Asparaginase erwinia chrysanthemi (recombinant)-rywn - Biologic Drug Details

Summary for asparaginase erwinia chrysanthemi (recombinant)-rywn

Tradenames:	1
High Confidence Patents:	2
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for asparaginase erwinia chrysanthemi (recombinant)-rywn

Established Pharmacologic Class	Asparagine-specific Enzyme
Chemical Structure	Asparaginase

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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 asparaginase erwinia chrysanthemi (recombinant)-rywn Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for asparaginase erwinia chrysanthemi (recombinant)-rywn Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Jazz Pharmaceuticals Ireland Limited	RYLAZE	asparaginase erwinia chrysanthemi (recombinant)-rywn	Injection	761179	10,787,671	2037-10-27	Company disclosures
Jazz Pharmaceuticals Ireland Limited	RYLAZE	asparaginase erwinia chrysanthemi (recombinant)-rywn	Injection	761179	8,288,127	2029-07-30	Company disclosures

3) Low Certainty: US Patents for asparaginase erwinia chrysanthemi (recombinant)-rywn Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

Market Dynamics and Financial Trajectory for Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn

Introduction to Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn

Asparaginase Erwinia chrysanthemi (recombinant)-rywn, marketed as Rylaze, is a biologic drug that has revolutionized the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). This enzyme, derived from the bacterium Erwinia chrysanthemi, is particularly significant for patients who are allergic to Escherichia coli (E. coli)-derived asparaginase.

Market Size and Growth

The global asparaginase market, which includes both E. coli and Erwinia chrysanthemi segments, was valued at USD 648.6 million in 2021. This market is expected to grow at a robust Compound Annual Growth Rate (CAGR) of 16.7% during the forecast period up to 2030[1].

Segment Analysis

Erwinia Chrysanthemi Segment

The Erwinia chrysanthemi segment is anticipated to register the fastest revenue growth rate over the forecast period. This is largely due to the increasing demand for asparaginase that does not cause allergic reactions associated with E. coli-derived products. The FDA approval of Rylaze in June 2021 has been a significant milestone, addressing the shortage of Erwinia asparaginase and providing a reliable treatment option for patients with ALL and LBL[1][3][4].

Escherichia coli Segment

Although the Escherichia coli segment is expected to account for the largest revenue share during the forecast period, it faces challenges due to the potential for allergic reactions in patients. Asparaginase derived from E. coli, such as Elspar, has been clinically shown to exhibit antitumor actions but requires careful patient selection and monitoring[1][2].

Regional Market Dynamics

Europe

Europe is expected to account for a significantly large revenue share in the asparaginase market between 2021 and 2030. Countries like Germany, the U.K., and France are major contributors to this region's revenue. The high prevalence of acute lymphoblastic leukemia in these countries, with around 790 new cases in the U.K. every year, drives the demand for asparaginase[1].

Asia-Pacific

The Asia-Pacific region is also expected to register a robust revenue CAGR throughout the forecast period. Developing countries such as India, China, Malaysia, and Indonesia are experiencing an increasing prevalence of ALL and LBL, which is driving market growth. Additionally, increasing research and development activities in this region are boosting market revenue[4].

Regulatory Approvals and Impact

The FDA approval of Rylaze in June 2021 was a critical event in addressing the shortage of Erwinia asparaginase. This approval has ensured a stable supply of the enzyme for patients who cannot tolerate E. coli-derived asparaginase. Similar approvals and regulatory support are expected to continue driving the market growth[1][3][4].

Research and Development

The asparaginase market is heavily influenced by ongoing research and development activities. For instance, the Indian Institute of Technology (IIT) Indore developed a new asparaginase drug using protein engineering to treat ALL with fewer side effects. Such innovations are expected to enhance the efficacy and safety of asparaginase treatments, further driving market growth[4].

Clinical Trials and New Developments

JZP458, a recombinant Erwinia chrysanthemi asparaginase, is another significant development in this field. Derived from a novel Pseudomonas fluorescens expression platform, JZP458 aims to address historical shortages of native Erwinia asparaginase and minimize cross-reactivity with E. coli-derived asparaginases. Clinical trials such as the AALL1931 trial are ongoing to evaluate the efficacy and safety of these new formulations[5].

Financial Trajectory

The financial trajectory of the asparaginase market is promising, driven by increasing demand, regulatory approvals, and advancements in research and development. Here are some key financial indicators:

• Market Size: Expected to grow from USD 648.6 million in 2021 to a significantly higher value by 2030, driven by a CAGR of 16.7%[1].
• Revenue Growth: The Erwinia chrysanthemi segment is expected to register the fastest revenue growth rate, driven by its non-allergenic properties and recent FDA approvals[1][4].
• Regional Contributions: Europe and the Asia-Pacific region are expected to be major contributors to the market revenue, driven by the prevalence of ALL and LBL and increasing R&D activities[1][4].

Challenges and Opportunities

Challenges

• Allergic Reactions: The potential for allergic reactions to E. coli-derived asparaginase remains a significant challenge, necessitating the development of alternative sources like Erwinia chrysanthemi[2][4].
• Supply Shortages: Historical shortages of native Erwinia asparaginase have been a concern, but recent developments like Rylaze and JZP458 are addressing this issue[3][5].

Opportunities

• Increasing Prevalence: The rising prevalence of ALL and LBL in various regions presents a growing market opportunity for asparaginase products[1][4].
• Innovations in R&D: Advances in protein engineering and recombinant technology offer opportunities for developing safer and more effective asparaginase formulations[4][5].

Key Takeaways

• The global asparaginase market is expected to grow significantly, driven by a CAGR of 16.7% up to 2030.
• The Erwinia chrysanthemi segment is anticipated to register the fastest revenue growth rate due to its non-allergenic properties.
• Regulatory approvals, such as the FDA approval of Rylaze, are crucial in addressing supply shortages and driving market growth.
• Ongoing research and development activities are enhancing the efficacy and safety of asparaginase treatments.
• The Asia-Pacific and European regions are expected to be major contributors to the market revenue.

FAQs

Q: What is Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn used for?

A: Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn, or Rylaze, is used to treat adults and children with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who are allergic to E. coli-derived asparaginase[3].

Q: Why is the Erwinia chrysanthemi segment growing faster?

A: The Erwinia chrysanthemi segment is growing faster due to the increasing demand for asparaginase that does not cause allergic reactions associated with E. coli-derived products[1][4].

Q: What are the key regions driving the asparaginase market?

A: Europe and the Asia-Pacific region are expected to be major contributors to the market revenue, driven by the prevalence of ALL and LBL and increasing R&D activities[1][4].

Q: What are the challenges faced by the asparaginase market?

A: The market faces challenges such as allergic reactions to E. coli-derived asparaginase and historical shortages of native Erwinia asparaginase, but recent developments are addressing these issues[2][3][5].

Q: How is research and development impacting the asparaginase market?

A: Ongoing research and development activities, such as the development of new formulations using protein engineering and recombinant technology, are enhancing the efficacy and safety of asparaginase treatments and driving market growth[4][5].

Sources:

1. Reports and Data: Asparaginase Market Size, Share, Growth, Analysis & Forecast 2030.
2. Haematologica: The amazing journey of the therapeutic anti-leukemia enzyme ...
3. National Cancer Institute: Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn - NCI.
4. BioSpace: Asparaginase Market Size 2022-2030- Growing Pharmaceutical ...
5. ASH Publications: Efficacy, Safety, and Population Pharmacokinetic Modeling of ...