– Results from pharmacokinetic (PK) similarity study demonstrate bioequivalence of AVT04 (ustekinumab) to the reference product Stelara®
REYKJAVIK, Iceland I May 16, 2022 I Alvotech Holdings S.A. (“Alvotech”), a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab).
The PK similarity study (AVT04-GL-101) utilized a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04, with US-licensed Stelara®, as well as EU-approved Stelara®. The study results demonstrated bioequivalence between AVT04 and the reference products.
Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the interleukin-12 and interleukin-23 cytokines. Stelara® is prescribed to treat a variety of inflammatory conditions including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. In 2021, Stelara’s worldwide net sales exceeded US$9 billion, making it one of the highest grossing biologic medicines. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT04 in the United States. STADA is Alvotech’s exclusive strategic partner for AVT04 for the European market.
“We are delighted at the continued progress of our pipeline of biosimilar candidates,” said Robert Wessman Founder and Chairman of Alvotech. “This continued progress demonstrates the strength of Alvotech’s purpose-built biosimilar platform.”
Chief Scientific Officer, Joseph McClellan added, “We are pleased with the successful outcome of the AVT04 PK similarity study and the continued progress of our overall pipeline. We expect the results from our confirmatory efficacy and safety study for AVT04 before the end of the 2nd quarter.”
Alvotech’s product portfolio includes AVT02, a biosimilar to Humira® (adalimumab). In addition to AVT04, Alvotech is advancing six other biosimilar candidates, using its highly integrated platform for development and manufacturing. Alvotech has established a global network of commercial partnerships in major markets, with the goal of expeditiously delivering its cost-effective biosimilar medicines to patients worldwide.
On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., (“OACB”) announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol “ALVO.” On May 11, 2022, Alvotech and OACB announced that the extraordinary general meeting of shareholders of OACB to approve the pending business combination between Alvotech, OACB and the legal entity named Alvotech, previously named Alvotech Lux Holdings S.A.S., (“TopCo”) is scheduled to be held on June 7, 2022.
About the AVT04-GL-101 pharmacokinetics, safety, and tolerability study
The AVT04-GL-101 pharmacokinetic (PK) study was conducted in Australia and New Zealand and enrolled 294 healthy adult volunteers. The study involved a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04, with US-licensed Stelara®, as well as EU-approved Stelara®.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). AVT04 was developed using the Sp2/0 host cell line and is manufactured using a continuous perfusion process. Ustekinumab binds to two cytokines called interleukin-12 and interleukin-23 that are involved in inflammatory and immune responses. Abnormal regulation of these cytokines has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and a biosimilar to Humira® (adalimumab), which inhibits tumor necrosis factor alpha (TNF-alpha). AVT02 is not approved outside of the EU, UK, and Canada. AVT02 dossiers are under review in multiple countries; in the US the initial BLA for approval as a biosimilar is in deferred status, pending the result of FDA inspections.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer. For more information, please visit www.alvotech.com.
SOURCE: Alvotech
Post Views: 312
– Results from pharmacokinetic (PK) similarity study demonstrate bioequivalence of AVT04 (ustekinumab) to the reference product Stelara®
REYKJAVIK, Iceland I May 16, 2022 I Alvotech Holdings S.A. (“Alvotech”), a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, today announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab).
The PK similarity study (AVT04-GL-101) utilized a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04, with US-licensed Stelara®, as well as EU-approved Stelara®. The study results demonstrated bioequivalence between AVT04 and the reference products.
Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the interleukin-12 and interleukin-23 cytokines. Stelara® is prescribed to treat a variety of inflammatory conditions including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. In 2021, Stelara’s worldwide net sales exceeded US$9 billion, making it one of the highest grossing biologic medicines. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is the exclusive strategic partner for the commercialization of AVT04 in the United States. STADA is Alvotech’s exclusive strategic partner for AVT04 for the European market.
“We are delighted at the continued progress of our pipeline of biosimilar candidates,” said Robert Wessman Founder and Chairman of Alvotech. “This continued progress demonstrates the strength of Alvotech’s purpose-built biosimilar platform.”
Chief Scientific Officer, Joseph McClellan added, “We are pleased with the successful outcome of the AVT04 PK similarity study and the continued progress of our overall pipeline. We expect the results from our confirmatory efficacy and safety study for AVT04 before the end of the 2nd quarter.”
Alvotech’s product portfolio includes AVT02, a biosimilar to Humira® (adalimumab). In addition to AVT04, Alvotech is advancing six other biosimilar candidates, using its highly integrated platform for development and manufacturing. Alvotech has established a global network of commercial partnerships in major markets, with the goal of expeditiously delivering its cost-effective biosimilar medicines to patients worldwide.
On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., (“OACB”) announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol “ALVO.” On May 11, 2022, Alvotech and OACB announced that the extraordinary general meeting of shareholders of OACB to approve the pending business combination between Alvotech, OACB and the legal entity named Alvotech, previously named Alvotech Lux Holdings S.A.S., (“TopCo”) is scheduled to be held on June 7, 2022.
About the AVT04-GL-101 pharmacokinetics, safety, and tolerability study
The AVT04-GL-101 pharmacokinetic (PK) study was conducted in Australia and New Zealand and enrolled 294 healthy adult volunteers. The study involved a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04, with US-licensed Stelara®, as well as EU-approved Stelara®.
About AVT04 (ustekinumab)
AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara® (ustekinumab). AVT04 was developed using the Sp2/0 host cell line and is manufactured using a continuous perfusion process. Ustekinumab binds to two cytokines called interleukin-12 and interleukin-23 that are involved in inflammatory and immune responses. Abnormal regulation of these cytokines has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
About AVT02 (adalimumab)
AVT02 is a monoclonal antibody and a biosimilar to Humira® (adalimumab), which inhibits tumor necrosis factor alpha (TNF-alpha). AVT02 is not approved outside of the EU, UK, and Canada. AVT02 dossiers are under review in multiple countries; in the US the initial BLA for approval as a biosimilar is in deferred status, pending the result of FDA inspections.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer. For more information, please visit www.alvotech.com.
SOURCE: Alvotech
Post Views: 312
