IMLYGIC Drug Profile

Summary for Tradename: IMLYGIC

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for IMLYGIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMLYGIC

Recent Clinical Trials for IMLYGIC

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Binhui Biopharmaceutical Co., Ltd.	Phase 1
University of California, San Francisco	Phase 1
University of Louisville	Phase 2

See all IMLYGIC clinical trials

Recent Litigation for IMLYGIC

Identify key patents and potential future biosimilar entrants

PTAB Litigation

Petitioner	Date
Replimune Limited et al.	2022-11-02

See all IMLYGIC 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 IMLYGIC Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for IMLYGIC 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
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518		2032-08-30	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518		2035-05-04	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518		2035-05-04	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518		2032-08-03	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518		2038-06-01	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518		2038-10-25	Patent claims search
Amgen Inc.	IMLYGIC	talimogene laherparepvec	For Injection	125518		2037-11-13	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: IMLYGIC

Introduction to IMLYGIC

IMLYGIC, also known as talimogene laherparepvec, is a genetically modified herpes simplex virus type 1 (HSV-1) designed for oncolytic virus therapy (OVT). It is the first FDA-approved oncolytic virus immunotherapy, specifically for the treatment of melanoma. Here, we delve into the market dynamics and financial trajectory of IMLYGIC.

Mechanism of Action and Clinical Use

IMLYGIC works by replicating within tumors and producing the immunostimulatory protein granulocyte-macrophage colony-stimulating factor (GM-CSF). This process leads to cell lysis, releasing tumor-derived antigens and promoting an antitumor immune response[1].

Market Assessment

The market for oncolytic virus immunotherapies, including IMLYGIC, is expected to grow significantly. According to Persistence Market Research, the oncolytic virus immunotherapy market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 12% from 2019 to 2029[4].

Key Markets

The primary markets for IMLYGIC include the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom. These regions are expected to drive the growth of the OVT market due to increasing adoption of adjuvant therapies and favorable reimbursement policies[1][4].

Clinical Trials and Development

IMLYGIC is currently involved in several clinical trials to expand its indications beyond melanoma. These include Phase II and Phase I/II trials in combination with other therapies like pembrolizumab and MK-3475 for various solid tumors, such as breast cancer, soft tissue sarcoma, Merkel cell carcinoma, and cutaneous squamous cell cancer[1].

Competitive Landscape

The OVT market is becoming increasingly competitive with the emergence of new therapies. IMLYGIC, being the first FDA-approved oncolytic virus, faces competition from late-stage emerging therapies. Companies are developing novel approaches to treat cancer, which could impact IMLYGIC's market dominance[1].

Financial Performance

Revenue and Sales

IMLYGIC's sales are part of Amgen's overall product portfolio. While specific revenue figures for IMLYGIC are not separately disclosed, Amgen's total revenues have shown significant growth. For instance, in 2022, Amgen's total revenues increased by 1% to $26.3 billion, driven by a 2% increase in product sales[5].

Impact on Amgen's Financials

Amgen's financial performance is influenced by its diverse portfolio, including IMLYGIC. The company has seen healthy volume growth across many of its products, including oncology and hematology therapies. However, the financial impact of IMLYGIC specifically is integrated into the broader performance of Amgen's oncology segment[3][5].

Regulatory Milestones and Development Activities

IMLYGIC has achieved several regulatory milestones, including its FDA approval in 2015. Ongoing clinical trials and developmental activities are crucial for its continued market presence. These activities include collaborations, mergers, and acquisitions that support the expansion of IMLYGIC's therapeutic indications[1].

Market Forecast

The market forecast for IMLYGIC is positive, with expected growth driven by increasing healthcare spending and the adoption of innovative cancer treatments. DelveInsight's report predicts that the market scenario for OVTs will change significantly due to extensive research and incremental healthcare spending, expanding the market size for IMLYGIC and other OVTs[1].

Challenges and Opportunities

Challenges

• Competition from Emerging Therapies: The launch of late-stage emerging therapies in the OVT market poses a significant challenge to IMLYGIC's market share.
• Regulatory Hurdles: Navigating regulatory requirements for new indications and combination therapies can be complex and time-consuming.
• Cost and Reimbursement: High costs associated with biologic therapies and varying reimbursement policies across different regions can affect market penetration.

Opportunities

• Expanding Indications: Ongoing clinical trials offer opportunities to expand IMLYGIC's use beyond melanoma to other solid tumors.
• Combination Therapies: Collaborations with other immunotherapies like pembrolizumab and MK-3475 can enhance treatment outcomes and market appeal.
• Favorable Reimbursement: Positive reimbursement policies in key markets can increase accessibility and adoption of IMLYGIC[1][4].

Key Takeaways

• IMLYGIC is a pioneering oncolytic virus immunotherapy with a growing market presence.
• The OVT market is expected to grow at a CAGR of approximately 12% from 2019 to 2029.
• IMLYGIC faces competition from emerging therapies but has opportunities for expansion through new indications and combination therapies.
• Regulatory milestones and favorable reimbursement policies are crucial for its continued success.
• Amgen's financial performance is influenced by its diverse portfolio, with IMLYGIC contributing to the company's oncology segment growth.

FAQs

What is IMLYGIC and how does it work?

IMLYGIC is a genetically modified HSV-1 virus designed to replicate within tumors, producing GM-CSF and promoting an antitumor immune response.

Which company developed IMLYGIC?

IMLYGIC was developed by Amgen.

What are the primary markets for IMLYGIC?

The primary markets include the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom.

What is the expected growth rate of the oncolytic virus immunotherapy market?

The market is expected to grow at a CAGR of approximately 12% from 2019 to 2029.

What are the key challenges facing IMLYGIC in the market?

Key challenges include competition from emerging therapies, regulatory hurdles, and cost and reimbursement issues.

What opportunities does IMLYGIC have for future growth?

Opportunities include expanding indications, combination therapies, and favorable reimbursement policies.

Sources

1. DelveInsight: "IMLYGIC Drug Insight and Market Forecast – 2032"
2. PR Newswire: "AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS"
3. Amgen: "2022 Letter to Shareholders"
4. Persistence Market Research: "Sales Revenue in the Oncolytic Virus Immunotherapy Market to Witness Growth at Robust CAGR 12 Percent During 2019 to 2029"
5. Amgen: "AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS"

Last updated: 2024-12-17