UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of April 2020
Commission File Number: 001-31368
SANOFI
(Translation of registrants name into English)
54, rue La Boétie, 75008 Paris, FRANCE
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ☐ No ☒
If Yes marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-________
In April 2020, Sanofi issued the press releases attached hereto as Exhibit 99.1, 99.2 and 99.3 which are incorporated herein by reference.
Exhibit List
Exhibit No. |
Description |
|
Exhibit 99.1 | Press release dated April 28, 2020: Annual General Meeting of April 28, 2020 | |
Exhibit 99.2 | Press release dated April 27, 2020: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival | |
Exhibit 99.3 | Press release dated April 27, 2020: Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients |
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Exhibit Index
Exhibit No. |
Description |
|
Exhibit 99.1 | Press release dated April 28, 2020: Annual General Meeting of April 28, 2020 | |
Exhibit 99.2 | Press release dated April 27, 2020: Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival | |
Exhibit 99.3 | Press release dated April 27, 2020: Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: April 29, 2020 | SANOFI | |||||
By |
/s/ Alexandra Roger |
|||||
Name: | Alexandra Roger | |||||
Title: |
Head of Securities Law and Capital Markets |
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Exhibit 99.1
Press Release Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) |
Annual General Meeting of April 28, 2020
* |
Approval of the financial statements for the fiscal year 2019 |
* |
Dividend of 3.15 per share payable as of May 6, 2020 |
* |
Board composition: renewals, ratification of a co-opting Director and appointment of two new Independent Directors |
Paris, France April 28, 2020 The Ordinary General Shareholders Meeting of Sanofi was held on April 28, 2020, without the physical presence of its shareholders, in accordance with the derogating measures adapting the rules governing the deliberation of general meetings taken by the French authorities as part of the fight against COVID-19, at the Companys registered office in Paris, under the chairmanship of Serge Weinberg.
All resolutions submitted to the vote were adopted by the shareholders, except for the nineteenth resolution relating to the compensation awarded for the 2019 financial year to Olivier Brandicourt, former Chief Executive Officer in office until August 31, 2019. The Board of Directors met after the meeting. The final financial terms of Olivier Brandicourts departure will be communicated in a separate press release.
The General Meeting approved the individual Company and consolidated financial statements for the fiscal year 2019. The General Meeting decided on the distribution of a cash dividend to the amount of 3.15 per share with payment as of May 6, 2020.
The General Meeting also renewed Laurent Attal, Carole Piwnica, Diane Souza and Thomas Südhof as Directors, ratified the co-opting of Paul Hudson and approved the appointment of Rachel Duan and Lise Kingo as Independent Directors in replacement of Suet-Fern Lee and Claudie Haigneré.
Following the General Meeting, the Board of Directors is still comprised of 16 members, of whom six are women and two are Directors representing employees. The Board of Directors remains for a large majority comprised of Independent Directors.
The voting results and the videocast of the Annual General Meeting are available on:
www.sanofi.com/AG2020
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Media Relations Contact
Quentin Vivant Tel.: +33 (0)1 53 77 46 46 mr@sanofi.com |
Investor Relations Contact
Félix Lauscher Tel.: +33 (0)1 53 77 45 45 ir@sanofi.com |
Exhibit 99.2
Press Release Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) |
Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival
|
Libtayo decreased the risk of death by 32.4% compared to chemotherapy |
|
Sanofi and Regeneron plan regulatory submissions in 2020 |
Paris and Tarrytown, N.Y. - April 27, 2020 Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the primary endpoint of overall survival (OS) was met in a Phase 3 trial comparing the PD-1 inhibitor Libtayo® (cemiplimab) to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in ³50% of tumor cells. Based on a recommendation by the independent Data Monitoring Committee to stop the trial early, the trial will be modified to allow all patients to receive Libtayo for this investigational use.
The data will form the basis of regulatory submissions in the U.S. and European Union (EU) in 2020.
While demonstrating a survival benefit in first-line NSCLC has been challenging for immunotherapies, the one FDA-approved anti-PD-1 monotherapy has changed the therapeutic paradigm, said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. We are pleased with the results of this trial that demonstrate the survival benefit of Libtayo in these patients and hope it may become a potential alternative for physicians and patients.
A protocol-specified interim analysis conducted by the Independent Data Monitoring Committee demonstrated that patients treated with Libtayo monotherapy had a significant increase in OS. Libtayo decreased the risk of death by 32.4% (HR=0.676; CI:0.525-0.870, p=0.002), compared to platinum doublet chemotherapy, despite a third of patients entering the trial within the past six months and all chemotherapy patients being able to crossover to Libtayo if their disease progressed. No new Libtayo safety signal was identified. Detailed trial data will be presented at a future medical meeting.
