Antihemophilic factor (recombinant), glycopegylated-exei - Biologic Drug Details

Summary for antihemophilic factor (recombinant), glycopegylated-exei

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

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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.

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1) High Certainty: US Patents for antihemophilic factor (recombinant), glycopegylated-exei Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (recombinant), glycopegylated-exei Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	ESPEROCT	antihemophilic factor (recombinant), glycopegylated-exei	For Injection	125671		2023-02-26	Company disclosures
Novo Nordisk Inc.	ESPEROCT	antihemophilic factor (recombinant), glycopegylated-exei	For Injection	125671		2023-02-26	Company disclosures
Novo Nordisk Inc.	ESPEROCT	antihemophilic factor (recombinant), glycopegylated-exei	For Injection	125671		2029-12-11	Company disclosures
Novo Nordisk Inc.	ESPEROCT	antihemophilic factor (recombinant), glycopegylated-exei	For Injection	125671		2029-12-11	Company disclosures
Novo Nordisk Inc.	ESPEROCT	antihemophilic factor (recombinant), glycopegylated-exei	For Injection	125671		2033-02-05	Company disclosures

3) Low Certainty: US Patents for antihemophilic factor (recombinant), glycopegylated-exei 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
No data available in table

Market Dynamics and Financial Trajectory for Antihemophilic Factor (Recombinant), GlycoPEGylated-exei (ESPEROCT)

Introduction

Antihemophilic Factor (Recombinant), GlycoPEGylated-exei, marketed as ESPEROCT, is a significant advancement in the treatment of hemophilia A. Developed by Novo Nordisk, this biologic drug has been approved by the FDA for use in adults and children with hemophilia A. Here, we delve into the market dynamics and financial trajectory of ESPEROCT.

Indications and Usage

ESPEROCT is indicated for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes in patients with hemophilia A[2][5].

Market Need

Hemophilia A is a genetic disorder characterized by the deficiency of coagulation Factor VIII (FVIII). The current treatment landscape includes over 10 licensed plasma-derived or recombinant FVIII products, but these often require frequent infusions due to their short half-life. ESPEROCT addresses this need by incorporating a 40-kDa polyethylene glycol (PEG) molecule, which prolongs the circulatory half-life of the recombinant FVIII, reducing the frequency of infusions[1].

Regulatory Approval

ESPEROCT received FDA approval in February 2019 after a thorough review process under the Biologics License Application (BLA) program. The FDA's Center for Biologics Evaluation and Research recommended approval based on the drug's efficacy and safety profile[1].

Competitive Landscape

The hemophilia A treatment market is highly competitive, with several established players offering both plasma-derived and recombinant FVIII products. However, ESPEROCT's extended half-life and reduced infusion frequency provide a competitive edge. The market is also influenced by the development of new products with extended half-lives, which are becoming increasingly popular due to their convenience and reduced treatment burden[1][3].

Financial Trajectory

Approval and Launch

The approval of ESPEROCT marked a significant milestone for Novo Nordisk, expanding its portfolio in the rare bleeding disorders segment. The launch of ESPEROCT was anticipated to contribute substantially to Novo Nordisk's revenue, given the high demand for more convenient and effective hemophilia A treatments.

Revenue Projections

Following its approval, ESPEROCT was expected to generate significant revenue due to its unique selling points, such as the extended half-life and reduced infusion frequency. Market analysts projected that ESPEROCT would capture a substantial share of the hemophilia A treatment market, contributing to Novo Nordisk's overall revenue growth.

Pricing Strategy

The pricing of ESPEROCT is critical in determining its market penetration. Given the high cost of existing hemophilia treatments, ESPEROCT's pricing strategy would need to balance the value it offers in terms of reduced treatment frequency and improved patient outcomes with the financial constraints of healthcare systems and patients.

Challenges and Risks

Immunogenicity

One of the significant challenges in the management of hemophilia A is the development of neutralizing anti-drug antibodies (inhibitors), which can occur in approximately 25-35% of previously untreated patients. The addition of a PEG moiety to ESPEROCT could potentially elicit immune responses, although extensive evaluations have been conducted to assess these risks[1][3].

Manufacturing Issues

Novo Nordisk has faced manufacturing issues, including the potential under-filling of some vials, although this issue was primarily related to NovoSeven® RT and not ESPEROCT. Such issues can impact supply chain reliability and patient trust, but the company's extensive quality control measures have mitigated these risks[4].

Market Impact

Patient Outcomes

ESPEROCT has the potential to significantly improve patient outcomes by reducing the frequency of bleeding episodes and the need for frequent infusions. This can lead to better quality of life, reduced joint damage, and lower morbidity and mortality associated with hemophilia A.

Healthcare System Impact

The extended half-life of ESPEROCT can also reduce the overall healthcare burden by decreasing the number of infusions required, which in turn can lower healthcare costs and improve resource allocation.

Key Takeaways

• Extended Half-Life: ESPEROCT's incorporation of a PEG moiety extends the circulatory half-life of recombinant FVIII, reducing the need for frequent infusions.
• Competitive Edge: The drug's convenience and reduced treatment burden provide a competitive edge in the hemophilia A treatment market.
• Regulatory Approval: FDA approval in February 2019 marked a significant milestone for Novo Nordisk.
• Financial Projections: ESPEROCT is expected to contribute substantially to Novo Nordisk's revenue due to its unique selling points.
• Challenges: Immunogenicity and manufacturing issues are key challenges that need to be managed.

FAQs

What is ESPEROCT used for?

ESPEROCT is used for the on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes in patients with hemophilia A[2].

How does ESPEROCT differ from other FVIII products?

ESPEROCT differs from other FVIII products due to its extended half-life achieved through the addition of a 40-kDa polyethylene glycol (PEG) molecule, reducing the need for frequent infusions[1].

What are the potential risks associated with ESPEROCT?

The potential risks include the development of neutralizing anti-drug antibodies (inhibitors) and immune responses due to the PEG moiety. However, extensive evaluations have been conducted to assess these risks[1][3].

How has ESPEROCT impacted patient outcomes?

ESPEROCT has the potential to significantly improve patient outcomes by reducing the frequency of bleeding episodes, the need for frequent infusions, and associated joint damage and morbidity[1].

What are the financial implications of ESPEROCT for Novo Nordisk?

ESPEROCT is expected to contribute substantially to Novo Nordisk's revenue due to its unique selling points and high demand in the hemophilia A treatment market.

Sources

1. FDA Summary Basis for Regulatory Action - ESPEROCT. February 15, 2019.
2. DailyMed - ESPEROCT.
3. Biological considerations of plasma-derived and recombinant factor VIII products. PubMed, June 15, 2017.
4. News from Novo Nordisk, Potential Under-filling of Some Vials on the Market. Hemophilia Federation of America, Updated June 21.
5. Dosing & Administration | Novoeight® (Antihemophilic Factor (Recombinant)). NovoMedLink.