Sanofi shipping BEYFORTUS® in US to help protect babies against RSV disease; new manufacturing line approved by FDA

Rhea-AI Summary

Sanofi is shipping BEYFORTUS (nirsevimab-alip) in the US to protect babies against RSV disease. The company aims to provide access for every eligible baby, with a new FDA-approved manufacturing line expanding capacity to meet demand. BEYFORTUS is the first long-acting monoclonal antibody approved for RSV prevention in newborns and infants up to 24 months old.

Sanofi has collaborated with the White House, CDC, and FDA to ensure wide availability. The company has launched a Reservation Program for private healthcare providers and is working with AstraZeneca to build inventory for current and future seasons. Another filling line is expected to provide doses for the 2024/2025 season, further increasing production capacity.

Positive

• FDA approval of new BEYFORTUS filling line to expand manufacturing capacity
• Anticipated sufficient supply for all eligible babies in the US
• Collaboration with government agencies to ensure wide availability
• Launch of BEYFORTUS Reservation Program for prioritized fulfillment
• Additional filling line expected to provide doses for 2024/2025 season

Negative

• None.

Insights

Medical Research Analyst

The launch of BEYFORTUS in the US marks a significant milestone in infant RSV prevention. As the first long-acting monoclonal antibody approved for this purpose, it addresses a critical medical need. The FDA's approval of a new filling line is crucial, as it expands manufacturing capacity to meet anticipated high demand.

The company's commitment to equitable access for all eligible infants is commendable. This approach could potentially reduce the burden on healthcare systems during RSV seasons. The real-world protection offered by BEYFORTUS, as mentioned, will be closely watched by the medical community to assess its effectiveness in diverse populations.

The collaboration with government agencies and the White House demonstrates the public health significance of this product launch. It's a positive step towards proactive disease prevention rather than reactive treatment.

Market Research Analyst

Sanofi's strategic approach to the BEYFORTUS launch is noteworthy. The BEYFORTUS Reservation Program is a smart move, allowing the company to gauge demand and prioritize distribution effectively. This could lead to optimized inventory management and potentially higher sales.

The collaboration with AstraZeneca for development and manufacturing showcases a synergistic partnership that could benefit both companies. The approval of additional filling lines indicates a scalable production strategy, which is important for meeting future demand.

The timing of the launch, ahead of the RSV season, is optimal for market penetration. If successful, this could potentially reshape the infant immunization market. Investors should monitor the uptake rate and any real-world data that emerges, as these factors will likely influence the product's long-term market position and Sanofi's revenue projections in this segment.

Financial Analyst

While specific financial figures aren't provided, the launch of BEYFORTUS represents a significant revenue opportunity for Sanofi. The potential market is substantial, considering that 2 out of 3 babies contract RSV. If Sanofi achieves its goal of providing access to every eligible infant, this could translate into considerable sales volume.

The investment in expanding manufacturing capacity through new filling lines demonstrates Sanofi's confidence in the product's market potential. This upfront capital expenditure could lead to economies of scale in the future, potentially improving profit margins.

Investors should pay attention to future earnings reports to gauge the impact of BEYFORTUS on Sanofi's top line. The success of this product could also strengthen Sanofi's position in the pediatric vaccine market, potentially leading to increased investor confidence and positive stock performance in the medium to long term.

• Company planning for every eligible baby in the US to have access to BEYFORTUS
• New BEYFORTUS filling line approved by the U.S. Food and Drug Administration (FDA) to expand manufacturing capacity and help meet demand
• 2 out of 3 babies get respiratory syncytial virus (RSV) disease¹

BRIDGEWATER, N.J., Sept. 16, 2024 /PRNewswire/ -- Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program to help ensure the majority of doses are available ahead of RSV season. The US market is anticipated to have enough supply so that every eligible baby born outside of the season will have access to immunization at a regular checkup and those born during the season will have access at birth. BEYFORTUS is the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Thomas Grenier
Head of Vaccines, North America, Sanofi
"We're proud to offer BEYFORTUS doses to help protect every eligible baby in the US this RSV season. This accomplishment aimed at equitable access was made possible through close partnership with the White House, Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and healthcare providers to make BEYFORTUS widely available. This upcoming season, we look forward to BEYFORTUS offering its demonstrated real-world protection to as many infants as possible."

In collaboration with AstraZeneca, which leads BEYFORTUS development and manufacturing, doses have already been produced and packaged on a new filling line for BEYFORTUS. With the recent FDA approval of this filling line, these doses are now ready to ship, expanding supply for the Northern Hemisphere ahead of the 2024/2025 RSV season (November – March).² Another filling line is expected to provide doses for the 2024/2025 season, adding additional production capacity. Sanofi continues to work with AstraZeneca to build inventory for this and future seasons.

Sanofi also took additional measures to ensure greater readiness for this season by launching the BEYFORTUS Reservation Program, which provides critical insight on private healthcare provider demand and allows for prioritized fulfillment of requests placed through the program. The company also continues to collaborate with government agencies, including the White House's Office of Pandemic Preparedness and Response Policy, to ensure readiness. Private customers interested in ordering BEYFORTUS doses should contact their Sanofi representative or request a representative at BEYFORTUS.com.

