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TARRYTOWN, N.Y., July 7, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today appear that, as allotment of Operation Warp Speed, the Biomedical Advanced Analysis and Development Authority (BARDA), allotment of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Bloom and Animal Services, and the Department of Defense Joint Affairs Executive Office for Chemical, Biological, Radiological and Nuclear Defense accept awarded Regeneron a $450 actor arrangement to accomplish and accumulation REGN-COV2. REGN-COV2 is Regeneron’s investigational bifold antibiotic cocktail that is currently in two Phase 2/3 analytic trials for the analysis of COVID-19 and in a Phase 3 balloon for the blockage of COVID-19 infection.
Regeneron began ascent up accomplishment of REGN-COV2 at business accident in bounce of 2020. This acceding supports connected accomplishment so that the artefact could be fabricated attainable anon in the United States if analytic trials are acknowledged and the U.S. Food and Biologic Administering (FDA) grants Emergency Use Authorization (EUA) or artefact approval. The acceding covers a anchored cardinal of aggregate lots that are advised to be completed in the abatement of 2020, as able-bodied as fill/finish and accumulator activities. The advancing REGN-COV2 analytic affairs is evaluating assorted dosages and will advice authorize the exact cardinal of abeyant analysis doses (estimated ambit of 70,000 to 300,000) or blockage doses (estimated ambit of 420,000 to 1,300,000) attainable from these lots in total. Initial doses may be attainable as aboriginal as end of summer. If EUA or artefact approval is granted, the government has committed to authoritative doses from these lots attainable to the American bodies at no bulk and would be amenable for their distribution.
“Regeneron’s thirty years of advance in our avant-garde VelociSuite® antibiotic analysis and development technologies and our all-embracing accomplishment facilities, accompanying with the adeptness and affection of our people, has enabled us to move the REGN-COV2 affairs advanced at arresting speed,” said Leonard S. Schleifer, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Regeneron. “We fabricated the accommodation aboriginal on to activate all-embracing accomplishment at our own accident in adjustment to ensure that artefact would be attainable anon if our analytic trials prove acknowledged and an Emergency Use Authorization is granted. This accomplishment and accumulation acceding with BARDA and the Department of Defense could advice REGN-COV2 adeptness abounding bodies quickly, hopefully allowance to change the advance of this baleful and still-raging pandemic.”
Regeneron continues to assignment to aerate accomplishment accommodation of REGN-COV2 aural Regeneron and with abeyant partners.
About REGN-COV2Regeneron scientists evaluated bags of fully-human antibodies produced by the company’s proprietary VelocImmune® mice, which accept been genetically-modified to accept a animal allowed system, as able-bodied as antibodies articular from bodies who accept recovered from COVID-19. They called the two best potent, non-competing and virus-neutralizing antibodies to actualize REGN-COV2 and accept scaled up this dual-antibody cocktail with the company’s centralized VelociMab® and accomplishment capabilities. REGN-COV2′s two antibodies bind non-competitively to the analytical receptor bounden area of the virus’s fasten protein, which diminishes the adeptness of aberrant bacilli to escape analysis and protects adjoin fasten variants that accept arisen in the animal population, as abundant in contempo Science publications. Added contempo analysis additionally demonstrates advantage adjoin the now accustomed D614G variant.
Regeneron acclimated the aforementioned ‘rapid response’ capabilities and cocktail access to advance REGN-EB3, a atypical amateur antibiotic analysis for Ebola that is now beneath authoritative analysis by the FDA. REGN-COV2′s development and accomplishment has been adjourned in allotment with federal funds from the BARDA beneath OT number: HHSO100201700020C.
About RegeneronRegeneron (NASDAQ: REGN) is a arch biotechnology aggregation that invents life-transforming medicines for bodies with austere diseases. Founded and led for over 30 years by physician-scientists, our different adeptness to again and consistently construe science into anesthetic has led to seven FDA-approved treatments and abundant artefact candidates in development, all of which were acquaintance in our laboratories. Our medicines and activity are advised to advice patients with eye diseases, allergic and anarchic diseases, cancer, cardiovascular and metabolic diseases, pain, communicable diseases and attenuate diseases.
Regeneron is accelerating and convalescent the acceptable biologic development action through our proprietary VelociSuite technologies, such as VelocImmune, which uses different genetically-humanized mice to aftermath optimized fully-human antibodies and bispecific antibodies, and through aggressive analysis initiatives such as the Regeneron Analysis Center, which is administering one of the better analysis sequencing efforts in the world.
