SNY Sanofi

50.55
-0.97  -2%
Previous Close 51.52
Open 51.11
52 Week Low 37.62
52 Week High 52.94
Market Cap $126,990,079,661
Shares 2,512,167,748
Float 2,512,167,748
Enterprise Value $146,381,755,157
Volume 795,114
Av. Daily Volume 1,516,379
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Upcoming Catalysts

Drug Stage Catalyst Date
Sutimlimab (BIVV009) - Cardinal
Cold agglutinin disease
PDUFA priority review
PDUFA priority review
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
SAR439859
Breast Cancer - third line
Phase 2
Phase 2
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Dupixent (dupilumab)
Asthma - 6-11 year-olds
Phase 3
Phase 3
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Dupixent (dupilumab)
Peanut Allergy
Phase 2
Phase 2
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Fitusiran (ATLAS)
Hemophilia
Phase 3
Phase 3
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Venglustat
Autosomal dominant polycystic kidney disease (ADPKD)
Phase 2/3
Phase 2/3
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Dupixent (dupilumab)
Prurigo nodularis (PN)
Phase 3
Phase 3
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Dupixent (dupilumab)
Bullous pemphigoid (BP)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Dupixent (dupilumab)
Eosinophilic esophagitis
Phase 2/3
Phase 2/3
Data from Phase 2 portion of Phase 2/3 trial met co-primary endpoints - May 22, 2020.
Kevzara (Sarilumab)
Coronavirus COVID-19
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - July 2, 2020.
Libtayo - Cemiplimab
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 enrolment to be completed 2H 2020.
mRNA vaccine
Coronavirus COVID-19
Phase 1b
Phase 1b
Phase 1 trial to commence by the end of 2020.
Venglustat
Tay-Sachs disease / GM-2 gangliosidoses
Phase 3
Phase 3
Phase 3 trial initiated early 2020.
Venglustat
Gaucher disease type 3
Phase 2/3
Phase 2/3
Phase 2/3 trial is ongoing.
Venglustat
Fabry disease
Phase 3
Phase 3
Phase 3 trial to be initiated 2021.
SAR442168 (PRN2246)
Multiple sclerosis
Phase 3
Phase 3
Phase 3 commencement of enrolment announced June 23, 2020.
Avalglucosidase alfa (NeoGAA) - COMET
Pompe disease
Phase 3
Phase 3
Phase 3 data presented June 16, 2020 met the primary endpoint demonstrating non-inferiority in improving respiratory function compared to alglucosidase alfa (standard of care) but not superiority.
Isatuximab - IKEMA
Refractory Multiple Myeloma
Phase 3
Phase 3
Phase 3 primary endpoint met - May 12, 2020.
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
Approved
Approved
FDA Approval announced May 26, 2020.
Adjuvanted COVID-19 vaccine
COVID-19 Coronavirus vaccine
Phase 1
Phase 1
Phase 1 trial to commence September 2020. Late-stage trial to potentially commence late-2020 or early-2021.
Cemiplimab
Basal cell carcinoma
Phase 2
Phase 2
Phase 2 pivotal data showed objective response rate (ORR) of 29%. Regulatory submission due 2020
Cemiplimab
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial stopped early due to significant improvement in overall survival - April 27, 2020.
MenQuadfi
Meningococcal meningitis
Approved
Approved
FDA approval announced April 24, 2020.
Kevzara (sarilumab)
Coronavirus COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 enrolment of global trial has been initiated - march 30, 2020.
Isatuximab
Refractory Multiple Myeloma
Approved
Approved
FDA Approval announced March 2, 2020.
Efpeglenatide
Type 2 diabetes
Phase 3
Phase 3
Phase 3 trial commenced 4Q 2017. Seeking partner to take over and commercialize efpeglenatide.
Olipudase alfa
Acid sphingomyelinase deficiency (ASMD)
Phase 2/3
Phase 2/3
Phase 3 data met two independent primary endpoints- January 30, 2020. Combination endpoint was not met.
Fluzone Quadrivalent (Influenza Vaccine)
Influenza A - children 6-35 months of age.
Approved
Approved
Approved January 23, 2019.
Dupixent (dupilumab)
Nasal polyps
Approved
Approved
FDA Approval announced June 26, 2019.
Dengvaxia
Dengue
Approved
Approved
FDA approval announced May 1, 2019.
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
Approved
Approved
FDA approval announced April 26, 2019.
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
Approved
Approved
FDA approval announced March 11, 2019.
Caplacizumab
Acquired thrombotic thrombocytopenic purpura (aTTP)
Approved
Approved
FDA Approval announced February 6, 2019.
Patisiran
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
Approved
Approved
FDA Approval announced August 10, 2018.
Dupixent (dupilumab)
Asthma
Approved
Approved
FDA approval announced October 19, 2018.
Cemiplimab
Cutaneous squamous cell carcinoma
Approved
Approved
FDA Approval announced September 28, 2018.
Dupixent (dupilumab)
Atopic dermatitis
Approved
Approved
Approved under priority review - March 28, 2017.
Sarilumab
Rheumatoid arthritis
Approved
Approved
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
REGN2810
Cutaneous squamous cell carcinoma
Phase 2
Phase 2
Pivotal Phase 2/3 trial ongoing.
Praluent (alirocumab)
High low-density lipoprotein (LDL) cholesterol
Approved
Approved
sBLA Approval announced April 25, 2017.
Admelog (insulin lispro injection)
Diabetes
Approved
Approved
Approval announced December 11, 2017.

