Fremanezumab-vfrm - Biologic Drug Details

Summary for fremanezumab-vfrm

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1
Suppliers: see list	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fremanezumab-vfrm

Recent Litigation for fremanezumab-vfrm

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Teva Pharmaceuticals International GmbH v. Eli Lilly and Company	2018-09-27

See all fremanezumab-vfrm litigation

PTAB Litigation

Petitioner	Date
Eli Lilly and Company	2018-09-28

See all fremanezumab-vfrm litigation

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 fremanezumab-vfrm Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for fremanezumab-vfrm Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089	8,007,794	2025-11-14	Company disclosures
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089	8,586,045	2025-11-14	Company disclosures
Teva Branded Pharmaceutical Products R&d, Inc.	AJOVY	fremanezumab-vfrm	Injection	761089	9,896,502	2034-03-21	Company disclosures

3) Low Certainty: US Patents for fremanezumab-vfrm 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

International Patents for fremanezumab-vfrm

Country	Patent Number	Estimated Expiration
Malaysia	153249
New Zealand	724442
Israel	190876
Norway	344099
South Korea	20160147755

Supplementary Protection Certificates for fremanezumab-vfrm

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
370 15-2019	Slovakia		PRODUCT NAME: FREMANEZUMAB; REGISTRATION NO/DATE: EU/1/19/1358 20190401
CA 2019 00026	Denmark		PRODUCT NAME: GALCANEZUMAB; REG. NO/DATE: EU/1/18/1330 20181116
CA 2019 00036	Denmark		PRODUCT NAME: FREMANEZUMAB; REG. NO/DATE: EU/1/19/1358 20190401
PA2019015,C2380592	Lithuania		PRODUCT NAME: FREMANEZUMABAS; REGISTRATION NO/DATE: EU/1/19/1358 20190328
CR 2019 00026	Denmark		PRODUCT NAME: GALCANEZUMAB; REG. NO/DATE: EU/1/18/1330 20181116

Market Dynamics and Financial Trajectory for Fremanezumab-vfrm (AJOVY®)

Introduction

Fremanezumab-vfrm, marketed as AJOVY®, is a humanized monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults. This article delves into the market dynamics and financial trajectory of AJOVY®, highlighting its clinical significance, market impact, and potential financial outcomes.

Clinical Significance of AJOVY®

AJOVY® is the first and only anti-calcitonin gene-related peptide (CGRP) treatment for migraine prevention that offers both quarterly and monthly dosing options. This flexibility is crucial for patient compliance and effectiveness[2].

Recent Clinical Data

The 4th interim analysis of the PEARL study presented at the 10th European Association of Neurology congress revealed significant insights into the long-term effectiveness and safety of AJOVY®. The data indicated that treatment pauses can lead to a rapid increase in migraine days and reduced treatment effectiveness upon reinitiation. Over 40% of patients experienced a significant increase in monthly migraine days after stopping the treatment, and only 35.7% and 45.5% of patients achieved significant reduction in monthly migraine days at Months 1 and 3, respectively, upon reinitiation[1].

Market Impact

Shifting Treatment Preferences

The findings from the PEARL study are likely to influence market dynamics by shifting patient and healthcare provider preferences towards continuous treatment plans. This could lead to increased demand for AJOVY®, potentially driving sales growth and altering reimbursement policies to favor uninterrupted treatment regimens[1].

Competitive Landscape

AJOVY® operates in a competitive market for migraine treatments, but its unique dosing options and strong clinical data set it apart. The approval and adoption of AJOVY® have expanded the treatment options for the millions of people affected by migraines, with about 40% of those living with migraine being potential candidates for preventive treatment[2].

Financial Trajectory

Sales Growth Potential

The new data from the PEARL study could significantly boost the sales of AJOVY®. If reimbursement policies are adjusted to allow for continuous treatment, it could result in more stable and predictable revenue streams for Teva Pharmaceutical Industries. Retail investors should note that changes in treatment guidelines and reimbursement policies could directly affect the company's financial performance in the long term[1].

Market Dynamics and Adoption

The market share and adoption of AJOVY® are expected to increase as more healthcare providers and patients opt for continuous treatment plans. This shift could lead to increased market penetration and higher sales volumes, contributing positively to Teva's financial performance.

