HAUPPAUGE: COVAXX, a U.S. company developing UB-612 a multitope peptide-based vaccine to fight COVID-19, 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.”
“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.”
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.
Commenting on the development, Mr. N. Govindarajan, Managing Director, Aurobindo Pharma Limited, said “We are proud to join hands with COVAXX for developing the first-ever peptide-based vaccine to combat the COVID-19 pandemic. This vaccine has immense potential in eliminating shedding and hence containing the spread of the pandemic.”
This 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 $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.
COVAXX is a subsidiary of United Biomedical Inc (UBI), founded in 1985, with headquarters in New York.
The company is a scientific trailblazer creating technological firsts, including the manufacture and commercialization of more than 100 million antibody blood diagnostic tests and 5 billion vaccine doses against infectious diseases in animal health.
With proprietary access to UBI’s core technology platforms, COVAXX can develop and commercialize high precision antibody tests and a promising COVID-19 vaccine that together would form a unique Differentiating Infected from Vaccinated Individuals (DIVI) system.
While COVAXX and its partners support the global effort by CEPI and the WHO to develop, manufacture and distribute COVID-19 vaccines through a program referred to as the “Covax Facility”, we are not directly related. www.covaxx.com
Aurobindo Pharma Limited headquartered at Hyderabad, India, 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.
he company’s robust product portfolio is spread over major therapeutic areas encompassing CVS, CNS, Antibiotics, Anti-Retrovirals, Gastroenterology, Anti-Allergies and Anti-Diabetics, supported by an outstanding R&D, manufacturing and distribution set-up. The Company is marketing these products globally, in over 150 countries.
Aurobindo Pharma has several WHO prequalified products. The company has completed manufacturing for conducting Phase 3 of its Pneumococcal conjugate vaccine (PCV) vaccine and expects to start Phase 3 trials for the PCV vaccine in early 2021.