Latest News

  1. CAMBRIDGE, Mass., July 9, 2020 /PRNewswire/ -- Kymera Therapeutics Inc. today announced the company has entered into a multi-program strategic collaboration with Sanofi (NASDAQ:SNY) to develop and commercialize first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases. The companies will also partner on a second earlier stage program. Kymera will receive $150 million in cash upfront and may receive more than $2 billion in potential development, regulatory and sales milestones, as well as significant royalty payments. Kymera retains the option to participate in US development and commercialization for both programs. This includes the ability to participate equally in the costs, profits and losses…

    CAMBRIDGE, Mass., July 9, 2020 /PRNewswire/ -- Kymera Therapeutics Inc. today announced the company has entered into a multi-program strategic collaboration with Sanofi (NASDAQ:SNY) to develop and commercialize first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases. The companies will also partner on a second earlier stage program. Kymera will receive $150 million in cash upfront and may receive more than $2 billion in potential development, regulatory and sales milestones, as well as significant royalty payments. Kymera retains the option to participate in US development and commercialization for both programs. This includes the ability to participate equally in the costs, profits and losses after opt-in, and to co-promote partnered products in the US.

    "This is an important collaboration for both companies and for the field of targeted protein degradation," said Nello Mainolfi, Ph.D., co-founder, President and CEO of Kymera Therapeutics. "Kymera is becoming a fully integrated biotechnology company advancing a pipeline of novel therapies with the potential to transform treatment paradigms. We are excited to partner with Sanofi, an organization with world-class  drug development and commercialization capabilities, to ensure maximal patient impact from two of our programs across multiple disease indications, while enabling Kymera to invest in key strategic areas to realize the broad potential of protein degrader therapies."

    Under terms of the collaboration, Sanofi will make an upfront payment of $150 million in cash to Kymera for global rights to develop its small molecule IRAK4 protein degraders in inflammation and immunology indications, and a second earlier stage undisclosed program. IRAK4 is believed to play a key role in multiple immune-inflammatory diseases, including hidradenitis suppurativa, atopic dermatitis and rheumatoid arthritis. Kymera will advance the IRAK4 program through Phase 1 clinical trials; Sanofi will assume clinical development and commercialization responsibilities thereafter. Sanofi will lead all clinical development activities for the second program. Kymera will have the option to participate in the development of both programs in the US during clinical development. Kymera will retain global rights to its IRAK4 program in oncology indications.

    IRAK4 is a key protein involved in inflammation mediated by the activation of toll-like receptors (TLRs) and IL-1 receptors (IL-1Rs). While TLR and IL-1R signaling via IRAK4 is involved in the normal immune response, aberrant activation of these pathways is the underlying cause of multiple immune-inflammatory conditions. In pre-clinical studies, Kymera has shown oral daily administration of an IRAK4 degrader can lead to complete knockdown of IRAK4 in skin and immune cells in higher species and is well tolerated. Data presented at the most recent annual meetings of the American College of Rheumatology and the European Hidradenitis Suppurativa Foundation showed potent anti-inflammatory activity in both in vitro and in vivo preclinical models.

    "Targeted protein degradation is an exciting modality. Kymera has developed an incredible drug discovery engine producing protein degraders with compelling and differentiated pharmacology against targets that, to date, have not been optimally addressed with other therapeutic modalities," said John Reed, Global Head of Research & Development at Sanofi. "We are excited to partner with the Kymera team to advance a new generation of first-in-class therapies with the potential to eliminate underlying drivers of disease."

