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Last Updated: February 8, 2025

POTELIGEO Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Yale UniversityPhase 2
Kyowa Kirin, Inc.Phase 2
University of Michigan Rogel Cancer CenterPhase 2

See all POTELIGEO clinical trials

Pharmacology for POTELIGEO
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 POTELIGEO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: POTELIGEO

Overview of POTELIGEO

POTELIGEO, developed by Kyowa Kirin, is a biologic drug primarily used to treat Cutaneous T-cell lymphoma (CTCL), a type of skin cancer. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Assessment

Current Market Position

POTELIGEO has been steadily growing in the global market, particularly in Europe and North America. Despite some delays in geographical expansion and insurance reimbursement challenges, the drug has managed to launch in new countries and regions, including 11 new launches in EMEA in 2022[1].

Competitive Landscape

The market for CTCL treatments is becoming increasingly competitive. POTELIGEO faces competition from other emerging therapies, which are expected to impact its market share in the coming years. The launch of late-stage emerging therapies will significantly influence the market dynamics for POTELIGEO[3].

Growth Forecast

The global biologics targeting CCR4 market, which includes POTELIGEO, is projected to grow at a CAGR of 11.3% from 2024 to 2030. This growth is driven by the increasing demand for effective treatments for CTCL and other related conditions[4].

Financial Performance

Revenue Growth

POTELIGEO's sales revenue has continued to grow over the past five years. In 2022, the drug's sales revenue increased, although slightly below the revised forecast due to delays in insurance reimbursement negotiations and geographical expansion[1].

Sales Projections

For 2023, Kyowa Kirin aimed to strengthen promotional activities for POTELIGEO, focusing on patients with blood tumors. The company targeted a 23% increase in sales revenue for POTELIGEO, reaching JPY27.5 billion[1].

Global Strategic Products

POTELIGEO is one of Kyowa Kirin's global strategic products, which are driving top-line growth. Along with other products like Crysvita and Nourianz, POTELIGEO is expected to contribute significantly to the company's overall revenue growth, with a targeted increase of JPY23.4 billion in revenues from overseas regions[1].

Regional Performance

Europe and North America

In Europe, POTELIGEO has faced challenges due to difficult insurance reimbursement negotiations, but it has still managed to launch in new countries. In North America, the drug is part of Kyowa Kirin's growth strategy, with ongoing efforts to enhance its market presence[1].

Japan

While the Japanese market has seen declines in sales of long-term listed drugs and generics due to NHI price revisions, POTELIGEO's performance in Japan is not as significantly impacted. However, the overall sales trend in Japan is closely monitored to limit declines[1].

Regulatory and Developmental Activities

Regulatory Milestones

POTELIGEO has achieved several regulatory milestones, including approvals in various regions. For instance, in Europe, it received approval for the TIO indication in 2022, which has helped in expanding its market reach[1].

Developmental Activities

The drug's development is supported by extensive research and clinical activities. Kyowa Kirin continues to accumulate know-how and evidence through years of activities, which are used to strengthen marketing efforts and deliver value to more patients[1].

Financial Impact on Kyowa Kirin

Revenue and Profit

In fiscal 2023, Kyowa Kirin reported a revenue increase of 11% year-over-year, with POTELIGEO contributing to this growth. The company achieved record high profits, with a net profit of JPY81.2 billion and an ROE of 10.2%, meeting the target set forth in the medium-term business plan[2].

Cost and Expense Management

The company's SG&A expenses increased due to aggressive investments in global strategic products, including POTELIGEO. However, the gross profit margin improved due to an enhanced product mix and technology revenues. For FY2024, the company expects a slight decrease in the gross profit margin due to changes in profit-sharing payments for Crysvita, but this is managed within the overall financial strategy[2].

Future Outlook

Market Forecast

The market forecast for POTELIGEO indicates continued growth, driven by increasing demand for CTCL treatments. However, the drug will face competition from emerging therapies, which could impact its market share. Detailed market assessments and forecasts until 2032 will help in strategic decision-making for Kyowa Kirin and other stakeholders[3].

Strategic Investments

Kyowa Kirin plans to continue investing in R&D and marketing activities to maximize the value of POTELIGEO and other global strategic products. This includes strengthening marketing efforts using accumulated know-how and evidence to deliver value to more patients[1].

Key Takeaways

  • Steady Growth: POTELIGEO has shown steady growth in sales revenue over the past five years.
  • Global Expansion: The drug has expanded its market presence in Europe and North America despite some challenges.
  • Competitive Landscape: The market is becoming increasingly competitive with the emergence of new therapies.
  • Financial Performance: POTELIGEO contributes significantly to Kyowa Kirin's revenue and profit growth.
  • Regulatory Milestones: The drug has achieved important regulatory approvals, enhancing its market reach.
  • Future Outlook: Continued growth is expected, but the drug will face competition from emerging therapies.

FAQs

What is POTELIGEO used for?

POTELIGEO is used to treat Cutaneous T-cell lymphoma (CTCL), a type of skin cancer.

How has POTELIGEO performed in the market?

POTELIGEO has shown steady growth in sales revenue over the past five years, despite some delays and challenges in geographical expansion and insurance reimbursement.

What are the key drivers of the market growth for POTELIGEO?

The market growth for POTELIGEO is driven by increasing demand for effective treatments for CTCL and other related conditions, as well as the company's strategic investments in marketing and R&D.

How does POTELIGEO contribute to Kyowa Kirin's financial performance?

POTELIGEO is one of Kyowa Kirin's global strategic products, contributing significantly to the company's revenue and profit growth.

What are the future challenges for POTELIGEO in the market?

POTELIGEO will face competition from emerging therapies, which could impact its market share. However, Kyowa Kirin plans to continue investing in R&D and marketing activities to maintain its market position.

How does the regulatory environment impact POTELIGEO?

Regulatory approvals, such as the TIO indication in Europe, have helped in expanding POTELIGEO's market reach. Ongoing regulatory activities are crucial for the drug's continued growth.

Sources

  1. Results Presentation Fiscal 2022 - Kyowa Kirin
  2. Transcript of Results Briefing Fiscal 2023 - Kyowa Kirin
  3. POTELIGEO Drug Insight and Market Forecast - 2032 - Research and Markets
  4. Biologics Targeting CCR4 Market Trends and Forecast - Lucintel

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