VECTIBIX Drug Profile

Summary for Tradename: VECTIBIX

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for VECTIBIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VECTIBIX

Recent Clinical Trials for VECTIBIX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
ECOG-ACRIN Cancer Research Group	Phase 3
Academic and Community Cancer Research United	Phase 2
University of Campania "Luigi Vanvitelli"	Phase 2

See all VECTIBIX clinical trials

Recent Litigation for VECTIBIX

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Taiho Pharmaceutical Co., Ltd. v. Eugia Pharma Specialities Ltd.	2023-10-20
Sorrento Therapeutics, Inc. and Official Committee of Unsecured Creditors	2023-02-13
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all VECTIBIX litigation

PTAB Litigation

Petitioner	Date
GEMoaB Monoclonals GmbH et al.	2019-12-20
	2018-03-20
Forty Seven, Inc.	2018-01-08

See all VECTIBIX litigation

Pharmacology for VECTIBIX

Mechanism of Action	HER1 Antagonists
Established Pharmacologic Class	Epidermal Growth Factor Receptor Antagonist
Chemical Structure	Antibodies, Monoclonal

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 VECTIBIX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	VECTIBIX	panitumumab	Injection	125147		2039-02-26	Company disclosures
Amgen Inc.	VECTIBIX	panitumumab	Injection	125147		2017-05-05	Company disclosures

3) Low Certainty: US Patents for VECTIBIX 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.	VECTIBIX	panitumumab	Injection	125147		2033-03-11	Patent claims search
Amgen Inc.	VECTIBIX	panitumumab	Injection	125147		2030-04-21	Patent claims search
Amgen Inc.	VECTIBIX	panitumumab	Injection	125147		2039-02-26	Patent claims search
Amgen Inc.	VECTIBIX	panitumumab	Injection	125147		2031-01-11	Patent claims search
Amgen Inc.	VECTIBIX	panitumumab	Injection	125147		2027-03-13	Patent claims search
Amgen Inc.	VECTIBIX	panitumumab	Injection	125147		2031-11-23	Patent claims search

International Patents for VECTIBIX

Country	Patent Number	Estimated Expiration
Canada	2288962
France	08C0006
South Korea	20010012243
Germany	69838062
Japan	3757986
Japan	2008273986

Supplementary Protection Certificates for VECTIBIX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
08C0006	France		PRODUCT NAME: PANITUMUMAB; REGISTRATION NO/DATE: EU/1/07/423/001 20071203
122008000027	Germany		PRODUCT NAME: PANITUMUMAB; REGISTRATION NO/DATE: EU/1/07/423/001-003 20071203
C 2008 003	Romania		PRODUCT NAME: PANITUMUMAB; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/423/001, RO EU/1/07/423/002, RO EU/1/07/423/003; DATE OF NATIONAL AUTHORISATION: 20071203; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/423/001, EU/1/07/423/002, EU/1/07/423/003; DATE OF FIRST AUTHORISATION IN EEA: 20071203
91411	Luxembourg		91411, EXPIRES: 20221203
C00979246/01	Switzerland		PRODUCT NAME: PANITUMUMABUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57872 14.10.2008
SPC/GB08/009	United Kingdom		PRODUCT NAME: PANITUMUMAB; REGISTERED: UK EU/1/07/423/001 20071205; UK EU/1/07/423/002 20071205; UK EU/1/07/423/003 20071205

VECTIBIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: VECTIBIX

Introduction

Vectibix (panitumumab) is a fully human monoclonal antibody used in the treatment of metastatic colorectal cancer, particularly in patients with wild-type RAS. Developed by Amgen, Vectibix has been a significant player in the oncology market. Here, we will delve into the market dynamics and financial trajectory of Vectibix.

Market Size and Growth

The market for panitumumab, the active ingredient in Vectibix, is projected to grow substantially. As of 2023, the panitumumab market was valued at USD 1.1 billion and is expected to reach USD 1.8 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.1% from 2024 to 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the Vectibix market:

Increasing Prevalence of Colorectal Cancer

The rising incidence of colorectal cancer globally, driven by factors such as aging populations and lifestyle changes, significantly boosts the demand for Vectibix[4].

Advancements in Oncology Therapies

Ongoing research and development in cancer treatments, especially targeted therapies like Vectibix, are expanding its use and driving market growth. New clinical trials and combination therapies also contribute to the increasing demand[4].

Growing Adoption of Targeted Therapies

As personalized medicine becomes more mainstream, targeted therapies like Vectibix, which specifically target the epidermal growth factor receptor (EGFR), are gaining traction over traditional chemotherapy, fueling the market[4].

