long-term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4
Inhibitor, in Patients with Psoriatic Arthritis: Pooled Safety Analysis of
Three Phase 3, Randomized, Controlled Trials; Mease, et al.

Abstract 317; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With
Long-term (52-Week) Improvement in Tender and Swollen Joint Counts in Patients
with Psoriatic Arthritis: Results from Three Phase 3, Randomized, Controlled
Trials; Cutolo, et al.

Abstract 331; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With
Long-term (52-Week) Improvement in Physical Function in Patients with
Psoriatic Arthritis: Results from Three Phase 3, Randomized, Controlled
Trials; Schett, et al.

Abstract 348; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Laboratory Abnormalities in Patients with Psoriatic Arthritis Receiving
Apremilast, an Oral Phosphodiesterase 4 Inhibitor: Pooled Safety Analysis of
Three Phase 3, Randomized, Controlled Trials; Mease, et al.


About PALACE Program

PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind,
placebo-controlled, parallel-group studies with two active-treatment groups.
In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to
receive either apremilast 20 mg BID, 30 mg BID or identically appearing
placebo for 24 weeks, with a subsequent extension in which all patients are
treated with apremilast. The three PALACE studies included a wide spectrum of
patients with active psoriatic arthritis, including those who had been
previously treated with oral DMARDs, and/or biologic DMARDs, including
patients who had previously failed an anti-tumor necrosis factor (TNF)
blocker. PALACE 3 includes a large subset of patients with significant skin
involvement with psoriasis.

The primary endpoint of the PALACE 1, 2 3 and 4 studies is the proportion of
patients in each treatment group who achieved the American College of
Rheumatology criteria for 20 percent improvement (ACR20) compared to baseline
at week 16. Secondary endpoints include other measures of signs and symptoms,
physical function and patient-reported outcomes at week 24. There is a
subsequent extension in which all patients are treated with apremilast.

In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to
receive either apremilast 20 mg BID, 30 mg BID or identically appearing
placebo for 24 weeks.

Taken together, the PALACE program includes the most comprehensive psoriatic
arthritis program to date intended for regulatory submission.

The New Drug Application (NDA) and the New Drug Submission (NDS), based on the
combined data from PALACE 1, 2 & 3 for psoriatic arthritis, were submitted to
health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively.
The NDA for psoriasis was submitted to health authorities in the US in the
third quarter of 2013. The Company previously announced it expects to submit a
separate NDS in Canada for psoriasis and a combined psoriatic
arthritis/psoriasis MAA in Europe in the second half of 2013.

About BCT-001

BCT-001 is a phase 2, multi-center, randomized, placebo-controlled,
double-blind, parallel-group study with two treatment arms (apremilast 30 mg
BID and placebo) in Behçet’s disease. The study consisted of a 90-day
pre-randomization phase, a 12-week treatment phase, a 12-week extension phase
and a 4-week post treatment observational follow-up phase. A total of 111
subjects with active Behçet’s disease were randomized 1:1 to receive either
apremilast 30 mg BID or identically appearing placebo, stratified by gender.
The primary endpoint of the study is the number of oral ulcers at day 85 (12
weeks). Because virtually all patients with Behçet’s disease have painful oral
ulcers, this manifestation was chosen as the primary efficacy measure. Less
common manifestations of Behçet’s disease, including genital ulcers, skin
lesions, inflammatory eye disease, involvement of the gastrointestinal,
vascular, and central nervous systems, and pain from oral and genital ulcers,
were chosen as secondary/exploratory efficacy variables or safety measures.

About Apremilast

Apremilast, an oral small-molecule specific inhibitor of phosphodiesterase 4
(PDE4), intracellularly modulates a network of pro-inflammatory and
anti-inflammatory mediators. PDE4 is a cyclic adenosine monophosphate
(cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4
inhibition elevates intracellular cAMP levels, which in turn down-regulates
the inflammatory response by modulating the expression of TNF-α, IL-23, and
other inflammatory cytokines. Elevation of cAMP also increases
anti-inflammatory cytokines such as IL-10.

About Psoriatic Arthritis

Psoriatic arthritis is a painful, chronic inflammatory disease associated with
the skin condition psoriasis. More than a million people in the U.S. and
Europe are diagnosed with this arthritic condition. Approximately 30 percent
of people with psoriasis eventually develop psoriatic arthritis. Psoriatic
arthritis is a chronic disorder with progressive and additive joint
inflammation that can lead to deleterious effects on quality of life and
increases work disability. In addition to psoriatic skin lesions, common
symptoms of psoriatic arthritis include pain, stiffness and swelling in
several to many joints, as well as inflammation of the spine. Patients often
experience psoriasis on average for 10 years before the onset of joint
symptoms, and many psoriatic arthritis patients go undiagnosed. To learn about
psoriatic arthritis and the role of PDE4, go to www.discoverpsa.com and
www.discoverpde4.com.

About Behçet’s Disease

Behçet’s disease is a chronic inflammatory vasculitis of unknown cause
characterized by recurrent oral and genital ulcers, multiple skin lesions
ranging from acne to vasculitic ulcerations, vascular involvement including
aneurysms and venous thrombosis, and inflammatory disease of the eye
manifesting as uveitis. Prevalence of Behçet’s disease is highest in the
Middle East, Asia and Japan, but it is classified as a rare or “orphan”
disease by the NIH in the United States. At this time, there are limited
therapies for this orphan indication in the United States or throughout
Europe. In some cases, uncontrolled inflammation may lead to blindness,
intestinal complications, stroke, and even meningitis, which can be fatal.
Although the root cause of Behçet’s disease is unknown, the disease is
associated with abnormalities of the immune system.

About Celgene

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned
subsidiary and international headquarters of Celgene Corporation. 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 gene and protein regulation. For more
information, please visit www.celgene.com.

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.

Contact:

Celgene International Sàrl
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
 
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