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Last Updated: February 7, 2025

LUMIZYME Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Valerion Therapeutics, LLCPhase 1/Phase 2
SanofiPhase 3
Genzyme, a Sanofi CompanyPhase 4

See all LUMIZYME clinical trials

Pharmacology for LUMIZYME
Established Pharmacologic ClassHydrolytic Lysosomal Glycogen-specific Enzyme
Chemical Structurealpha-Glucosidases
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 LUMIZYME Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for Lumizyme (Alglucosidase alfa)

Overview of Lumizyme

Lumizyme, also known as alglucosidase alfa, is a biologic drug approved by the US Food and Drug Administration (FDA) for the treatment of Pompe disease, a rare genetic disorder. It was approved for late-onset (non-infantile) Pompe disease in May 2010 and later for infantile-onset Pompe disease in August 2014[1].

Market Assessment

Historical Sales Data

The sales data for Lumizyme from 2017 to 2023 show a mixed trend. Historically, Lumizyme has been a significant player in the treatment of Pompe disease, but its sales have been impacted by the introduction of newer therapies.

  • In 2023, the sales of Lumizyme decreased by 20.4% to €160 million, primarily due to the conversion of patients to Nexviazyme/Nexviadyme, a newer treatment option for Pompe disease[2].

Geographic Performance

Lumizyme's sales performance varies across different regions:

  • United States: The US market has seen a decline in Lumizyme sales as patients switch to Nexviazyme/Nexviadyme. Despite this, the US remains a significant market for the drug.
  • Europe: Sales in Europe have also been affected by the transition to newer therapies, although the decline is somewhat mitigated by the overall growth in the biologics market.
  • Japan and Rest of the World: These regions have shown varying degrees of decline, with the Rest of the World segment experiencing a slower transition to newer treatments[2][3].

Competitive Landscape

Market Competitors

The market for Pompe disease treatments is becoming increasingly competitive:

  • Nexviazyme/Nexviadyme: This newer therapy has significantly impacted Lumizyme sales. Nexviazyme/Nexviadyme sales increased by 115.4% in the fourth quarter of 2023, driven by patient conversions and new patient accruals[2].
  • Other Approved Products: Other treatments for Pompe disease and related conditions also pose competition, further fragmenting the market share of Lumizyme.

Emerging Therapies

The landscape is evolving with ongoing research and development of novel therapies:

  • Clinical Trials and Pipeline: Several clinical trials and pipeline products are focused on improving the treatment outcomes for Pompe disease, which could further alter the market dynamics for Lumizyme[1].

Financial Trajectory

Revenue Trends

The financial performance of Lumizyme has been declining in recent years due to several factors:

  • Generic Competition: While Lumizyme itself is not facing generic competition, the broader biologics market is seeing increased competition from biosimilars and generics, which indirectly affects its sales.
  • New Product Launches: The launch of newer therapies like Nexviazyme/Nexviadyme has led to a significant shift in patient treatment preferences, resulting in decreased sales for Lumizyme[2][3].

Sales Figures

  • In 2023, the total sales for the Pompe franchise (including Nexviazyme/Nexviadyme and Myozyme/Lumizyme) were €291 million, with Lumizyme contributing €160 million. This represents a decline from previous years due to the transition to newer treatments[2].

Regulatory and Developmental Activities

Approvals and Milestones

Lumizyme has undergone several regulatory milestones:

  • FDA Approvals: Approved for late-onset Pompe disease in 2010 and for infantile-onset Pompe disease in 2014[1].
  • Clinical Trials: Ongoing and completed clinical trials have provided valuable data on the efficacy and safety of Lumizyme, although the focus is now shifting towards newer therapies.

Product Development

The development activities for Lumizyme are largely centered around maintaining its market presence amidst emerging competitors:

  • Research and Development: Efforts are focused on optimizing treatment protocols and addressing any challenges that could influence Lumizyme's market position[1].

SWOT Analysis

Strengths

  • Established Market Presence: Lumizyme has been a well-established treatment for Pompe disease for several years.
  • Clinical Efficacy: It has a proven track record of efficacy in treating the condition.

Weaknesses

  • Declining Sales: The transition to newer therapies like Nexviazyme/Nexviadyme has led to a decline in sales.
  • Competition: Increasing competition from emerging therapies and other approved products.

Opportunities

  • Global Healthcare Spending: Incremental healthcare spending across the world could expand the market size for biologic drugs.
  • Research and Development: Opportunities exist in assessing novel approaches to treat Pompe disease.

Threats

  • Market Competition: The launch of late-stage emerging therapies will significantly impact the market share of Lumizyme.
  • Regulatory Changes: Changes in regulatory environments could affect the drug's market position[1].

Key Findings and Market Insights

Market Size and Growth

The global biologics market, including treatments for rare genetic disorders like Pompe disease, is expected to grow significantly. However, the specific market for Lumizyme is expected to decline as patients transition to newer therapies.

Patient Conversion

The conversion of patients from Lumizyme to Nexviazyme/Nexviadyme is a significant trend, with Nexviazyme/Nexviadyme now accounting for 45% of global Pompe sales[2].

Geographic Variations

The impact of newer therapies varies geographically, with the US seeing a more rapid transition compared to other regions[2][3].

Conclusion

The market dynamics and financial trajectory for Lumizyme are characterized by a decline in sales due to the emergence of newer, more effective therapies. Despite its established market presence, Lumizyme faces significant competition from Nexviazyme/Nexviadyme and other treatments. The global healthcare spending and ongoing research offer opportunities, but the overall trend suggests a continued decline in Lumizyme's market share.

Key Takeaways

  • Declining Sales: Lumizyme sales have declined due to patient conversions to newer therapies.
  • Competitive Landscape: The market is highly competitive with emerging therapies like Nexviazyme/Nexviadyme.
  • Geographic Variations: The impact of newer therapies varies across different regions.
  • Regulatory and Developmental Activities: Ongoing research and development are crucial for maintaining market presence.
  • Global Market Trends: The global biologics market is growing, but Lumizyme's share is decreasing.

FAQs

What is Lumizyme used for?

Lumizyme (alglucosidase alfa) is used for the treatment of Pompe disease, a rare genetic disorder.

When was Lumizyme approved by the FDA?

Lumizyme was approved by the FDA in May 2010 for late-onset Pompe disease and in August 2014 for infantile-onset Pompe disease[1].

Why are Lumizyme sales declining?

Lumizyme sales are declining due to the transition of patients to newer therapies like Nexviazyme/Nexviadyme[2].

What is the current market share of Lumizyme in the Pompe disease treatment market?

Nexviazyme/Nexviadyme now accounts for 45% of global Pompe sales, indicating a significant decline in Lumizyme's market share[2].

What are the key factors influencing the market dynamics of Lumizyme?

Key factors include the emergence of newer therapies, patient conversions, and changes in global healthcare spending[1][2][3].

Sources

  1. ResearchAndMarkets.com: "Lumizyme (Alglucosidase alfa) - Drug Insight and Market Forecast - 2030"[1].
  2. Sanofi: "Press Release Q4 2023 English"[2].
  3. Sanofi: "Press release Q3 2024 English"[3].

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