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GreenLight Biosciences Holdings, PBC (GRNA) enters into multitarget licensing agreement with Serum Institute of India to develop and commercialize messenger RNA products for emerging markets globally

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GreenLight Biosciences has announced a licensing agreement with Serum Institute of India to create three messenger RNA products, including a shingles vaccine. This collaboration aims to enhance access to mRNA vaccines in emerging markets with a population exceeding 5 billion. Serum Institute will manage development and commercialization in these markets while GreenLight maintains rights in North America and select regions. GreenLight will receive initial payments, milestone payments, and a profit share from products sold in emerging markets, reinforcing both companies' commitment to vaccine equity.

Positive
  • GreenLight secures a licensing agreement with Serum Institute, expanding market reach.
  • Access to a population of over 5 billion in emerging markets for mRNA products.
  • GreenLight receives upfront payments and profit-sharing opportunities.
Negative
  • GreenLight retains no rights to commercialization in emerging markets.

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  • Serum Institute of India has engaged GreenLight to design three messenger RNA products, including a vaccine for shingles. Serum Institute of India also has an option to expand the relationship further for two additional vaccine or therapeutic targets.

  • Serum Institute of India will receive a license to develop, manufacture, and commercialize the resulting products in a number of emerging markets, including Africa, Latin America, the Middle East, and much of Asia.

  • GreenLight retains the right to develop, manufacture and commercialize those products in North America, Europe, Australia, New Zealand, China, Japan, and South Korea.

  • GreenLight will make a technology transfer of its scalable and cost-effective manufacturing process to Serum Institute of India.

  • GreenLight will receive payments upfront, and for near-term milestones and in a profit-sharing agreement.

  • Serum Institute of India will pay all development, manufacturing, and commercialization costs for each product in the emerging markets.

BOSTON and PUNE, India, March 14, 2022 (GLOBE NEWSWIRE) -- GreenLight Biosciences Holdings PBC today announced a licensing agreement with Serum Institute of India, Pvt, Ltd., aimed at accelerating accessibility to messenger RNA products in emerging markets globally.

Serum Institute of India (SII) is the world’s largest vaccine manufacturer by number of doses produced and sold. GreenLight Biosciences is a public benefit corporation whose RNA platform focuses on discovery, design, development, manufacturing, and commercialization of products for human, animal, and plant health.

The agreement reflects the commitment to vaccine equity by both GreenLight and SII. Their shared vision is to produce enough messenger RNA vaccines to meet the health needs of billions of people per year.

SII will have access to GreenLight’s proprietary technology platform to develop, manufacture, and commercialize up to three messenger RNA products in markets with a total population of more than 5 billion, including Africa, Latin America, the Middle East, and Asia (excluding China, Japan, and South Korea).

“GreenLight’s approach resonates with our mission to make healthcare equitable for all. Messenger RNA technology will play a key role in reducing the burden of human suffering caused by vaccine-preventable diseases across LMICs," said Adar Poonawalla, CEO, Serum Institute of India.

SII has an option to expand this license agreement to two additional messenger RNA vaccines or therapies to be named later. GreenLight retains the right to develop, manufacture, and commercialize those products licensed to SII in North America, Europe, Australia, New Zealand, China, Japan, and South Korea.

GreenLight will work to discover and design messenger RNA-based vaccine candidates, beginning with a shingles product, for SII to undertake clinical development, manufacturing, and commercialization. In furtherance of this goal, GreenLight will transfer its existing clinical-scale manufacturing process to SII’s facility in Pune, India. SII will work to bring the products through clinical trials and, assuming successful trials, to the production levels required for its markets.

“We are delighted to deepen our partnership with the world's largest vaccine manufacturer,” said Andrey Zarur, CEO of GreenLight. “Serum shares our ambition of making messenger RNA accessible to billions of people for their essential healthcare needs. This partnership reaffirms our commitment to help provide access to state-of-the art healthcare solutions to as many members of the human family as possible.”

Today’s announcement follows on from a $10M investment in GreenLight Biosciences announced by Serum Life Sciences, a subsidiary of Serum Institute of India, in November 2021.

Under the terms of the licensing agreement for shingles, GreenLight will receive payments upfront and following near-term milestones. GreenLight is eligible to receive fees for future target exclusivity, development milestones, and manufacturing technology transfer.

SII will pay for all development, manufacturing, and commercialization costs for each product in the emerging markets, with GreenLight receiving its percentage of calculated profits arising from future products sold in these markets.

About Serum Institute of India Pvt. Ltd.

Driven by the philanthropic philosophy of affordable vaccines, Serum Institute of India Pvt, Ltd. (SIIPL) is the world's largest vaccine manufacturer by the number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's least expensive and WHO-accredited vaccines to as many as 171 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute's objective has been proliferated by bringing down the prices of newer vaccines such as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps, and Rubella vaccines. SII also launched India’s first indigenously developed pneumococcal vaccine – PNEUMOSIL®️ to improve pneumococcal conjugate vaccine affordability and enabling sustainable access for low- and middle-income countries. SII is credited with bringing world-class technology to India, through its state-of-the-art equipped multifunctional production facility in Manjri, Pune; along with spearheading the race of vaccine development against the COVID-19 pandemic.

About GreenLight

Founded in 2008, GreenLight aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA platform, which is protected by numerous patents, allows for cost-effective production of RNA. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions. Many factors including changes in the market for mRNA vaccines could cause actual future events to differ materially from the forward-looking statements in this press release. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and GreenLight assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contact

Thomas Crampton
SVP & Head of Corporate Affairs
GreenLight Biosciences
tcrampton@greenlightbio.com
+44 7826 995794
+1-914-202-2762

Mayank Sen
Serum Institute of India
mayank.sen@seruminstitute.com
+919867974055

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3c501836-dbfd-430f-929a-ab8569dc0f80


FAQ

What is the licensing agreement between GreenLight and Serum Institute of India about?

The agreement involves GreenLight licensing three mRNA products, including a shingles vaccine, to Serum Institute for development in emerging markets.

What markets will Serum Institute of India target with the mRNA products?

Serum Institute will target emerging markets in Africa, Latin America, the Middle East, and much of Asia, covering over 5 billion people.

How will GreenLight benefit financially from this agreement?

GreenLight will receive upfront payments, milestone payments, and a share of profits from products sold in emerging markets.

What types of vaccines will be developed under this agreement?

The agreement includes the development of three mRNA products, starting with a vaccine for shingles.

What rights does GreenLight retain in the licensing agreement?

GreenLight retains the rights to develop, manufacture, and commercialize the products in North America, Europe, Australia, New Zealand, China, Japan, and South Korea.
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