お知らせ • Sep 08
Regeneron Pharmaceuticals, Inc. Advances Allergy Pipeline with Two Positive Phase 3 Trials Evaluating First-In-Class Antibody-Blockers of Cat and Birch Allergies
Regeneron Pharmaceuticals, Inc. announced results evaluating its first-in-class investigational allergen-blocking antibodies in allergen-challenge Phase 3 trials in adults with moderate-to-severe cat or birch allergies. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees and research and clinical programs now underway or planned, including without limitation the REGN1908/REGN1909 combination therapy for cat allergy and the REGN5713/REGN5715 combination therapy for birch allergy as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products and regeneron's Product Candidates (such as those referenced above); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates, such as the REGN1909 and REGN5713/RE GN5713/REGN 5715 combination therapies and other allergy therapies and other allergy therapies discussed or referenced in this release; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products andRegeneron's Product Cand candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron's Product Cand candidates in clinical trials; the extent to which the results from the research and development programs conducted by Regeneron and/or's collaborators or licensees may be replicated and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; 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 Regeneron's Product Cand candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other Third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks risks and risks, and risks of the foregoing and any potential regulatory approval of the foregoing or any potential Regulatory approval of Regeneron's Product Candidate and the potential for any license, including Regeneron's Product Cand candidates (whether conducted by Regeneron's Product Candidates) in patients, on the foregoing or others and the studies discussed in this press release, including the studies discussed in this press press release, on any potential for this press release, on any potential regulatory approval of the studies discussed or referenced in the studies discussed or referenced in this press release, on September 8, 2022, including the foregoing or referenced in this release, including the foregoing or planned, including the studies discussed or planned, including the foregoing or any potential for Regeneron's product candidates and the foregoing; the foregoing or referenced in this press release.