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Last Updated: December 25, 2024

VAXELIS Drug Profile


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Summary for Tradename: VAXELIS
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for VAXELIS
Recent Clinical Trials for VAXELIS

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Merck Sharp & Dohme Corp.Phase 4
Johns Hopkins Bloomberg School of Public HealthPhase 4
Merck Sharp & Dohme Corp.Phase 3

See all VAXELIS clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for VAXELIS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for VAXELIS Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for VAXELIS Derived from Patent Text Search

No patents found based on company disclosures

VAXELIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VAXELIS

Introduction

VAXELIS, the first 6-in-1 childhood vaccine available in the US, has been a significant player in the pediatric vaccine market since its launch in 2020. Developed by Sanofi and Merck & Co., this vaccine combines protections against six diseases: diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b. Here, we delve into the market dynamics and financial trajectory of VAXELIS.

Market Position and Adoption

VAXELIS has quickly gained traction in the US market due to its unique benefits. By reducing the shot burden for infants and increasing adherence to vaccination schedules, it has become a preferred choice for pediatricians and parents alike. It is anticipated to account for almost a third of all DTaP vaccinations in the US by 2028, indicating strong market penetration[1].

Financial Projections

The financial outlook for VAXELIS is promising. Sales of VAXELIS are expected to achieve annual sales of $841 million in the US by 2028. This projection is significant, especially considering that VAXELIS is only viable for the first three doses of the primary DTaP vaccine series[1].

Market Growth Drivers

Several factors drive the market growth of VAXELIS:

  • Convenience and Compliance: By combining six vaccines into one, VAXELIS simplifies the vaccination process, reducing the number of shots infants need to receive. This convenience is likely to increase compliance with vaccination schedules.
  • Clinical Benefits: The vaccine's comprehensive protection against multiple diseases makes it a valuable asset in pediatric healthcare.
  • Partnership and Distribution: The equal profit-sharing arrangement between Sanofi and Merck & Co. ensures robust distribution and marketing efforts, further boosting its market presence[4].

Global Market Dynamics

While VAXELIS is driving growth in the US market, global dynamics present a mixed picture:

  • US Market: VAXELIS is expected to be a key driver of market growth in the US pediatric vaccine segment.
  • Indian Market: In contrast, the Indian pediatric combination vaccine market is expected to contract due to the launch of domestically developed and manufactured vaccines at substantial discounts. This contraction is projected to be around $9 million, impacting the overall global market[1].

Competitive Landscape

The pediatric vaccine market is competitive, with several other vaccines available:

  • Shingrix by GSK: Although Shingrix is targeted at a different demographic (adults), it highlights the competitive landscape in the broader vaccine market. Shingrix has seen significant growth and is an example of how successful vaccine products can dominate their respective markets[5].
  • COVID-19 Vaccines: The absence of COVID-19 vaccine sales in recent quarters has impacted overall vaccine sales for companies like Sanofi, but VAXELIS remains unaffected by this trend due to its focus on pediatric vaccinations[4].

Financial Performance of Parent Companies

The financial performance of Sanofi and Merck & Co. provides context for VAXELIS's trajectory:

  • Sanofi: Sanofi reported strong Q2 2024 sales growth of 10.2% at constant exchange rates (CER), with business EPS of €1.73. However, vaccine sales, excluding COVID-19 vaccines, were down 4.8% due to unfavorable phasing in the Rest of World and the US. Despite this, VAXELIS became the market leader in the three-dose primary series market[4].
  • Merck & Co.: While specific financial details for Merck & Co.'s contribution from VAXELIS are not consolidated, the equal profit-sharing arrangement indicates that both companies are benefiting from the vaccine's success.

Challenges and Opportunities

  • Market Competition: The launch of domestically manufactured vaccines in countries like India poses a challenge to the global market share of VAXELIS.
  • Regulatory Approvals: Continuous regulatory approvals and expansions, such as the submission for additional filling lines for Beyfortus, indicate opportunities for growth and capacity augmentation[4].

Impact on Public Health

VAXELIS has a significant impact on public health by:

  • Increasing Vaccination Rates: By simplifying the vaccination process, VAXELIS can lead to higher adherence to vaccination schedules, thereby improving public health outcomes.
  • Reducing Disease Burden: The comprehensive protection offered by VAXELIS against six diseases helps in reducing the overall disease burden in pediatric populations.

Key Takeaways

  • Market Leadership: VAXELIS is expected to become a market leader in the US pediatric vaccine market.
  • Financial Projections: Annual sales of $841 million in the US by 2028.
  • Global Dynamics: While the US market is growing, the Indian market is contracting due to domestic competition.
  • Partnership Benefits: Equal profit-sharing between Sanofi and Merck & Co. enhances distribution and marketing efforts.

FAQs

  1. What diseases does VAXELIS protect against? VAXELIS protects against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b.

  2. Who are the developers of VAXELIS? VAXELIS is developed by Sanofi and Merck & Co.

  3. What is the expected annual sales of VAXELIS in the US by 2028? The expected annual sales of VAXELIS in the US by 2028 is $841 million.

  4. How does VAXELIS impact vaccination schedules? VAXELIS simplifies the vaccination process by combining six vaccines into one, which can increase adherence to vaccination schedules.

  5. What is the impact of domestic vaccines in India on VAXELIS sales? The launch of domestically developed and manufactured vaccines in India at substantial discounts is expected to cause a market contraction, impacting VAXELIS sales globally.

Sources

  1. Global Pediatric Combination Vaccines Drug Forecast and Market Analysis to 2028 - ResearchAndMarkets.com
  2. Press Release: Strong 2021 sales and business EPS growth - Globenewswire
  3. FOOD AND DRUG ADMINISTRATION (FDA) Center for Biologics Evaluation and Research - FDA
  4. Sanofi Q2: strong performance with 10% sales growth; 2024 guidance upgraded - Sanofi
  5. GLAXOSMITHKLINE Q1 2021 FINANCIAL RESULTS - GSK

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