    Aquilo Partners, L.P. acted as financial advisor to Kymera on this transaction.

    About Kymera Therapeutics

    Kymera Therapeutics is a biotechnology company pioneering a transformative new approach to treating previously untreatable diseases. The company is advancing the field of targeted protein degradation, accessing the body's innate protein recycling machinery to degrade dysregulated, disease-causing proteins. Kymera's Pegasus targeted protein degradation platform harnesses the body's natural protein recycling machinery to degrade disease-causing proteins, with a focus on un-drugged nodes in validated pathways currently inaccessible with conventional therapeutics. Kymera is accelerating drug discovery with an unmatched ability to target and degrade the most intractable of proteins, and advance new treatment options for patients. For more information, visit www.kymeratx.com.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global pharmaceutical 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. For more information, visit www.sanofi.com.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kymera-therapeutics-and-sanofi-enter-into-strategic-partnership-to-advance-novel-protein-degrader-therapies-to-patients-301090453.html

    SOURCE Kymera Therapeutics Inc.

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  2. CAMBRIDGE, Mass. and TARRYTOWN, N.Y., June 19, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab). The pre-filled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration. This new pre-filled pen will provide patients with a more convenient option for administering Dupixent.  

    "We know that administering or receiving an injection, especially for a medicine that patients need to receive regularly, can seem daunting for patients or their parents or caregivers," said Bill Sibold

    CAMBRIDGE, Mass. and TARRYTOWN, N.Y., June 19, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab). The pre-filled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes use in certain patients with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration. This new pre-filled pen will provide patients with a more convenient option for administering Dupixent.  

    "We know that administering or receiving an injection, especially for a medicine that patients need to receive regularly, can seem daunting for patients or their parents or caregivers," said Bill Sibold, Executive Vice President and Head of Sanofi Genzyme. "The Dupixent pre-filled pen was developed based on patient input and offers the latest technology, including visual and audio cues, to help provide support when taking this medicine."

    The 300 mg pre-filled pen is expected to be available in the U.S. in the third quarter of 2020. The pre-filled pen features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration. Regeneron and Sanofi are working with the FDA to provide additional data they require to complete their review of the 200 mg pre-filled pen. The pre-filled syringe continues to be available in both 200 mg and 300 mg doses for use in a clinic or at home by self-administration. Both methods of administration require training by a healthcare professional.

    "Chronic type 2 inflammatory diseases such as atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyps can be incredibly complex to manage, leaving patients burdened and apprehensive about their treatment options," said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer at Regeneron. "The Dupixent pre-filled pen was specifically designed to provide patients with an easy-to-use, convenient option so they can feel more comfortable administering their injections."

    Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.

    Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and CRSwNP. Across all approved indications globally, more than 150,000 patients have been treated with Dupixent.

    About Dupixent

    Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled. In adolescents 12 years of age or older, it is recommended that Dupixent be administered by or under the supervision of an adult. In children younger than 12 years of age, Dupixent should be administered by a caregiver.

    Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including the EU and Japan. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. The 200 mg and 300 mg pre-filled pens are currently approved in the EU.

    Dupilumab Development Program

    To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are also studying dupilumab in a broad range of clinical development programs for diseases driven by allergic and other type 2 inflammation, including pediatric asthma (6 to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 2/3), eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and food and environmental allergies (Phase 2). These potential uses are investigational, and the safety and efficacy have not been evaluated by any regulatory authority. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

    U.S. Indications

    DUPIXENT is a prescription medicine used:

    • to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age.
    • with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age.
    • with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.

    IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS

    Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.

    Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:

    • have eye problems
    • have a parasitic (helminth) infection
    • are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with DUPIXENT.
    • are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
      • There is a pregnancy exposure registry for women who take DUPIXENT during pregnancy to collect information about the health of you and your baby. Your healthcare provider can enroll you or you may enroll yourself. To get more information about the registry call 1–877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
    • are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. 

    Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis or CRSwNP, and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.

    DUPIXENT can cause serious side effects, including:

    • Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems, fever, general ill feeling, swollen lymph nodes, swelling of the face, mouth and tongue, hives, itching, fainting, dizziness, feeling lightheaded (low blood pressure), joint pain, or skin rash.
    • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.
    • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, shortness of breath, persistent fever, chest pain, or a feeling of pins and needles or numbness of your arms or legs.

