KEPIVANCE Drug Profile

Summary for Tradename: KEPIVANCE

High Confidence Patents:	4
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KEPIVANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KEPIVANCE

Recent Clinical Trials for KEPIVANCE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Spectrum Pharmaceuticals, Inc	Phase 1/Phase 2
AstraZeneca	Phase 1
City of Hope Medical Center	Phase 1

See all KEPIVANCE clinical trials

Recent Litigation for KEPIVANCE

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2018-04-30

See all KEPIVANCE litigation

Pharmacology for KEPIVANCE

Physiological Effect	Increased Epithelial Proliferation
Established Pharmacologic Class	Mucocutaneous Epithelial Cell Growth Factor
Chemical Structure	Fibroblast 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

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 KEPIVANCE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KEPIVANCE 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	5,677,278	2039-03-29	Company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	5,814,605	2015-09-29	Company disclosures
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	5,824,643	2015-10-20	Company disclosures

3) Low Certainty: US Patents for KEPIVANCE 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
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,016,338	2033-03-11	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,195,188	2036-06-13	Patent claims search
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	10,206,894	2031-05-16	Patent claims search

International Patents for KEPIVANCE

Country	Patent Number	Estimated Expiration
Japan	H08277227
Australia	684278
Czech Republic	285996

Supplementary Protection Certificates for KEPIVANCE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300217	Netherlands		PRODUCT NAME: PALIFERMIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/05/314/001 20051025
2006C/006	Belgium		PRODUCT NAME: PALIFERMIN; AUTHORISATION NUMBER AND DATE: EU/1/05/314/001 20051027
SZ 4/2006	Austria		PRODUCT NAME: PALIFERMIN

KEPIVANCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Kepivance

Introduction to Kepivance

Kepivance, also known as palifermin, is a recombinant human keratinocyte growth factor (KGF) developed by Amgen. It is the first and only therapy approved by the U.S. Food and Drug Administration (FDA) to decrease the incidence and duration of severe oral mucositis in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant[1][5].

Mechanism of Action

Kepivance works by protecting the existing epithelial cells that line the mouth and throat from the damage caused by chemotherapy and radiation. It also stimulates the growth and development of new epithelial cells to build up the mucosal barrier, thereby reducing the incidence and duration of severe oral mucositis[1][5].

Clinical Efficacy

Clinical trials have demonstrated the efficacy of Kepivance in significantly reducing the incidence and duration of severe oral mucositis. For instance, the incidence of grade 4 mucositis was reduced by three times, and the incidence of grade 3-4 mucositis was reduced by approximately one-third compared to placebo. Additionally, Kepivance reduced the duration of painful oral mucositis by almost half, from 14 days to 8 days[1].

Patient Benefits

Patients treated with Kepivance reported significantly less mouth and throat soreness and improvements in their ability to eat, drink, swallow, and talk. They also required fewer days of morphine for pain management compared to those receiving placebo[1].

Regulatory Approvals

Kepivance received FDA approval in December 2004 and has also received a positive regulatory opinion for approval in Europe. Amgen has applied for regulatory approval in other countries, including Australia, Canada, and Switzerland[1][5].

Market Position

Biologic Drugs Market

The biologic therapeutic drugs market, which includes Kepivance, is expected to experience significant growth. The global market for biologic therapeutic drugs is projected to grow from $452.9 billion in 2023 to $823.4 billion by 2028, at a compound annual growth rate (CAGR) of 12.7%[4].

Competition and Market Share

Kepivance operates in a competitive market where other biologic drugs are also vying for market share. However, its unique indication for severe oral mucositis in hematologic cancer patients undergoing high-dose chemotherapy and bone marrow transplant positions it as a specialized treatment with a specific market niche[1][4].

Financial Trajectory

Revenue and Sales

While specific financial data for Kepivance alone is not readily available, the overall performance of Amgen and the biologics market can provide some insights. The biologics market is driven by strong demand for therapeutic proteins and other biologic treatments, which suggests a positive financial trajectory for drugs like Kepivance.

