The regulatory submissions for this new indication seek to expand the use of CIMZIA for the treatment of patients with moderate-to-severe chronic plaque psoriasis
Data from three positive Phase 3 studies support the regulatory submissions
BRUSSELS, Belgium and MENLO PARK, CA, USA I July 25, 2017 I UCB (Euronext: UCB) and Dermira, Inc. (NASDAQ: DERM) today announced the UCB submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for CIMZIA® (certolizumab pegol). Separately, UCB also submitted a regulatory filing with the European Medicines Agency (EMA). Both regulatory filings seek to expand the approved indications for CIMZIA to include treatment of adult patients with moderate-to-severe chronic plaque psoriasis. An additional submission to expand the use of CIMZIA in this patient population is also planned with Health Canada.
The Phase 3 CIMZIA clinical development program in psoriasis was led by Dermira, Inc., in collaboration with UCB as the regulatory sponsor. Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the United States, Canada and the EU. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market CIMZIA to dermatologists in the United States and Canada. UCB will retain marketing rights for CIMZIA in the U.S. and Canada for rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ankylosing spondylitis. In the rest of world, UCB retains marketing rights for CIMZIA for all approved indications, including psoriasis, subject to approval.
“UCB is proud to have achieved this important regulatory milestone in partnership with Dermira. Based on the results of our Phase 3 clinical trial program, we believe CIMZIA, the only Fc-free, PEGylated anti-TNF, has the potential to be a valuable treatment option for patients living with moderate-to-severe chronic plaque psoriasis. This underserved patient population faces a heavy disease burden, including pain and a reduced quality of life. Our psoriasis development program, and our collaboration with Dermira, aims to provide value and broaden access to CIMZIA,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB
“Despite the tremendous progress that has been made in psoriasis drug development during the last decade and the number of FDA-approved treatment options that are currently available, healthcare professionals and patients continue to express the need for additional treatment options,” said Tom Wiggans, chairman and chief executive officer of Dermira. “If approved, we believe CIMZIA would represent an important new treatment option for previously untreated patients living with moderate-to-severe chronic plaque psoriasis, as well as patients who have received prior treatment with another biologic therapy.”
The regulatory submissions are based on results from three Phase 3 clinical trials – CIMPASI-1, CIMPASI-2 and CIMPACT, which each evaluated the efficacy and safety of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis. The co-primary endpoints evaluated in both CIMPASI-1 and CIMPASI-2 were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. The primary endpoint in CIMPACT was the percentage of patients on CIMZIA achieving a PASI 75 response, compared with placebo, at week 12. Secondary endpoints of the CIMPACT trial included a comparison of the efficacy of CIMZIA to ENBREL® (etanercept) as measured by PASI 75 response at week 12 and the percentage of patients who achieved at least a two-point improvement to a final score representing clear or almost clear skin on the five-point PGA scale, at week 12.
The three Phase 3 trials enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products. In CIMPASI-1 and CIMPASI-2, patients were randomized to one of three dosing arms—400 mg every two weeks, 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks, or placebo every two weeks. In CIMPACT, patients were randomized to one of four dosing arms—CIMZIA at 400 mg every two weeks, CIMZIA at 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks, ENBREL at 50 mg twice weekly, or placebo every two weeks. In all three trials, CIMZIA demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at all treatment doses.
CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
About Psoriasis
Psoriasis is a common, chronic, immune-mediated inflammatory disorder with primary involvement of the skin. It affects nearly three percent of the population, or approximately 125 million people worldwide. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.2
About Cimzia® in the U.S.
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
About Cimzia® in the EU/EEA
In the EU, Cimzia® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.
Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
Cimzia®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Cimzia® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:
Ankylosing spondylitis (AS) – adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
Axial spondyloarthritis (axSpA) without radiographic evidence of AS – adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.4
References
1. UCB Data on File.
2. International Federation of Psoriasis Associations. Accessed July 14, 2016 at http://www.worldpsoriasisday.com/web/page.aspx?refid=130
CIMZIA® is a registered trademark of the UCB Group of Companies.
ENBREL® (etanercept) is a registered trademark of Amgen Inc.
