LEMTRADA Drug Profile

Summary for Tradename: LEMTRADA

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

Recent Clinical Trials for LEMTRADA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 1

See all LEMTRADA clinical trials

Pharmacology for LEMTRADA

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 LEMTRADA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for LEMTRADA 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	LEMTRADA	alemtuzumab	Injection	103948		2013-08-13	Company disclosures
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948		2013-08-13	Company disclosures
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948		2014-08-05	Company disclosures
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948		2015-12-08	Company disclosures

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

International Patents for LEMTRADA

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

Supplementary Protection Certificates for LEMTRADA

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
PA2016019,C2066352	Lithuania		PRODUCT NAME: ALEMTUZUMABAS; REGISTRATION NO/DATE: EU/1/13/869 20130912

Market Dynamics and Financial Trajectory for LEMTRADA (Alemtuzumab)

Introduction

LEMTRADA (alemtuzumab) is a biologic drug developed by Sanofi and Genzyme, primarily used for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). This article delves into the market dynamics and financial trajectory of LEMTRADA, highlighting its clinical efficacy, market performance, and the impact of various factors on its sales.

Clinical Efficacy of LEMTRADA

LEMTRADA has demonstrated significant clinical efficacy in reducing relapses and slowing disability progression in patients with RRMS. In two 2-year clinical trials against Rebif (interferon beta-1a), LEMTRADA showed a lower annual relapse rate of 0.26 compared to 0.52 for Rebif. Additionally, 13% of patients who took LEMTRADA experienced confirmed disability progression, whereas 21% of those who took Rebif did so[1].

Market Approval and Collaboration

LEMTRADA is approved under different trade names for various conditions. Initially approved as Campath for the treatment of B-cell chronic lymphocytic leukemia (CLL), it was later optimized and rebranded as LEMTRADA for MS treatment. Sanofi and Genzyme collaborated with Bayer HealthCare for its co-promotion in the MS market[4].

Sales Performance

The sales of LEMTRADA have been influenced by several factors, including market competition, regulatory approvals, and global health crises.

Impact of COVID-19

The COVID-19 pandemic significantly impacted LEMTRADA sales, with a 60.3% decrease in the fourth quarter of 2020 and a 58.7% decrease for the full year 2020. This decline was largely attributed to the pandemic's disruption of healthcare services and patient access to treatments[5].

Geographic Sales

Sales forecasts and actual sales data indicate that LEMTRADA's performance varies across different regions. The drug has been forecasted to generate significant revenue in top markets such as the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China, and India. However, the actual sales have been affected by various regional factors, including competition and healthcare policies[4].

Financial Trajectory

Revenue Trends

Despite the initial promise, LEMTRADA's revenue has faced challenges. The drug's sales have not met the expected levels, partly due to the COVID-19 pandemic and intense competition in the MS treatment market. For instance, in 2020, the fourth-quarter and full-year sales of LEMTRADA were significantly lower than anticipated[5].

Business Operating Income

Sanofi's overall business operating income (BOI) has shown resilience, but the specific impact on LEMTRADA is less favorable. In 2020, Sanofi's BOI increased by 0.3% to €2,052 million, but this growth was not reflected in LEMTRADA's sales. The ratio of BOI to net sales increased, but this was more due to the performance of other products rather than LEMTRADA[5].

Competitive Landscape

The MS treatment market is highly competitive, with several drugs vying for market share. LEMTRADA competes with other biologics and disease-modifying therapies, which has impacted its sales. The competitive landscape includes drugs like Rebif, which LEMTRADA has been compared against in clinical trials, as well as newer entrants that may offer alternative treatment options[4].

Regulatory and Development Updates

LEMTRADA's development and regulatory status have been crucial for its market dynamics. The drug has undergone extensive clinical trials, and its efficacy has been established. However, regulatory approvals and market access have been influenced by various factors, including the withdrawal of Campath from the US and EU markets to focus on MS treatment[4].

Patient Outcomes and Long-Term Studies

Long-term studies have shown that patients treated with LEMTRADA have a higher likelihood of remaining relapse-free compared to those treated with Rebif. At the end of a 6-year study, 77% of patients who took LEMTRADA had stabilized or improved disability, indicating a positive long-term outcome[1].

Market Strategies and Future Outlook

Sanofi and Genzyme have employed several strategies to optimize LEMTRADA's market performance. These include focusing on R&D to enhance the drug's profile, managing expenses, and reinvesting savings into growth drivers. Despite current challenges, the companies remain committed to investing in R&D and leveraging AI to unlock the full potential of their pipeline, including LEMTRADA[3].

Conclusion

LEMTRADA's market dynamics and financial trajectory are complex and influenced by multiple factors. While the drug has shown significant clinical efficacy, its sales have been impacted by the COVID-19 pandemic, market competition, and regulatory considerations. As the biopharma landscape continues to evolve, Sanofi and Genzyme are focusing on R&D and strategic investments to improve LEMTRADA's market position.

Key Takeaways

• Clinical Efficacy: LEMTRADA reduces relapses and slows disability progression in RRMS patients.
• Market Impact: COVID-19 significantly reduced LEMTRADA sales in 2020.
• Competitive Landscape: Intense competition in the MS treatment market affects LEMTRADA's sales.
• Regulatory and Development: Ongoing R&D and regulatory approvals are crucial for LEMTRADA's market performance.
• Long-Term Outcomes: Patients treated with LEMTRADA show better long-term disability outcomes.

FAQs

Q: What is LEMTRADA used for? A: LEMTRADA (alemtuzumab) is used for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS).

Q: How does LEMTRADA compare to Rebif in clinical trials? A: LEMTRADA showed a lower annual relapse rate and reduced disability progression compared to Rebif in clinical trials[1].

Q: What was the impact of the COVID-19 pandemic on LEMTRADA sales? A: The COVID-19 pandemic led to a significant decline in LEMTRADA sales, with a 60.3% decrease in the fourth quarter of 2020[5].

Q: Which regions are key markets for LEMTRADA? A: The key markets include the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China, and India[4].

Q: What are the future outlook and strategies for LEMTRADA? A: Sanofi and Genzyme are focusing on R&D, expense management, and strategic investments to improve LEMTRADA's market performance and unlock its full potential[3].

Sources

1. LEMTRADA® (alemtuzumab) Clinical Study Results - LEMTRADA.
2. Press Release: Strong 2021 sales and business EPS growth - Sanofi.
3. Press Release Q4 2023 English - Sanofi.
4. Research and Markets: Lemtrada (Multiple Sclerosis) - Forecast and Market Analysis to 2022 - Business Wire.
5. Sanofi delivered close to double-digit Q4 2020 business EPS - Sanofi.