CALGARY, AB, June 1, 2021 

- Biological E. Limited to run pivotal trial in India and seek emergency use authorization

- Target of 1 billion dose production capacity in 2022

- Providence to export 30 million doses from existing North American capacity

Calgary, Canada and Hyderabad, India: Providence Therapeutics Holdings Inc. (“Providence”) and Biological E. Limited (“Biological E”) announce the execution of a term sheet (the “Term Sheet”), that sets forth the material terms for a definitive licensing and collaboration agreement (the “Definitive Agreement”) and also outlines the terms for sale by Providence of up to 30 million doses of Providence’s proprietary messenger RNA vaccine, PTX-COVID19-B, to Biological E and other End-Buyers. This sale represents the sale of all the remaining 2021 Providence production, plus a portion of the early 2022 Providence production, after accounting for the first sale of Providence vaccines to the Province of Manitoba, Canada.  

The financial terms of the transaction have not been disclosed. 

Providence will provide the necessary technology transfer for Biological E to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses. Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India and other jurisdictions licensed by Biological E. 

About Providence Therapeutics 

Providence is a leading Canadian clinical-stage biotechnology company pioneering mRNA therapeutics and vaccines with operations in Calgary, Alberta and Toronto, Ontario. In response to a worldwide need for a COVID-19 vaccine, Providence expanded its focus beyond oncology therapies and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19. Providence is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs. For more information, please visit providencetherapeutics.com.  

Media Contacts for Providence Therapeutics:

Noy Wong

Investor Relations and Communications

Phone Contact: +1(403) 800-3031 (Canada) OR Toll Free 1 (877) 324 -0006

Email: 

“The mRNA platform has emerged as the front runner in delivering the first vaccines for emergency use to combat the COVID-19 pandemic. Biological E. is very pleased to be able to work with Providence on its promising mRNA vaccine candidate. We hope to provide India and other countries yet another option to ramp up their efforts towards achieving herd immunity against COVID-19” said Mahima Datla, Managing Director of Biological E Limited.

  • PTX-COVID19-B was generally safe and well-tolerated
  • PTX-COVID19-B exhibited strong virus neutralization capability across the 16µg, 40µg and 100µg dose cohorts
  • PTX-COVID19-B 40µg dose was selected for Phase 2 study
  • PTX-COVID19-B will be evaluated in additional Phase 1 population cohorts

About Biological E. Limited 

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.  

For further details, please visit www.biologicale.com and follow us on Facebook, LinkedIn and Twitter.

 

Media Contact for Biological E. Limited:

Vijay Amruth Raj K.

Corporate Communications Lead 

Phone: +91 83740 77433 

www.biologicale.com/news

FORWARD-LOOKING STATEMENTS

The forward-looking statements and information in this press release include but are not limited to statements with respect to the successful negotiation and entering into the Definitive Agreement described in this press release and the satisfaction of each party's obligations in accordance with the Definitive Agreement. Such statements and information reflect the current views of Providence and Biological E. with respect to risks and uncertainties that may cause actual results to differ materially from those contemplated in those forward-looking statements and information. Such statements are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections in the forward-looking statements will not occur. Except as required by law, Providence and Biological E. Limited disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Providence's and Biological E. Limited’s current expectations and speak only as of the date hereof.