Medicago and GSK Announce Health Canada Approval of COVIFENZ®, an Adjuvanted Plant-Based COVID-19 Vaccine

For media and investors only

Issued: London, UK

  • A vaccine made in factories and developed in Canada

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announced that Health Canada has granted approval for COVIFENZ®, COVID-19 vaccine, (viral particles of plant origin [VLP], recombinant, adjuvanted). This vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in persons 18-64 years of age.

“The approval of our COVID-19 vaccine is an important step for Canada in the fight against the pandemic. We appreciate the timely review by Health Canada,” said Takashi Nagao, President and CEO of Medicago. “We are also grateful for the support of the Government of Canada in the development of this new vaccine, and we are manufacturing doses to begin fulfilling its order.

Roger Connor, Chairman of GSK Vaccines, added: “This first approval is an important step in our approach of combining GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect people against the disease. COVID-19. We look forward to working with Medicago to make the vaccine available in Canada and to advance other regulatory submissions. »

The Government of Canada has a contract with Medicago (the Marketing Authorization Holder) to supply the COVID-19 vaccine. Medicago undertakes to execute this order as soon as possible.

“Given that a top priority of our government has been to reverse the 40-year decline facing the biomanufacturing sector in Canada, we are thrilled to see the approval of Medicago’s vaccine. This is an important step for the Canadian biotechnology sector and for local innovation. We will continue to support companies that want to produce vaccines in Canada and join the growing domestic biomanufacturing sector. said the Honorable François-Philippe Champagne, Minister of Innovation, Science and Industry.

Health Canada based its decision on scientific data shared by Medicago as part of its Continuing Submission which began in April 2021 under an Interim Order and ended with the filing of a New Drug Submission -CV.

“Today is a great day for Medicago COVIFENZ® becomes its first approved vaccine. I would like to thank the clinical investigators involved in our trials as well as the passionate and curious team at Medicago, which includes more than 500 scientific experts and employees. Today only reinforces our commitment to using our technology to provide rapid responses to emerging global health challenges and to advance therapies for life-threatening diseases around the world. said Yosuke Kimura, scientific director of Medicago.

On COVIFENZ®
COVIFENZ® utilizes coronavirus-like particle (CoVLP) technology with the vaccine consisting of recombinant spike (S) glycoprotein expressed as virus-like particles (VLP) co-administered with GSK’s pandemic adjuvant. The vaccination schedule provides for two doses administered intramuscularly 21 days apart (3.75 micrograms of CoVLP antigen in combination with the pandemic adjuvant GSK in the same injection). The vaccine is stored between 2°C and 8°C. COVIFENZ® the antigen will be manufactured in Canada and North Carolina (USA).

COVIFENZ® is not currently approved or authorized for the prevention of COVID-19 or any other indication outside of Canada.

Use permitted in Canada
Medicago COVIFENZ®, COVID-19 vaccine (plant-derived virus-like particles) [VLP]recombinant, adjuvanted), approved by Health Canada, is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 18 to 64.

About Medicago
Medicago’s mission is to help improve global public health using the power of plants. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in herbal therapies. We are proudly anchored in Quebec, with manufacturing capacity in Canada and the United States. Our passionate and curious team of more than 500 scientific experts and employees are dedicated to using our technology to provide rapid responses to emerging global health challenges and to advance therapies for life-threatening diseases around the world. . Medicago is an affiliate of Mitsubishi Tanabe Pharma Corporation. For more information: www.medicago.com

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the majority parent company of Medicago, is one of Japan’s leading pharmaceutical companies, headquartered in Osaka, Japan. It is positioning vaccines as one of its key R&D areas as part of its 21-25 Medium-Term Management Plan and is also working on the development of new vaccine modalities. The MTPC group will further contribute to the prevention of infectious diseases, which is one of the most important social problems in the world, by providing a new option of herbal VLP vaccine as a new type of vaccine. For more information, please visit https://www.mt-pharma.co.jp/e/.

About GSK and its commitment to the fight against COVID-19
GSK is a science-driven global healthcare company. For more information, visit www.gsk.com/about-us.

GSK is collaborating with companies and research groups around the world working on promising vaccine candidates against COVID-19 through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it can reduce the amount of vaccine protein required per dose, allowing more doses of vaccine to be produced and therefore helping to protect more people.

Caution Regarding Forward-Looking Statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. These factors include, but are not limited to, those described in the Company’s Annual Report on Form 20-F for 2020, GSK’s fourth quarter 2021 results and any impacts from the COVID-19 pandemic.

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