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Robert J. Hugin, President and CEO, gave guidance for data from the PALACE-4, phase-III study of Apremilast in psoriatic arthritis. He stated, "On PALACE-4, I think we are expecting that data imminently. So, we would expect some top-line results hopefully here in the next month or so."
Source: Q1 2013, earnings conference call, 4/25/13.

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Apremilast: Data from the PALACE-1 trial in psoriatic arthritis were presented at the American College of Rheumatology meeting in November, 2012. Results from PALACE-2 and -3 are expected to be presented in 2013. In addition, results from PALACE-4 in treatment-naïve psoriatic arthritis are expected during the first half of 2013.
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Source: press release, 1/24/13. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=17775...

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Robert J. Hugin, President and CEO, commented on the progress being made for the Apremilast PALACE-4 trial. He stated, "We are also pleased to announce that we have recently completed enrollment in PALACE-4, our Apremilast monotherapy study in psoriatic arthritis patients not previously treated with any DMARDs. This study is an important component of our label expansion strategy, and when completed, the full PALACE program will cover all psoriatic arthritis patients in need of therapy."
Source: Q2 2012, earnings conference call, 7/26/12.

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Robert J. Hugin, President and CEO, gave guidance for the various Apremilast programs. He stated, "Apremilast holds the promise of a novel oral agent with a unique profile in a new therapeutic franchise for Celgene. We completed enrollment of our 5 Phase III registration studies in psoriasis and psoriatic arthritis and expect pivotal data beginning in the middle of this year. We also will initiate our phase III study in ankylosing spondylitis this quarter and look forward to phase II data in rheumatoid arthritis this spring, all significant milestones in realizing the potential of apremilast."
Source: Q4 2011, earnings conference call, 1/26/12.

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Robert J. Hugin, President and CEO, maintained guidance for the enrollment completion of the Apremilast phase III programs. He stated, "Our immunology and inflammation franchise is making significant progress with full enrollment of the 6 phase III Apremilast studies expected by year end."
Source: Q2 2011, earnings conference call, 7/28/11.

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PALACE-4 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study Of TWO DOSES OF Apremilast (CC-10004) In Subjects With Active Psoriatic Arthritis Who Have Not Been Previously Treated With Disease Modifying Anti-rheumatic Drugs

Estimated Enrollment: 495
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01307423?term=apremilast&phase=2&r...

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Apremilast (CC-10004) Psoriatic arthritisRheumatologyPsoriatic arthritisAnti-inflammatoryImmune system

Mechanism of action: CC-10004 (apremilast), a SM-inhibitor, down regulates inflammatory reactions via an orally available small molecules that inhibit the production of multiple pro inflammatory mediators including: interleukin-2 (IL-2), IL-12, interferon-gamma, TNF-alpha, leukotrienes, and nitric oxide synthase.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2013-05-01 - 2013-06-30

Results:

Oral Apremilast Monotherapy Demonstrated Long-Term Clinical Benefits in Psoriatic Arthritis Patients Naïve to Previous DMARD Therapy
PALACE 4 achieves primary endpoint of ACR 20 at week 16 with nearly 60 percent of patients who completed 52 weeks on apremilast achieving an ACR 20 response

PALACE 4 is the first large randomized controlled study to examine the efficacy and safety of a novel agent in patients naïve to previous DMARD therapy

Long-term, clinically meaningful improvements seen in manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis

BOUDRY, Switzerland--(BUSINESS WIRE)--Oct. 29, 2013-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of its long-term phase III study on apremilast, the Company’s first-in-class oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in systemic or biologic DMARD-naïve psoriatic arthritis patients at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.

PALACE 4 is the first large, randomized, controlled study to examine the efficacy and safety of a novel agent exclusively in systemic or biologic DMARD-naïve psoriatic arthritis patients. Apremilast monotherapy demonstrated clinical benefits over 52 weeks in this treatment-naïve patient population, including clinically meaningful improvements in signs and symptoms of psoriatic arthritis, as well as manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis.