About Dermira
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s product pipeline includes three late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
SOURCE: UCB
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The regulatory submissions for this new indication seek to expand the use of CIMZIA for the treatment of patients with moderate-to-severe chronic plaque psoriasis
Data from three positive Phase 3 studies support the regulatory submissions
BRUSSELS, Belgium and MENLO PARK, CA, USA I July 25, 2017 I UCB (Euronext: UCB) and Dermira, Inc. (NASDAQ: DERM) today announced the UCB submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for CIMZIA® (certolizumab pegol). Separately, UCB also submitted a regulatory filing with the European Medicines Agency (EMA). Both regulatory filings seek to expand the approved indications for CIMZIA to include treatment of adult patients with moderate-to-severe chronic plaque psoriasis. An additional submission to expand the use of CIMZIA in this patient population is also planned with Health Canada.
The Phase 3 CIMZIA clinical development program in psoriasis was led by Dermira, Inc., in collaboration with UCB as the regulatory sponsor. Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop CIMZIA in psoriasis in the United States, Canada and the EU. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market CIMZIA to dermatologists in the United States and Canada. UCB will retain marketing rights for CIMZIA in the U.S. and Canada for rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ankylosing spondylitis. In the rest of world, UCB retains marketing rights for CIMZIA for all approved indications, including psoriasis, subject to approval.
“UCB is proud to have achieved this important regulatory milestone in partnership with Dermira. Based on the results of our Phase 3 clinical trial program, we believe CIMZIA, the only Fc-free, PEGylated anti-TNF, has the potential to be a valuable treatment option for patients living with moderate-to-severe chronic plaque psoriasis. This underserved patient population faces a heavy disease burden, including pain and a reduced quality of life. Our psoriasis development program, and our collaboration with Dermira, aims to provide value and broaden access to CIMZIA,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB
“Despite the tremendous progress that has been made in psoriasis drug development during the last decade and the number of FDA-approved treatment options that are currently available, healthcare professionals and patients continue to express the need for additional treatment options,” said Tom Wiggans, chairman and chief executive officer of Dermira. “If approved, we believe CIMZIA would represent an important new treatment option for previously untreated patients living with moderate-to-severe chronic plaque psoriasis, as well as patients who have received prior treatment with another biologic therapy.”
The regulatory submissions are based on results from three Phase 3 clinical trials – CIMPASI-1, CIMPASI-2 and CIMPACT, which each evaluated the efficacy and safety of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis. The co-primary endpoints evaluated in both CIMPASI-1 and CIMPASI-2 were the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. The primary endpoint in CIMPACT was the percentage of patients on CIMZIA achieving a PASI 75 response, compared with placebo, at week 12. Secondary endpoints of the CIMPACT trial included a comparison of the efficacy of CIMZIA to ENBREL® (etanercept) as measured by PASI 75 response at week 12 and the percentage of patients who achieved at least a two-point improvement to a final score representing clear or almost clear skin on the five-point PGA scale, at week 12.
The three Phase 3 trials enrolled approximately 1,000 patients, including patients with and without prior treatment experience with biologic products. In CIMPASI-1 and CIMPASI-2, patients were randomized to one of three dosing arms—400 mg every two weeks, 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks, or placebo every two weeks. In CIMPACT, patients were randomized to one of four dosing arms—CIMZIA at 400 mg every two weeks, CIMZIA at 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks, ENBREL at 50 mg twice weekly, or placebo every two weeks. In all three trials, CIMZIA demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at all treatment doses.
CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
About Psoriasis
Psoriasis is a common, chronic, immune-mediated inflammatory disorder with primary involvement of the skin. It affects nearly three percent of the population, or approximately 125 million people worldwide. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.2
About Cimzia® in the U.S.
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
About Cimzia® in the EU/EEA
In the EU, Cimzia® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.
Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA® in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
Cimzia®, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Cimzia® is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:
Ankylosing spondylitis (AS) – adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
Axial spondyloarthritis (axSpA) without radiographic evidence of AS – adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.4
References
1. UCB Data on File.
2. International Federation of Psoriasis Associations. Accessed July 14, 2016 at http://www.worldpsoriasisday.com/web/page.aspx?refid=130
CIMZIA® is a registered trademark of the UCB Group of Companies.
ENBREL® (etanercept) is a registered trademark of Amgen Inc.
About Dermira
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s product pipeline includes three late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), which has completed a Phase 3 program for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
SOURCE: UCB
Post Views: 145
