Celgene International Sárl Release: Signs and Symptoms of Psoriatic Arthritis Significantly Improved in Patients Receiving Long-Term Oral Apremilast Treatment in Phase III Study (PALACE-1)
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BOUDRY, Switzerland – (June 12, 2013) –Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced 52-week results from PALACE 1, the Company’s first phase III study in psoriatic arthritis at the European Congress of Rheumatology (EULAR) annual meeting in Madrid, Spain. The results were included in the EULAR press conference, which highlights data considered representative of highest quality and most meaningful research presented at EULAR. The full PALACE 1 oral presentation will be presented later today. (https://b-com.mci- group.com/AbstractList/EULAR2013.aspx).
Long-term results presented from PALACE 1 revealed meaningful improvements in American College of Rheumatology (ACR) 20 scores from week 24 through week 52. Patients who received apremilast for 52 weeks demonstrated ACR scores of 63% for apremilast 20 mg BID and 55% for apremilast 30 mg BID. Similar improvements over time were observed in the ACR 50 and ACR 70 scores.
“I am excited that results from the first long-term PALACE data were selected for inclusion at the EULAR press conference,” stated Dr. Arthur Kavanaugh, Professor of Clinical Medicine and Director of the Center for Innovative Therapy at the University of California, San Diego School of Medicine. “There is a high unmet medical need for additional efficacious, well-tolerated treatment options for patients with psoriatic arthritis.”
PALACE 1 is the first completed pivotal phase III, randomized, placebo-controlled study evaluating the Company’s oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with oral DMARDs. PALACE 2 and PALACE 3 have completed the primary end-point phases and are in long-term follow-up.
The safety and tolerability profile of apremilast during the 52-week period was consistent with what was observed in the placebo-controlled portion of the trial (0-24 weeks) and with what was observed in other PALACE trials to date. Importantly, there were no safety signals with respect to major cardiac events, malignancies, including lymphoma or systemic opportunistic infections, and no cases of reactivations of tuberculosis were reported for the 52-week period. At week 52, the most common treatment-emergent adverse events (TEAEs) reported (>5%) included nausea, diarrhea, headache, URTI and nasopharyngitis.
These results are from investigational studies. Apremilast is not an approved product for any indication. The NDA/NDS submissions, based on the combined data from PALACE 1, 2 & 3 for PsA, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. The Company previously announced it expects to file a separate NDA/NDS in the US/Canada for psoriasis and a combined PsA/psoriasis MAA submission in Europe in the second half of 2013.
About PALACE Program
PALACE 1, 2, 3 & 4 are four pivotal phase III multi-center, double-blind, placebo-controlled, parallelgroup studies with two active-treatment groups. In PALACE 1, 2 & 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 DMARD, biologic DMARD, as well as patients who had previously failed a TNF blocker. PALACE-3 includes a subset of 270 patients with significant skin involvement with psoriasis.
The primary endpoint of the PALACE 1, 2 & 3 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.
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, with a subsequent extension in which all patients are treated with apremilast.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis studies to date intended for regulatory submission. Results from PSA-001, the phase II study of apremilast in psoriatic arthritis, were published online in the journal Arthritis & Rheumatism (http://onlinelibrary.wiley.com/doi/10.1002/art.34580/abstract).
About Apremilast
Apremilast, an oral small-molecule 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-a, 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. Up to 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 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 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 the role of PDE4 in psoriatic arthritis, go to www.discoverpde4.com/.
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.
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BOUDRY, Switzerland – (June 12, 2013) –Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced 52-week results from PALACE 1, the Company’s first phase III study in psoriatic arthritis at the European Congress of Rheumatology (EULAR) annual meeting in Madrid, Spain. The results were included in the EULAR press conference, which highlights data considered representative of highest quality and most meaningful research presented at EULAR. The full PALACE 1 oral presentation will be presented later today. (https://b-com.mci- group.com/AbstractList/EULAR2013.aspx).
Long-term results presented from PALACE 1 revealed meaningful improvements in American College of Rheumatology (ACR) 20 scores from week 24 through week 52. Patients who received apremilast for 52 weeks demonstrated ACR scores of 63% for apremilast 20 mg BID and 55% for apremilast 30 mg BID. Similar improvements over time were observed in the ACR 50 and ACR 70 scores.
“I am excited that results from the first long-term PALACE data were selected for inclusion at the EULAR press conference,” stated Dr. Arthur Kavanaugh, Professor of Clinical Medicine and Director of the Center for Innovative Therapy at the University of California, San Diego School of Medicine. “There is a high unmet medical need for additional efficacious, well-tolerated treatment options for patients with psoriatic arthritis.”
PALACE 1 is the first completed pivotal phase III, randomized, placebo-controlled study evaluating the Company’s oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with oral DMARDs. PALACE 2 and PALACE 3 have completed the primary end-point phases and are in long-term follow-up.
The safety and tolerability profile of apremilast during the 52-week period was consistent with what was observed in the placebo-controlled portion of the trial (0-24 weeks) and with what was observed in other PALACE trials to date. Importantly, there were no safety signals with respect to major cardiac events, malignancies, including lymphoma or systemic opportunistic infections, and no cases of reactivations of tuberculosis were reported for the 52-week period. At week 52, the most common treatment-emergent adverse events (TEAEs) reported (>5%) included nausea, diarrhea, headache, URTI and nasopharyngitis.
These results are from investigational studies. Apremilast is not an approved product for any indication. The NDA/NDS submissions, based on the combined data from PALACE 1, 2 & 3 for PsA, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. The Company previously announced it expects to file a separate NDA/NDS in the US/Canada for psoriasis and a combined PsA/psoriasis MAA submission in Europe in the second half of 2013.
About PALACE Program
PALACE 1, 2, 3 & 4 are four pivotal phase III multi-center, double-blind, placebo-controlled, parallelgroup studies with two active-treatment groups. In PALACE 1, 2 & 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 DMARD, biologic DMARD, as well as patients who had previously failed a TNF blocker. PALACE-3 includes a subset of 270 patients with significant skin involvement with psoriasis.
The primary endpoint of the PALACE 1, 2 & 3 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.
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, with a subsequent extension in which all patients are treated with apremilast.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis studies to date intended for regulatory submission. Results from PSA-001, the phase II study of apremilast in psoriatic arthritis, were published online in the journal Arthritis & Rheumatism (http://onlinelibrary.wiley.com/doi/10.1002/art.34580/abstract).
About Apremilast
Apremilast, an oral small-molecule 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-a, 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. Up to 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 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 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 the role of PDE4 in psoriatic arthritis, go to www.discoverpde4.com/.
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.
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