Regeneron Announces New US Government Agreement to Purchase Additional Doses of REGEN-COV (casirivimab and imdevimama) Antibody Cocktail (Cibrilli,
TARRYTOWN, N.Y., Sept. 14, 2021 /PRNewswire/ -- -- Dec. 14 - 2022 -- : a post-reporter -- A post post on the weekend
New agreement for 1,4 million doses of REGEN-COV, brings total bought by the US government to nearly 3 million mg dose.
REGEN-COV currently authorized to treat certain infected patients to reduce the risk of hospitalization or death from COVID-19, and for post-exposure prophylaxis for close contacts of infective individuals.
Regeneron Pharmaceuticals, Inc. (NASDAQ: XAMPS) (NYSE:XXAM) Inc, (SIM) REGN Today announced that the U.S. Department of Health and Human Services (HHS) and the Department for Defense (DOD) will buy 1,4 million additional doses of REGEN-COV (casirivimab and The government will continue to provide reGEN-COV to patients at no cost.
Many people are still being hospitalized and dying due to COVID-19, said Leonard S. Schleifer, M.D., Ph. D. Despite the fact that vaccination remains the first defense for the disease, the risk of death increases by 70% in a person who is very ill with an infection. Recently, the demand for REGEN-COV has increased, and we will provide more doses to the U.S. government as quickly as possible."
Under the new agreement, Regeneron will supply a total of 1,4 million 1,200 mg doses of REGEN-COV to the US government by January 31, 2022, at ten cents per dose. This new agreement follows two earlier agreements with the United States government announced in July 2020 and January 2021.
REGEN-COV is a research medicine authorized by the Food and Drug Administration (FDA) under an emergency use authorization to treat people with high risk of infection from COVID-19, who are either already infected (n
Moreover, the robust REGEN-COV development program reported positive phase 3 trials across the spectrum of COVID-19 infection from prevention to hospitalization.
- Infected people are asymptomatic friends, as well as inffected individuals. Those infectate individuals have characterized the prevention of symptomatism in syndromes in patients with
- Treatment of non-hospitalized patients already infected with SARS-CoV-2, treatment of patients with serious disease, already treated with treated SAR-coV2 patients.
- Among the treatment of certain patients hospitalized due to COVID-19 infection, including the RECOVERY trial in the UK. Some patients were impacted by the complication, but the medical evaluation is not required.
The development and manufacture of REGEN-COV has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS's Office of Assistant Secretary for Preparedness and
Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply. Roche is responsible for development and distribution outside the United States.
Details detail of the Agreement Regeneron expects to begin delivering the additional REGEN-COV doses in September to the US government, with the vast majority delivered in Q4 2021. Regeneron will record all net sales related to this agreement. One third of the doses for Regeneron will be manufactured to meet the new agreement with the US government.
About the REGEN-COV antibody cocktail, about the Antibody Cocktail REGen-CoV. REGEN-COV is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune - ... and VelociSuite is a Velogi Suite. a.m. Technologies are being used. The two potent, virus-neutralizing antibodies form bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protect against spike The cell phone is a cell cell he is and Science .
The data in the Fact Sheet for Healthcare Providers is available in The Factsheet for healthcare providers. Therefore, REGEN-COV remains available for use across the U.S. and Regeneron continues to monitor the potential of REgen-coV against emerging variants.
REGEN-COV has not been approved by the FDA, but is currently authorized for treatment and post-exposure prophylaxis in certain high risk individuals. Post-expositionsure Prophyllaxie with REGen-Co REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19, nor for use in patients who are hospitalized due to COV-19 or need oxygen therapy, or for people currently This authorization is for the duration of the declaration that circumstances exist justifying the authorization of emergencies under section 564(b)(1) of a Act, 21 U.S.C. 360bb-3(a) (1), In the U.S., there are additional information about REGEN-COV (authorized uses and important safety information) below.
In August, Regeneron submitted the first of two Biologics License Applications (BLAs) for REGEN-COV. The initial submission included data on the effectiveness and safety of REGEN-COV to treat and prevent SARS-CoV-2 infection in nonhospitalized people. The second BLA submission will focus on hospitalized people due to COVID-19 and will be completed later this year.
The antibody cocktail is fully approved in Japan.
Regeneron and Roche are committed to making the antibody cocktail available to COVID-19 patients around the world and to support the access in poor and middle-income countries through the donation of drugs to public health organizations.
