Gemtuzumab ozogamicin - Biologic Drug Details

Summary for gemtuzumab ozogamicin

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for gemtuzumab ozogamicin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for gemtuzumab ozogamicin

Recent Clinical Trials for gemtuzumab ozogamicin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
German Cancer Research Center	Phase 1
University Hospital Heidelberg	Phase 1
University Hospital Dresden	Phase 1

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Recent Litigation for gemtuzumab ozogamicin

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11
AbbVie Inc. v. Alvotech hf.	2021-04-27

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PTAB Litigation

Petitioner	Date
	2017-12-20

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Pharmacology for gemtuzumab ozogamicin

Mechanism of Action	CD33-directed Antibody Interactions
Established Pharmacologic Class	CD33-directed Immunoconjugate

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 gemtuzumab ozogamicin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Gemtuzumab Ozogamicin

Introduction

Gemtuzumab ozogamicin (GO), a targeted therapy for acute myeloid leukemia (AML), has undergone significant developments and challenges since its introduction. This article delves into the market dynamics and financial trajectory of this biologic drug, highlighting its current status, market size, and future projections.

Approval and Clinical Use

Gemtuzumab ozogamicin was approved in 2017 by the US FDA for the treatment of adults with newly diagnosed CD33-positive (CD33+) AML and for adults and pediatric patients with CD33+ relapsed/refractory (R/R) AML[2].

Market Size and Forecast

The global market for gemtuzumab ozogamicin was estimated to be worth US$ 214.3 million in 2023. However, it is forecast to readjust to a size of US$ 179.5 million by 2030, with a Compound Annual Growth Rate (CAGR) of -2.5% during the forecast period of 2024-2030[1].

Key Players

Pfizer is one of the main players in the gemtuzumab ozogamicin market, given its significant role in the drug's development and commercialization[1].

Applications and Types

The drug is primarily used in hospitals and pharmacies. It is available in different formulations, including 5mg/Vial and 4.5mg/Vial[1].

Budget Impact Analysis

A budget impact analysis revealed that the introduction of GO can have varying financial implications. In the combination setting with conventional induction chemotherapy, GO can reduce the overall budget of a health plan, with estimated net cost savings ranging from $72,969 to $745,426 over a five-year period. However, in the monotherapy setting, GO is associated with increased net costs, ranging from $4,118 to $31,885 over the same period[2].

Clinical Efficacy and Dosing Schedule

Recent studies have shown that higher cumulative doses of GO, delivered in fractionated doses, can improve outcomes for AML patients. The optimal dosing schedule, however, remains a subject of ongoing research, with variations between high and low doses and single versus repetitive administration being critical factors[4].

Mechanism of Action

Gemtuzumab ozogamicin is an immunoconjugate between a humanized IgG4 CD33 monoclonal antibody and a calicheamicin–γ1 derivative. It targets the CD33 antigen, which is expressed on myeloid cells and leukemic blasts but absent on pluripotent hematopoietic stem cells and non-hematopoietic cells. The binding of GO to the CD33 antigen leads to the internalization of the drug-antigen complex and the hydrolytic release of the toxic calicheamicin component[5].

Market Challenges

Despite its clinical efficacy, GO has faced several challenges, including temporary market withdrawal due to lack of survival benefit and excessive toxicity in certain patient populations. The drug's use is particularly debated in younger AML patients as a first-line treatment, although it shows significant efficacy in elderly patients receiving it as monotherapy or with low-dose cytotoxics[5].

Financial Implications for Health Plans

The financial impact of incorporating GO into treatment protocols varies significantly depending on the setting. For instance, in the combination setting, GO can lead to cost savings, but as a monotherapy, it increases costs. These variations highlight the need for careful budget planning and analysis when introducing this drug into healthcare systems[2].

Future Prospects

Ongoing clinical trials are expected to further define the role of GO in AML therapy. The identification of the most efficacious and least toxic GO administration schedule is crucial for its continued use. Despite the forecasted decline in market size, GO remains a significant player in the treatment of AML, particularly for elderly patients and those with relapsed/refractory disease[4][5].

Competitive Landscape

The oncology market is highly competitive, with several other drugs and therapies vying for market share. GO's success depends on its ability to demonstrate superior efficacy and safety profiles compared to other treatments. The market dynamics are also influenced by regulatory approvals, pricing strategies, and the availability of alternative therapies[3].

Regulatory Considerations

Regulatory approvals and compliance are critical for the continued commercialization of GO. Any changes in regulatory requirements or safety reporting can significantly impact the drug's market performance and financial trajectory[3].

Patient Population and Unmet Needs

GO targets a specific patient population with high unmet needs, particularly elderly patients with AML who are not candidates for standard chemotherapy. The drug's ability to address these unmet needs is a key factor in its market positioning and financial performance[5].

Conclusion

Gemtuzumab ozogamicin's market dynamics are complex, influenced by its clinical efficacy, dosing schedule, and financial implications. While the drug faces challenges such as temporary market withdrawal and varying cost impacts, it remains a valuable treatment option for specific AML patient populations. The forecasted decline in market size highlights the need for ongoing research and optimization of treatment protocols to ensure the drug's continued relevance in the oncology market.

Key Takeaways

• Market Size: Forecasted to be US$ 179.5 million by 2030.
• Key Player: Pfizer.
• Applications: Hospitals and pharmacies.
• Types: 5mg/Vial and 4.5mg/Vial.
• Budget Impact: Varies between cost savings and increased costs depending on the treatment setting.
• Clinical Efficacy: Improved outcomes with fractionated doses.
• Market Challenges: Temporary market withdrawal and toxicity concerns.
• Future Prospects: Ongoing clinical trials to define its role in AML therapy.

FAQs

Q1: What is the current market size of gemtuzumab ozogamicin? The current market size of gemtuzumab ozogamicin was estimated to be US$ 214.3 million in 2023[1].

Q2: Who are the main players in the gemtuzumab ozogamicin market? Pfizer is one of the main players in the gemtuzumab ozogamicin market[1].

Q3: What are the primary applications of gemtuzumab ozogamicin? The primary applications of gemtuzumab ozogamicin are in hospitals and pharmacies[1].

Q4: How does the dosing schedule of gemtuzumab ozogamicin impact its efficacy? The dosing schedule of gemtuzumab ozogamicin, particularly the use of fractionated doses, has been shown to improve outcomes for AML patients[4].

Q5: What are the financial implications of introducing gemtuzumab ozogamicin into a health plan? The financial implications vary, with potential cost savings in the combination setting and increased costs in the monotherapy setting[2].

Sources

1. Valuates Reports: Gemtuzumab Ozogamicin - Market Size.
2. PubMed: Budget Impact Analysis of Gemtuzumab Ozogamicin for Acute Myeloid Leukemia.
3. Jazz Pharmaceuticals: JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY.
4. Blood: Gemtuzumab ozogamicin in AML: the next chapter.
5. PLOS ONE: Targeted Drug Delivery by Gemtuzumab Ozogamicin.