TARRYTOWN, N.Y., July 7, 2020 /PRNewswire/ — Regeneron Prescription drugs, Inc. (NASDAQ: REGN) as we speak introduced that, as a part of Operation Warp Pace, the Biomedical Superior Analysis and Growth Authority (BARDA), a part of the Workplace of the Assistant Secretary for Preparedness and Response on the U.S. Division of Well being and Human Companies, and the Division of Protection Joint Program Govt Workplace for Chemical, Organic, Radiological and Nuclear Protection have awarded Regeneron a $450 million contract to fabricate and provide REGN-COV2. REGN-COV2 is Regeneron’s investigational double antibody cocktail that’s at the moment in two Part 2/three scientific trials for the therapy of COVID-19 and in a Part three trial for the prevention of COVID-19 an infection.
Regeneron started scaling up manufacturing of REGN-COV2 at enterprise danger in spring of 2020. This settlement helps continued manufacturing in order that the product might be made accessible instantly in the USA if scientific trials are profitable and the U.S. Meals and Drug Administration (FDA) grants Emergency Use Authorization (EUA) or product approval. The settlement covers a hard and fast variety of bulk heaps which are meant to be accomplished within the fall of 2020, in addition to fill/end and storage actions. The continuing REGN-COV2 scientific program is evaluating a number of dosages and will assist set up the precise variety of potential therapy doses (estimated vary of 70,000 to 300,000) or prevention doses (estimated vary of 420,000 to 1,300,000) accessible from these heaps in complete. Preliminary doses could also be prepared as early as finish of summer season. If EUA or product approval is granted, the federal government has dedicated to creating doses from these heaps accessible to the American individuals for free of charge and could be accountable for their distribution.
“Regeneron’s thirty years of funding in our progressive VelociSuite® antibody discovery and improvement applied sciences and our large-scale manufacturing amenities, coupled with the experience and fervour of our individuals, has enabled us to maneuver the REGN-COV2 program ahead at exceptional velocity,” stated Leonard S. Schleifer, M.D., Ph.D., Co-Founder, President and Chief Govt Officer of Regeneron. “We made the choice early on to start large-scale manufacturing at our personal danger to be able to be certain that product could be accessible instantly if our scientific trials show profitable and an Emergency Use Authorization is granted. This manufacturing and provide settlement with BARDA and the Division of Protection might assist REGN-COV2 attain many individuals shortly, hopefully serving to to vary the course of this lethal and still-raging pandemic.”
Regeneron continues to work to maximise manufacturing capability of REGN-COV2 inside Regeneron and with potential companions.
Regeneron scientists evaluated hundreds of fully-human antibodies produced by the corporate’s proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, in addition to antibodies recognized from people who’ve recovered from COVID-19. They chose the 2 most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail with the corporate’s in-house VelociMab® and manufacturing capabilities. REGN-COV2’s two antibodies bind non-competitively to the essential receptor binding area of the virus’s spike protein, which diminishes the power of mutant viruses to flee therapy and protects in opposition to spike variants which have arisen within the human inhabitants, as detailed in latest Science publications. Newer analysis additionally demonstrates protection in opposition to the now prevalent D614G variant.
Regeneron used the identical ‘fast response’ capabilities and cocktail strategy to develop REGN-EB3, a novel triple antibody therapy for Ebola that’s now beneath regulatory evaluate by the FDA. REGN-COV2’s improvement and manufacturing has been funded partially with federal funds from the BARDA beneath OT quantity: HHSO100201700020C.
Regeneron (NASDAQ: REGN) is a number one biotechnology firm that invents life-transforming medicines for individuals with critical illnesses. Based and led for over 30 years by physician-scientists, our distinctive capacity to repeatedly and constantly translate science into drugs has led to seven FDA-approved therapies and quite a few product candidates in improvement, all of which had been homegrown in our laboratories. Our medicines and pipeline are designed to assist sufferers with eye illnesses, allergic and inflammatory illnesses, most cancers, cardiovascular and metabolic illnesses, ache, infectious illnesses and uncommon illnesses.
Regeneron is accelerating and bettering the standard drug improvement course of by our proprietary VelociSuite applied sciences, similar to VelocImmune, which makes use of distinctive genetically-humanized mice to provide optimized fully-human antibodies and bispecific antibodies, and thru formidable analysis initiatives such because the Regeneron Genetics Middle, which is conducting one of many largest genetics sequencing efforts on the earth.
