Lifileucel - Biologic Drug Details

Summary for lifileucel

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for lifileucel

Recent Clinical Trials for lifileucel

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Kansas Medical Center	Phase 2
National Cancer Institute (NCI)	Phase 2
Richard Wu	Phase 1/Phase 2

See all lifileucel clinical trials

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 lifileucel Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Lifileucel (Amtagvi)

Introduction

Lifileucel, marketed as Amtagvi, is a groundbreaking biologic drug developed by Iovance Biotherapeutics for the treatment of advanced melanoma. Following its FDA approval in February 2024, Amtagvi has been making significant waves in the oncology market. Here, we delve into the market dynamics and financial trajectory of this innovative therapy.

FDA Approval and Market Entry

Amtagvi was approved by the U.S. FDA on February 16, 2024, as the first treatment option for advanced melanoma after anti-PD-1 therapy. This approval marked a significant milestone in the treatment of melanoma, offering new hope for patients with limited treatment options[1][3][5].

Revenue Growth and Projections

Since its launch, Amtagvi has shown robust revenue growth. In the second quarter of 2024, Iovance reported $12.8 million in revenue from Amtagvi sales, contributing to a total product revenue of $31.1 million. By the third quarter, this figure surged to $42.1 million, with total product revenue reaching $58.6 million[2][3][5].

For the full year 2024, Iovance anticipates total product revenue to be within the range of $160 to $165 million, primarily driven by Amtagvi sales. Looking ahead to 2025, the company expects revenue to significantly increase, projecting a range of $450 to $475 million. This growth is attributed to the expanding adoption of Amtagvi and the onboarding of new authorized treatment centers (ATCs)[2][3][5].

Patient Adoption and Treatment Centers

The adoption of Amtagvi has been strong, with over 146 patients infused with the drug since its launch. This includes more than 55 patients infused since April 2024, indicating a steepening adoption curve. Iovance has also completed the onboarding process at more than 50 U.S. ATCs across 29 states, further facilitating access to the treatment[2][3].

Cost of Sales and Manufacturing

The cost of sales for Amtagvi includes inventory, overhead, and related cash and non-cash expenses. In the second quarter of 2024, the cost of sales was $31.4 million, significantly higher than the $2.1 million in the same period of 2023. This increase is due to the initiation of commercial manufacturing and related expenses tied to the U.S. launch of Amtagvi[3][5].

Gross Margins and Financial Health

Iovance expects gross margins to surpass 70% over the next several years as the launch of Amtagvi advances. The company's strong cash position, with $403.8 million as of September 30, 2024, is expected to fund operations, including manufacturing expansion, into early 2026[2][3].

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses have increased to support the growth of the business and the commercialization of Amtagvi. In the second quarter of 2024, these expenses rose to $39.6 million from $21.9 million in the same period of 2023, driven by increases in headcount, stock-based compensation, and other corporate infrastructure costs[3][5].

Clinical Pipeline and Combination Therapies

Iovance is advancing its clinical pipeline with Amtagvi in multiple indications, including frontline melanoma and non-small cell lung cancer (NSCLC). The company is also testing various combinations of Lifileucel with other immunotherapies, which is expected to expand its market reach and penetration[3][4].

Market Drivers and Competition

The TIL (Tumor Infiltrating Lymphocytes) therapy market, where Amtagvi is a key player, is driven by the increasing prevalence of cancer and the need for effective, personalized therapies. The FDA's Fast Track and Breakthrough Therapy designations for TIL therapies have expedited their regulatory process, attracting more investment and fueling market growth. While the market is relatively nascent, it is expected to see significant competition as more companies enter the space[4].

Future Outlook

The TIL therapy market is poised for significant growth, with Lifileucel at the forefront. As manufacturing processes become more scalable and combination therapies gain traction, the market opportunity for TIL therapies is expected to reach beyond $400 million by 2028. Iovance's strategic approach to expanding its network of ATCs, increasing manufacturing capacity, and advancing its clinical pipeline positions Amtagvi for continued success and market dominance[2][3][4].

Key Takeaways

• Strong Revenue Growth: Amtagvi has shown significant revenue growth since its launch, with projections indicating continued robust growth.
• Expanding Adoption: Over 146 patients have been infused with Amtagvi, with more than 50 ATCs onboarded across the U.S.
• Financial Health: Iovance has a strong cash position and expects gross margins to surpass 70% in the coming years.
• Clinical Advancements: The company is advancing its clinical pipeline in multiple indications and testing combination therapies.
• Market Potential: The TIL therapy market is expected to grow significantly, driven by the need for personalized and effective cancer treatments.

FAQs

What is Amtagvi (Lifileucel), and how is it used?

Amtagvi (Lifileucel) is a biologic drug approved for the treatment of advanced melanoma after anti-PD-1 therapy. It is a type of TIL therapy that involves using a patient's own immune cells to fight cancer.

What are the revenue projections for Amtagvi in 2024 and 2025?

For 2024, Iovance anticipates total product revenue to be within the range of $160 to $165 million. For 2025, the projected revenue range is $450 to $475 million.

How many patients have been treated with Amtagvi since its launch?

As of the third quarter of 2024, over 146 patients have been infused with Amtagvi since its launch.

What is the current cash position of Iovance Biotherapeutics?

As of September 30, 2024, Iovance had cash, cash equivalents, investments, and restricted cash of $403.8 million.

What are the expected gross margins for Amtagvi in the coming years?

Iovance expects gross margins for Amtagvi to surpass 70% over the next several years.

Sources

1. Iovance Biotherapeutics Reports First Quarter 2024 Financial Results and Corporate Updates. Iovance Biotherapeutics.
2. Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Third Quarter and First Nine Months 2024. Stock Titan.
3. Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2024. Stock Titan.
4. Global Tumor Infiltrating Lymphocytes Therapy Market Report 2023. PR Newswire.
5. Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2024. GlobeNewswire.

Last updated: 2024-12-22