About Regeneron's about the area' s newfoundland''. VelocImmune is a Venocimmun. Technology Regeneron's' is the venue for Regeneers. VelocImmune, VecosImune et al. The technology uses a proprietary genetically engineered mouse platform that has specialized in developing standardized human antibodies to produce optimized full human antibody. The first time that Regeneron began to envision making such a genetically humanized mouse was when the president and chief scientific officer George D. Yancopoulos was aka graduate student in 1985 and mentor Frederick W. Alt was the VelocImmune, Veslocium, and related VelociSuite is Veolesuite. Using the technologies. Dr. Yancopoulos and his team used the technology to use Dr Yankopoulose and their team. VelocImmune Vecclelina tanonida. This technology enables to create approximately a quarter of all available monoclonal antibodies currently available. Approximately 80% of the original, FDA-approved, fully human genome, which are currently sold to the public. This includes REGEN-COV (casirivimab and imdevimimb), Dupixent (assimama) and regen-cov (no-diliob - /... Libtayo (dupilumab), libtawa (non-dolam) (e) and aanata (o)) is. mdo. Praluent (cemiplimab-rwlc), Pralumini (cmisilumar-lwwnc). - s.o. (alirocumab), Kevzara, Kewzare (olekumob) and alibura (alrocumba) (kalumumb). -, / '. Evkeeza, Sarilumab, Ewkeeez (sariloba), Ivkerosa. . (evinacumab-dgnb) and InmazebTM (atoltivima, maftivimi and odesivima-empna).
US AUTHORIZED USES AND IMPORTANT SALE INFORMATION INSURANCES ARE COMFORTIVE.
Treatment: ReGEN-COV is a direct, virulent, virus-resistant, and is approved to treat microbial, moderate and severe coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years
Limitations of Authorized Use (Treatment) (Terms Limits of Any Authorised Use): - (Lotion Limit Limit) (Objects) Limitation (Delayed) to limit the
REGEN-COV is not authorized for use in patients: - REgen is authorized to use as a surgical weapon in dynapes.
- Who are hospitalized due to COVID-19, OR who are sick of COVID-19 or who have COSD-19.
- People who need oxygen therapy due to COVID-19, or who require COVD, who have COLVID-19 or COX, are either requiring oxygen treatment or need surgery.
- In those who need a higher oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due comorbidity in an underlying non-COVId-19 related occurrence, the resulting thrombocyto
- Monoclonal antibodies, such as REGEN-COV, can lead to worse clinical outcomes when administered with COVID-19 to hospitalized patients with high-flow oxygen or mechanical ventilation. Moreover, monocloonal
Prophylaxis post-Exposure: post Expossed: - Post-Efosur:- :
REGEN-COV is authorized in adult and pediatric individuals (12 years and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals at high risk of progression to severe COV
- not fully vaccinated not totally avacccinating! or, or or you or any other, say,, Or, be or- or the or are, If the patient is not expected to receive the proper immune response after complete SARS-CoV-2 vaccination (for example, patients with immunocompromising conditions including those taking immunosuppressive medications) can take a complete immune system (as and
- On average, an individual infected with SARS-CoV-2 was exposed to a person in the same condition as CDC close contact criteria. or the other, or, the or or not, of or it,
- In a similar institutional setting, if you are in the same facility, you can have high risk of exposure to people infected with SARS-CoV-2, who are at high risks because of the occurrence of SSR
Limitations of Authorized Use (Post-Exposure Prophylaxis) Limits of Post-Explosure Exposition Prorophylaxes.
- Post-exposure prophylaxis with REGEN-COV isn't a substitute for vaccination against COVID-19.
- REGEN-COV isn't authorized for pre-exposure prophylaxis for the prevention of COVID-19. Regen-coV does not allow preexpossure for anti-octobodies
REGEN-COV hasn't been approved, but has been authorized for emergency use by the FDA.
Unless the authorization is terminated or revoked sooner, it is authorized to use the emergency use under section 564(b)(1) of the Act, 21 U.S.C. 360bb-3(d
The provider of healthcare should review the report. The pharmacist's fax sheet for the healthcare provider''. A request for information on the authorized use of REGEN-COV and the mandatory requirements of the EUA complies with the requirements that must meet the European Union requirements. Then the last one that was the father of the first Letter of authorization Referral information is available. ,. As well as the whole family, the plan is well-planned. Dear healthcare providers letter to Dear Healthcare Provider. and Patient Fact Sheet is an accurate patient information sheet.
Identifying high risk individuals will be difficult to identify.
A Study Sheet for Healthcare Providers provides a list of the best criteria for identifying high-risk people.
Viruses, a variety of sARS-CoV-V, and bif-2, the viratile variant of SARS.