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Ahead-Wanting Statements and Use of Digital Media
This press launch consists of forward-looking statements that contain dangers and uncertainties regarding future occasions and the longer term efficiency of Regeneron Prescription drugs, Inc. (“Regeneron” or the “Firm”), and precise occasions or outcomes might differ materially from these forward-looking statements. Phrases similar to “anticipate,” “anticipate,” “intend,” “plan,” “imagine,” “search,” “estimate,” variations of such phrases, and comparable expressions are meant to establish such forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. These statements concern, and these dangers and uncertainties embrace, amongst others, the affect of SARS-CoV-2 (the virus that has precipitated the COVID-19 pandemic) on Regeneron’s enterprise and its workers, collaborators, and suppliers, different third events on which Regeneron depends, Regeneron’s and its collaborators’ capacity to proceed to conduct analysis and scientific packages (together with these mentioned on this press launch), Regeneron’s capacity to handle its provide chain, internet product gross sales of merchandise marketed by Regeneron and/or its collaborators (collectively, “Regeneron’s Merchandise”), and the worldwide financial system; the character, timing, and attainable success and therapeutic functions of Regeneron’s Merchandise and product candidates and analysis and scientific packages now underway or deliberate, together with with out limitation REGN-COV2 (Regeneron’s investigational twin antibody cocktail for the prevention and therapy of COVID-19) and REGN-EB3 (Regeneron’s novel triple antibody therapy for Ebola); the probability, timing, and scope of attainable regulatory approval and business launch of Regeneron’s product candidates (similar to REGN-COV2 and REGN-EB3) and new indications for Regeneron’s Merchandise; unexpected issues of safety ensuing from the administration of Regeneron’s Merchandise and product candidates (similar to REGN-COV2 and REGN-EB3) in sufferers, together with critical issues or negative effects in reference to using Regeneron’s Merchandise and product candidates in scientific trials; whether or not Regeneron will be capable of meet any drug product manufacturing milestones set forth within the manufacturing and provide settlement with the Biomedical Superior Analysis and Growth Authority and the Joint Mission Govt Workplace for Chemical, Organic, Radiological and Nuclear Protection with the U.S. Division of Protection (collectively, the “U.S. Authorities”) mentioned on this press launch (the “Manufacturing and Provide Settlement”), the quantity of funds (if any) Regeneron might obtain pursuant to the Manufacturing and Provide Settlement, and whether or not the Manufacturing and Provide Settlement is terminated by the U.S. Authorities or in any other case previous to completion; determinations by regulatory and administrative governmental authorities which can delay or limit Regeneron’s capacity to proceed to develop or commercialize Regeneron’s Merchandise and product candidates, together with with out limitation REGN-COV2 and REGN-EB3; ongoing regulatory obligations and oversight impacting Regeneron’s Merchandise, analysis and scientific packages, and enterprise, together with these regarding affected person privateness; uncertainty of market acceptance and business success of Regeneron’s Merchandise and product candidates and the affect of research (whether or not carried out by Regeneron or others and whether or not mandated or voluntary) on the business success of Regeneron’s Merchandise and product candidates; the supply and extent of reimbursement of Regeneron’s Merchandise from third-party payers, together with personal payer healthcare and insurance coverage packages, well being upkeep organizations, pharmacy profit administration corporations, and authorities packages similar to Medicare and Medicaid; protection and reimbursement determinations by such payers and new insurance policies and procedures adopted by such payers; competing medication and product candidates that could be superior to Regeneron’s Merchandise and product candidates; the extent to which the outcomes from the analysis and improvement packages carried out by Regeneron or its collaborators could also be replicated in different research and result in therapeutic functions; the power of Regeneron to fabricate and handle provide chains for a number of merchandise and product candidates; the power of Regeneron’s collaborators, suppliers, or different third events (as relevant) to carry out manufacturing, filling, ending, packaging, labelling, distribution, and different steps associated to Regeneron’s Merchandise and product candidates; unanticipated bills; the prices of creating, producing, and promoting merchandise; the power of Regeneron to satisfy any of its monetary projections or steering and modifications to the assumptions underlying these projections or steering; the potential for any license or collaboration settlement, together with Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated corporations, as relevant), to be cancelled or terminated with none additional product success; and dangers related to mental property of different events and pending or future litigation relating thereto (together with with out limitation the patent litigation and different associated proceedings regarding Dupixent® (dupilumab) and Praluent® (alirocumab)), different litigation and different proceedings and authorities investigations regarding the Firm and/or its operations, the last word consequence of any such proceedings and investigations, and the affect any of the foregoing might have on Regeneron’s enterprise, prospects, working outcomes, and monetary situation. A extra full description of those and different materials dangers will be present in Regeneron’s filings with the U.S. Securities and Alternate Fee, together with its Kind 10-Okay for the yr ended December 31, 2019 and its Kind 10-Q for the quarterly interval ended March 31, 2020. Any forward-looking statements are made based mostly on administration’s present beliefs and judgment, and the reader is cautioned to not depend on any forward-looking statements made by Regeneron. Regeneron doesn’t undertake any obligation to replace publicly any forward-looking assertion, together with with out limitation any monetary projection or steering, whether or not on account of new data, future occasions, or in any other case.
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SOURCE Regeneron Prescription drugs, Inc.
Posted: July 2020