    The most common side effects include:

    • Atopic dermatitis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, and cold sores in your mouth or on your lips.
    • Asthma: injection site reactions, pain in the throat (oropharyngeal pain), and high count of a certain white blood cell (eosinophilia).
    • Chronic rhinosinusitis with nasal polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, high count of a certain white blood cell (eosinophilia), trouble sleeping (insomnia), toothache, gastritis, and joint pain (arthralgia).

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Use DUPIXENT exactly as prescribed. Your healthcare provider will tell you how much DUPIXENT to inject and how often to inject it. DUPIXENT is an injection given under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver.

    Please see full Prescribing Information including Patient Information.

    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

    Media Relations Contact for Sanofi

    Nicolas Kressmann

    Tel.: +1 (732) 532-5318

    Investor Relations Contact for Sanofi

    Felix Lausher

    Tel.: +33 (0)1 53 77 45 45





    Media Relations Contact for Regeneron

    Sharon Chen

    Tel: +1 (914) 847-1546

      

    Investor Relations Contact for Regeneron

    Mark Hudson

    Tel: +1 (914) 847-3482

     



    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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, 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 Sanofi's 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 Regeneron's business and its employees, collaborators, suppliers, and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed by Regeneron and/or its collaborators (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's product candidates and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab); uncertainty of market acceptance and commercial success of Regeneron's 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 Regeneron's Products and product candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's product candidates and new indications for Regeneron's Products, such as dupilumab for the treatment of pediatric asthma, pediatric atopic dermatitis, eosinophilic esophagitis, chronic obstructive pulmonary disease, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food and environmental allergies, and other potential indications; unforeseen safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and product candidates in clinical trials; 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 product 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 of Regeneron's Products (such as Dupixent) 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 Regeneron's Products and product candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may lead to advancement of product candidates to clinical trials or therapeutic applications; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's 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 Regeneron's 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 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 Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended March 31, 2020.  Any forward-looking statements are made based on management's 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 Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).

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  3. BRIDGEWATER, N.J., June 15, 2020 /PRNewswire/ -- Preclinical data for Sanofi's investigational compounds in breast, lung, multiple myeloma and other cancers will be featured at the American Academy of Cancer Research (AACR) Virtual Annual Meeting II on June 22-24. The results that will be presented underscore the Company's commitment to transforming scientific knowledge and advances in innovative oncology therapies.

    "We believe the innovation and efforts we are driving in oncology have the potential to make a significant difference in the lives of people living with cancer," said Yong Jun Liu, Global Head of Research, Senior Vice President R&D at Sanofi. "Preclinical data presented at this year's AACR Virtual Meeting II showcase the depth of our pipeline and support the continued exploration of our investigational assets that reflect some of the most cutting-edge scientific technologies and platforms in oncology."

    Preclinical data show anti-tumor activity and support further research across a range of solid tumors, including evolving evidence in breast and lung cancers

    Sanofi continues to embrace a variety of technological approaches to address some of the hardest-to-treat forms of cancer, including breast and lung cancer.

    Abstract 3452: Pre-clinical development of next generation Selective Estrogen Receptor Degrader – SAR439859 (Dr. Fangxian Sun, Sr.; Tuesday, June 23: Virtual Minisymposium Session, 10:20-10:30 AM)

    SAR439859 (SERD '859) is a oral endocrine backbone therapy in hormone receptor positive (HR+) breast cancer that selectively binds to estrogen receptors in breast cancer cells to block signaling and trigger their degradation. Breast cancer is the second most common form of cancer worldwide, with an estimated 70-80% of breast cancers being HR+.

    • Preclinical research from SERD '859 demonstrated anti-tumor activity in HR+ breast cancer cell lines.
    • SERD '859 showed significant anti-tumor activity against endocrine-therapy-resistant, patient-derived tumor models that correlated with pharmacokinetic (PK) exposure and pharmacodynamic (PD) modulation in target tissue.
    • Looking to potential combination therapies, researchers observed strong synergistic activity between SERD '859 and palbociclib, a CDK4/6 inhibitor

    Abstract 561/16: Pre-clinical efficacy data for the anti-CEACAM5-DM4 ADC SAR408701 supports further development in lung and gastro-intestinal cancers (Dr. Stephanie Decary; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

    SAR408701 (SAR '701) is Sanofi's potential first-in-class antibody-drug conjugate targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-squamous non-small cell lung cancers (NSCLC). Approximately 20-30% of lung cancers have a high expression of CEACAM5.

