NUCALA Drug Profile

Summary for Tradename: NUCALA

High Confidence Patents:	0
Applicants:	1
BLAs:	2
Recent Clinical Trials:	See clinical trials for NUCALA

Recent Clinical Trials for NUCALA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
Johns Hopkins University	Early Phase 1
Bio-Thera Solutions	Phase 1

See all NUCALA clinical trials

Pharmacology for NUCALA

Mechanism of Action	Interleukin-5 Antagonists
Established Pharmacologic Class	Interleukin-5 Antagonist

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 NUCALA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for NUCALA 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
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,028,940	2033-08-13	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,047,033	2035-05-13	Patent claims search
Glaxosmithkline Llc	NUCALA	mepolizumab	For Injection	125526	10,111,968	2032-02-15	Patent claims search

NUCALA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: NUCALA

Introduction to NUCALA

NUCALA, also known as mepolizumab, is a biologic drug developed by GlaxoSmithKline (GSK) for the treatment of severe asthma and other conditions such as hypereosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis (EGPA). It is an anti-IL-5 monoclonal antibody that targets interleukin-5, a cytokine involved in the growth and survival of eosinophils, which are often elevated in these conditions.

Market Position and Growth

NUCALA is part of the growing biologics market, which has seen significant expansion in recent years. The biologics sector has outpaced the growth of small molecules, with biologic revenues increasing by 70% over the last five years to reach $232 billion[1].

Asthma Biologics Market

The asthma biologics market, where NUCALA is a key player, was valued at $6.5 billion in 2022 and is projected to grow at a CAGR of 12.5% from 2023 to 2031, reaching over $19.2 billion by 2031[4]. This growth is driven by increasing prevalence of asthma, expanding healthcare infrastructure, and government initiatives to improve healthcare access.

Financial Performance

GSK's financial reports highlight the strong performance of NUCALA within their Specialty Medicines segment.

Sales Growth

In 2023, GSK reported strong sales growth across their Specialty Medicines, including a significant contribution from NUCALA. The company's respiratory business, which includes NUCALA, saw good progress, with NUCALA sales increasing by 18% on a constant exchange rate (CER) basis[3].

Revenue Contribution

NUCALA is one of the key products driving GSK's revenue growth in the respiratory segment. The company's overall sales from new products launched since 2017, including NUCALA, contributed more than £11 billion to their revenue in 2023[3].

Competitive Landscape

The asthma biologics market is highly consolidated, with a few leading players dominating the market. GSK, along with other major pharmaceutical companies like AstraZeneca, Novartis, and Sanofi, competes in this space. The competitive strategy often involves expanding product portfolios and engaging in mergers and acquisitions to maintain market share[4].

Regulatory and Market Dynamics

Biosimilars and Pricing Pressure

The introduction of biosimilars is a significant factor affecting the biologics market, including drugs like NUCALA. While biosimilars can increase access to biologic treatments by reducing costs, they also introduce pricing pressure that can dampen the growth of original biologic products. However, in some markets, the initial increase in volume due to wider access can offset the immediate impact of price reductions[1].

Therapeutic Expansion

NUCALA's approval for multiple indications beyond severe asthma, such as HES and EGPA, has expanded its therapeutic reach. This diversification helps in maintaining and growing its market share despite potential competition from biosimilars.

Pipeline and Future Prospects

GSK continues to invest heavily in research and development, ensuring a robust pipeline of future products. While NUCALA is a current growth driver, the company's focus on developing new vaccines and medicines, including those in the respiratory segment, will help sustain long-term growth. The company's upgraded outlook for sales growth of more than 7% from 2021 to 2026 reflects this strategic focus[3].

Key Takeaways

• Market Growth: NUCALA operates within a rapidly growing biologics market, particularly in the asthma segment.
• Financial Performance: Strong sales growth of NUCALA contributes significantly to GSK's revenue in the Specialty Medicines segment.
• Competitive Landscape: The market is highly consolidated, with GSK competing against other major pharmaceutical companies.
• Regulatory Dynamics: The introduction of biosimilars may introduce pricing pressure but can also increase access to biologic treatments.
• Future Prospects: Continued investment in R&D and expansion into new therapeutic areas will support long-term growth.

FAQs

What is NUCALA used for?

NUCALA (mepolizumab) is used for the treatment of severe asthma, hypereosinophilic syndrome (HES), and eosinophilic granulomatosis with polyangiitis (EGPA).

How has NUCALA performed financially?

NUCALA has seen strong sales growth, contributing significantly to GSK's revenue in the Specialty Medicines segment, with an 18% increase in sales on a CER basis in 2023.

What are the market dynamics affecting NUCALA?

The market is influenced by the growing demand for biologics, the introduction of biosimilars, and the competitive landscape dominated by a few major pharmaceutical companies.

How does the introduction of biosimilars impact NUCALA?

Biosimilars can increase access to biologic treatments but also introduce pricing pressure, potentially dampening the growth of original biologic products like NUCALA.

What are GSK's future prospects for NUCALA and similar products?

GSK has a robust pipeline of future products, including new vaccines and medicines in the respiratory segment, which will help sustain long-term growth beyond NUCALA.

Sources

1. IQVIA: Disruption and maturity: The next phase of biologics.
2. GSK: Full-year and fourth quarter 2022 results announcement.
3. GSK: Annual Report 2023.
4. Transparency Market Research: Asthma Biologics Market Share, Size Statistics Report 2031.