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Form 6-K Sanofi For: Nov 19

November 19, 2020 1:28 PM

 

 

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 November 2020

Commission File Number: 001-31368

 

 

SANOFI

(Translation of registrant’s 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 November 2020, Sanofi issued the press releases attached hereto as Exhibits 99.1, 99.2, 99.3 and 99.4 which are incorporated herein by reference.

Exhibit List

 

Exhibit No.

  

Description

Exhibit 99.1    Press release dated November 18, 2020: European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
Exhibit 99.2    Press release dated November 18, 2020: Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia
Exhibit 99.3    Press release dated November 18, 2020: FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease
Exhibit 99.4    Press release dated November 14, 2020: FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease

 

2


Exhibit Index

 

Exhibit No.

  

Description

Exhibit 99.1    Press release dated November  18, 2020: European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
Exhibit 99.2    Press release dated November 18, 2020: Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia
Exhibit 99.3    Press release dated November 18, 2020: FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease
Exhibit 99.4    Press release dated November 14, 2020: FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease

 

3


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: November 19, 2020     SANOFI
                                 By  

/s/ Alexandra Roger

      Name:   Alexandra Roger
      Title:   Head of Securities Law and Capital Markets

 

4

Exhibit 99.1

 

LOGO  

Press Release

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

European Commission approves Supemtek® (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older

 

  *

First and only recombinant influenza vaccine approved in the European Union

 

  *

Contains three times more antigen than standard-dose vaccines

 

  *

Phase 3 efficacy trial demonstrated improved protection against influenza compared to standard-dose influenza vaccine, and reduced the risk of influenza by an additional 30% in adults aged 50 years and older1,2

PARIS – November 18, 2020 – The European Commission has granted a marketing authorization for Supemtek®, a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. Supemtek is the first and only recombinant influenza vaccine now approved in the European Union.

Supemtek is produced using recombinant technology, which allows an exact match to the key component of the influenza strains recommended by the World Health Organization, avoiding the risk of viral mutations. Supemtek also contains three times more antigen than both egg-based and cell-based standard-dose vaccines. This increased amount of antigen and the use of recombinant technology provide improved protection against influenza, particularly in those aged 50 and older. In comparison with a standard-dose egg-based quadrivalent influenza vaccine, Supemtek reduced the risk of influenza by an additional 30% for adults aged 50 years and older1,2.

The authorization is based on clinical data demonstrating safety, immunogenicity and efficacy of Supemtek in two Phase 3 randomized controlled trials1,2 involving more than 10,000 patients in total. Specifically, the relative efficacy of Supemtek was demonstrated in a Phase 3 multicenter (40 outpatient centers in the US, involving more than 9,000 adults), randomized controlled efficacy trial1,2.

“In the context of the COVID-19 pandemic, preventing influenza remains a public health priority,” said Thomas Triomphe, Head of Sanofi Pasteur. “Today’s approval of Supemtek supports our strong commitment in advancing influenza vaccine technology. With Supemtek, we provide European health authorities with an additional innovative solution that has demonstrated increased ability to prevent influenza and its potentially severe complications, as well as the burden this causes on healthcare systems.”

 

1 

Dunkle LM, Izikson R, Patriarca P, et al. 2017

2 

Dunkle LM, Izikson R, et al. 2017a


Each year, influenza-associated deaths range from 290,000 to 650,0003,4 globally, and the burden on hospitals is around 10 million of influenza-related hospitalizations5. Recent data also show that influenza can multiply the risk of heart attack by up to 10 times, and the risk of stroke by up to 8 times, in the week after influenza infection6 – demonstrating that the burden of influenza goes beyond its well-known respiratory complications.

The first European launches are expected for the 2022/2023 influenza season, with a possibility of accelerating the availability of doses as early as the 2021/2022 season in certain countries. Outside of the EU, Supemtek is also approved in the U.S. under the tradename Flublok Quadrivalent®.

About the recombinant technology

The recombinant technology is a new way of producing influenza vaccines which differs significantly from the two other technologies currently in use (egg-based and cell-based technologies) as it avoids the risk of viral mutations that can lower vaccine efficacy. It ensures the exact match to the key component of the influenza strains recommended by the World Health Organization every year for producing influenza vaccines.

In an independent systematic review7 published in October 2020, the European Center for Disease Prevention notes that “the recombinant haemagglutinin was found to provide a greater protective effect against overall influenza compared with no vaccination and with traditional influenza vaccination […] this effect may be attributable to either the restriction of mutations seen with egg-based vaccines or the higher dose of antigen seen in this type of influenza vaccine”.