    • Results from patient-derived xenograft mouse studies of SAR '701 in non-small cell lung cancer will be presented.
    • Findings revealed a potential correlation between preclinical activity of the compound and the expression of CEACAM5 in lung tumors.
    • Further exploration of SAR '701 clinical activity is also ongoing across a number of CEACAM5-expressing solid tumors.

    Abstract 1943/10: SHP2 inhibition as the backbone of targeted therapy combinations for the treatment of cancers driven by oncogenic mutations in the RAS pathway (Dr. Jacqueline Smith; Monday, June 22: Poster Display, 9:00AM-6:00PM)

    SAR442720 (RMC-4630) is an investigational inhibitor of the cellular enzyme SHP2 developed jointly by Sanofi and Revolution Medicines. Inhibitors of SHP2 are designed to reduce cell growth signaling in the RAS-MAP kinase pathway that is frequently overactive in human cancers, like NSCLC. 

    • Results from preclinical combination studies showed SAR442720 enhanced the anti-tumor activity of EGFR-mutant or KRASG12C inhibitors.

    Preclinical data add to growing body of evidence supporting Sarclisa (isatuximab-irfc) in multiple myeloma and other blood cancers

    Sanofi is committed to investigating new treatments for patients with multiple myeloma, a difficult-to-treat blood cancer, who often need multiple lines of therapy. Despite available treatments, multiple myeloma remains an incurable malignancy and is associated with significant patient burden.

    Abstract 5179/5: Isatuximab based combinations induce potent tumor growth inhibition in pre-clinical models of multiple myeloma and acute lymphocytic leukemia (Dr. Chen Zhu; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

    Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. It is currently approved for use in the U.S. and EU in combination with pomalidomide and dexamethasone for the treatment of certain adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

    • Results from a study using patient-derived mouse xenograft models showed anti-tumor activity with Sarclisa in combination with standard-of-care treatments in both multiple myeloma (pomalidomide, lenalidomide, bortezomid, carfilzomib, melphalan) and acute lymphocytic leukemia (vincristine, cytarabine, cyclophosphamide). These potential uses of Sarclisa are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

    Early science: new approaches in blood cancer research

    Abstract 2266/1: SAR442085, a next generation anti-CD38 antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) against multiple myeloma (Dr. Angela Virone-Oddos; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

    Current anti-CD38 treatments in combination with standard treatments represent a major advancement in the treatment of patients with relapsed and refractory multiple myeloma, but unmet needs remain.  Sanofi scientists investigating a next-generation anti-CD38 antibody SAR442085 for the treatment of multiple myeloma will present preclinical data at the meeting.

    • Findings from a study of SAR442085 include antibody-dependent cellular cytotoxicity activity in vivo compared to currently available anti-CD38 antibodies.
    • SAR442085 demonstrated a higher level of natural killer (NK) cell activation against primary plasma cells in patient samples and potent in vivo single-agent activity against tumor cells expressing human CD38 in a C57BL/6 mouse model.
    • SAR442085 is currently being evaluated in Phase I clinical trials in patients with relapsed/refractory multiple myeloma.

    Abstract 5641/2: CD28 expression on multiple myeloma cells enhances the cytotoxic activity of CD38/CD28xCD3 trispecific T-cell engager (Dr. Nizar El-Murr; Monday, June 22: Poster Display, 9:00 AM-6:00 PM)

    Sanofi scientists are also investigating the trispecific T-cell engager SAR442257 (CD38/CD28xCD3) as a potential treatment for multiple myeloma.

    • Preclinical data show that SAR442257 is active on CD38 in multiple myeloma models.
    • SAR442257 can also directly target CD28, a T-cell activating protein expressed on tumor cells, enhancing the protein's anti-tumor activity and allowing it to bind to tumor cells when CD38 is occupied by other antibodies.

    The clinical significance of the preclinical findings relating to SERD '859, SAR '701, SAR442720, Sarclisa, SAR442085 and SAR442257 described above are currently under investigation.

    About Sarclisa

    Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.

    Sarclisa is approved in the EU, U.S., Switzerland, Canada and Australia in combination with pom-dex for the treatment of certain adults with relapsed refractory MM. In the U.S., the generic name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration.

    Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The safety and efficacy of these additional uses have not been evaluated by any regulatory authority.

    For more information on Sarclisa clinical trials please visit www.clinicaltrials.gov.

    IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

    What is SARCLISA?

    SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma.

    It is not known if SARCLISA is safe and effective in children.

    Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).

    Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you:

    • are pregnant or plan to become pregnant. SARCLISA may harm your unborn baby. You should not receive SARCLISA during pregnancy.
    • Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after your last dose of SARCLISA. Talk to your healthcare provider about birth control methods that you can use during this time.

    Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA.

    • are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treatment with SARCLISA.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    How will I receive SARCLISA?

    • SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
    • SARCLISA is given in treatment cycles of 28 days (4 weeks), together with the medicines pomalidomide and dexamethasone.
    • In cycle 1, SARCLISA is usually given weekly.
    • Starting in cycle 2, SARCLISA is usually given every 2 weeks.

    Your healthcare provider will decide how long you should receive SARCLISA.

    • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
    • Your healthcare provider will give you medicines before each dose of SARCLISA to help reduce the risk of infusion reactions (make them less frequent and severe).

    What are the possible side effects of SARCLISA?

    SARCLISA may cause serious side effects, including:

    • Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe.
    • Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose of SARCLISA.
    • Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA, if you have an infusion reaction.

    Tell your healthcare provider right away if you develop any of the following symptoms of infusion reaction during or within 24 hours after an infusion of SARCLISA: 

    • feeling short of breath
    • cough
    • chills
    • nausea
    • Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory infections.

    Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA.

    Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA.

    • Risk of new cancers. New cancers have happened in people during treatment with SARCLISA. Your healthcare provider will monitor you for new cancers during treatment with SARCLISA.
    • Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment with SARCLISA. Tell all of your healthcare providers that you are being treated with SARCLISA before receiving blood transfusions.

    The most common side effects of SARCLISA include:



    -lung infection (pneumonia)

    -upper respiratory tract infection









    -decreased red blood cell counts

     (anemia)

    -diarrhea

    -decreased platelet counts (thrombocytopenia)



    These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist.

    Please see full Prescribing Information, including Patient Information.

    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

    Sally Bain

    Tel: +1 (781) 264-1097

    Investor Relations Contact

    Felix Lauscher

    Tel.: +33 (0)1 53 77 45 45

    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 Sanofi's 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, Sanofi's 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 Sanofi's 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.

    Source: Sanofi (EURONEXT: SAN) (NASDAQ:SNY).

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  4. CAMBRIDGE, Mass., June 14, 2020 /PRNewswire/ -- Sanofi and Sobi™, together with the World Federation of Hemophilia (WFH) and WFH USA, today announced an extension of their support of the WFH Humanitarian Aid Program with an additional donation of up to 500 million IUs of factor therapy for humanitarian use, fulfilling the 2014 pledge to donate up to an unprecedented 1 billion IUs over a ten-year period. Since the initial pledge to donate their medicine to the program, over 450 million IUs have been provided and over 17,200 people with hemophilia have been treated with factor donated by Sanofi and Sobi between 2015 and 2019. Additionally, the companies will continue to provide financial support for initiatives such as treatment, access and education…

    CAMBRIDGE, Mass., June 14, 2020 /PRNewswire/ -- Sanofi and Sobi™, together with the World Federation of Hemophilia (WFH) and WFH USA, today announced an extension of their support of the WFH Humanitarian Aid Program with an additional donation of up to 500 million IUs of factor therapy for humanitarian use, fulfilling the 2014 pledge to donate up to an unprecedented 1 billion IUs over a ten-year period. Since the initial pledge to donate their medicine to the program, over 450 million IUs have been provided and over 17,200 people with hemophilia have been treated with factor donated by Sanofi and Sobi between 2015 and 2019. Additionally, the companies will continue to provide financial support for initiatives such as treatment, access and education programs for a period up to five years,

    "Through this partnership with Sanofi and Sobi, our Founding Visionary Contributors, we have been able to significantly expand the reach of the WFH Humanitarian Aid Program, which is leading to a paradigm shift in the management of hemophilia in areas with limited or no access to treatment and care," said Alain Baumann, Chief Executive Officer, World Federation of Hemophilia. "With their continued support, we are confident that people with hemophilia in these countries will continue to receive much needed treatment that is both predictable and sustainable – the foundation of the WFH Humanitarian Aid Program. Our vision at WFH is treatment for all."

    Significant unmet need in developing world

    More than 75% of people with hemophilia have limited or no access to diagnosis and treatment, particularly in the developing world. People with severe hemophilia in these countries often do not survive to adulthood; those who do, often face a life of severe disability, isolation and chronic pain. The underlying physical and psychological toll of hemophilia can be significant without reliable access to care.

