Partnership on clinical development, manufacturing and marketing of the vaccine
COVAXX, a U.S. company developing UB-612 a multitope peptide-based vaccine to fight COVID-19, has announced an exclusive agreement with Aurobindo Pharma to expand its global development and commercialization of UB-612 to India and the United Nations Children’s Fund (UNICEF) agency.
“COVAXX is committed to providing an equitable distribution of UB-612 vaccine by prioritizing markets where the unmet need is greatest,” said Mei Mei Hu, co-founder and CEO of COVAXX.
“During this global health crisis response, we must establish partners with the strongest capabilities, like Aurobindo, to expand the manufacturing and delivery of our vaccine.
“As one of the leading industry players with a strong track record of execution and investment in vaccines, Aurobindo Pharma is the ideal partner to advance UB-612 in India and other emerging nations and to support our mission of democratizing health worldwide,” Hu said on 24 Dec 2020.
“All countries need vaccines but not all countries possess the robust, complex and costly infrastructure necessary to handle the extreme cold-chain systems required by some of the approved vaccines,” said Lou Reese, co-founder and Executive Chairman of COVAXX.
“Partnering with top-tier organizations such as Aurobindo is a crucial step in expanding our global scale, reach and impact,” said Reese.
Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX’s vaccine candidate, UB-612. Under the signed license agreement, Aurobindo Pharma has obtained the exclusive rights to commercialize in India and to UNICEF and non-exclusive rights in other select emerging and developing markets.
COVAXX will supply the bulk product and Aurobindo will manufacture the finished doses at its facilities in Hyderabad, India. Aurobindo has an initial capacity of 220 million doses in multi-dose presentation and is building additional facilities to increase its capacity to have nearly 480 million doses manufactured by June 2021. The financial terms of the agreement are not disclosed.
“This vaccine has immense potential in eliminating shedding and hence containing the spread of the pandemic,” said N. Govindarajan, Managing Director, Aurobindo Pharma Limited.
“We are proud to join hands with COVAXX for developing the first-ever peptide-based vaccine to combat the COVID-19 pandemic,” he said.
The agreement is in addition to the recently announced advanced purchase commitments of more than 140 million doses of COVAXX’s UB-612 vaccine, totaling over US$2.8 billion, to deliver the vaccine in multiple countries. COVAXX is currently completing a Phase 1 clinical trial of UB-612 in Taiwan and will begin Phase 2/3 clinical trials in Asia, Latin America and the U.S.
The COVAXX mission is to democratize health and safeguard lives worldwide by tackling the global COVID-19 pandemic using cost-effective, scalable and proven science-based solutions. Produced from a commercially proven, vaccine platform, UB-612 is a multitope vaccine designed to activate both B and T-cell arms of the immune system. Preclinical studies have shown that the UB-612 vaccine candidate generated high titers of neutralizing antibodies.
COVAXX is a subsidiary of United Biomedical Inc (UBI), founded in 1985, with headquarters in New York.
Aurobindo Pharma Limited (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS, Bloomberg: ARBP:IN), headquartered in Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. #health #vaccines #COVID-19 #manufacturing /fiinews.com
