MEDICAGO
16.12.2021 20:02:09 CET | Business Wire | Press release
Medicago, a biopharmaceutical company headquartered in Quebec City, is pleased to announce submission of the positive Phase 3 data for regulatory review by Health Canada as part of the New Drug Submission for COVID (NDS-CV) rolling review for Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant. Medicago is seeking review and approval for the vaccine candidate for indication in healthy adults, aged 18 years and above.
“We are pleased to submit our Phase 3 data as the final portion of the rolling submission for our COVID-19 vaccine candidate for review,” said Dr. Judith Atkins, Vice-President of Regulatory Affairs at Medicago. “We are grateful to Health Canada for their review, and we hope this brings Canadians and the world one step closer to having greater vaccine diversity.”
Thomas Breuer, Chief Global Health Officer, GSK, added: “We are one step closer to our goal of making this innovative adjuvanted, plant-based vaccine available. As a refrigerator-stable option that builds on our established adjuvant technology, we are hopeful it will play an important role in the efforts to overcome the COVID-19 pandemic.”
The New Drug Submission for COVID (NDS-CV) process allowed the submission of nonclinical sections, quality, clinical safety, and efficacy information as they became available for Health Canada’s immediate review to accelerate the overall review process. Submitting the Phase 3 data completes the submission process.
The regulatory filing process for the COVID-19 vaccine candidate has been initiated with the FDA (US) and MHRA (UK). Preliminary discussion is underway with the WHO for preparation of the submission. A Phase 1/2 trial has also been initiated in Japan where Medicago plans to submit for regulatory approval in combination with the Phase 2/3 global study results next spring. The vaccine candidate has not yet been approved by any health authorities.
“If authorized, Medicago’s COVID-19 vaccine would be the world’s first ever plant-based vaccine approved for human use,” said Takashi Nagao, CEO and President of Medicago. “It would also be the first Canadian vaccine approved in over 20 years, signaling a powerful step forward for Canada’s vaccine preparedness strategy.”
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
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/ .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211216005780/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Rimini Street and Datacom Announce Strategic Partnership to Accelerate AI Adoption and Drive IT Optimisation Across ANZ14.9.2026 22:00:00 CEST | Press release
Collaboration delivers expert third-party support for Oracle and SAP, keeping systems secure, compliant and stable for immediate Agentic AI ERP innovation while freeing up capital for growth and profitability Rimini Street Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle and SAP software, today announced a strategic partnership with Datacom, one of Australasia’s largest homegrown technology services and solutions providers. The reseller agreement will see Datacom offer Rimini Support™ for Oracle and SAP software to its public and private sector customers across Australia and New Zealand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914070894/en/ Rimini Street and Datacom Announce Strategic Partnership to Accelerate AI Adoption and Drive IT Optimisation Across ANZ This collaboration brings together Rimini Street's third-party software support, t
Lattice to Showcase Next Gen Automotive Sensing Innovations at AutoSens Europe 202614.9.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced its exhibition plan for the upcoming AutoSens Europe 2026, taking place on Sept. 22 – 24, 2026, in Barcelona, Spain. As part of the event, Lattice will deliver a technical presentation and host a demo showcase focused on how its low power FPGA solutions are enabling next-generation automotive sensing, ADAS, and in-vehicle networking applications. Who: Lattice Semiconductor What / When (GMT+2): Sept. 22 – 24, 2026 Lattice Demo Showcase at Booth #215 from local dimming, camera monitoring system, sensor security, and more. Presentation (Sept. 23 at 2:30 p.m., Room 5) “Efficient 360° threat detection for parked vehicles – A distributed, event-driven approach” Where: La Farga de L’Hospitalet, Barcelona, Spain AutoSens Europe is the automotive industry's premier conference and exhibition for perception systems, ADAS, and autonomous vehicle technology. Bringing together over 1,000 en
iQmetrix to Deliver 2026 Telecom Industry Address and Product Announcements, Unveiling the Next Wave of Intelligent Commerce14.9.2026 19:40:00 CEST | Press release
iQmetrix's annual industry briefing goes global on October 28, pairing a year of worldwide market intelligence with the company's outlook on AI-native commerce and a first look at what's next for its Intelligent Commerce Operating System iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, today opened registration for the 2026 Telecom Industry Address and Product Announcements, taking place Wednesday, October 28, 2026. For the first time in the event's history, iQmetrix will run two dedicated virtual sessions: one built specifically for European audiences, alongside its long-running North American event. Both are free to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914992633/en/ Now in its seventh year, the Industry Address has become the telecom channel's annual checkpoint: an unfiltered read on where the market is heading, delivered by a company that sits at the intersection of
The Estée Lauder Companies Announces Partnership with Profound to Expand AI Visibility Across Its Global Brand Portfolio14.9.2026 18:32:00 CEST | Press release
Partnership enables the company to lead prestige beauty's transition to AI-powered discovery while better understanding how consumers discover, evaluate, and engage with its brands across AI answer engines The Estée Lauder Companies Inc. (NYSE: EL) today announced a global strategic partnership with Profound, the category-defining AI marketing platform, advancing its ambition to be prestige beauty’s leader in AI-native discovery. The partnership will provide the company with visibility into how its full portfolio of brands is represented across leading generative AI platforms, as well as opportunities to optimize that representation. This partnership establishes the company as the first in prestige beauty to deploy Profound’s capabilities globally across the company’s full portfolio and operationalize Generative Engine Optimization (GEO) and AI marketing at scale. As consumers increasingly turn to ChatGPT, Gemini, and other AI assistants to discover products, compare recommendations, a
AMAALA Yacht Club Opens, Putting the Red Sea on the Global Yachting Map14.9.2026 18:00:00 CEST | Press release
Luxury sailing, wellness and exploration converge at Saudi Arabia's newest yachting destination Red Sea Global (RSG), the regenerative tourism developer, has announced that AMAALA Yacht Club has officially begun operations, marking a major milestone in establishing the Saudi Red Sea as a new global destination for luxury yachting, sailing and marine tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914160771/en/ AMAALA Yacht Club, the new luxury yachting destination on Saudi Arabia’s Red Sea coast. Nestled within AMAALA Marina Village, the AMAALA Yacht Club is now welcoming founding members and visiting yachts to moor and explore the destination. Located approximately 2,000 nautical miles from Monaco, the club provides a new winter destination for the world’s luxury sailing community, which traditionally migrates from the Mediterranean to the Caribbean or Indian Ocean from October. Positioned closer to the Mediterra
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom