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6/10/2020

Panacea Biotec and Refana Announce Landmark Collaboration for COVID-19 Vaccine

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Collaboration will enable global development, manufacturing and distribution of the Candidate COVID-19 vaccine

Panacea Biotec is advancing its response to address the unprecedented challenges of COVID-19 by collaborating with Refana Inc. USA to make candidate Covid-19 vaccine widely accessible around the world in an equitable manner through a Joint Venture company based in Ireland.
 
The collaboration aims to bring to patients a whole inactivated virus-based vaccine for Covid-19. Under the collaboration, Panacea Biotec would be responsible for product development and commercial manufacturing, Joint Venture for undertaking clinical development and regulatory submissions across the World. Both Panacea and Refana will undertake sales and distribution of the vaccine in their respective territories.
 
Dr. Rajesh Jain, Managing Director, Panacea Biotec, said, “The world needs a vaccine that is safe, effective, and scalable in a cGMP compliant manufacturing facility that has sizeable capacity and capability to cater to global demand. Our collaboration with Refana aims to manufacture over 500 million doses of our Covid-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year. Whole inactivated viral vaccines have a higher probability of being safe and efficacious, given their long history and better understanding of their mechanism of action, which has been eluciated over many decades. This vaccine has the potential to become the Vaccine of Choice for the global fight against Covid-19. We believe and hope that our vaccine will enable the world to get back to work fearlessly as soon as possible.”

Dr Phillip Schwartz stated "Refana and its international network of scientific researchers and practitioners are dedicated to finding practical solutions to complex and urgent global medical problems. We are grateful for the input we have obtained from dozens of medical scientists and epidemiologists in more than a dozen countries in this unprecedented worldwide collaboration to end Covid-19. Our partnership with Panacea Biotec brings this dream to a practical realization with the ability to manufacture 500 million Covid-19 vaccines over 12 months. Utilizing proven models of viral pathogenesis and parallel conduct of multiple pre-clinical and clinical studies, Refana believes it can significantly accelerate the vaccine development and approval process for its tried and true whole inactivated viral vaccine approach. We are very excited to combine this approach with Panacea Biotec's world class technology, development and production capabilities." 
 
About Panacea Biotec
Panacea Biotec is an innovation-led biopharmaceutical group that focuses on discovery, development, and commercialisation of prescription medicines primarily, focusing on Vaccines, Diabetes, Transplant, and Oncology. Its facilities are WHO Prequalified, US FDA approved and cGMP compliant. It is also undertaking development of a novel Tetravalent Dengue Vaccine, Pneumococcal Conjugate vaccine among other differentiated drug development programs.

In April 2019, India Resurgence Fund (IndiaRF), a leading India-focussed investment platform, promoted by Piramal Enterprises Limited and Bain Capital Credit, announced an investment of up to INR 992 Crorse/US$ 144 Million in Panacea Biotec.

For more information, visit: www.panaceabiotec.com

About Refana
Dr Schwartz is the Chief Scientific and Medical advisor to Refana Inc., and the founder and president of NASDAQ listed EnteraBio. Refana Inc., is a United States registered private corporation dedicated to finding practical and innovative solutions to the world's medical problems. By utilizing a highly collaborative open source system of research and development Refana has been able to attract world leaders in their respective scientific and medical fields to work on these problems. Through this model Refana hopes to greatly accelerate the vaccine development process for Covid-19 and help protect not only the health of the world, but also the economies and stability of nations at risk. 

​For more information regarding Refana and this announcement, please contact Debbie Fuller. Tel: +44 7494 636015. Email: pr@refana.com. 

Read on the FT here.

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6/10/2020

Indian firm Panacea says aiming to make COVID-19 vaccine

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BENGALURU (Reuters) - Indian biotech firm Panacea Biotec Ltd said on Wednesday it would partner with U.S.-based Refana Inc to make a potential vaccine for COVID-19.

The collaboration aims to make more than 500 million doses of the vaccine candidate, with over 40 million doses expected to be available early next year, Panacea said in a statement to stock exchanges. (bit.ly/3dPPZQM)

Panacea’s shares jumped 20% in morning trading on India’s National Stock Exchange after the news.

​This article appeared on Reuters.
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6/10/2020

Panacea Biotech hits upper circuit on tie-up with Refana for COVID-19 vaccine

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Panacea Biotech Limited locked in upper circuit post-announcing its collaboration with Refana Inc. USA for the global development, manufacturing and distribution of a COVID-19 vaccine.

The two companies aim to make the COVID-19 vaccine widely accessible worldwide, serving equitably through a joint venture company based in Ireland. Both the companies will undertake the sales and distribution of the vaccine in their respective territories.

In line with the partnership terms, Panacea Biotec will be responsible for product development and commercial manufacturing, with the Joint Venture undertaking clinical development and regulatory submissions across the world.

As informed by the management of Panacea Biotech, this association targets at manufacturing over 500 million doses of the vaccine, with over 40 million doses anticipated to be available for delivery early next year. Whole inactivated viral vaccines have a greater probability of being safe and effective, given their long history and better understanding of their mechanism of action.

The management of Refana Inc. further stated that by utilizing proven models of viral pathogenesis and parallel conduct of multiple pre-clinical and clinical studies, it can significantly accelerate the vaccine development and approval process for its tried and true whole inactivated viral vaccine approach.

Panacea Biotech is a biotechnology company focusing on developing pharmaceutical medicines for chronic diseases such as diabetes, osteoporosis, organ transplantation, pain management, oncology and gastroenterology and vaccines for common morbid conditions such as pneumonia, hepatitis B, polio, dengue and tetanus among others.

In the December 2019 quarter, Panacea’s revenue rose 45 per cent YoY to Rs 160.6 crore. The pharmaceutical segment grew 29 per cent YoY while the vaccines segment grew 90 per cent YoY during the quarter.

Panacea Biotech’s stock hit upper circuit of 20 per cent at Rs 202.80 on Wednesday, from its previous close of Rs 169 on BSE.

This article was written by Apurva Joshi and appeared in Dalal Street Investment Journal.

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6/10/2020

Panacea Biotec shares zoom 20 pc on collaboration with US-based Refana to develop COVID-19 vaccine

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New Delhi, Jun 10 () Shares of Panacea Biotec on Wednesday zoomed 20 per cent after the company said it was setting up a JV in Ireland with US-based Refana Inc to develop a vaccine for COVID-19.

Following the announcement, shares of Panacea Biotec advanced 20 per cent to Rs 202.80 -- its upper circuit limit -- on the BSE.

The scrip jumped 20 per cent to Rs 203.70 -- its highest trading permissible limit -- for the day on the NSE.


This article was written by Business Insider India.

Read the full article here.

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6/10/2020

Panacea joins hands with Ireland's Refana to develop COVID-19 vaccine by early next year

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Panacea Biotec Managing Director Rajesh Jain has said the aim is to manufacture over 500 million doses of COVID-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year.

Biopharmaceutical company Panacea Biotec on June 10 announced its collaboration with Ireland-based biotech Refana to develop, manufacture and distribute an inactivated COVID-19 vaccine.

Under the collaboration, Panacea Biotec will be responsible for product development and commercial manufacturing, with the joint venture undertaking clinical development and regulatory submissions across the world.

Both Panacea and Refana will undertake sales and distribution of the vaccine in their respective territories.

Rajesh Jain, Managing Director of Panacea Biotec, said the aim is to manufacture over 500 million doses of COVD-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year.

"The world needs a vaccine that is safe, effective, and scalable in a cGMP compliant manufacturing facility that has sizeable capacity and capability to cater to global demand," Jain said.

"Whole inactivated viral vaccines have a higher probability of being safe and efficacious, given their long history and better understanding of their mechanism of action, which has been elucidated over many decades," Jain added.

"Our partnership with Panacea Biotec brings this dream to a practical realisation with the ability to manufacture 500 million COVID-19 vaccines over 12 months," said Dr Phillip Schwartz, Chief Scientific and Medical advisor to Refana Inc., and the founder and president of NASDAQ-listed EnteraBio.

"Utilising proven models of viral pathogenesis and parallel conduct of multiple pre-clinical and clinical studies, Refana believes it can significantly accelerate the vaccine development and approval process for its tried and true whole inactivated viral vaccine approach. We are very excited to combine this approach with Panacea Biotec's world-class technology, development and production capabilities," Schwartz said.

Panacea is one of the leading Indian vaccine makers. The company sells WHO-prequalified vaccines. It is also undertaking development of a novel Tetravalent Dengue Vaccine, Pneumococcal Conjugate vaccine among other differentiated drug development programmes.

In April 2019, India Resurgence Fund (IndiaRF), a leading India-focused investment platform, promoted by Piramal Enterprises and Bain Capital, invested Rs 992 crore in the company.

Indian companies with large vaccine manufacturing capacities are sought after by biotechs and research institutions in the West, that are developing vaccine.

Billions of doses of vaccine are needed to protect people from COVID-19 and build herd immunity against the pandemic.  So far the world has reported 7.2 million confirmed COVID-19 cases and 4,11,276 deaths according to Johns Hopkins Coronavirus Resource Center.  India has reported 2,76,146 cases, the fifth-highest in world, with 7750 deaths.

This article appeared in Money Control

​
Viswanath Pilla @viswanath_pilla

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6/10/2020

pR: Panacea Biotec and Refana announce landmark collaboration for Covid-19 vaccine

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​

Collaboration will enable global development, manufacturing and distribution of the Candidate Covid-19 vaccine
​

PRESS RELEASE: 10th June 2020

Panacea Biotec is advancing its response to address the unprecedented challenges of COVID-19 by collaborating with Refana Inc. USA to make candidate Covid-19 vaccine widely accessible around the world in an equitable manner through a Joint Venture company based in Ireland.
 
The collaboration aims to bring to patients a whole inactivated virus-based vaccine for Covid-19. Under the collaboration, Panacea Biotec would be responsible for product development and commercial manufacturing, Joint Venture for undertaking clinical development and regulatory submissions across the World. Both Panacea and Refana will undertake sales and distribution of the vaccine in their respective territories.
 
Dr. Rajesh Jain, Managing Director, Panacea Biotec, said, “The world needs a vaccine that is safe, effective, and scalable in a cGMP compliant manufacturing facility that has sizeable capacity and capability to cater to global demand. Our collaboration with Refana aims to manufacture over 500 million doses of our Covid-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year. Whole inactivated viral vaccines have a higher probability of being safe and efficacious, given their long history and better understanding of their mechanism of action, which has been eluciated over many decades. This vaccine has the potential to become the Vaccine of Choice for the global fight against Covid-19. We believe and hope that our vaccine will enable the world to get back to work fearlessly as soon as possible.”

Dr Phillip Schwartz stated "Refana and its international network of scientific researchers and practitioners are dedicated to finding practical solutions to complex and urgent global medical problems. We are grateful for the input we have obtained from dozens of medical scientists and epidemiologists in more than a dozen countries in this unprecedented worldwide collaboration to end Covid-19. Our partnership with Panacea Biotec brings this dream to a practical realization with the ability to manufacture 500 million Covid-19 vaccines over 12 months. Utilizing proven models of viral pathogenesis and parallel conduct of multiple pre-clinical and clinical studies, Refana believes it can significantly accelerate the vaccine development and approval process for its tried and true whole inactivated viral vaccine approach. We are very excited to combine this approach with Panacea Biotec's world class technology, development and production capabilities." 
 
About Panacea Biotec
Panacea Biotec is an innovation-led biopharmaceutical group that focuses on discovery, development, and commercialisation of prescription medicines primarily, focusing on Vaccines, Diabetes, Transplant, and Oncology. Its facilities are WHO Prequalified, US FDA approved and cGMP compliant. It is also undertaking development of a novel Tetravalent Dengue Vaccine, Pneumococcal Conjugate vaccine among other differentiated drug development programs.

In April 2019, India Resurgence Fund (IndiaRF), a leading India-focussed investment platform, promoted by Piramal Enterprises Limited and Bain Capital Credit, announced an investment of up to INR 992 Crorse/US$ 144 Million in Panacea Biotec.

For more information, visit: www.panaceabiotec.com

About Refana
Dr Schwartz is the Chief Scientific and Medical advisor to Refana Inc., and the founder and president of NASDAQ listed EnteraBio. Refana Inc., is a United States registered private corporation dedicated to finding practical and innovative solutions to the world's medical problems. By utilizing a highly collaborative open source system of research and development Refana has been able to attract world leaders in their respective scientific and medical fields to work on these problems. Through this model Refana hopes to greatly accelerate the vaccine development process for Covid-19 and help protect not only the health of the world, but also the economies and stability of nations at risk. 

​For more information regarding Refana and this announcement, please contact Debbie Fuller. Tel: +44 7494 636015. Email: pr@refana.com. 

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6/6/2020

COVID-19 vaccine development pipeline gears up

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Vaccine makers are racing to develop COVID-19 vaccines, and have advanced ten candidates into clinical trials. But challenges remain. Asher Mullard reports.

Vaccine development is typically a long game. The US Food and Drug Administration only approved a first vaccine against Ebola virus last year, 43 years after the deadly virus was discovered. Vaccinologists have made little headway with HIV or respiratory syncytial virus, despite huge investments. On average, it takes 10 years to develop a vaccine. With the COVID-19 crisis looming, everyone is hoping that this time will be different.

This article was written by Asher Mullard and appeared in The Lancet on 06 June.

Download a pdf of the full article.

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