For added advice about the company, amuse appointment www.regeneron.com or chase @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital MediaThis columnist absolution includes advanced statements that absorb risks and uncertainties apropos to approaching contest and the approaching achievement of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and absolute contest or after-effects may alter materially from these advanced statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and agnate expressions are advised to analyze such advanced statements, although not all advanced statements accommodate these anecdotic words. These statements concern, and these risks and uncertainties include, amid others, the appulse of SARS-CoV-2 (the virus that has acquired the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers, added third parties on which Regeneron relies, Regeneron’s and its collaborators’ adeptness to abide to conduct analysis and analytic programs (including those discussed in this columnist release), Regeneron’s adeptness to administer its accumulation chain, net artefact sales of articles marketed by Regeneron and/or its collaborators (collectively, “Regeneron’s Products”), and the all-around economy; the nature, timing, and attainable success and ameliorative applications of Regeneron’s Articles and artefact candidates and analysis and analytic programs now underway or planned, including after limitation REGN-COV2 (Regeneron’s investigational bifold antibiotic cocktail for the blockage and analysis of COVID-19) and REGN-EB3 (Regeneron’s atypical amateur antibiotic analysis for Ebola); the likelihood, timing, and ambit of attainable authoritative approval and bartering barrage of Regeneron’s artefact candidates (such as REGN-COV2 and REGN-EB3) and new break for Regeneron’s Products; abrupt assurance issues consistent from the administering of Regeneron’s Articles and artefact candidates (such as REGN-COV2 and REGN-EB3) in patients, including austere complications or ancillary furnishings in affiliation with the use of Regeneron’s Articles and artefact candidates in analytic trials; whether Regeneron will be able to accommodated any biologic artefact accomplishment milestones set alternating in the accomplishment and accumulation acceding with the Biomedical Advanced Analysis and Development Authority and the Joint Project Executive Office for Chemical, Biological, Radiological and Nuclear Defense with the U.S. Department of Defense (collectively, the “U.S. Government”) discussed in this columnist absolution (the “Manufacturing and Accumulation Agreement”), the bulk of payments (if any) Regeneron may accept pursuant to the Accomplishment and Accumulation Agreement, and whether the Accomplishment and Accumulation Acceding is concluded by the U.S. Government or contrarily above-mentioned to completion; determinations by authoritative and authoritative authoritative authorities which may adjournment or bind Regeneron’s adeptness to abide to advance or commercialize Regeneron’s Articles and artefact candidates, including after limitation REGN-COV2 and REGN-EB3; advancing authoritative obligations and blank impacting Regeneron’s Products, analysis and analytic programs, and business, including those apropos to accommodating privacy; ambiguity of bazaar accepting and bartering success of Regeneron’s Articles and artefact candidates and the appulse of studies (whether conducted by Regeneron or others and whether allowable or voluntary) on the bartering success of Regeneron’s Articles and artefact candidates; the availability and admeasurement of acceding of Regeneron’s Articles from third-party payers, including clandestine payer healthcare and allowance programs, bloom aliment organizations, pharmacy account administration companies, and government programs such as Medicare and Medicaid; advantage and acceding determinations by such payers and new behavior and procedures adopted by such payers; aggressive drugs and artefact candidates that may be above to Regeneron’s Articles and artefact candidates; the admeasurement to which the after-effects from the analysis and development programs conducted by Regeneron or its collaborators may be replicated in added studies and advance to ameliorative applications; the adeptness of Regeneron to accomplish and administer accumulation chains for assorted articles and artefact candidates; the adeptness of Regeneron’s collaborators, suppliers, or added third parties (as applicable) to accomplish manufacturing, filling, finishing, packaging, labelling, distribution, and added accomplish accompanying to Regeneron’s Articles and artefact candidates; hasty expenses; the costs of developing, producing, and affairs products; the adeptness of Regeneron to accommodated any of its banking projections or advice and changes to the assumptions basal those projections or guidance; the abeyant for any authorization or accord agreement, including Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their corresponding affiliated companies, as applicable), to be annulled or concluded after any added artefact success; and risks associated with bookish acreage of added parties and awaiting or approaching action apropos thereto (including after limitation the apparent action and added accompanying affairs apropos to Dupixent® (dupilumab) and Praluent® (alirocumab)), added action and added affairs and government investigations apropos to the Aggregation and/or its operations, the ultimate aftereffect of any such affairs and investigations, and the appulse any of the above may accept on Regeneron’s business, prospects, operating results, and banking condition. A added complete description of these and added actual risks can be begin in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year concluded December 31, 2019 and its Form 10-Q for the annual aeon concluded March 31, 2020. Any advanced statements are fabricated based on management’s accepted behavior and judgment, and the clairvoyant is cautioned not to await on any advanced statements fabricated by Regeneron. Regeneron does not undertake any obligation to amend about any advanced statement, including after limitation any banking bump or guidance, whether as a aftereffect of new information, approaching events, or otherwise.
Regeneron uses its media and broker relations website and amusing media outlets to broadcast important advice about the Company, including advice that may be accounted actual to investors. Banking and added advice about Regeneron is commonly acquaint and is attainable on Regeneron’s media and broker relations website ( http://newsroom.regeneron.com ) and its Twitter augment ( http://twitter.com/regeneron ).
Media RelationsAlexandra BowieTel: 1 (914) [email protected]
Investor RelationsVesna TosicTel: 1 (914) [email protected]
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SOURCE Regeneron Pharmaceuticals, Inc.
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