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Last Updated: February 14, 2025

Palifermin - Biologic Drug Details


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Summary for palifermin
Recent Clinical Trials for palifermin

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SponsorPhase
Spectrum Pharmaceuticals, IncPhase 1/Phase 2
AstraZenecaPhase 1
City of Hope Medical CenterPhase 1

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Recent Litigation for palifermin

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District Court Litigation
Case NameDate
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2018-04-30

See all palifermin litigation

Pharmacology for palifermin
Physiological EffectIncreased Epithelial Proliferation
Established Pharmacologic ClassMucocutaneous Epithelial Cell Growth Factor
Chemical StructureFibroblast Growth Factor 7
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 palifermin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Swedish Orphan Biovitrum Ab (publ) KEPIVANCE palifermin For Injection 125103 ⤷  Try for Free 2039-03-29 Company disclosures
Swedish Orphan Biovitrum Ab (publ) KEPIVANCE palifermin For Injection 125103 ⤷  Try for Free 2015-09-29 Company disclosures
Swedish Orphan Biovitrum Ab (publ) KEPIVANCE palifermin For Injection 125103 ⤷  Try for Free 2015-10-20 Company disclosures
Swedish Orphan Biovitrum Ab (publ) KEPIVANCE palifermin For Injection 125103 ⤷  Try for Free 2019-07-16 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

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

These patents were obtained by searching patent claims

Supplementary Protection Certificates for palifermin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
SPC005/2006 Ireland ⤷  Try for Free SPC005/2006: 20061023, EXPIRES: 20190427
2006C/006 Belgium ⤷  Try for Free PRODUCT NAME: PALIFERMIN; AUTHORISATION NUMBER AND DATE: EU/1/05/314/001 20051027
91215 Luxembourg ⤷  Try for Free 91215, EXPIRES: 20190428
06C0004 France ⤷  Try for Free PRODUCT NAME: PALIFERMIN; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
C300230 Netherlands ⤷  Try for Free PRODUCT NAME: PALIFERMIN; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for the Biologic Drug: Palifermin

Introduction

Palifermin, marketed as Kepivance, is a biologic drug that has been approved by the FDA to reduce the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and radiation therapy followed by stem cell rescue. Here, we delve into the market dynamics and financial trajectory of this critical biologic drug.

Clinical Use and Benefits

Palifermin is a modified version of the naturally occurring human protein keratinocyte growth factor (KGF), manufactured in a laboratory. It is specifically designed to protect the cells lining the mouth, reducing the risk and duration of severe mucositis, a common side effect of intense cancer treatments[1].

Market Size and Growth

The anti-oral mucositis drug market, which includes palifermin, is driven by several key factors. The rising prevalence of cancer, particularly among the geriatric population, significantly increases the demand for oral mucositis treatments. Regions with aging populations, such as Japan and China, are expected to see substantial market growth[4].

Competitive Landscape

The biologic drug market is characterized by high barriers to entry due to the complex nature of these products and the stringent regulatory requirements. Palifermin, being a first-in-class drug for oral mucositis, enjoys a competitive advantage. However, the market is also witnessing the emergence of follow-on biologics (FOBs), which could potentially alter the competitive dynamics in the future. FOBs, though, are expected to have limited short-term impact due to factors such as low perceived substitutability and high fixed costs of entry[3].

Economic Impact

Palifermin has shown a favorable economic profile in addition to its clinical benefits. A study on the economic impact of palifermin prophylaxis indicated that it can reduce hospital costs associated with transplantation. The study found that palifermin prophylaxis resulted in significant cost savings, robust across various sensitivity analyses[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of biologic drugs. Palifermin's approval by the FDA highlights the stringent regulatory standards these drugs must meet. The approval process for FOBs is also under scrutiny, with legislation and regulatory frameworks influencing the speed and extent of their entry into the market[3].

