CAMPATH Drug Profile

Summary for Tradename: CAMPATH

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for CAMPATH
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CAMPATH

Recent Clinical Trials for CAMPATH

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Children's Hospital Medical Center, Cincinnati	Phase 2
City of Hope Medical Center	Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2

See all CAMPATH clinical trials

Recent Litigation for CAMPATH

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all CAMPATH litigation

PTAB Litigation

Petitioner	Date
Miltenyi Biomedicine GmbH et al.	2022-04-12
GEMoaB Monoclonals GmbH et al.	2019-12-20
Forty Seven, Inc.	2018-01-08

See all CAMPATH litigation

Pharmacology for CAMPATH

Mechanism of Action	CD52-directed Antibody Interactions
Established Pharmacologic Class	CD52-directed Cytolytic Antibody

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 CAMPATH Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2013-08-13	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2013-08-13	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2014-08-05	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2015-12-08	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2013-12-28	Company disclosures

3) Low Certainty: US Patents for CAMPATH 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
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2033-03-11	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2028-04-10	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2039-02-26	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2033-02-08	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948		2034-11-21	Patent claims search

International Patents for CAMPATH

Country	Patent Number	Estimated Expiration
Austria	E95068
European Patent Office	1477183
European Patent Office	0770395
European Patent Office	1502600
Germany	10199051

Supplementary Protection Certificates for CAMPATH

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2016 00026	Denmark		PRODUCT NAME: ALEMTUZUMAB; REG. NO/DATE: EU/1/13/869 20130916
16C0023	France		PRODUCT NAME: ALEMTUZUMAB; REGISTRATION NO/DATE: EU/1/13/869 20130916
122008000043	Germany		PRODUCT NAME: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYP A (150KD), FREI VON KOMPLEXPROTEINEN; REGISTRATION NO/DATE: 57093.00.00 20050531
122008000042	Germany		PRODUCT NAME: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYP A (150KD), FREI VON KOMPLEXPROTEINEN; REGISTRATION NO/DATE: 57093.00.00 20050531
PA2016019,C2066352	Lithuania		PRODUCT NAME: ALEMTUZUMABAS; REGISTRATION NO/DATE: EU/1/13/869 20130912

Market Dynamics and Financial Trajectory for the Biologic Drug: Campath (Alemtuzumab)

Introduction

Campath, also known as alemtuzumab, is a biologic drug that has undergone a complex and evolving journey in the pharmaceutical market. This article delves into the market dynamics and financial trajectory of Campath, highlighting its development, commercial history, and future prospects.

Development and Licensing History

Campath was first developed in the early 1980s by researchers at the University of Cambridge. The rights for the Campath-1 cell lines were assigned to BTG, which later licensed Campath-1M to Wellcome Biotech in 1985. As research progressed, the focus shifted to Campath-1H, which showed more promising clinical potential. Despite initial skepticism, Wellcome Biotech invested in clinical trials for Campath-1H, targeting diseases such as rheumatoid arthritis, leukemia, and lymphoma[4].

Commercial History and Challenges

The commercial history of Campath has been marked by several challenges and changes in ownership. In 1995, Wellcome (which had merged with Glaxo to form Glaxo-Wellcome) decided to abandon the development of Campath-1H due to concerns over its market potential and side effects. However, the academic researchers continued to believe in its potential and sought new partners. In 1997, LeukoSite Inc. took over the license, and after merging with Millennium Pharmaceuticals in 1999, they partnered with ILEX Oncology to complete the development. Campath-1H was finally approved by the FDA in 2001 for the treatment of B-cell chronic lymphocytic leukemia (CLL)[4].

Acquisition and Relaunch

In 2004, Genzyme Corporation acquired ILEX Oncology and the production rights to Campath-1H. Genzyme was later acquired by Sanofi in 2011. In 2012, Campath was withdrawn from the US and EU markets to prevent off-label use for multiple sclerosis (MS) and to prepare for a relaunch under the brand name Lemtrada, specifically for MS treatment. This strategic move was aimed at capturing a higher-priced market segment[1].

Financial Performance

The revenue from Campath for CLL treatment was significant, with around $100 million in revenue in the year preceding its withdrawal. However, the potential revenue from its use in treating early relapsing-remitting MS was expected to be much higher. The relaunch as Lemtrada for MS treatment marked a new financial trajectory for the drug, with higher pricing and a targeted market approach[4].