This is the largest clinical trial evaluating a PD-1 inhibitor as a first-line monotherapy in patients with advanced non-small cell lung cancer with high PD-L1 expression. The positive results are extremely encouraging, and we look forward to advancing a potential new treatment option for these patients, said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. We are grateful to all of the investigators and patients who participated in the global trial.
Lung cancer is the leading cause of cancer death worldwide. In 2020, more than 2.2 million new cases are expected to be diagnosed globally, with 228,800 new cases in the U.S. alone. Approximately 85% of all lung cancers are NSCLC, with an estimated 25% to 30% of cases expected to test positive for PD-L1 in ³50% of tumor cells. While immunotherapies have transformed advanced NSCLC treatment in recent years, there remains an unmet need to optimize the identification and treatment of patients with high PD-L1 expression.
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Libtayo is being jointly developed and commercialized by Regeneron and Sanofi under a global collaboration agreement.
The use of Libtayo to treat advanced NSCLC is investigational and has not been fully evaluated by any regulatory authority.
About the Phase 3 Trial
The open-label, randomized, multi-center Phase 3 trial investigated the first-line treatment of Libtayo monotherapy compared to platinum doublet chemotherapy in squamous or non-squamous advanced NSCLC that tested positive for PD-L1 in ³50% of tumor cells. The trial included 712 patients (of whom 710 were included in the interim analysis) with locally advanced NSCLC (Stage IIIB/C), who were not candidates for surgical resection or definitive chemoradiation or had progressed after treatment with definitive chemoradiation, or previously untreated metastatic NSCLC (Stage IV). The trial offers the largest data set from a pivotal trial currently available for this patient population.
Patients were randomized 1:1 to receive either Libtayo 350 mg administered intravenously every three weeks for up to 108 weeks, or an investigator-selected, standard-of-care, platinum-based, doublet chemotherapy regimen for four to six cycles (with or without maintenance pemetrexed chemotherapy). The co-primary endpoints are OS and progression free survival (PFS), and secondary endpoints include overall response rate, duration of response and quality of life.
The trial was designed to reflect current and emerging treatment paradigms. Inclusion criteria allowed patients with NSCLC that had: controlled hepatitis B, hepatitis C or HIV; pre-treated and stable brain metastases; and/or locally advanced disease that had progressed on definitive chemoradiation. Patients whose disease progressed in the trial were able to change their therapy: those in the chemotherapy arm were allowed to crossover into the Libtayo arm, while those in the Libtayo arm were allowed to combine Libtayo treatment with four to six cycles of chemotherapy.
A separate Phase 3 trial evaluating a first-line combination of Libtayo and chemotherapy in patients with advanced NSCLC irrespective of PD-L1 expression is also underway and expected to be fully enrolled in 2020.
About Libtayo
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.
Libtayo is approved in the U.S., European Union, and other countries for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.
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The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes a potentially registrational Phase 2 trial in basal cell carcinoma and additional trials in adjuvant and neoadjuvant CSCC. Libtayo is also being investigated in a potentially registrational Phase 3 trial in cervical cancer, as well as in trials combining Libtayo with novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Sanofi Media Relations Contact
Regeneron Media Relations Contact
Tel: +1 (914) 847-1328 daren.kwok@regeneron.com |
Sanofi Investor Relations Contact
Regeneron Investor Relations Contact
Tel: +1 (914) 847-5443 Vesna.Tosic@regeneron.com |
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives,
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Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, suppliers, and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs (including those discussed in this press release), Regenerons ability to manage its supply chain, net product sales of products marketed by Regeneron and/or its collaborators (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and Regenerons product candidates and research and clinical programs now underway or planned, including without limitation Libtayo® (cemiplimab) as a monotherapy and combination therapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) and as a monotherapy or in combination with conventional treatments or other investigational agents (as applibcable) for the treatment of basal cell carcinoma, adjuvant and neoadjuvant cutaneous squamous cell carcinomas, cervical cancer, blood cancers, and other potential indications; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and lead to therapeutic applications; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons product candidates and new indications for Regenerons Products, including without limitation any possible regulatory approval of Libtayo (as a monotherapy or in combination with conventional treatments or other investigational agents, as applicable) for the treatment of NSCLC, basal cell carcinoma, adjuvant and neoadjuvant cutaneous squamous cell carcinomas, cervical cancer, blood cancers, and other potential indications; unforeseen safety issues resulting from the administration of Regenerons Products and product candidates in patients, including serious complications or side effects in connection with the use of Regenerons Products and product candidates (such as Libtayo) in clinical trials (including those referenced in this press release); determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and product candidates; ongoing regulatory obligations and oversight impacting Regenerons Products (such as Libtayo), research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Regenerons Products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regenerons Products and product candidates; the availability and extent of reimbursement of Regenerons Products (such as Libtayo) from third-party payers, including private payer 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 payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to Regenerons Products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regenerons collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; 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 or collaboration agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to Dupixent® (dupilumab) and Praluent® (alirocumab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
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Exhibit 99.3
Press Release Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) |
Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients
|
Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced critical group with Kevzara higher-dose versus placebo and discontinuing less advanced severe group |
|
Phase 3 trial will be amended to enroll only critical patients |
|
Phase 3 trial will also be amended to discontinue lower-dose Kevzara (200 mg); all new patients to receive either higher-dose Kevzara (400 mg) or placebo |
|
No new safety findings were observed for Kevzara use in COVID-19 patients |
Paris and Tarrytown, N.Y. - April 27, 2020 Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzara® (sarilumab), an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with severe or critical respiratory illness caused by COVID-19. Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only critical patients continue to be enrolled to receive Kevzara 400 mg or placebo.
