LEXINGTON, Mass.--(BUSINESS WIRE)--Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, announced today a multi-year research and development collaboration and exclusive licensing agreement with Sanofi Pasteur, the vaccines global business unit of Sanofi (NYSE: SNY), to develop mRNA vaccines for up to five undisclosed infectious disease pathogens.
Under the agreement, Translate Bio and Sanofi Pasteur will jointly conduct research and development activities to advance mRNA vaccines during an initial three-year research term. Sanofi Pasteur will make an upfront payment of $45 million to Translate Bio. In total, Translate Bio is eligible to receive up to $805 million in payments, which also includes certain development, regulatory and sales-related milestones across several vaccine targets, and option exercise fees if Sanofi Pasteur exercises its option related to development of vaccines for additional pathogens. In addition, Translate Bio is also eligible to receive tiered royalty payments associated with worldwide sales of the developed vaccines. Sanofi Pasteur will pay for all costs during the research term and will receive exclusive worldwide commercialization rights. Translate Bio will be responsible for clinical manufacture and will be entitled to additional payments under a separate supply agreement to be established.
“Sanofi Pasteur is pursuing a variety of emerging technologies that will allow us to continue to lead in research and development of next-generation vaccines,” said John Shiver, Senior Vice President, R&D, Sanofi Pasteur. “We believe mRNA technology has significant potential for rapid and versatile manufacturing, reduced industrialization costs for multiple vaccines, and the improved breadth of immune response for infectious disease vaccines. The Translate Bio platform may allow us to further address medical needs worldwide, including those not readily accessible using conventional vaccine strategies.”
“Sanofi Pasteur is at the forefront of vaccine research and development which makes them an ideal partner as we expand upon our promising early efforts in vaccines,” said Ronald Renaud, Chief Executive Officer, Translate Bio. “We believe that this partnership validates the potential of our mRNA platform, and also enables us to apply our mRNA technology beyond the current therapeutic applications that we are pursuing in cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency, ultimately advancing our goal of delivering innovative medicines to patients.”
The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976 in the United States.
About mRNA Vaccines
Vaccines work by mimicking disease
agents to stimulate the immune system; building up a defense mechanism
that can be deployed to fight future infections. mRNA vaccines offer an
innovative approach by delivering the nucleotide sequence encoding any
protein associated with prevention or treatment of a pathogen. Because
of their high potency, capacity for rapid development and potential for
low-cost manufacture and safe administration, mRNA vaccines represent a
potentially innovative alternative to conventional vaccine approaches. A
desired protein can be expressed from mRNA without the need to adjust
the production process offering maximum flexibility in development,
potentially enabling the development of vaccines for disease areas where
vaccination is not a viable option today.
About Translate Bio
Translate Bio is a clinical-stage mRNA
therapeutics company developing a new class of potentially
transformative medicines to treat diseases caused by protein or gene
dysfunction. The Company’s MRT platform is designed to develop product
candidates that deliver mRNA carrying instructions to produce
intracellular, transmembrane and secreted proteins for therapeutic
benefit. The Company believes that its MRT platform is applicable to a
broad range of diseases caused by insufficient protein production or
where production of proteins can modify disease, including diseases that
affect the lung, liver, eye, central nervous system, lymphatic system
and circulatory system. The Company also believes its platform may be
applied to produce therapeutic antibodies and vaccines in areas such as
infectious disease and oncology. The Company’s two lead programs are
being developed as treatments for cystic fibrosis (CF) and ornithine
transcarbamylase (OTC) deficiency. For more information about the
Company, please visit www.translate.bio
or on Twitter at @TranslateBio.
Forward-Looking Statements
This press release contains
forward-looking statements. Such forward-looking statements include
those regarding the expected timing and benefits of Translate Bio’s
research and development collaboration and exclusive licensing agreement
with Sanofi, the potential of mRNA vaccines to be an innovative
alternative to conventional vaccine approaches and Translate Bio’s
plans, strategies and prospects for its mRNA platform. The words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “would,” “could,” “potential,” “possible,” “hope,”
“strategy,” “milestone,” “will,” and similar expressions are intended to
identify forward-looking statements, although not all forward-looking
statements contain these identifying words. Such statements are subject
to numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from Translate Bio’s
current expectations and beliefs, including: the timely receipt of HSR
clearance for the transaction with Sanofi; Translate Bio’s ability to
maintain the agreement with Sanofi; Translate Bio’s results of
preclinical studies and clinical trials; the content and timing of
decisions made by the U.S. Food and Drug Administration and other
regulatory authorities; Translate Bio’s ability to obtain and maintain
requisite regulatory approvals and to enroll patients in its planned and
ongoing clinical trials; and Translate Bio’s ability to obtain, maintain
and enforce patent and other intellectual property protection for any
product candidates it is developing. Any forward-looking statements
contained in this press release speak only as of the date hereof, and
Translate Bio expressly disclaims any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
