Pegvisomant - Biologic Drug Details

Summary for pegvisomant

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

Recent Clinical Trials for pegvisomant

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3
Unity Health Toronto	Phase 3

See all pegvisomant clinical trials

Recent Litigation for pegvisomant

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Supernus Pharmaceuticals, Inc v. Actavis Inc.	2016-02-23

See all pegvisomant 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 pegvisomant Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	5,849,535	2015-09-21	Company disclosures

3) Low Certainty: US Patents for pegvisomant 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
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,111,968	2032-02-15	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,112,021	2026-06-08	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,182,561	2024-12-29	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,214,540	2032-07-03	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,656,152	2029-01-29	Patent claims search
Pharmacia & Upjohn Company Llc	SOMAVERT	pegvisomant	For Injection	021106	10,799,473	2040-11-06	Patent claims search

International Patents for pegvisomant

Country	Patent Number	Estimated Expiration
Canada	2001774
European Patent Office	0851925
Germany	68929151
Japan	2006104205
South Africa	967973
World Intellectual Property Organization (WIPO)	9209690

Supplementary Protection Certificates for pegvisomant

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2005C/037	Belgium		PRODUCT NAME: PEGVISOMANT; AUTHORISATION NUMBER AND DATE: EU/1/02/240/001 20021115
05C0043	France		PRODUCT NAME: PEGVISOMANT; REGISTRATION NO/DATE: EU/1/02/240/001-003 20021113
122006000003	Germany		PRODUCT NAME: WIRKSTOFFZUSAMMENSETZUNG UMFASSEND PEGVISOMANT; REGISTRATION NO/DATE: EU/1/02/240/001-003 20021113
91204	Luxembourg		91204, EXPIRES: 20171113
300210	Netherlands		PRODUCT NAME: PEGVISOMANT; NATIONAL REGISTRATION NO/DATE: EU/1/02/240/002 20021115; FIRST REGISTRATION: EU EU/1/02/240/001 20021115
SPC/GB05/047	United Kingdom		PRODUCT NAME: PEGVISOMANT, OPTIONALLY IN THE FORM OF A PEGYLATION VARIANT; REGISTERED: UK EU/1/02/240/001 20021115; UK EU/1/02/240/002 20021115; UK EU/1/02/240/003 20021115

Market Dynamics and Financial Trajectory for the Biologic Drug: Pegvisomant

Introduction

Pegvisomant, marketed under the brand name Somavert, is a biologic drug used for the treatment of acromegaly, a rare hormonal disorder caused by excessive growth hormone production. This article delves into the market dynamics and financial trajectory of pegvisomant, highlighting its current market size, growth projections, cost-effectiveness, and the challenges faced in its development and commercialization.

Market Size and Growth Projections

The global market for pegvisomant has been steadily growing. As of 2023, the market was estimated to be worth approximately $268 million and is forecast to reach $331.5 million by 2030[1]. Another report indicates that the global pegvisomant market size was $276.30 million in 2024 and is projected to reach $341.77 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 3.1%[4].

Development and Commercialization Challenges

The development of pegvisomant was marked by significant challenges. John Kopchick, the discoverer of the drug, and his business partner, John Hawkins, faced numerous hurdles, including raising capital for a rare disease market and overcoming manufacturing obstacles. The drug's development involved innovative solutions such as pegylation to extend its half-life and partnerships with companies like Genentech and Corning to secure manufacturing capabilities[5].

Cost-Effectiveness and Economic Analysis

A cost-utility analysis and budget impact analysis conducted in Poland highlighted the economic implications of using pegvisomant for treating acromegaly. The study showed that replacing somatostatin analogues (SSA) with pegvisomant results in a significant cost per Quality Adjusted Life Year (QALY) gained. The cost was estimated to be around 742,724 PLN (approximately €172,470) from the public payer's perspective and 714,800 PLN (approximately €165,986) from the patient's and public payer's combined perspective[2].

Budget Impact Analysis

The budget impact analysis revealed that the annual expenditure of the Polish National Health Fund (PNHF) would increase substantially over the first three years if pegvisomant were to be reimbursed. The estimated increases were approximately 11.95 million PLN in the first year, 26.39 million PLN in the second year, and 26.5 million PLN in the third year[2].

Market Dynamics and Competition

The market for acromegaly treatments is niche but competitive. Pegvisomant competes with other treatments such as somatostatin analogues and surgical interventions. The drug's unique mechanism as a growth hormone receptor antagonist sets it apart, but it also faces competition from newer treatments and generic versions of existing drugs.

Patient Population and Treatment Landscape

The patient population for acromegaly is relatively small, but the disease's complexity and the need for effective treatments drive demand for drugs like pegvisomant. The treatment landscape is evolving, with ongoing research into new therapies and combination treatments, which could impact the market dynamics for pegvisomant in the future.

Financial Performance and Revenue Streams

Pegvisomant has been a significant revenue generator since its approval in 2003. Annual worldwide sales of Somavert reached $277 million in 2020. The drug's financial performance is closely tied to its reimbursement status and market penetration. The royalty payments from Somavert have also been substantial, with Ohio University and its inventors receiving $105 million in royalties between the drug's approval and 2019[5].

Impact of Regulatory and Reimbursement Decisions

Regulatory and reimbursement decisions play a crucial role in the financial trajectory of pegvisomant. The cost-utility analysis and budget impact analysis highlight the importance of these decisions in determining the drug's accessibility and market size. Reimbursement policies can significantly affect the drug's adoption and revenue growth.

Future Outlook and Growth Potential

The future outlook for pegvisomant is positive, driven by the growing awareness of acromegaly and the need for effective treatments. The market is expected to continue growing, albeit at a moderate rate, as new patients are diagnosed and treated. However, the drug will need to navigate the challenges of competition from new therapies and changes in reimbursement policies.

Key Takeaways

• Market Size and Growth: The global pegvisomant market is projected to grow from $268 million in 2023 to $331.5 million by 2030.
• Cost-Effectiveness: Pegvisomant is costly but can offer significant health benefits, with a high cost per QALY gained.
• Development Challenges: The drug faced significant development and manufacturing challenges, which were overcome through innovative partnerships and technologies.
• Financial Performance: Pegvisomant has been a substantial revenue generator, with significant royalty payments.
• Regulatory Impact: Reimbursement decisions are critical for the drug's market size and financial performance.

FAQs

What is pegvisomant used for?

Pegvisomant is used for the treatment of acromegaly, a rare hormonal disorder caused by excessive growth hormone production.

How much is the global pegvisomant market worth?

As of 2023, the global pegvisomant market was estimated to be worth approximately $268 million and is forecast to reach $331.5 million by 2030[1].

What are the challenges in using pegvisomant for treating acromegaly?

The main challenges include high costs, with a significant cost per QALY gained, and the need for reimbursement approval to ensure accessibility[2].

Who developed pegvisomant?

Pegvisomant was developed by John Kopchick and his business partner, John Hawkins, through their company Sensus Drug Development Corp., which was later acquired by Pfizer[5].

What is the current market growth rate for pegvisomant?

The global pegvisomant market is projected to grow at a CAGR of 3.1% from 2024 to 2031[4].

Sources

1. Valuates Reports: Global Pegvisomant Drugs Industry Report.
2. Journal of Health, Policy and Outcomes Research: Cost-utility analysis and budget impact analysis of pegvisomant for the treatment of adult patients with acromegaly in Poland.
3. Pfizer: Q4 2023 Earnings Release.
4. Proficient Market Insights: Pegvisomant Market Report.
5. Ohio University: A Tale of Two Titans.