Rilonacept - Biologic Drug Details

Summary for rilonacept

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for rilonacept
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rilonacept

Recent Clinical Trials for rilonacept

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Kiniksa Pharmaceuticals (UK), Ltd.	Phase 3
Kiniksa Pharmaceuticals, Ltd.	Phase 3
Kiniksa Pharmaceuticals (UK), Ltd.	Phase 2

See all rilonacept clinical trials

Recent Litigation for rilonacept

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all rilonacept 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 rilonacept Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2013-10-20	Company disclosures
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2018-09-25	Company disclosures
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2018-09-25	Company disclosures

3) Low Certainty: US Patents for rilonacept 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
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2034-04-21	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2031-03-09	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2034-12-04	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2037-01-12	Patent claims search

International Patents for rilonacept

Country	Patent Number	Estimated Expiration
Hong Kong	1008346
Japan	2002525119
Norway	329976
South Africa	948242

Supplementary Protection Certificates for rilonacept

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15/2010	Austria		PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023
CA 2010 00016	Denmark		PRODUCT NAME: RILONACEPT
C20100004 00030	Estonia		PRODUCT NAME: ARCALYST-RILONACEPT; REG NO/DATE: C(2009)8377 23.10.2009
122010000023	Germany		PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023

Market Dynamics and Financial Trajectory for the Biologic Drug: Rilonacept

Introduction

Rilonacept, a biologic drug, is primarily used to treat certain inflammatory conditions by acting as an interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) cytokine trap. Here, we will delve into the market dynamics and financial trajectory of rilonacept, highlighting key aspects such as market size, growth projections, and financial performance.

Market Size and Growth Projections

The global market for rilonacept drugs has been growing steadily. As of 2023, the market was estimated to be worth US$ 13 million. It is forecasted to reach a readjusted size of US$ 17 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.1% during the forecast period of 2024-2030[1][4].

Segmentation of the Market

The rilonacept drugs market is segmented based on several criteria:

By Application

The market is divided into hospital and retail pharmacy segments. These segments are crucial as they indicate the primary channels through which rilonacept is distributed and consumed[4].

By Product

Rilonacept is available in two forms: lyophilized and liquid. Each form has its own market share and growth prospects, influenced by factors such as patient preference, ease of administration, and storage requirements[1][4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own set of market dynamics, regulatory environments, and patient populations that influence the demand for rilonacept[4].

Key Players and Market Share

Kiniksa Pharmaceuticals is one of the main players in the rilonacept market, particularly with its product ARCALYST (rilonacept). Kiniksa has reported significant financial success with ARCALYST, which is a key driver of the company's revenue.

Financial Performance of Kiniksa Pharmaceuticals

In the second quarter of 2024, Kiniksa reported strong financial results, with ARCALYST net product revenue growing 90% year-over-year to $103.4 million. The company increased its 2024 ARCALYST revenue guidance to $405-$415 million. This growth is attributed to the increasing adoption of ARCALYST among the target population, with approximately 11% of the 14,000 multiple-recurrence target population actively on ARCALYST treatment[2][3].

Market Drivers and Opportunities

Several factors are driving the growth of the rilonacept market:

Increasing Prevalence of Inflammatory Conditions

The rising prevalence of inflammatory conditions such as periodic fever syndromes and other autoimmune diseases is driving the demand for effective treatments like rilonacept.

Advancements in Biologic Therapies

Continuous advancements in biologic therapies and the approval of new indications for rilonacept are expanding its market potential.

Strong Commercial Performance

Kiniksa's robust commercial operation and strategic investments have enabled the company to reach a greater number of prescribers and increase the frequency of interactions, thereby boosting sales[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

Regulatory Hurdles

Stringent regulatory requirements and the need for ongoing clinical trials to validate new indications can slow market growth.

Competition from Other Therapies

The presence of other biologic and non-biologic therapies in the market can pose competition to rilonacept, affecting its market share.

Economic and Social Factors

Economic constraints, such as high drug prices and reimbursement issues, can limit access to rilonacept, especially in regions with limited healthcare resources[4].

Financial Trajectory

Kiniksa Pharmaceuticals' financial trajectory is closely tied to the performance of ARCALYST. Here are some key financial highlights:

Revenue Growth

For the full-year 2023, ARCALYST generated $233.2 million in net product revenue. The company has guided to a 2024 net product revenue range of $405-$415 million, representing a 63% year-on-year growth at the midpoint[3].

Cash Position

As of June 30, 2024, Kiniksa had a strong cash position of $218.8 million with no debt, indicating financial stability and the ability to fund ongoing clinical developments and commercial activities[2].

Net Loss and Operating Expenses

Despite the revenue growth, Kiniksa reported a net loss of $3.9 million in Q2 2024, primarily due to increased operating expenses, including collaboration expenses and total operating costs[2].

Clinical Development and Future Prospects

Kiniksa is actively involved in the clinical development of its portfolio assets, including abiprubart and mavrilimumab, in addition to ARCALYST.

Abiprubart

Abiprubart, a humanized anti-CD40 monoclonal antibody, is being developed for multiple autoimmune indications, including Sjögren's Disease. The initiation of the Phase 2b trial in the second half of 2024 is a significant milestone[3].

Mavrilimumab

Mavrilimumab, a monoclonal antibody inhibitor targeting GM-CSFRα, has shown therapeutic potential in multiple mid-stage studies. Kiniksa is evaluating potential partnership opportunities for this asset[3].

Key Takeaways

• The global rilonacept market is expected to grow to US$ 17 million by 2030 with a CAGR of 4.1%.
• Kiniksa Pharmaceuticals' ARCALYST is a major driver of this growth, with significant revenue increases and a strong cash position.
• The market is segmented by application, product form, and geography.
• Despite growth, the market faces challenges such as regulatory hurdles, competition, and economic constraints.
• Ongoing clinical developments and strategic investments are crucial for future market expansion.

FAQs

What is the forecasted market size of rilonacept drugs by 2030?

The global market for rilonacept drugs is forecasted to reach US$ 17 million by 2030[1].

Who is the main player in the rilonacept market?

Kiniksa Pharmaceuticals is the main player in the rilonacept market, particularly with its product ARCALYST (rilonacept)[2][3].

What is the CAGR of the rilonacept market from 2024 to 2030?

The CAGR of the rilonacept market from 2024 to 2030 is 4.1%[1].

What are the key applications of rilonacept?

Rilonacept is primarily used in hospitals and retail pharmacies[4].

What is the current revenue guidance for ARCALYST in 2024?

Kiniksa has increased its 2024 ARCALYST revenue guidance to $405-$415 million[2][3].

Sources

1. Valuates Reports: Global and United States Rilonacept Drugs Market Report[1].
2. Stock Titan: Kiniksa Pharmaceuticals Reports Second Quarter 2024 Financial Results and Recent Portfolio Execution[2].
3. Kiniksa Pharmaceuticals: 2023 Annual Report[3].
4. Market Research Intellect: Rilonacept Drugs Market Size And Forecast[4].