Regulatory and Reimbursement Implications

Impact on Reimbursement Policies

The PEARL study findings challenge current reimbursement guidelines that recommend treatment pauses after one year of continuous use. The data suggest that continuous treatment with fremanezumab yields better patient outcomes, which could lead to revisions in reimbursement policies to support uninterrupted treatment regimens. This would be a significant win for Teva, as it would stabilize revenue and reduce the financial uncertainty associated with treatment pauses[1].

Global Expansion

Efficacy and Safety in Diverse Populations

Recent Phase 3 trial results in China have confirmed the efficacy and safety of AJOVY® for the prevention of migraine. This study demonstrated that fremanezumab significantly reduced the number of migraine days experienced per month and was well-tolerated with no significant safety signals. This expansion into new markets, such as China, further enhances the global reach and financial potential of AJOVY®[4].

Challenges and Risks

Market Competition and Regulatory Risks

Despite the positive outlook, there are several challenges and risks associated with the commercial success of AJOVY®. These include competition from other migraine treatments, regulatory uncertainties, and the potential for changes in healthcare policies and reimbursement rates. Additionally, Teva faces risks related to the commercialization of new products, competition from generics, and global economic uncertainties[2].

Industry Expert Insights

"Migraine is a disabling neurological disease that affects more than 36 million people in the United States," said Stephen Silberstein, MD, Director, Jefferson Headache Center at Thomas Jefferson University Hospital. "I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days." This sentiment reflects the broader medical community's appreciation for effective preventive treatments like AJOVY®[2].

Illustrative Statistics

• Over 40% of patients experienced a rapid increase in monthly migraine days after pausing fremanezumab treatment[1].
• Only 35.7% and 45.5% of patients achieved significant reduction in monthly migraine days at Months 1 and 3, respectively, upon reinitiation of treatment[1].
• AJOVY® has been shown to significantly reduce the number of migraine days experienced per month in clinical trials, including the Phase 3 study in China[4].

Key Takeaways

• Continuous Treatment Preference: The PEARL study data suggest that continuous treatment with fremanezumab yields better patient outcomes compared to treatment pauses.
• Market Impact: The findings are likely to shift market dynamics towards continuous treatment plans, potentially increasing demand for AJOVY®.
• Financial Trajectory: Adjustments in reimbursement policies could lead to stable and predictable revenue streams for Teva.
• Global Expansion: Positive results in diverse populations, such as the Phase 3 trial in China, enhance the global reach and financial potential of AJOVY®.
• Challenges and Risks: Teva faces competition, regulatory uncertainties, and global economic risks that could impact the commercial success of AJOVY®.

FAQs

Q: What is the significance of the PEARL study findings for AJOVY®?

A: The PEARL study findings indicate that pausing treatment with fremanezumab can lead to a rapid increase in migraine days and reduced treatment effectiveness upon reinitiation, advocating for continuous treatment plans.

Q: How does AJOVY® differ from other migraine treatments?

A: AJOVY® is the first and only anti-CGRP treatment with both quarterly and monthly dosing options, offering flexibility and effectiveness in migraine prevention.

Q: What are the potential financial implications of the PEARL study findings for Teva?

A: The findings could lead to increased demand for AJOVY®, driving sales growth and potentially resulting in more stable and predictable revenue streams if reimbursement policies are adjusted.

Q: What are the key risks associated with the commercial success of AJOVY®?

A: Risks include competition from other treatments, regulatory uncertainties, changes in healthcare policies, and global economic uncertainties.

Q: How does the Phase 3 trial in China impact the global market for AJOVY®?

A: The positive results from the Phase 3 trial in China confirm the efficacy and safety of AJOVY® in diverse populations, enhancing its global reach and financial potential.

Sources

1. Stock Titan: New AJOVY® (fremanezumab) Migraine Prevention Data Challenges Treatment Pauses[1].
2. BioSpace: Teva Announces U.S. Approval of AJOVYTM (fremanezumab-vfrm) Injection[2].
3. Samsung Bioepis: Biosimilar Market Report - SAMSUNG BIOEPIS[3].
4. Teva Pharmaceutical Industries: Teva Confirms Efficacy and Safety of AJOVY® (fremanezumab) for the Prevention of Migraine With Results from Phase 3 Trial in China[4].