Cost and Reimbursement

The cost of Kepivance and its reimbursement policies can significantly impact its financial performance. The availability of reimbursement and the reimbursement policies imposed by third-party payors, including governments and private insurance plans, can affect sales. Additionally, trends toward managed care and healthcare cost containment may influence the pricing and usage of Kepivance[1].

Challenges and Opportunities

Regulatory and Market Challenges

Kepivance faces regulatory challenges, including the need for ongoing approval and compliance with changing regulatory standards. Market competition from other biologic drugs and potential changes in reimbursement policies also pose challenges[1].

Opportunities for Growth

The growing demand for biologic therapeutic drugs presents opportunities for Kepivance. Expanding its indication to other types of cancers or conditions could further increase its market share. Additionally, advancements in cell and gene therapy, which are vital in modern biologic manufacturing, could enhance the production and efficacy of Kepivance[4].

Pharmacokinetics and Safety

Pharmacokinetics

The pharmacokinetics of Kepivance have been studied in both healthy subjects and patients with hematologic malignancies. The drug exhibits linear pharmacokinetics with a rapid decline in concentration post-dose and a terminal decline phase. No accumulation of Kepivance occurs after multiple doses[2].

Safety Profile

Clinical trials have shown that Kepivance is generally safe and effective. However, as with any biologic drug, there is a potential for side effects and the development of antibodies against Kepivance. Monitoring for these factors is crucial to ensure patient safety[2].

Conclusion

Kepivance is a significant player in the biologic therapeutic drugs market, particularly for its unique indication in reducing severe oral mucositis in hematologic cancer patients. Its clinical efficacy, patient benefits, and regulatory approvals position it for continued market presence. However, it must navigate the challenges of a competitive market, regulatory changes, and reimbursement policies to maintain its financial trajectory.

Key Takeaways

• Unique Indication: Kepivance is the first and only therapy approved to decrease the incidence and duration of severe oral mucositis in patients with hematologic cancers.
• Clinical Efficacy: Reduces the incidence and duration of severe oral mucositis, improving patients' ability to eat, drink, swallow, and talk.
• Regulatory Approvals: Approved by the FDA and received positive regulatory opinion in Europe.
• Market Growth: Part of a growing biologic therapeutic drugs market expected to reach $823.4 billion by 2028.
• Challenges: Faces regulatory, market, and reimbursement challenges.
• Opportunities: Potential for expanding indications and benefiting from advancements in biologic manufacturing.

FAQs

What is Kepivance used for?

Kepivance is used to decrease the incidence and duration of severe oral mucositis in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant[1].

How does Kepivance work?

Kepivance works by protecting existing epithelial cells from damage caused by chemotherapy and radiation and stimulating the growth of new epithelial cells to build up the mucosal barrier[1][5].

What are the clinical benefits of Kepivance?

Patients treated with Kepivance experience reduced incidence and duration of severe oral mucositis, less mouth and throat soreness, and improved ability to eat, drink, swallow, and talk. They also require fewer days of morphine for pain management[1].

Is Kepivance approved globally?

Kepivance is approved by the FDA in the U.S. and has received a positive regulatory opinion in Europe. Amgen has also applied for regulatory approval in other countries such as Australia, Canada, and Switzerland[1][5].

What are the potential challenges for Kepivance in the market?

Kepivance faces challenges such as regulatory changes, market competition from other biologic drugs, and potential changes in reimbursement policies[1].

How does the pharmacokinetics of Kepivance affect its administration?

Kepivance exhibits linear pharmacokinetics with a rapid decline in concentration post-dose and no accumulation after multiple doses, making it safe for administration as per the recommended dosing schedule[2].

Sources

1. FDA Approves Kepivance for Severe Oral Mucositis in Cancer Patients - Amgen Inc.
2. Kepivance - FDA Label.
3. Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress - Karyopharm.
4. Big Growth Ahead Biologic Drugs Market to Hit 823.4 Billion by 2028 - BCC Research.
5. Kepivance(TM) (palifermin) Receives Positive Regulatory Opinion for Approval in Europe - Amgen.