Ocugen, Inc., a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, announced that it has entered into an agreement with Jubilant HollisterStier of Spokane, Washington for manufacturing of vaccine candidate COVAXIN® for the US and Canadian markets.
“We are fully committed to bringing COVAXIN to the US and Canadian markets because it has the potential to save lives by adding a weapon to the arsenal in the fight against emerging variants.” said J.P. Gabriel, Senior Vice President, Manufacturing and Supply Chain. “Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada. Based on Bharat’s strong track record of developing and commercializing vaccines globally and Jubilant’s proven track record in manufacturing, we are well-prepared to transition US manufacturing of COVAXIN® to our new partner.”
“We are excited to expand our basket of vaccine products and meet the increasing demand from our customers for COVID-19 vaccines in the US.” said Amit Arora, President Jubilant HollisterStier.
“We are pleased to partner with Ocugen and support the ongoing fight against COVID-19. With two facilities in North America working to manufacture multiple COVID-19 vaccines and therapies, we remain committed to supporting efforts to eradicate this global pandemic.” stated Pramod Yadav, CEO Jubilant Pharma Limited.
About Jubilant HollisterStier
Jubilant HollisterStier, a part of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, otics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full-range of support to streamline the manufacturing process, from process qualifications through commercial release.
About Jubilant Pharma Limited
Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy
Products and Contract Manufacturing of Sterile Injectables and Non Sterile products through six US FDA approved manufacturing facilities in the US, Canada and India and a network of 48 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a ‘Partner of Choice’ by leading pharmaceutical companies globally.
COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Based on a well-established, and time-tested vaccine platform that has a long-established safety profile, COVAXIN continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of the Phase 3 clinical trial.
In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8°C.
COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology have found that COVAXIN demonstrated potential effectiveness against the Brazil variant of SARS-CoV-2, B.1.128.2, the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. In ICMR studies, COVAXIN-vaccinated sera effectively neutralized several SARS-CoV-2 variants including B.1.617, India, double mutant, B.1.1.7, United Kingdom, B.1.1.28, Brazil P2, and heterologous strain) in an in-vitro plaque reduction neutralization assay. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market.