The recombinant technology is also used for the development of one of Sanofi’s vaccines against COVID-19, developed in partnership with GSK and with the support of US Biomedical Advanced Research and Development Authority (BARDA). The Companies announced the start of the Phase 1/2 clinical trial for their adjuvanted recombinant COVID-19 vaccine candidate in September and anticipate first results in December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year. If these data are sufficient for licensure application, Sanofi and GSK plan to request regulatory approval in the first half of 2021.

 

3 

Centers for Disease Control and Prevention. Flu symptoms and complications

4 

WHO factsheet

5 

Lancet Respir Med 2019; 7: 69–89

6 

Warren-Gash C, et al. Eur Respir J. 2018:51

7 

Systematic review of the efficacy, effectiveness and safety of newer and enhanced seasonal influenza vaccines. ECDC. Oct 2020


Increased production of seasonal influenza vaccines in the unique context of the COVID-19 pandemic

As the leading manufacturer of influenza vaccines, Sanofi Pasteur, the vaccines global business unit of Sanofi, is supporting health authorities in their efforts to strengthen influenza vaccination campaigns in the unique context of COVID-19. For the 2020/2021 influenza season, the Company is delivering globally 20% more doses of flu vaccines, reaching an unprecedented production level of 250 million doses, across its influenza vaccine portfolio which includes a wide range of vaccines (standard doses and differentiated vaccines) that are proven to protect people of all ages from the risks of influenza.

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
Nicolas Kressmann
Tel.: +1 (732) 532-5318
[email protected]
  

Investor Relations Contacts Paris
Eva Schaefer-Jansen
Arnaud Delepine

Yvonne Naughton

 

Investor Relations Contacts North America
Felix Lauscher

Fara Berkowitz

Suzanne Greco

 

IR main line:

Tel.: +33 (0)1 53 77 45 45
[email protected]

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.

Exhibit 99.2

 

LOGO   

Press Release

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

Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia

 

  *

Phase 3 trial initiated to evaluate rilzabrutinib, the potential first BTK inhibitor (Bruton’s tyrosine kinase inhibitor) for the treatment of immune thrombocytopenia

 

  *

Rilzabrutinib previously granted FDA orphan drug designation

PARIS – November 18, 2020 The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the oral investigational Bruton’s tyrosine kinase (BTK) inhibitor, rilzabrutinib, which has the potential to be the first BTK inhibitor for the treatment of immune thrombocytopenia (ITP). In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation from the FDA for the treatment of ITP in October 2018.

“By awarding Fast Track Designation to rilzabrutinib, an investigational candidate for the treatment of ITP, the FDA has recognized rilzabrutinib’s potential to meaningfully improve outcomes for patients with this debilitating disease. This is an excellent acknowledgement as we initiate our Phase 3 study,” said Dolca Thomas, Chief Medical Officer of Principia, a Sanofi company. “FTD is designed to facilitate the development and expedite the review of investigational treatments that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.”

About Fast Track Designation

FTD is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses. Fast Track designation can lead to an Accelerated Approval and Priority Review if certain criteria are met.

About Immune thrombocytopenia

ITP is characterized by immune-mediated platelet destruction and impairment of platelet production, which leads to downstream thrombocytopenia, a predisposition to bleeding, and adverse impact on patient quality of life. There remains an unmet medical need in ITP to achieve rapid and durable remission rates for patients who have relapsed or are refractory to corticosteroids.


About Rilzabrutinib

Rilzabrutinib is an oral, reversible covalent, Bruton’s tyrosine kinase (BTK) inhibitor being investigated for the treatment of immune mediated diseases. BTK is involved in innate and adaptive immune responses and is a signalling molecule in immune mediated diseases. Rilzabrutinib data demonstrate an ability to block inflammatory immune cells, eliminate autoantibody destructive signalling, and prevent new autoantibody production without depleting B cells. Rilzabrutinib has the potential to target the underlying disease pathogenesis and has not been shown to alter platelet aggregation. The clinical significance of these mechanisms is currently under investigation and its safety and efficacy have not been reviewed by any regulatory authority.

Editor’s Note: Rilzabrutinib is being investigated in a Phase 3 trial for pemphigus, an immune mediated disease characterized by blisters in mucous membranes and skin. Additionally, a Phase 2 study in the autoimmune condition IgG4 Disease has also been initiated.

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 1091

[email protected]

  

Investor Relations Contacts Paris

Eva Schaefer-Jansen

Arnaud Delepine

Yvonne Naughton

 

Investor Relations Contacts North America

Felix Lauscher

Fara Berkowitz

Suzanne Greco

 

IR main line:

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

[email protected]

 

https://www.sanofi.com/en/investors/contact


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.