Market Dynamics

Market Size and Growth

The biologics market, which includes drugs like Campath, is experiencing rapid growth. The global biologics market is projected to grow from $452.9 billion in 2023 to $823.4 billion by 2028, with a compound annual growth rate (CAGR) of 12.7% during the forecast period[3].

Competitive Landscape

The biologics market is highly competitive, with several key players. The emergence of biosimilars, which offer cost-effective alternatives to original biologic pharmaceuticals, is a significant factor in this market. Companies like Genzyme (now part of Sanofi) and other major biopharmaceutical firms are key players in this landscape[5].

Regulatory and Technological Factors

The development and approval of biologic drugs like Campath are heavily regulated and involve complex biotechnological processes. Advances in drug delivery technologies and the integration of cell and gene therapy are driving the market forward. However, high production costs and extensive research and development requirements remain significant challenges[5].

Geographical Distribution

North America dominates the biologics market, driven by a high prevalence of chronic diseases, favorable reimbursement policies, and substantial R&D investments. The region is expected to continue growing at a rapid CAGR during the forecast period[5].

Future Prospects

Expanding Therapeutic Indications

Campath, now marketed as Lemtrada for MS, has the potential to expand its therapeutic indications further. The drug's ability to treat early relapsing-remitting MS and its potential in other autoimmune diseases make it a valuable asset in the biologics market[4].

Innovation in Drug Delivery

Innovations in drug delivery technologies are expected to enhance the efficacy and safety of Campath. These advancements could lead to better patient outcomes and increased market penetration[5].

Collaboration and Partnerships

The biologics market thrives on collaborations and partnerships between academic researchers, pharmaceutical companies, and regulatory bodies. Continued collaboration will be crucial for the further development and commercial success of Campath and similar biologic drugs[5].

Key Takeaways

• Complex Development History: Campath's development involved multiple licensing agreements and changes in ownership.
• Strategic Relaunch: The drug was withdrawn and relaunched as Lemtrada for MS treatment to capture a higher-priced market segment.
• Market Growth: The biologics market is growing rapidly, driven by technological advancements and expanding therapeutic indications.
• Regulatory and Technological Challenges: High production costs and regulatory hurdles are significant challenges in the biologics market.
• Geographical Dominance: North America leads the biologics market due to favorable reimbursement policies and high R&D investments.

FAQs

What is Campath (alemtuzumab), and how was it developed?

Campath, or alemtuzumab, is a biologic drug developed by researchers at the University of Cambridge in the early 1980s. It was initially licensed to Wellcome Biotech and later underwent several changes in ownership before being approved for B-cell chronic lymphocytic leukemia (CLL) in 2001.

Why was Campath withdrawn from the market in 2012?

Campath was withdrawn from the US and EU markets in 2012 to prevent off-label use for multiple sclerosis (MS) and to prepare for a relaunch under the brand name Lemtrada, specifically for MS treatment.

What are the future prospects for Campath (Lemtrada)?

Campath, now marketed as Lemtrada, has potential in treating early relapsing-remitting MS and possibly other autoimmune diseases. Innovations in drug delivery technologies and continued collaboration between researchers and pharmaceutical companies will be crucial for its further development.

How does the biologics market impact the financial trajectory of Campath?

The biologics market is growing rapidly, driven by technological advancements and expanding therapeutic indications. This growth, along with the strategic relaunch of Campath as Lemtrada, positions the drug for significant financial gains in the future.

What are the main challenges in the development and commercialization of biologic drugs like Campath?

High production costs, extensive research and development requirements, and regulatory hurdles are significant challenges in the development and commercialization of biologic drugs like Campath.

Which region dominates the biologics market, and why?

North America dominates the biologics market due to a high prevalence of chronic diseases, favorable reimbursement policies, and substantial R&D investments.

Sources

1. Wikipedia: Alemtuzumab
2. Northwestern University: Reports Required by Government Auditing Standards and OMB 2
3. BCC Research: Big Growth Ahead Biologic Drugs Market to Hit 823.4 Billion by 2028
4. University of Cambridge: Campath: from innovation to impact
5. Biospace: Biologics Market Worth USD 717.0 Billion From 2024 to 2031