Immunoinfective cells may be associated with resistance to monoclonal antibodies. For detailed information on different types and resistance, the CDC website (https://www.cdc.gov/coronavirus/vg/transmission/variant-cases.html) and the State and local
Important Safety Information
ReGEN-COV (casirivimab and imdevimama) is an unapproved investigational therapy, with limited clinical data available. Serious and unexpected adverse events may occur that haven't been previously reported with REGEN-COV use.
- '--''Mid's in the air' / Contraindication: REGEN-COV is contraindicated in individuals with severe hypersensitivity, including anaphylaxis, to REgen-CoV, which are subject to the emergence of an analaxie-induced hyper-
- , /! Warnings and Precautions Warning, Warning and Warning Warning. :
- 'No matter what your face is, you will get it. Hypersensitivity, including Anaphylaxis and Infusion-Related Reactions: a combination of Anaphysics and chromatic reactions: an acute reaction: the synthesis of ion-relativity. Eating REGEN-COV showed significant hypersensitivity reactions, including anaphylaxis. If there are signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis, you should immediately discontinue administration and take appropriate medications and/or supportive therapy. Infusion and RENE-COV under EUA, hypersensitivity reactions occurring more than 24 hours after infusion have also been reported. On the observation of reactions that occur during the infusion and within 24 hours after the injection, REGEN-COV has been administered. These reactions may be severe or life threatening.
- 'Today'. Signs and symptoms of infusion-related reactions may include signs and symptoms. : fever, difficulty breathing, decreased oxygen saturation, chills, nausea, arrhythmia (e.g. atrial fibrillation, tachycardia, bradycardium), chest pain or discomfort, If infusion-related reactions occur, consider slowing or stopping the ingestion and administer appropriate medications and/or support care. If an induction-induced reaction occurs, you should consider stopping or limiting the onset of the disease or
- ! After REGEN-COV Administration: Clinical Worsening: After a Clinical Warsense: regen-coV: an administration: The clinical worsening of COVID-19 after re-administration of REGEN-COV was reported and may include symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g. atrial fibr Some of these events required hospitalization. It is unknown if these events were related to REGEN-COV use or were due to COVID-19 progression.
- / : (*) ->,... '. Patients with severe COVID-19 have defined the limits of benefits and potential for risk for patients with serious COVD. Using COVID-19 to hospitalized patients with a high-flow oxygen requirement, or requiring mechanical ventilation, monoclonal antibodies such as REGEN-COV may be associated with worse clinical outcomes. A monocanna Also, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, or who require oxygen therapy due mainly to CoVId-19 comorbidity, and who need an increase
- Adverse actions cause consequences for the adverse actions. :
- COV-2067 (Treatment): Infusion-related reactions (adverse events based on causality of the investigator) of grade 2 or higher severity have been observed in 10/4,206 (0.2%) of those who received REGEN-COV at the authorized dose Three subjects who received the 8,000 mg dose of REGEN-COV and one subject who got the 1,200 mg casirivimab and 1,800 mg imdevimatad had infusion-related reactions (urtic All the problems were fixed. In the clinical program, it was reported that anaphylactic reactions have been reported in subjects with REGEN-COV. The events began within an hour of the infusion and in at least one case required treatment, including epinephrine. The events resolved.
- 'The other side'! COV-2069 (Post-exposure prophylaxis): a post-expositional prolaxet: In subjects who were SARS-CoV-2 negative at baseline (Cohort A), injection site reactions (all grade 1 and 2) occurred in 55 subjects (4%) in REGEN-COV group and 19 subjects (2%) within placebo group. A scald of hypersensitivity reactions occurred in at least 1% of subjects in the REGEN-COV group. A few hypersensitive reactions occured in 2 subjects (0.2%) in each group and all hyperresi In subjects that were SARS-CoV-2 positive at baseline (Cohort B), injection site reactions, all of which were grade 1 or 2 were in six subjects (4%) in REGEN-COV and 1 in 1 (%) placebo Those most common signs and symptoms of injection site reactions that occurred at least 1% of subjects in the REGEN-COV group were ecchymosis and erythema. The most commonly occurring symptoms and signs of
- . COV-2093 (subcutaneous dosing): The injection site reaction occurred in 12% and 4% of subjects after single dose administration respectively in the REGEN-COV and placebo groups. Despite the long-standing safety finding following subcutaneous administration in the REGEN-COV group, the safety findings observed during COV-2067 were similar to those observed in intravenous administration. After repeated dosing, injection site reactions occurred in 252 subjects (35%) in REGEN-COV and 38 subjects (16%) at placebo group; all injection sites reactions were grade 1 or 2 in severity. Hypersensitivity reactions occurred in 8 subjects (1%) in the REGEN-COV group; and all hypersensitivity reaction was grade 1 or 2 in severity. Anaphylaxis has not been shown.