Exhibit 99.3

 

LOGO  

Press Release

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

FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease

 

  *

The FDA decision date for avalglucosidase alfa, an investigational enzyme replacement therapy, is set for May 18, 2021

 

  *

Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, respectively

 

  *

Avalglucosidase alfa received FDA Breakthrough Therapy and Fast Track designations for the treatment of people with Pompe Disease

 

  *

Pompe disease, a rare degenerative muscle disorder, affects approximately 3,500 people in the U.S.

 

  *

Milestone reinforces 20+year commitment to Pompe disease community

PARIS – November 18, 2020 - The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency). The target action date for the FDA decision is May 18, 2021.

Avalglucosidase alfa is an investigational enzyme replacement therapy designed to improve the delivery of acid alpha-glucosidase (GAA) enzyme to muscle cells, and if approved, would offer a potential new standard of care for patients with Pompe disease.

In October, the European Medicines Agency accepted for review the Marketing Authorization Application for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The Medicines and Healthcare Products Regulatory Agency in the UK has granted Promising Innovative Medicine designation for avalglucosidase alfa.

“The hallmarks of Pompe disease are the relentless and debilitating deterioration of the muscles, which causes decreased respiratory function and mobility,” said Karin Knobe, Head of Development for Rare Diseases and Rare Blood Disorders at Sanofi. “Avalglucosidase alfa is specifically designed to deliver more GAA enzyme into the lysosomes of the muscle cells. We have been greatly encouraged by positive clinical trial results in patients with late-onset and infantile-onset Pompe disease.”

Pompe disease is a rare, degenerative muscle disorder that can impact an individual’s ability to move and breathe. It affects an estimated 3,500 people in the U.S. and can manifest at any age from infancy to late adulthood.i


The BLA is based on positive data from two trials:

 

   

Pivotal Phase 3, double-blind, global comparator-controlled trial (COMET), which evaluated the safety and efficacy of avalglucosidase alfa compared to alglucosidase alfa (standard of care) in patients with late-onset Pompe disease. Results from this trial were presented during a Sanofi-hosted virtual scientific session in June 2020 and in October 2020 at World Muscle Society and the American Association of Neuromuscular and Electrodiagnostic Medicine.

 

   

The Phase 2 (mini-COMET) trial evaluated the safety and exploratory efficacy of avalglucosidase alfa in patients with infantile-onset Pompe disease previously treated with alglucosidase alfa. Results from this trial were presented at the WORLDSymposium, in February 2020.

Delivery of GAA to Clear Glycogen

Pompe disease is caused by a genetic deficiency or dysfunction of the lysosomal enzyme GAA, which results in build-up of complex sugars (glycogen) in muscle cells throughout the body. The accumulation of glycogen leads to irreversible damage to the muscles, including respiratory muscles and the diaphragm muscle supporting lung function, and other skeletal muscles that affect mobility.

To reduce the glycogen accumulation caused by Pompe disease, the GAA enzyme must be delivered into the lysosomes within muscle cells. Research led by Sanofi has focused on ways to enhance the delivery of GAA into the lysosomes of muscle cells by targeting the mannose-6-phosphate (M6P) receptor that plays a key role in the transport of GAA.

Avalglucosidase alfa is designed with approximately 15-fold increase in M6P content, compared to standard of care alglucosidase alfa, and aims to help improve cellular enzyme uptake and enhance glycogen clearance in target tissues.ii The clinical relevance of this difference has not been confirmed.

Avalglucosidase alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority worldwide.

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 1091

[email protected]

  

Investor Relations Contacts Paris
Eva Schaefer-Jansen
Arnaud Delepine

Yvonne Naughton

 

Investor Relations Contacts North America
Felix Lauscher

Fara Berkowitz

Suzanne Greco

 

IR main line:

Tel.: +33 (0)1 53 77 45 45
[email protected]

 

https://www.sanofi.com/en/investors/contact

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.

 

i 

https://rarediseases.org/rare-diseases/pompe-disease/

ii 

Zhou Q. Bioconjug Chem. 2011 Apr 20;22(4):741-51

Exhibit 99.4

 

LOGO   

Press Release

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

FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease

 

  *

Complete Response Letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility

PARIS – November 14, 2020 - The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.

The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. There were no clinical or safety deficiencies noted in the CRL with respect to the application. Satisfactory resolution of the observations by the third-party manufacturer is required before the BLA can be approved and Sanofi remains in close contact with the FDA and the third-party manufacturer to reach a resolution in a timely manner.

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.: +1 781-264-1091

[email protected]

  

Investor Relations – Contacts Paris

Eva Schaefer-Jansen

Arnaud Delepine

Yvonne Naughton

 

Investor Relations – Contacts North America

Felix Lauscher

Fara Berkowitz

Suzanne Greco

 

Investor Relations Main Line

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

[email protected]

 

https://www.sanofi.com/en/investors/contact


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.

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