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UNIFORMi Study builds on prior successful Phase 1 and Phase 3 studies
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Intended to support harmonized global filing for BOW015 in 2017
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BOW015 is a biosimilar for Remicade®, which had global sales of $8.8 billion in 2014
BOSTON, MA, USA I February 09, 2016 I EPIRUS Biopharmaceuticals, Inc. (EPRS), a pure-play biosimilar company focused on the development and commercialization of biosimilar monoclonal antibodies (mAbs), today announced the initiation of its global registration study for BOW015 (infliximab, reference biologic Remicade®ii) in active Rheumatoid Arthritis (RA) patients. EPIRUS plans to enroll over 500 patients in the UNIFORM Study, which will be conducted at sites in Europe, North America and Latin America.
The UNIFORM Study is a 58-week, double-blind, one-to-one randomized, comparator-controlled multi-center global study to compare efficacy, safety and immunogenicity and demonstrate clinical equivalence of BOW015 with Remicade. The primary endpoint at week 16 is the proportion of patients that meet ACR20 (20 percent or greater improvement in American College of Rheumatology assessment). EPIRUS is targeting a harmonized global filing for marketing approval for BOW015 in 2017 based on 30-week data.
“The initiation of the UNIFORM Study is a major milestone for the BOW015 biosimilar clinical program,” said Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. “Following completion last quarter of manufacturing process lock, which we believe is an important risk-reducing milestone in our development program, our team continues to make progress toward market entry in the United States and Europe. This study, along with patient exposure and pharmacovigilance data from patients currently receiving treatment, is designed to provide the foundation for our global filing.”
The UNIFORM Study continues the global clinical development program, building on positive data from EPIRUS’ Phase 1 study in healthy volunteers and Phase 3 study in active RA patients presented at recent American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) meetings. The data presented reinforced the analytical, pharmacokinetic, safety and efficacy profile for BOW015, further demonstrating biosimilarity between BOW015 and infliximab. To date nearly 1,000 patients have already been treated with BOW015.
About BOW015 (infliximab, reference biologic Remicade)
BOW015 is a monoclonal antibody against tumor necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, including rheumatoid arthritis. BOW015 is currently approved in India and has been launched in collaboration with commercialization partner Sun Pharma under the trade name, Infimab™. EPIRUS is actively progressing applications for marketing approval for BOW015 in targeted accessible markets, including Latin America, where EPIRUS recently signed a distribution deal with mAbxience.
About EPIRUS Biopharmaceuticals
EPIRUS Biopharmaceuticals (EPRS) is a pure-play biosimilar company focused on the global development and commercialization of biosimilar monoclonal antibodies (mAbs). EPIRUS’ goal is to improve global patient access to important, cost-effective medicines. The company’s current pipeline of biosimilar product candidates includes: BOW015 (infliximab, reference biologic Remicade®); BOW050 (adalimumab, reference biologic Humira®); BOW070 (tocilizumab, reference biologic Actemra®); BOW080 (eculizumab, reference biologic Soliris®); BOW090 (ustekinumab, reference biologic STELARA®); and BOW100 (golimumab, reference biologic SIMPONI®)ii. The reference products for these candidates together generated approximately $29.2 billion in global sales for 2014, according to EvaluatePharma®. EPIRUS has established multiple partnerships to support its regulatory and commercialization efforts in global markets.
SOURCE: Epirus Biopharmaceuticals
Post Views: 181
-
UNIFORMi Study builds on prior successful Phase 1 and Phase 3 studies
-
Intended to support harmonized global filing for BOW015 in 2017
-
BOW015 is a biosimilar for Remicade®, which had global sales of $8.8 billion in 2014
BOSTON, MA, USA I February 09, 2016 I EPIRUS Biopharmaceuticals, Inc. (EPRS), a pure-play biosimilar company focused on the development and commercialization of biosimilar monoclonal antibodies (mAbs), today announced the initiation of its global registration study for BOW015 (infliximab, reference biologic Remicade®ii) in active Rheumatoid Arthritis (RA) patients. EPIRUS plans to enroll over 500 patients in the UNIFORM Study, which will be conducted at sites in Europe, North America and Latin America.
The UNIFORM Study is a 58-week, double-blind, one-to-one randomized, comparator-controlled multi-center global study to compare efficacy, safety and immunogenicity and demonstrate clinical equivalence of BOW015 with Remicade. The primary endpoint at week 16 is the proportion of patients that meet ACR20 (20 percent or greater improvement in American College of Rheumatology assessment). EPIRUS is targeting a harmonized global filing for marketing approval for BOW015 in 2017 based on 30-week data.
“The initiation of the UNIFORM Study is a major milestone for the BOW015 biosimilar clinical program,” said Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. “Following completion last quarter of manufacturing process lock, which we believe is an important risk-reducing milestone in our development program, our team continues to make progress toward market entry in the United States and Europe. This study, along with patient exposure and pharmacovigilance data from patients currently receiving treatment, is designed to provide the foundation for our global filing.”
The UNIFORM Study continues the global clinical development program, building on positive data from EPIRUS’ Phase 1 study in healthy volunteers and Phase 3 study in active RA patients presented at recent American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) meetings. The data presented reinforced the analytical, pharmacokinetic, safety and efficacy profile for BOW015, further demonstrating biosimilarity between BOW015 and infliximab. To date nearly 1,000 patients have already been treated with BOW015.
About BOW015 (infliximab, reference biologic Remicade)
BOW015 is a monoclonal antibody against tumor necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, including rheumatoid arthritis. BOW015 is currently approved in India and has been launched in collaboration with commercialization partner Sun Pharma under the trade name, Infimab™. EPIRUS is actively progressing applications for marketing approval for BOW015 in targeted accessible markets, including Latin America, where EPIRUS recently signed a distribution deal with mAbxience.
About EPIRUS Biopharmaceuticals
EPIRUS Biopharmaceuticals (EPRS) is a pure-play biosimilar company focused on the global development and commercialization of biosimilar monoclonal antibodies (mAbs). EPIRUS’ goal is to improve global patient access to important, cost-effective medicines. The company’s current pipeline of biosimilar product candidates includes: BOW015 (infliximab, reference biologic Remicade®); BOW050 (adalimumab, reference biologic Humira®); BOW070 (tocilizumab, reference biologic Actemra®); BOW080 (eculizumab, reference biologic Soliris®); BOW090 (ustekinumab, reference biologic STELARA®); and BOW100 (golimumab, reference biologic SIMPONI®)ii. The reference products for these candidates together generated approximately $29.2 billion in global sales for 2014, according to EvaluatePharma®. EPIRUS has established multiple partnerships to support its regulatory and commercialization efforts in global markets.
SOURCE: Epirus Biopharmaceuticals
Post Views: 181
