TARRYTOWN, N.Y., Aug. 22, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced an agreement with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) to manufacture and study two antibody therapies for the potential prevention and treatment of Middle East Respiratory Syndrome (MERS). Regeneron has previously published details on how its proprietary VelociGene® and VelocImmune® technologies enabled the rapid identification and preclinical validation of these antibody candidates.
HHS will provide funding to Regeneron of up to $8.9 million to support packaging and labeling of the antibodies for human use (known as "fill and finish"), the preparation and submission of an Investigational New Drug application with the U.S. Food and Drug Administration (FDA), and a National Institutes of Health-conducted clinical trial in healthy volunteers. Currently there are no approved medicines or vaccines to treat or prevent MERS, which causes severe respiratory tract infections and is associated with high death rates. Cases of MERS have been reported in the Middle East, South Korea, Europe, the United States, Africa and other countries in Asia.
"Regeneron has built a unique rapid response platform to address emerging infectious disease threats. In addition to the programs in MERS and Ebola that we are advancing with BARDA, we are also quickly progressing a preclinical program targeting the Zika virus," said Neil Stahl, Ph.D., Executive Vice President of Research and Development at Regeneron. "We are committed to partnering with the government and other organizations to swiftly address these emerging public health emergencies."
Regeneron and BARDA have an existing agreement to advance a potential therapy for Ebola that was discovered and developed at Regeneron. The investigational Ebola therapeutic has recently entered a Phase 1 human clinical study and received Orphan Drug Designation from the FDA.
The MERS antibodies have been discovered and developed pursuant to Regeneron's antibody discovery and preclinical development agreement with Sanofi and are subject to Sanofi's opt-in rights for development and commercialization.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) 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 rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer 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 potential antibody therapies for the treatment of Middle East Respiratory Syndrome, Ebola, and Zika; 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, including without limitation Regeneron's potential antibody therapies for the treatment of Middle East Respiratory Syndrome, Ebola, and Zika; serious complications or side effects in connection with the use of Regeneron's products and product candidates in clinical trials; coverage and reimbursement determinations by third-party payers, including Medicare, Medicaid, and pharmacy benefit management companies; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs, and business, including those relating to the enrollment, completion, and meeting of the relevant endpoints of post-approval studies; 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; 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 (or their respective affiliated companies, as applicable) and the agreement with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services discussed in this news release, to be cancelled or terminated without any 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, 2015 and its Form 10-Q for the quarterly period ended June 30, 2016. 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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IR Contact at Regeneron:
Manisha Narasimhan, Ph.D., Tel. 914.847.5126
E-Mail: [email protected]
Media Contact at Regeneron:
Hala Mirza, Tel. 914.847.3422
E-Mail: [email protected]
SOURCE Regeneron Pharmaceuticals, Inc.