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Last Updated: February 15, 2025

ELELYSO Drug Profile


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Summary for Tradename: ELELYSO
Recent Clinical Trials for ELELYSO

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Ari ZimranPhase 4
PfizerPhase 4
Shaare Zedek Medical CenterN/A

See all ELELYSO clinical trials

Pharmacology for ELELYSO
Established Pharmacologic ClassHydrolytic Lysosomal Glucocerebroside-specific Enzyme
Chemical StructureGlucosylceramidase
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 ELELYSO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

Market Dynamics and Financial Trajectory for the Biologic Drug: ELELYSO

Introduction

ELELYSO (taliglucerase alfa) is a biologic drug developed by Protalix BioTherapeutics for the treatment of Gaucher disease, a rare genetic disorder. Here, we delve into the market dynamics and financial trajectory of ELELYSO, highlighting its performance, challenges, and future prospects.

Market Presence and Approval

ELELYSO was first approved by the FDA in May 2012 and has since been approved for marketing in 23 countries, including the United States, Brazil, Israel, and several European nations[1][2][4].

Revenue Performance

ELELYSO has been a significant revenue generator for Protalix BioTherapeutics. As of 2022, it generated approximately $54 million in revenue, although this figure has seen fluctuations. In 2023, the company reported $15.2 million in revenue from ELELYSO sales to Pfizer in the second quarter, reflecting a consistent performance driven by long-term contracts[2][3].

Historical Revenue

  • 2020: $45 million
  • 2021: $50 million
  • 2022: $54 million
  • 2023 (Q2): $15.2 million[2]

Market Share and Competition

ELELYSO holds a notable share of the U.S. enzyme replacement therapy (ERT) market for Gaucher disease, estimated at around $1 billion. However, its market share has been declining due to increased competition and market saturation. As of 2022, ELELYSO's market share stood at about 4%, down from 7% in 2021[2].

Competitive Landscape

The market for Gaucher disease treatments is competitive, with other ERTs like Cerezyme and VPRIV (Takeda Shire) being major players. ELELYSO faces challenges from biosimilars and alternative treatments, which are eroding its customer base. The average market price for ELELYSO is approximately $73,000 per year per patient, competing with lower-cost alternatives[2][5].

Strategic Partnerships

Protalix has engaged in several strategic partnerships to enhance the market presence of ELELYSO. Notably, the company has a licensing agreement with Pfizer for the global rights to ELELYSO, excluding Brazil. This agreement has contributed significantly to the company's revenue stability. Additionally, Protalix has a partnership with Chugai Pharmaceutical Co., Ltd. for the commercialization of ELELYSO in Japan, which includes potential milestone payments and royalties[1][2].

Financial Stability and Growth

Despite the decline in sales of older formulations like ELELYSO, the drug remains a cash cow for Protalix, ensuring a steady revenue stream. The company's gross margin for ELELYSO has been high, around 75% in Q1 2023, indicating strong operational efficiency[2].

Revenue Streams

  • Sales to Pfizer: $12.5 million in 2023
  • Sales to Brazilian MoH: $10.4 million in 2023 for BioManguinhos alfataliglicerase (the Brazilian version of ELELYSO)[1]

Challenges and Setbacks

ELELYSO has faced several challenges, including increased competition and market saturation. The drug's sales have declined from $28.4 million in 2021 to $18.3 million in 2022. Additionally, the entry of biosimilars and alternative treatments has further pressured ELELYSO's market position[2].

Future Prospects

Despite current challenges, ELELYSO is expected to show moderate growth as partners continue their commercialization efforts. Protalix is investing profits from revenue-generating products like ELELYSO into new candidates, such as PEGylated uricase (PRX-115) and Long Acting (LA) DNase I (PRX-119)[3].

Market Growth Trends

The global rare disease market, which includes ELELYSO, is projected to reach $413 billion by 2026, growing at a CAGR of around 11.4% from 2021 to 2026. This growth is driven by advancements in biotechnology and the increasing number of patients diagnosed with rare diseases[2].

Innovative Production Platform

Protalix's proprietary ProCellEx platform, used for manufacturing ELELYSO, offers several advantages. It allows for rapid horizontal scale-up, low initial capital investment, and does not involve the risk of mammalian viral contamination. This platform is crucial for the company's strategy to develop proprietary recombinant proteins addressing high, unmet needs in the biopharmaceutical market[1].

Key Takeaways

  • Established Market Presence: ELELYSO has a strong market presence in the U.S. and other countries.
  • Revenue Stability: Long-term contracts and strategic partnerships ensure stable revenue.
  • Competitive Challenges: Increased competition and market saturation have led to declining sales.
  • Future Growth: Moderate growth expected through continued commercialization efforts and investment in new candidates.
  • Innovative Production: The ProCellEx platform enhances operational efficiency and scalability.

FAQs

What is ELELYSO used for?

ELELYSO (taliglucerase alfa) is used for the treatment of patients with Gaucher disease, a rare genetic disorder.

Who are the key partners for ELELYSO?

Protalix has partnered with Pfizer for the global rights to ELELYSO, excluding Brazil, and with Chugai Pharmaceutical Co., Ltd. for commercialization in Japan.

What is the current market size for Gaucher disease treatments?

The Gaucher disease market was valued at $1.22 billion in 2022, with a projected CAGR of less than 1% from 2022 to 2032[5].

How does ELELYSO's pricing compare to competitors?

ELELYSO's average market price is approximately $73,000 per year per patient, which is competitive with but generally higher than some alternative treatments[2].

What are the future prospects for ELELYSO?

ELELYSO is expected to show moderate growth as partners continue their commercialization efforts, and Protalix invests in new product candidates to expand its portfolio[3].

Sources

  1. Protalix Biotherapeutics INC Form 10-K - Filed 03/14/2024
  2. Protalix BioTherapeutics, Inc. (PLX) BCG Matrix Analysis - dcf.fm
  3. Zacks Small-Cap Research - Protalix BioTherapeutics, Inc. (PLX) - August 2023
  4. PROTALIX BIOTHERAPEUTICS, INC. - Annual Reports - 2013
  5. Gaucher Disease Market Opportunity Assessment, Epidemiology - GlobalData, December 2023

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