{"id":702533,"date":"2022-10-28T08:04:55","date_gmt":"2022-10-28T12:04:55","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/inmazeb-atoltivimab-maftivimab-and-odesivimab-ebgn-wins-prestigious-2022-prix-galien-usa-best-biotechnology-product-award\/"},"modified":"2022-10-28T08:04:55","modified_gmt":"2022-10-28T12:04:55","slug":"inmazeb-atoltivimab-maftivimab-and-odesivimab-ebgn-wins-prestigious-2022-prix-galien-usa-best-biotechnology-product-award","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/inmazeb-atoltivimab-maftivimab-and-odesivimab-ebgn-wins-prestigious-2022-prix-galien-usa-best-biotechnology-product-award\/","title":{"rendered":"Inmazeb\u2122 (atoltivimab, maftivimab, and odesivimab-ebgn) Wins Prestigious 2022 Prix Galien USA Best Biotechnology Product Award"},"content":{"rendered":"
\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n Inmazeb is the first FDA-approved treatment for Zaire<\/span> ebolavirus<\/i><\/b>\n <\/p>\n

\n
\n TARRYTOWN, N.Y.<\/span>
\n <\/span>, Oct. 28, 2022<\/span><\/span> \/PRNewswire\/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Inmazeb\u2122 (atoltivimab, maftivimab, and odesivimab-ebgn) has been recognized as the “Best Biotechnology Product” of 2022 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition. The Prix Galien USA<\/span> Award was presented in a ceremony in New York City<\/span> last night.<\/p>\n

“We are honored that the Galien Foundation has recognized Inmazeb, which was invented by Regeneron scientists committed to helping people impacted by the deadly Ebola virus,” said George D. Yancopoulos<\/span>, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “Our ability to rapidly respond to Ebola was based on decades of deep investment in our enabling antibody technologies, starting with our remarkable VelocImmune\u00ae<\/sup><\/i>mouse. Our scientists realized that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola. The success with Ebola ushered in a new era in which monoclonal antibodies could be used to fight viral diseases and global pandemics.”<\/p>\n

“Our groundbreaking ‘rapid response’ application of our VelociSuite\u00ae<\/sup><\/i>technologies to address the Ebola outbreak laid the foundation for our COVID-19 efforts,” said Christos Kyratsous<\/span>, Ph.D., Senior Vice President, Research, at Regeneron. “By strategically pursuing a multi-antibody approach, parallel tracking certain steps and speeding hand-offs between groups, we are able to advance novel antibody treatments in a very expedited manner. Thank you for this recognition of the decades of diligent scientific research and technological investment that led to this important therapeutic discovery.”<\/p>\n

In October 2020<\/span>, Inmazeb became the first therapy approved by the U.S. Food and Drug Administration (FDA) for Zaire<\/span> ebolavirus<\/i>. The three antibody combination neutralizes the Ebola virus by blocking the virus from entering into host cells via the glycoprotein and\/or enables antibody-dependent effector function by bringing in other immune cells to target infected cells, which is a way for an antibody to get extra help from the immune system in order to clear infected cells from the body.<\/p>\n

The safety and efficacy of Inmazeb was established through the 681-patient PALM \u00a0(PAmoja TuLinde Maisha) Trial, a randomized, multicenter, controlled trial initiated in 2018 in the Democratic Republic of the Congo<\/span> (DRC). The World Health Organization (WHO), the National Institutes of Health (NIH) and the Institut National de Recherche Biom\u00e9dicale (INRB) in the DRC jointly sponsored and served as co-principal investigators of the trial. In 2019, as reported in the\u00a0New England Journal of Medicine<\/a><\/i>, the PALM Trial was stopped early following a pre-specified interim analysis that showed superiority of Inmazeb to ZMapp (another three antibody combination) and remdesivir (an antiviral) with respect to mortality.\u00a0Adverse events (AEs) that occurred in at least 10% of Inmazeb patients were chills, elevation in fever (pyrexia), rapid heartbeat (tachycardia), rapid breathing (tachypnea), vomiting, low blood pressure (hypotension), diarrhea and inadequate oxygen supply to the tissue (hypoxia); of these, only chills occurred more frequently with Inmazeb than ZMapp. The evaluation of AEs in Inmazeb patients may have been confounded by the signs and symptoms of the underlying\u00a0Zaire<\/span> ebolavirus<\/i>\u00a0infection.<\/p>\n

In keeping with our mission and values, Regeneron is committed to making this important medicine available to the people who need it. Since 2018, we have worked with the WHO, FDA and other global organizations to offer Inmazeb under compassionate-use protocol to affected African countries. Importantly, these countries received our treatment at no cost. To be prepared for potential new outbreaks, Regeneron has an internal leadership group focused on advancing our access strategy to ensure continued access to Inmazeb in low- and middle income countries (LMICs). Regeneron is actively working with non-governmental organizations and public health agencies to ensure continued access to Inmazeb in LMICs.<\/p>\n

\n About Inmazeb<\/b>\n <\/div>\n

Inmazeb, previously called REGN-EB3, was created using Regeneron’s VelocImmune\u00ae<\/sup><\/i> platform and associated VelociSuite\u00ae<\/sup><\/i> technologies. The treatment consists of three monoclonal antibodies of similar structure, atoltivimab, maftivimab and odesivimab, that bind to different, non-overlapping epitopes on Zaire<\/span> ebolavirus<\/i> glycoprotein. The three antibodies help neutralize the Ebola virus by blocking its ability to invade patients’ and\/or enlisting other immune cells to target infected cells and remove them from the body.<\/p>\n

Inmazeb is administered as a single, weight-based intravenous infusion (50 mg atoltivimab, 50 mg maftivimab and 50 mg odesivimab per kg). Inmazeb was developed in collaboration and with federal funds from BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the HHS under ongoing USG Contract Nos. HHSO100201700016C and HHSO100201500013C.<\/p>\n

\n About Regeneron’s VelocImmune Technology<\/b>\n <\/div>\n

Regeneron’s VelocImmune<\/i> technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos<\/span> was a graduate student with his mentor Frederick W. Alt<\/span> in 1985, they were the first to envision<\/a> making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune<\/i> and related VelociSuite<\/i> technologies. Dr. Yancopoulos and his team have used VelocImmune<\/i> technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV\u00ae<\/sup> (casirivimab and imdevimab), Dupixent, Libtayo\u00ae<\/sup> (cemiplimab-rwlc), Praluent\u00ae<\/sup> (alirocumab), Kevzara\u00ae<\/sup> (sarilumab), Evkeeza\u00ae<\/sup> (evinacumab-dgnb) and Inmazeb.<\/p>\n

\n IMPORTANT SAFETY INFORMATION AND INDICATION<\/b>\n <\/div>\n
\n WARNINGS AND PRECAUTIONS<\/b>\n <\/div>\n

\n Hypersensitivity Reactions Including Infusion-Associated Events:\u00a0<\/b>Hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with INMAZEB. These may include acute, life-threatening reactions during and after the infusion. Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever, during and following INMAZEB infusion. In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of INMAZEB immediately and administer appropriate emergency care.<\/p>\n

Infusion could not be completed in 1% of subjects who received INMAZEB due to infusion-associated adverse events. The rate of infusion of INMAZEB may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse events.<\/p>\n

\n ADVERSE REACTIONS:<\/b>\n <\/div>\n