The randomized Phase 2 portion of the trial compared intravenously-administered Kevzara higher dose (400 mg), Kevzara lower dose (200 mg) and placebo. It assessed 457 hospitalized patients, who were categorized at baseline as having either severe illness (28% of patients), critical illness (49% of patients) or multi-system organ dysfunction (MSOD) (23% of patients). Patients were classified as severe if they required oxygen supplementation without mechanical or high-flow oxygenation; or critical if they required mechanical ventilation or high-flow oxygenation or required treatment in an intensive care unit.
Preliminary analysis of the Phase 2 portion of the trial demonstrated that Kevzara rapidly lowered C-reactive protein, a key marker of inflammation, meeting the primary endpoint (see table below).
Baseline levels of IL-6 were elevated across all treatment arms, with higher levels observed in critical patients compared to severe patients. Additionally, no new safety findings were observed with the use of Kevzara in COVID-19 patients.
Analysis of clinical outcomes in the Phase 2 trial were exploratory and pre-specified to focus on the severe and critical groups. In the preliminary Phase 2 analysis, Kevzara had no notable benefit on clinical outcomes when combining the severe and critical groups, versus placebo. However, there were negative trends for most outcomes in the severe group, while there were positive trends for all outcomes in the critical group (see table below). Subsequent to the IDMC review, Regeneron and Sanofi conducted a review of the discontinued severe group that
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revealed the negative trends in the Phase 2 (n=126) were not reproduced in Phase 3 (n=276), and that clinical outcomes were balanced across all treatment arms. Outcomes for the severe group were better than expected based on prior reports, regardless of treatment assignment: for example, in the Phase 2 portion, approximately 80% were discharged, 10% of patients died and 10% remain hospitalized.
Even in a pandemic setting, its both crucial and possible to obtain controlled data in adequately-sized trials to provide the evidence needed to inform optimal medical care, said George D. Yancopoulos, M.D., Ph.D., Regeneron Co-Founder, President and Chief Scientific Officer. Emerging evidence with Kevzara and other repurposed drugs in the COVID-19 crisis highlight the challenges of making decisions about existing medicines for new viral threats using small, uncontrolled studies. We await results of the ongoing Phase 3 trial to learn more about COVID-19, and better understand whether some patients may benefit from Kevzara treatment. In addition, there is an acute need for tailored approaches that specifically target this virus. To that end, Regeneron is rapidly advancing our targeted anti-SARS-CoV-2 antibody cocktail and we plan to initiate clinical trials in June.
The Kevzara trial was designed after a small (n=21), single-arm study in China (Xu et al) among mostly severe, febrile hospitalized COVID-19 patients, which found elevated IL-6 levels, and suggested that inhibiting this pathway with the IL-6 inhibitor tocilizumab rapidly reduced fever and improved oxygenation in severe patients, allowing for successful hospital discharge. These uncontrolled findings require confirmation in adequately-sized and well-controlled trials. Last month, Regeneron and Sanofi moved rapidly to evaluate Kevzara in a prospective, randomized, placebo-controlled adaptively-designed U.S. Phase 2/3 trial in collaboration with U.S. groups including the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, the Food and Drug Administration (FDA), and hospitals across the country.
At Sanofi, we are committed to help combat the global COVID-19 pandemic. As we quickly follow the science to better understand this disease and explore how best to treat patients, these initial results from the randomized clinical trial setting provide physicians much needed insights and information regarding Kevzara for patients with COVID-19, said John Reed, M.D., Ph.D., Sanofis Global Head of Research and Development. While our evaluation of the use of Kevzara for COVID-19 treatment remains an investigational approach, Sanofi continues to stay at the forefront of multiple initiatives to fight this disease, including researching other potential treatment options, developing vaccine candidates that can be manufactured at large-scale, and a potential collaboration for an innovative SARS-CoV-2 smartphone-based self-testing solution.