    "Patients are at the center of all that we do, and our support of the WFH Humanitarian Aid Program, together with Sobi, builds on Sanofi Genzyme's legacy of helping patients around the world have access to the treatments they need," said Bill Sibold, Executive Vice President and Head of Sanofi Genzyme. "In the past five years, we have seen the life-changing impact a reliable supply of factor therapy can have for people in developing countries; access to prophylactic treatment for children, corrective surgeries, all helping to reduce the burden of this disease. We are honored to play our role in providing hope to those patients and families most in need."

    "For lasting change to become a reality, we need to recognize that access to treatment is a fundamental human right. We are proud to do our part to address this critical health issue, in partnership with Sanofi," said Guido Oelkers, CEO and President at Sobi. "Partnership in reaching the goals is essential. We are pleased to see others following our lead and encourage more companies to join in the shift that the WFH and their local organizations have made possible and that we together can carry forward. Only through a broad long-term commitment to increase awareness, knowledge and access to treatments will the effect of our donation be sustainable and withstanding."

    The WFH Humanitarian Aid Program has over the years made significant improvements in providing access to care. A predictable supply of factor therapy is essential to improving treatment and care. In addition, education programs for treaters and patients are critical initiatives helping to develop in-country capacities to improve diagnosis and treatment monitoring; all of which are needed to create a sustainable treatment environment which lead to better outcomes for patients. Sanofi and Sobi's continued support of the WFH Humanitarian Aid Program for up to five more years, provides for a potential total contribution up to 1 billion IUs of extended half-life factor therapy for a period up to ten years, with the continued opportunity to address the treatment gap and raise the standard of care in the developing world.

    A far-reaching impact on hemophilia care

    With the provision of a consistent supply of factor, corrective surgeries and prophylaxis treatment for young children have become possible. Since initial shipments of Sanofi and Sobi medicines to the WFH Humanitarian Aid Program began, the impact has been far reaching. Through 2019:

    • 450 million IUs of clotting factor have treated over 17,200 people in 42 countries
    • 900 children under the age of 10 are receiving prophylaxis treatment
    • More than 160,000 acute bleeds have been treated
    • More than 2,300 surgeries have taken place including those that were life- and limb-saving

    Sanofi and Sobi believe all patients should have access to the treatment they need regardless of where they live.

    About the WFH Humanitarian Aid Program

    The WFH Humanitarian Aid Program improves the lack of access to care and treatment by providing much-needed support for people with inherited bleeding disorders in developing countries. By providing patients with a more predictable and sustainable flow of humanitarian aid donations, the WFH Humanitarian Aid Program makes it possible for patients to receive consistent and reliable access to treatment and care. None of this would be possible without the generous support of Sanofi Genzyme and Sobi, our Founding Visionary Contributors; Bayer, our Visionary Contributor; Grifols and Roche, our Leadership Contributors; and our Contributor, CSL Behring. The WFH and WFH USA collaborate to manage and control the WFH Humanitarian Aid Program. To learn more about the WFH Humanitarian Aid Program, visit www.treatmentforall.org

    About Sobi

    Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare diseases. Sobi is providing sustainable access to innovative therapies in the areas of haematology, immunology and specialty indications. Today, Sobi employs approximately 1,400 people across Europe, North America, the Middle East, Russia and North Africa. In 2019, Sobi's revenues amounted to SEK 14.2 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.

    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

    Sanofi Investor Relations

    Nicolas Kressmann

    Felix Lauscher

    Tel: +1 (732) 532-5318

    Tel.: +33 (0)1 53 77 45 45





    Sobi Media Relations

    Sobi Investor Relations

    Linda Holmström

    Paula Treutiger

    + 46 708 734 095

    + 46 733 666 599

     

    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 Sanofi's 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, Sanofi's 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 Sanofi's 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.

    Source: Sanofi (EURONEXT: SAN) (NASDAQ:SNY)

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  5. SUZHOU, China, June 8, 2020 /PRNewswire/ -- Alphamab Oncology (stock code: 9966 HK) a clinical stage biopharmaceutical company focusing on innovative biologics medicine for oncology, and Sanofi (NASDAQ:SNY), a global biopharmaceutical leader, announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi (China) Investment Co., Ltd (" Sanofi") to establish strategic collaboration to advance clinical studies to investigate KN026 in combination with Taxotere® (Docetaxel) in HER2+ breast cancer, and Sanofi is granted an exclusivity period to negotiate the in-licensing of KN026 subject to the achievement of certain clinical milestones.