Increasing Healthcare Expenditure

Higher investments in healthcare infrastructure, particularly in developing countries, are facilitating better diagnosis and treatment access, which in turn supports the demand for advanced biologic treatments like Vectibix[4].

Geographic Market Dynamics

The demand for Vectibix varies across different regions:

North America

This region is a significant market for Vectibix due to high healthcare expenditure and advanced healthcare infrastructure.

Europe

Europe follows closely, with extensive regulatory frameworks and healthcare systems that support oncology treatments. Countries like Germany, France, and the United Kingdom are key markets[4].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth fueled by the rising incidence of colorectal cancer, improving healthcare access, and increasing investments in healthcare infrastructure. Countries like China and India exhibit high demand due to an expanding middle class and a growing focus on cancer treatment options[4].

Latin America and Middle East & Africa

These regions are witnessing gradual growth driven by improving healthcare services, rising cancer awareness, and the establishment of better regulatory environments. However, challenges such as limited healthcare access and lower awareness of targeted therapies remain[4].

Financial Performance of Vectibix

Quarterly Sales

In the third quarter of 2024, Vectibix sales increased 12% year-over-year to $282 million, primarily driven by volume growth. Similarly, in the second quarter of 2024, sales increased 9% year-over-year to $270 million, driven by higher net selling price and volume growth[2][5].

Annual Sales

For the full year 2022, Vectibix sales decreased 2% year-over-year due to unfavorable foreign exchange impacts, despite a 10% increase in unit volumes. However, the overall trend has been positive, with sales growth driven by volume increases in subsequent quarters[1].

Clinical and Regulatory Updates

Vectibix has demonstrated superior overall survival compared to bevacizumab in combination with chemotherapy in patients with wild-type RAS colorectal cancer. The PARADIGM study showed that the mFOLFOX6 + Vectibix combination provides a statistically significant improvement in overall survival[3].

Competitive Landscape

Vectibix faces competition from other oncology treatments, including biosimilars. However, its targeted therapy mechanism and positive clinical outcomes have helped it maintain a strong market position.

Financial Guidance and Outlook

Amgen's financial guidance for 2024 includes total revenues in the range of $33.0 billion to $33.8 billion. The company expects GAAP EPS in the range of $8.71 to $9.56 and non-GAAP EPS in the range of $19.20 to $20.00. Capital expenditures are expected to be approximately $1.3 billion, and share repurchases are not to exceed $500 million[2].

Impact of External Factors

Sales of Vectibix are affected by various external factors, including pricing pressure, political and public scrutiny, and reimbursement policies imposed by third-party payers. Global economic conditions and regulatory developments also play a significant role in shaping the market dynamics of Vectibix[3].

Key Takeaways

• Market Growth: The panitumumab market is projected to grow at a CAGR of 7.1% from 2024 to 2031.
• Drivers: Increasing prevalence of colorectal cancer, advancements in oncology therapies, growing adoption of targeted therapies, and increasing healthcare expenditure.
• Geographic Dynamics: Strong demand in North America, Europe, and the Asia-Pacific region, with growing markets in Latin America and the Middle East & Africa.
• Financial Performance: Positive sales growth in recent quarters driven by volume and price increases.
• Clinical and Regulatory: Demonstrated superiority in overall survival compared to bevacizumab in clinical trials.
• Competitive Landscape: Faces competition from biosimilars but maintains a strong market position due to its targeted therapy mechanism.

FAQs

What is Vectibix used for?

Vectibix (panitumumab) is used in the treatment of metastatic colorectal cancer, particularly in patients with wild-type RAS.

How is the market for Vectibix expected to grow?

The panitumumab market is expected to grow at a CAGR of 7.1% from 2024 to 2031, reaching USD 1.8 billion by 2031.

What are the key drivers of the Vectibix market?

Key drivers include the increasing prevalence of colorectal cancer, advancements in oncology therapies, growing adoption of targeted therapies, and increasing healthcare expenditure.

How has Vectibix performed financially in recent quarters?

In the third quarter of 2024, Vectibix sales increased 12% year-over-year to $282 million, and in the second quarter of 2024, sales increased 9% year-over-year to $270 million.

What are the main geographic markets for Vectibix?

The main markets are North America, Europe, and the Asia-Pacific region, with growing demand in Latin America and the Middle East & Africa.

Sources

1. AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS - Amgen
2. AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS - Amgen
3. NEW HEAD-TO-HEAD DATA SHOW VECTIBIX® (PANITUMUMAB) DEMONSTRATED SUPERIOR OVERALL SURVIVAL COMPARED TO BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN JAPANESE PATIENTS WITH WILD-TYPE RAS COLORECTAL CANCER - PR Newswire
4. Panitumumab Market Size, Trends, & Forecast - Verified Market Research
5. AMGEN REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS - PR Newswire