Market Trends

Several trends are shaping the market for palifermin and other anti-oral mucositis drugs:

  • Rising Demand for Advanced Therapeutics: The need for quick and efficient treatments for oral mucositis is driving the development of advanced therapeutics. This trend is particularly pronounced in regions with high cancer incidence rates, such as North America[4].
  • Natural Products: There is a growing preference for natural products that reduce side effects, leading to increased investment in research and development of these alternatives[4].
  • Technological Innovations: The integration of new technologies, such as cryotherapy devices and innovative gel products, is enhancing the treatment landscape for oral mucositis[4].

Financial Performance

The financial performance of palifermin is closely tied to its parent company, Amgen Inc. In the early 2000s, Amgen experienced significant growth, with adjusted earnings per share and revenue increasing at compound annual growth rates of 27% and 29%, respectively. Although 2007 was a challenging year for Amgen due to restructuring and intellectual property disputes, the company continued to deliver strong financial results, including growth in product sales outside of its ESA franchise[2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the biologic drug market. While it has presented opportunities for growth due to increased demand for vaccines and treatment drugs, it has also led to delays in product launches, design and development cancellations, and skips in clinical trials. This has restrained the growth of anti-oral mucositis products, including palifermin, to some extent[4].

Key Players and Investments

Amgen Inc., the manufacturer of palifermin, continues to invest in research and development. The company has a strong pipeline and has successfully defended its intellectual property rights, which is crucial for maintaining market share. Other key players, such as Soligenix Inc. and BMG Pharma, are also making significant investments in the development of new treatments for oral mucositis[4].

Future Outlook

The future outlook for palifermin and the anti-oral mucositis drug market is promising but complex:

  • Market Growth: The market is expected to grow driven by the increasing prevalence of cancer and the demand for advanced therapeutics.
  • Competitive Dynamics: The entry of FOBs and other new treatments will shape the competitive landscape, though their immediate impact is expected to be limited.
  • Regulatory and Economic Factors: The economic benefits of palifermin, combined with its clinical efficacy, position it favorably in the market. However, regulatory changes and economic factors such as healthcare infrastructure and patient affordability will continue to influence its financial trajectory[3][4].

Key Takeaways

  • Palifermin is a critical biologic drug for reducing oral mucositis in cancer patients.
  • The market is driven by rising cancer incidence rates and the demand for advanced therapeutics.
  • Palifermin has a favorable economic profile, reducing hospital costs.
  • The regulatory environment and competitive dynamics, including the potential entry of FOBs, will shape the market.
  • Technological innovations and natural products are emerging trends.
  • The COVID-19 pandemic has had a mixed impact on the market.

FAQs

What is palifermin used for?

Palifermin is used to reduce the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and radiation therapy followed by stem cell rescue.

Who manufactures palifermin?

Palifermin is manufactured by Amgen Inc. and is marketed as Kepivance.

What are the economic benefits of palifermin?

Palifermin has been shown to reduce hospital costs associated with transplantation, offering a favorable economic profile in addition to its clinical benefits.

How does the COVID-19 pandemic affect the market for palifermin?

The COVID-19 pandemic has led to delays in product launches and clinical trials, restraining the growth of anti-oral mucositis products, but it has also increased demand for certain biologic drugs due to the broader healthcare needs.

What are the key trends in the anti-oral mucositis drug market?

Key trends include the rising demand for advanced therapeutics, the growing preference for natural products, and the integration of new technologies such as cryotherapy devices.

Sources

  1. FDA: Palifermin (marketed as Kepivance) - FDA.
  2. Annual Reports: Amgen 2007 Annual Report and Financial Summary.
  3. Duke University: The Effect on Federal Spending of Legislation Creating a Regulatory Pathway for Follow-on Biologics.
  4. Allied Market Research: Anti-Oral Mucositis Drug Market Size and Growth Analysis - 2030.
  5. PubMed: Economic impact of palifermin on the costs of hospitalization for hematopoietic stem cell transplantation.

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