    KN026…

    SUZHOU, China, June 8, 2020 /PRNewswire/ -- Alphamab Oncology (stock code: 9966 HK) a clinical stage biopharmaceutical company focusing on innovative biologics medicine for oncology, and Sanofi (NASDAQ:SNY), a global biopharmaceutical leader, announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of Alphamab Oncology, signed an agreement with Sanofi (China) Investment Co., Ltd (" Sanofi") to establish strategic collaboration to advance clinical studies to investigate KN026 in combination with Taxotere® (Docetaxel) in HER2+ breast cancer, and Sanofi is granted an exclusivity period to negotiate the in-licensing of KN026 subject to the achievement of certain clinical milestones.

    KN026 is an anti-HER2 bispecific antibody which can simultaneously bind two non-overlapping epitopes of HER2 and lead to a dual HER2 signal blockade, presumedly causing HER2 to aggregate on the cell surface and endocytose. Current clinicals trials shown promising preliminary efficacy and excellent safety profile in late-stage breast cancer patients who have failed multiple treatments in China, laying a solid foundation for future development of combination therapies in multiple front line settings. Given its clinical profile, KN026 has the potential to address the medical needs of around 2 million patients suffering from HER2-positive breast cancer in China, USA and key European markets.

    Taxotere® (Docetaxel) is a microtubule inhibitor that interferes with the growth and spread of cancer cells in the body. It is used to treat breast cancer, lung cancer, prostate cancer, gastric cancer. In China, Taxotere® is indicated for breast cancer (BC) including: 1) single agent for locally advanced or metastatic BC after chemotherapy failure; 2) with trastuzumab for the 1st line treatment of metastatic BC patients with HER2 overexpression; 3) and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC.

    Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "KN026 is a core candidate of our innovative bispecific antibody pipeline, and has shown convincing advantages in safety and efficacy from current clinical studies. There are significant unmet need for the treatment of HER2-positive breast cancer. We hope, through the collaboration with Sanofi, a global biopharmaceutical leader, to further drive KN026's China and global development strategy, to provide a superior therapeutic solution to Her-2 positive patients."

    Pius S. Hornstein, PhD, General Manager General Medicines and Country Lead, Sanofi China commented, "Building on Sanofi's heritage in oncology, we see a significant opportunity to impact the health of breast cancer patients by partnering with Alphamab, a biopharmaceutical leader in China. This strategic partnership also demonstrates Sanofi's ambition to play a more active role in the Chinese healthcare ecosystem, offering more new treatments for the large Chinese population with joint efforts from other leading companies."

    Under terms of the agreement, Jiangsu Alphamab and Sanofi will collaborate to evaluate the combination of KN026 and Taxotere® (Docetaxel) for HER2+ breast cancer. Patient enrollment has started for the initial multicenter, open-label study.

    About KN026

    KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.

    KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has excellent safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.

    About Alphamab Oncology

    Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.

    Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into Phase I – III clinical development phases in China, US and Japan. 

    The Company also has state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA's cGMP standards.Alphamab Oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.

    Visit http://www.alphamabonc.com for more information.

    About Sanofi China

    Sanofi is a leading global biopharmaceutical company focused on human health. In 1982, Sanofi opened an office in China as one of the first multinational corporations to support China's opening-up and reform. Sanofi China has a diversified business that ranges from pharmaceuticals and human vaccines to consumer healthcare. Sanofi has 12 offices, 4 R&D sites, 3 production sites and 1 digital innovation hub in China. Sanofi is committed to introducing innovative medicines and vaccines in China, and leading digital innovations to serve the broadest base of the Chinese people.

    For more information, please visit www.sanofi.cn or subscribe to the Sanofi China official WeChat account: SanofiChina and LinkedIn account: Sanofi.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. Sanofi is a global biopharmaceutical company focused on human health. Sanofi prevents illness with vaccines, provides innovative treatments to fight pain and ease suffering. Sanofi stands 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

    Alphamab Oncology Forward-Looking Statements

    This press release contains statements related to our future business and financial performance and future events or developments involving Alphamab Oncology that may constitute forward-looking statements. 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. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Alphamab Oncology's management and business operation, many of which are difficult to predict and generally beyond Alphamab Oncology's control. These are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Alphamab Oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and Alphamab Oncology's disclosures. Should one or more of these risks or uncertainties materialize, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Other than as required by applicable law, Alphamab Oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

     

    Cision View original content:http://www.prnewswire.com/news-releases/alphamab-oncology-and-sanofi-enter-collaboration-on-kn026-in-her2-breast-cancer-301072422.html

    SOURCE Alphamab Oncology

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