HHS will provide initial funding of approximately $17 million to support preclinical development and antibody manufacturing. This initial funding is designed to support an Investigational New Drug application with the U.S. Food and Drug Administration (FDA). Options in the agreement provide for an additional $21 million for a Phase 1 study in healthy volunteers, which is planned for January 2016, and further manufacturing and development studies.
Regeneron utilized its proprietary VelociGene® and VelocImmune® technologies, which enable the rapid identification and preclinical validation of fully human monoclonal antibodies, to develop a novel antibody therapy “cocktail” which includes a mixture of three antibodies. These technologies enabled the rapid identification and scale-up of the investigational antibody therapy. To date, Regeneron has conducted pre-clinical studies in animal models of Ebola virus infection. These antibodies have been discovered and developed pursuant to Regeneron’s 2009 antibody discovery and development agreement with Sanofi and are subject to Sanofi’s opt-in rights for development and commercialization.
“We’re proud to work with BARDA to apply our unique rapid response capabilities to Ebola, one of the most critical global health crises of recent times,” said Neil Stahl, Ph.D., Executive Vice President of Research and Development at Regeneron. “Regeneron’s mission is to use science and technology to transform outcomes for people living with serious diseases. In the midst of an emerging outbreak, every day counts for people who are infected or at risk. Regeneron’s technologies create manufacturing-ready cell lines of validated fully human antibodies in just months, offering the distinct promise of better treatments in shorter timeframes.”
In addition to Ebola, Regeneron’s proprietary antibody rapid response platform has been used to generate antibodies for Middle East Respiratory Syndrome (MERS) and has the potential to address other emerging infectious diseases.
About Regeneron Pharmaceuticals, Inc.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital Media
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s products, product candidates, and research and clinical programs now underway or planned, including without limitation Regeneron’s monoclonal antibody therapy for the treatment of Ebola virus infection; the extent to which the results from Regeneron’s research programs or preclinical testing may lead to advancement of product candidates to clinical trials or therapeutic applications; unforeseen safety issues and possible liability resulting from the administration of products and product candidates in patients; serious complications or side effects in connection with the use of Regeneron’s products and product candidates in clinical trials; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products, research and clinical programs, and business; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates and new indications for marketed products; competing drugs and product candidates that may be superior to Regeneron’s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron’s products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron’s agreements with Sanofi and Bayer HealthCare LLC, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2014 and its Form 10-Q for the quarterly period ended June 30, 2015. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
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