REG - GlaxoSmithKline PLC - Canada Approval For Medicago GSK Covid-19 Vaccine

GSKAnnouncement

24/02/2022 15:15

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RNS Number : 7580C  GlaxoSmithKline PLC  24 February 2022

Issued: 24 February 2022, London UK

 

Medicago and GSK announce the approval by Health Canada of COVIFENZ®, an
adjuvanted plant-based COVID-19 vaccine

 

·   A vaccine manufactured in plants 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, (plant-based virus-like particles  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 individuals 18 to 64
years of age.

 

"The approval of our COVID-19 vaccine is a significant milestone for Canada in
the fight against the pandemic. We appreciate Health Canada's timely review,"
said Takashi Nagao, President and CEO at Medicago. "We're also grateful for
the Government of Canada's support in the development of this new vaccine, and
we are manufacturing doses to start fulfilling its order."

 

Roger Connor, President of GSK Vaccines, added, "This first approval is an
important milestone in our approach of pairing GSK's well-established pandemic
adjuvant with promising antigens to develop protein-based, refrigerator-stable
COVID-19 vaccines to help protect people against COVID-19 disease. We look
forward to working with Medicago to make the vaccine available in Canada and
to progress further regulatory submissions."

 

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

 

"As one of our government's top priority has been to reverse the 40-year
decline faced by Canada's biomanufacturing sector, we are pleased to see
Medicago's vaccine approval. It is a great milestone for Canada's
biotechnology sector and for homegrown innovation. We will continue to support
companies that want to produce vaccines in Canada and join the growing
national biomanufacturing sector." said the Honourable François-Philippe
Champagne, Minister of Innovation, Science and Industry.

 

Health Canada based its decision on scientific data shared by Medicago as part
of their rolling submission that began in April 2021 under an Interim Order,
and concluded with the filing of a New Drug Submission-CV.

 

"Today is a great day for Medicago as COVIFENZ® becomes its first approved
vaccine. I'd like to thank the Clinical Investigators involved in our trials
as well as Medicago's passionate and curious team of over 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 advancing therapeutics against life-threatening diseases worldwide."
said Yosuke Kimura, Chief Scientific Officer at Medicago.

 

About COVIFENZ®

COVIFENZ® uses Coronavirus-Like Particle (CoVLP) technology with the vaccine
composed of recombinant spike (S) glycoprotein expressed as virus-like
particles (VLPs) co-administered with GSK's pandemic adjuvant. The vaccination
regimen calls for two doses given intramuscularly 21 days apart (3.75
micrograms of CoVLP antigen in combination with GSK pandemic adjuvant in the
same injection). The vaccine is stored at 2 °C to 8 °C. COVIFENZ® antigen
will be manufactured in Canada and in North Carolina (US).

 

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

 

Authorized use in Canada

Medicago's COVIFENZ®, COVID-19 vaccine (plant-based 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
individuals 18 to 64 years of age.

 

About Medicago

Medicago is on a mission 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 plant-based therapeutics. We are proudly rooted in Quebec, with
manufacturing capacity in both Canada and the US. Our passionate and curious
team of over 500 scientific experts and employees are dedicated to using our
technology to provide rapid responses to emerging global health challenges,
and to advancing therapeutics against life-threatening diseases worldwide.
Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation. For
more information: www.medicago.com (http://www.medicago.com/)

 

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation (MTPC) Group, the majority parent company
of Medicago, is one of the large Japanese pharmaceutical companies, with its
headquarters in Osaka, Japan. It positions vaccines as one of its key R&D
areas under its Medium-Term Management Plan 21-25 and is also working to
develop new modalities of vaccines. MTPC Group will further contribute to the
prevention of infectious diseases which is one of the world's important social
issues, by delivering a new option of plant-based VLP vaccine as a new type of
vaccine. For further information please visit https://www.mt-pharma.co.jp/e/
(https://www.mt-pharma.co.jp/e/) .

 

About GSK and its commitment to tackling COVID-19

GSK is a science-led global healthcare company. For further information please
visit www.gsk.com/about-us (https://www.gsk.com/en-gb/about-us/) .

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

 

 

 GSK enquiries:
 Media enquiries:             Tim Foley         +44 (0) 20 8047 5502  (London)
                              Simon Moore       +44 (0) 20 8047 5502  (London)
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 Analyst/Investor enquiries:  Nick Stone        +44 (0) 7717 618834   (London)
                              Sonya Ghobrial    +44 (0) 7392 784784   (Consumer)
                              James Dodwell     +44 (0) 20 8047 2406  (London)
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                              Josh Williams     +44 (0) 7385 415719   (London)
                              Jeff McLaughlin   +1 215 751 7002       (Philadelphia)
                              Frannie DeFranco  +1 215 751 4855       (Philadelphia)

 

Cautionary statement 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. Such factors include, but are not limited to, those described in
the Company's Annual Report on Form 20-F for 2020, GSK's 2021 Q4 Results and
any impacts of the COVID-19 pandemic.

 

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