At week 16, a statistically significantly greater proportion of patients treated with apremilast monotherapy achieved a modified ACR20 (the study’s primary endpoint) versus placebo: 29.2% (apremilast 20 mg; P=0.0076) and 32.3% (apremilast 30 mg; P=0.0011) versus 16.9% (placebo). For those patients randomized to apremilast and completing 52 weeks of the study, an ACR20 response of 53.4% (apremilast 20 mg) and 58.7% (apremilast 30 mg) at week 52 was observed. ACR 50 and 70 was reached by 31.9% and 18.1% of patients, respectively, for apremilast 30 mg.

“In addition to maintaining its long-term safety and tolerability profile consistent with the previously reported data, apremilast monotherapy showed significant clinical benefit in systemic or biologic DMARD-naïve psoriatic arthritis patients,” said Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, US. “These encouraging results suggest that apremilast may have the potential to be used alone and as a first-line therapy.”

Durable improvements in multiple endpoints—including enthesitis (inflammation at sites where tendons, ligaments or joint capsule fibers insert into bone), dactylitis (swelling of a finger or toe), impaired physical function as assessed by HAQ-DI, swollen and tender joint counts and associated skin psoriasis—were maintained or increased in patients completing 52 weeks of treatment.

Apremilast monotherapy demonstrated an acceptable safety profile and was generally well-tolerated up to 52 weeks. No new safety concerns were identified with longer treatment duration, and the profile was consistent with previously reported safety data on apremilast. The most common adverse events (AEs) reported through 52 weeks were nausea, diarrhea and headache. Discontinuation rates for diarrhea and nausea in the combined apremilast treatment groups were less than 2% over 52 weeks. No serious AEs of diarrhea or nausea were reported in any treatment group up to 52 weeks. No systemic opportunistic infections, including no cases of tuberculosis (new or reactivations), were reported.

These results are from investigational studies. Apremilast is not an approved product for any indication.

The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.
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Source: press release, 10/29/13. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=18694...

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Apremilast Achieves Statistical Significance for the Primary and Major Secondary Endpoints in Fourth Pivotal Phase III Study (PALACE 4) of Patients with Psoriatic Arthritis

PALACE 4 was the first apremilast trial in DMARD-naïve patients and included more than 500 patients

No new safety and tolerability signals identified, with fewer AEs and SAEs reported than in (PALACE 1, 2&3)

Apremilast NDA/NDS for psoriatic arthritis submitted to health authorities in the US and Canada in Q1’2013 and Q2’2013 respectively

Apremilast NDA in US for psoriasis and combined psoriatic arthritis/psoriasis MAA submission in Europe planned for 2H’2013

BOUDRY, Switzerland--(BUSINESS WIRE)--May. 6, 2013-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30 mg BID monotherapy in PALACE 4. PALACE 4 is the fourth randomized, placebo-controlled study evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis. This is the first Company-sponsored trial studying patients who had not previously received an oral disease-modifying antirheumatic drug (DMARD).

“Despite recent advances in the treatment of psoriatic arthritis, there remains a significant need for more oral DMARD treatment options for DMARD-naïve patients,” said Randall Stevens, VP of Clinical Research and Development for Inflammation & Immunology. “PALACE-4 is now the fourth major randomized apremilast Phase III study to provide promising results for patients with psoriatic arthritis.”

Patients on apremilast also achieved a statistically significant benefit over placebo in key secondary endpoints, as demonstrated in various measures of physical function and signs and symptoms, including enthesitis.

No new safety and tolerability signals identified, with fewer AEs and SAEs reported than in PALACE 1, 2&3. Importantly, in PALACE 4, no systemic opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. The most common AEs in PALACE 4 (≥5%) were nausea, diarrhea and headache.

The PALACE 4 study is ongoing and the study extension remains blinded until all patients complete week 52. Full data from this phase III study will be submitted for presentation at appropriate medical meetings.
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Source: press release, 5/06/13. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=18158...