Sutimlimab-jome - Biologic Drug Details

Summary for sutimlimab-jome

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for sutimlimab-jome

Mechanism of Action	Classical Complement Pathway Inhibitors
Established Pharmacologic Class	Classical Complement Pathway Inhibitor

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 sutimlimab-jome Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for sutimlimab-jome Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for sutimlimab-jome Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Sutimlimab-jome (Enjaymo)

Overview of Sutimlimab-jome (Enjaymo)

Sutimlimab-jome, marketed as Enjaymo, is a groundbreaking biologic drug specifically designed to treat cold agglutinin disease (CAD), a rare B-cell lymphoproliferative disorder. It is the first and only FDA-approved treatment for this condition, targeting the reduction of hemolysis in adult patients with CAD[4].

Market Size and Growth

The cold agglutinin disease drugs market, driven significantly by Enjaymo, is projected to experience substantial growth. As of 2024, the market is valued at USD 134 million and is anticipated to reach USD 558 million by 2031, with a compound annual growth rate (CAGR) of 22.6% during this period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the cold agglutinin disease drugs market, particularly for Enjaymo:

• FDA Approval: The FDA approval of Enjaymo in February 2022 marked a significant milestone, providing a targeted treatment for CAD patients. This approval has been a major driver of market growth[4].
• Rising Prevalence: The increasing prevalence of CAD, especially among aging populations, is contributing to the demand for effective treatments like Enjaymo[1].
• Growing Awareness: Enhanced awareness about CAD and its treatment options is also boosting the market[1].
• Research and Development: Ongoing research and development activities aimed at improving treatment outcomes for CAD patients further support market expansion[1].

Financial Performance of Enjaymo

Enjaymo has demonstrated strong financial performance since its approval:

• Revenue Generation: Over the last 12 months as of August 2024, Enjaymo generated approximately €100 million in revenue. It is expected to achieve peak sales of €250-300 million, more than double the current levels[2].
• Acquisition by Recordati: Recordati's acquisition of the global rights to Enjaymo from Sanofi for an upfront payment of US$825 million, along with potential commercial milestone payments of up to US$250 million, underscores the drug's financial potential[2].
• Cost-Effectiveness Concerns: Despite its clinical benefits, Enjaymo's high cost has raised concerns about its cost-effectiveness. A study suggested that the drug would need an 80% price reduction or a maximum usage duration of 1.5 years to meet standard cost-effectiveness benchmarks in the United States[5].

Pricing and Cost-Effectiveness

The pricing of Enjaymo has been a subject of discussion due to its high cost:

• Current Pricing: The list price of Enjaymo is $1,800 per vial, with six to seven vials required for each infusion, depending on the patient's weight. This results in significant costs for patients and healthcare systems[5].
• Cost-Effectiveness Study: A study published in the American Journal of Hematology indicated that Enjaymo is not cost-effective at its current price, with costs exceeding $2 million per quality-adjusted life-year (QALY) compared to standard care. The study suggested that a substantial price reduction or limited treatment duration would be necessary to achieve cost-effectiveness[5].

Competitive Landscape

The market for CAD treatments is relatively niche but competitive, with several major players involved:

• Major Players: Companies like Sanofi, Novartis, Incyte Corporation, Apellis Pharmaceuticals, and Sobi are key players in the cold agglutinin disease drugs market. The acquisition of Enjaymo by Recordati further highlights the competitive and strategic moves in this space[1][2][4].

Treatment Approach and Clinical Benefits

Enjaymo is administered via infusion and has shown significant clinical benefits:

• Treatment Mechanism: Enjaymo works by inhibiting the activation of the classical complement pathway, thereby reducing hemolysis, anemia, and the need for red blood cell transfusions in CAD patients[4].
• Clinical Outcomes: Clinical data from the CARDINAL study indicate that Enjaymo enhances quality of life and reduces dependency on transfusions for up to 2.5 years of treatment[5].

Regulatory and Approval Milestones

Enjaymo has received regulatory approvals in several key markets:

• FDA Approval: Approved by the U.S. Food and Drug Administration in February 2022[4].
• European Commission and Japanese Approvals: Also approved by the European Commission and the Japanese Ministry of Health, Labor and Welfare in 2022[2].

Conclusion

The market dynamics and financial trajectory for sutimlimab-jome (Enjaymo) are characterized by strong growth driven by FDA approval, rising prevalence of CAD, and increasing awareness. However, the high cost of the drug poses significant challenges to its cost-effectiveness. As the market continues to evolve, strategic acquisitions and ongoing research will play crucial roles in shaping the future of CAD treatment.

Key Takeaways

• Market Growth: The cold agglutinin disease drugs market is expected to grow from USD 134 million in 2024 to USD 558 million by 2031.
• Financial Performance: Enjaymo generated €100 million in revenue over the last 12 months and is expected to reach peak sales of €250-300 million.
• Cost-Effectiveness: Despite clinical benefits, Enjaymo's high cost raises concerns about its cost-effectiveness.
• Regulatory Approvals: Enjaymo is approved by the FDA, European Commission, and Japanese Ministry of Health, Labor and Welfare.
• Competitive Landscape: Major players include Sanofi, Novartis, Incyte Corporation, Apellis Pharmaceuticals, and Sobi.

FAQs

Q: What is the current market size of the cold agglutinin disease drugs market? A: The cold agglutinin disease drugs market is valued at USD 134 million in 2024[1].

Q: What is the expected growth rate of the cold agglutinin disease drugs market? A: The market is anticipated to grow at a CAGR of 22.6% from 2024 to 2031[1].

Q: Who are the major players in the cold agglutinin disease drugs market? A: Major players include Sanofi, Novartis, Incyte Corporation, Apellis Pharmaceuticals, and Sobi[1].

Q: What is the mechanism of action of Enjaymo? A: Enjaymo inhibits the activation of the classical complement pathway, reducing hemolysis and anemia in CAD patients[4].

Q: Is Enjaymo cost-effective at its current price? A: No, Enjaymo is not considered cost-effective at its current price, requiring an 80% price reduction or a maximum usage duration of 1.5 years to meet standard cost-effectiveness benchmarks[5].

Sources

1. Coherent Market Insights: Cold Agglutinin Disease Drugs Market Report.
2. GlobeNewswire: RECORDATI ANNOUNCES AGREEMENT TO ACQUIRE THE GLOBAL RIGHTS TO ENJAYMO.
3. Sanofi: Sanofi 2024 Pricing Principles Report.
4. OpenPR: Cold Agglutinin Disease Treatment Market Growth Demand.
5. Thalassaemia.org.cy: CAD | Enjaymo Not Cost-Effective at Current Price, According to US Study.

Last updated: 2024-12-18