About RSV
RSV is a highly contagious virus that can lead to serious respiratory illness for infants.³ Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday.^1,4 Most of the time RSV will cause a mild, cold-like illness.⁵ However, RSV is the most common cause of LRTD, including bronchiolitis and pneumonia, in infants.² RSV LRTD is the leading cause of hospitalization in babies under one, with most hospitalizations for RSV occurring in healthy infants born at term.^5,6 Each year in the US, an estimated 590,000 RSV cases in babies under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.⁷

About BEYFORTUS
BEYFORTUS is a single-dose long-acting antibody designed to help prevent RSV LRTD in infants through 5 months, the length of the typical RSV season in the US. For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery. An additional dose of BEYFORTUS is also indicated for children up to 24 months of age, regardless of body weight, who remain vulnerable to severe RSV disease through their second RSV season.

As a long-acting antibody provided directly to newborns and infants as a single dose, BEYFORTUS offers fast-acting protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system.⁸ BEYFORTUS administration can be timed to coincide with the RSV season.

BEYFORTUS has been approved for use in the US, the European Union, China, Japan, and many other countries around the world. Special designations to facilitate expedited development of BEYFORTUS were granted by several regulatory agencies, including Breakthrough Therapy Designation and Fast Track Designation from the U.S. Food and Drug Administration; Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and BEYFORTUS has been named "a medicine for prioritized development" under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development.

INDICATION
BEYFORTUS is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in:

• Newborns and babies under 1 year of age born during or entering their first RSV season.
• Children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.

IMPORTANT SAFETY INFORMATION
Your child should not take BEYFORTUS if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in BEYFORTUS.

Before your child receives BEYFORTUS, tell your healthcare provider about all of your child's medical conditions, including if your child:

• has ever had a reaction to BEYFORTUS.
• has bleeding or bruising problems. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Your infant should not receive a medicine called palivizumab if they have already received BEYFORTUS in the same RSV season.

Serious allergic reactions have happened with BEYFORTUS. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction:

• swelling of the face, mouth, or tongue
• difficulty swallowing or breathing
• unresponsiveness
• bluish color of skin, lips, or under fingernails
• muscle weakness
• severe rash, hives, or itching

The most common side effects of BEYFORTUS include rash and pain, swelling, or hardness at the site of your child's injection. These are not all the possible side effects of BEYFORTUS. Call your healthcare provider if you have questions about side effects.

Please see full Prescribing Information, including Patient Information for more details.

MAT-US-2408133-v2.0-09/2024

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY 

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com

Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 |arnaud.delepine@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates 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 pandemics or other global crises may 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. 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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

References

^{1. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140(6):543-546.}

^{2. Respiratory Syncytial Virus Infection (RSV). "RSV in Infants and Young Children," June 5, 2024. https://www.cdc.gov/rsv/infants-young-children/index.html.}

^{3. RSV Symptoms and Diagnosis | American Lung Association. https://www.lung.org/lung-health-diseases/lung-disease-lookup/rsv/symptoms-diagnosis.}

^{4. Walsh, EE. Respiratory Syncytial Virus Infection: An Illness for All Ages. Clinics in Chest Medicine. 2017;38(1):2936. https://doi.org/10.1016/j.ccm.2016.11.010.}

^{5. Suh M, Movva N, Jiang X, et al. Respiratory syncytial virus is the leading cause of United States infant hospitalizations, 2009-2019: a study of the national (nationwide) inpatient sample. J Infect Dis. 2022;226(suppl 2):S154-S163.}

^{6. Arriola CS, Kim L, Langley G, et al. Estimated burden of community-onset respiratory syncytial virus–associated hospitalizations among children aged <2 years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9(5):587-595.}

^{7. Rainisch G, Adhikari B, Meltzer MI, Langley G. Estimating the impact of multiple immunization products on medically-attended respiratory syncytial virus (RSV) infections in infants. Vaccine. 2020;38(2):251-257.}

^{8. Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed August 2023.}

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SOURCE Sanofi

FAQ

What is BEYFORTUS and what is it used for?

BEYFORTUS (nirsevimab-alip) is the first long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease in newborns and infants up to 24 months old. It helps protect babies against respiratory syncytial virus (RSV) disease.

When will Sanofi (SNY) start shipping BEYFORTUS in the US?

Sanofi is already shipping BEYFORTUS doses in the US as of September 16, 2024, to private healthcare providers and the CDC's Vaccines for Children program, aiming to have the majority of doses available ahead of the RSV season.

How has Sanofi (SNY) increased production capacity for BEYFORTUS?

Sanofi has received FDA approval for a new BEYFORTUS filling line, expanding manufacturing capacity. Additionally, another filling line is expected to provide doses for the 2024/2025 season, further increasing production capacity.

What is the BEYFORTUS Reservation Program launched by Sanofi (SNY)?

The BEYFORTUS Reservation Program is an initiative by Sanofi that provides insight on private healthcare provider demand and allows for prioritized fulfillment of requests placed through the program, ensuring greater readiness for the RSV season.