Apremilast ESTEEM Program Meets Primary and Major Secondary Endpoint in
Pivotal Phase III Psoriasis Trials
Clinical Data from two pivotal phase III (ESTEEM 1&2) randomized,
placebo-controlled studies including approximately 1,250 patients demonstrated
statistically significant and clinically meaningful improvements for the
primary and major secondary endpoint
NDA submission based on ESTEEM program in psoriasis planned for H2’2013; MAA
submission for psoriasis and psoriatic arthritis planned for H2’2013
No new safety signals were observed and tolerability improved over phase II
psoriasis trial results; Safety and tolerability consistent with phase III
psoriatic arthritis trials
Data from the phase III ESTEEM program is planned for presentation at upcoming
major medical meetings
BOUDRY, Switzerland -- January 7, 2013
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ:
CELG), today announced that statistical significance for the primary endpoint
of PASI 75 at week 16 was achieved for patients receiving apremilast 30 mg BID
monotherapy in both the ESTEEM 1 & 2 phase III studies. ESTEEM 1 & 2 are the
two pivotal phase III, randomized, placebo-controlled studies evaluating
apremilast, the company’s oral small-molecule inhibitor of phosphodiesterase 4
(PDE4) in patients with moderate to severe chronic plaque psoriasis.
Patients on apremilast also achieved a statistically significant benefit over
placebo in the major secondary endpoint, Static Physician Global Assessment
“Psoriasis is a common immune-mediated skin disease affecting nearly 125
million people worldwide,” said Kim Papp, M.D., Ph.D. of Probity Medical
Research, Canada. “Despite advances in treatment over the last decade, a
significant proportion of moderate to severe psoriasis patients remain
inadequately treated. The primary reason for psoriasis patients not receiving
adequate therapy is the burden associated with available treatment options. As
a consequence, there is a high unmet medical need for an efficacious, safe,
oral option that patients can take long-term.”
An NDA submission for psoriasis, based on ESTEEM 1 & 2 data, is expected in
the second half of 2013. The company previously announced it expects to file
an NDA for psoriatic arthritis (PsA) in the first quarter of 2013 and a
combined MAA for psoriasis and psoriatic arthritis in Europe in the second
half of the year.
The Phase III safety and tolerability data are improved over previously
observed phase II psoriasis data and consistent with results from the phase
III psoriatic arthritis trials. The overall psoriasis safety database includes
nearly 2,000 patients to date. ESTEEM 1 & 2 are ongoing trials. Subjects are
being evaluated for safety and efficacy in the long-term extension studies for
up to an additional four years. Approximately one-third of the study
population was treatment-naïve and two-thirds had prior exposure to either
systemic and/or phototherapy; approximately one-third of the overall study
population had prior biologic therapy.
To date, the five positive phase III studies from the ESTEEM and PALACE
programs represent the most comprehensive clinical data for submission for
patients with psoriatic disease. Clinical data from ESTEEM 1 & 2 are planned
for presentation at upcoming major medical meetings.
About ESTEEM 1 & 2
ESTEEM 1 & 2 are two pivotal phase III randomized, placebo-controlled study
evaluating apremilast in subjects with a diagnosis of moderate to severe
chronic plaque psoriasis for at least 12 months prior to the screening, and at
baseline, and who are also a candidate for phototherapy and/or systemic
therapy. Approximately 1,250 patients were randomized 2:1 to receive either
apremilast 30 mg BID or placebo for the first 16 weeks, followed by a
maintenance phase from weeks 16-32 in which placebo subjects were switched to
apremilast 30 mg BID through week 32, and a randomized withdrawal phase for
responders from Week 32-Week 52 based on their initial randomization and PASI
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4),
works intracellularly to modulate 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 other
anti-inflammatory cytokines such as IL-10.
Psoriasis is an immune-mediated, non-contagious chronic inflammatory skin
disorder of unknown cause. The disorder is a chronic recurring condition which
varies in severity from minor localized patches to complete body coverage.
Plaque psoriasis is the most common type of psoriasis. About 80 percent of
people who develop psoriasis have plaque psoriasis, which appears as patches
of raised, reddish skin covered by silvery-white scales. These patches, or
plaques, frequently form on the elbows, knees, lower back, and scalp.
Psoriasis occurs nearly equally in males and females. Recent studies show that
there may be an ethnic link. Psoriasis is believed to be most common in
Caucasians and slightly less common in other ethnic groups. Worldwide,
psoriasis is most common in Scandinavia and other parts of northern Europe.
About 10 percent to 30 percent of patients with psoriasis also develop a
condition called psoriatic arthritis, which causes pain, stiffness and
swelling in and around the joints.
About Celgene International Sàrl
Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel,
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 the Company's website at
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"estimates," "plans," "will," “outlook” and similar expressions.
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