The Phase 2 numerical results are presented in the table below, including exploratory clinical endpoints for the critical group, which is the focus of the ongoing Phase 3 trial.
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U.S. Kevzara Trial Phase 2 Efficacy Results
Placebo |
Kevzara 200 mg |
Kevzara 400 mg |
||||
PRIMARY ENDPOINT (REDUCTION IN C-REACTIVE PROTEIN) |
||||||
(n=77) | (n=136) | (n=145) | ||||
% change from baseline in CRP
|
-21% | -77% | -79% | |||
EXPLORATORY CLINICAL ENDPOINTS IN CRITICAL GROUP |
||||||
(n=44) | (n=94) | (n=88) | ||||
Died or On a ventilator |
24 (55%) | 43 (46%) | 28 (32%) | |||
Died |
12 (27%) | 34 (36%) | 20 (23%) | |||
On a ventilator |
12 (27%) | 9 (10%) | 8 (9%) | |||
Clinical improvement
|
18 (41%) | 48 (51%) | 52 (59%) | |||
Off oxygenation |
18 (41%) | 40 (43%) | 51 (58%) | |||
Discharged |
18 (41%) | 37 (39%) | 47 (53%) |
1. 7-point scale consists of: 1) death; 2) hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4) hospitalized, requiring supplemental oxygen; 5) hospitalized, not requiring supplemental oxygen requiring ongoing medical care (COVID-19 related or otherwise); 6) hospitalized, not requiring supplemental oxygen no longer requires ongoing medical care; 7) discharged from hospital.
The ongoing portion of the Phase 3 trial, which is continuing to enroll, currently includes more than 600 patients in the critical group. Regeneron and Sanofi remain blinded to the ongoing portion of the Phase 3 trial and expect to report results by June.
In addition, the companies are also conducting a second trial in countries outside of the U.S. The Phase 3 trial of Kevzara in approximately 400 patients hospitalized with COVID-19 infection is currently enrolling in Italy, Spain, Germany, France, Canada, Russia, Israel and Japan. Initial results from this second trial are expected in the third-quarter. The findings from the U.S. trial will be shared immediately with the IDMC and similar amendments to the trial outside the U.S. will be considered.
The U.S. Kevzara trial has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; and BARDA, under OT number: HHSO100201700020C.
The use of Kevzara to treat the symptoms of COVID-19 is investigational and has not been fully evaluated by any regulatory authority.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
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Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Sanofi Media Relations
Ashleigh Koss Tel.: +1 (908) 981-8745 Ashleigh.Koss@sanofi.com |
Sanofi Investor Relations
Felix Lauscher Tel.: +33 (0)1 53 77 45 45 ir@sanofi.com |
|
Regeneron Media Relations Sarah Cornhill Tel: +1 (914) 847-5018 sarah.cornhill@regeneron.com |
Regeneron Investor Relations Vesna Tosic Tel: +1 (914) 847-5443 Vesna.Tosic@regeneron.com |
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions. Although Sanofis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofis ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofis annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc.(Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regenerons business and its employees, collaborators, suppliers, and other third parties on which Regeneron relies, Regenerons and its collaborators ability to continue to conduct research and clinical programs (including those discussed in this press release), Regenerons ability to manage its supply chain, net product sales of products marketed by Regeneron and/or its collaborators (collectively, Regenerons Products), and the global economy; the nature, timing, and possible success and therapeutic applications of Regenerons Products and product candidates and research and clinical programs now underway or planned, including without limitation Kevzara® (sarilumab) for the treatment of hospitalized patients with severe or critical respiratory illness caused by COVID-19 and Regenerons novel antibody cocktail for the prevention and treatment of COVID-19 (the COVID-19 Multi-antibody Therapy); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regenerons product candidates and new indications for Regenerons Products, such as Kevzara for the treatment of patients with COVID-19 and the COVID-19 Multi-antibody Therapy; unforeseen safety issues resulting from the administration of Regenerons Products and product candidates (such as Kevzara and the COVID-19 Multi-antibody Therapy) in patients, including serious complications or side effects in connection with the use of Regenerons Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regenerons ability to continue to develop or commercialize Regenerons Products and product candidates, including without limitation Kevzara and the COVID-19 Multi-antibody Therapy; ongoing regulatory obligations and oversight impacting Regenerons Products (such as Kevzara), research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Regenerons Products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regenerons Products and product candidates; the availability and extent of reimbursement of Regenerons Products from third-party payers, including private payer 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 payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to Regenerons Products and product candidates; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regenerons collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regenerons Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; 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 or collaboration agreement, including Regenerons agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd.(or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to Dupixent® (dupilumab) and Praluent® (alirocumab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regenerons business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regenerons filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019. Any forward-looking statements are made based on managements current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regenerons media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
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