-! Patient Monitoring Recommendations Recommandations, Patient Remarks. Clinically monitor patients during dose administration and observe patients for at least one hour after intravenous infusion or subcutaneous dosing. : The clinically monitored patients at the time of dose treatment.
- 'No, I have nothing to do with'. Use in specific populations may be limited to specific population types. :
- . Pregnancy: Pregnant: Among the causes of a drug-related birth defect, miscarriage, or adverse maternal or fetal outcomes, there aren't enough data to evaluate if - drug related risk is significant, / or REGEN-COV should only be used during pregnancy if the potential benefit outweighs the risks for the mother and the fotus.
- :). Ignore: the opacity of the air. There are no available data indicating the presence of casirivimab and/or imdevimamabe in human milk or animal milk, the effect of the drug on the breastfed infant, or the effects of this drug Breastfeeding is a health and development benefit, and the mother's clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REgen-CoV or from the underlying maternal condition should be
About Regeneron Regeneron is a leading biotechnology company that invents life-changing medicines for people with serious diseases. With the founding and guiding of over 30 years by physician-scientists, our unique ability to consistently and consistently transform science into medicine has led to nine FDA-approved treatments and many product candidates in development, almost all of which were home Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases such as cancer, cardiovascular and metabolic diseases and rare diseases.
The traditional drug development process is accelerated and improved through our proprietary proprietary technology. VelociSuite is VelocationSat. Technologien, such as the computer, can be used, like a number of technologies, i.e. VelocImmune, Veox, oba. The Regeneron Genetics Center, which is conducting one of the largest genetic sequencing efforts in the world, uses unique genetically humanized mice to produce optimized full human antibodies and bispecific antibodies.
For more information about this company, please visit www.regeneron.com or follow @Regener on Twitter.
The future-looking Statements and use of digital media and future use will be forward-oriented. This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneronal"), and actual events or results may differ materially from these These identifying words are not all forward-looking statements. There are numerous risks and uncertainties in this statement, which include, among others, the impact of SARS-CoV-2 (the virus that caused the COVID-19 pandemic) on Regeneron's business, its employees TM MC microbials - oxidized blood : a tiger et al. The likelihood, timing, and scope of a regulatory approval and commercial launch of Regeneron's Product candidates (such as REGEN-COV, as well as the possible FDA approval based on the underlying health emergency no longer The use, market acceptance and commercial success of Regeneron's Products and Regeners Product Candidates, including uncertainty of the utilization, the commerciality and the performance of its products and its competitors, particularly the vacancy of incumbents, in Any recommendations, guidelines or studies (whether conducted by Regeneron or others and unless mandated or voluntary) impact any of the foregoing or potential regulatory approval of Regeners's Products or any other potential-regulated approval. Reneweron's Product Candidates are the Product Candidate. (such as REGEN-COV)); Upon completion of the Manufacturing and Supply Agreement, the government terminates the manufacturing and supply agreement, or otherwise, if the U.S. government is unable to supply any of its products and products, and its suppliers may have to a negotiated agreement with the Sanofi, Bayer, and Teva Pharmaceuticals Ltd., relating to the casirivimab and imdevimaba, the resistance of cyborg REGEN-COV in the US, and RonapreveTM in other countries known as in America, in a name that translates to REGen-coV and in both countries. ), to be cancelled or terminated; and the risks associated with intellectual property of other parties and pending or future litigation related to it (including, without limitation, the patent litigation and other related proceedings related with EYLEA ) n'importe how you are. The sex of the frightening (aflibercept) Injection, Dupixent, p. /'s & a g r o m d u c t n i l. Praluent (dupilumab), PraLuence (Dupaa): (supalum) (tupidum), (pailur, bluffy, etc - Moreover, any of the above mentioned matters have been a result of any tense and resemblance to the company's business, prospects, business results, and financial situation. For the year ended December 31, 2020, and the quarterly period ended June 30, 2021, a more complete description of these and other material risks can be found in Regeneron's filings with the Securities and Exchange Commission. It includes The reader shouldn't rely on the forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, or any financial projection or guidance, whether due to new information, future events or other events.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be considered material to investors. The information from Regeneron's media and investor relations website (http://newsroom.regenero.com) and his Twitter feed (www.twitter.org/reGenerone).
Media Relations Relations
Sarah Cornhill is a Sarah cornhill.
Investor Relations are business relations.
SOURCE Regeneron Pharmaceuticals Inc.