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Last Updated: January 4, 2025

ARZERRA Drug Profile


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Recent Clinical Trials for ARZERRA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Henan Provincial People's HospitalPhase 1/Phase 2
Tang-Du HospitalPhase 1/Phase 2
TerSera TherapeuticsPhase 2

See all ARZERRA clinical trials

Recent Litigation for ARZERRA

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Acerta Pharma B.V. v. Cipla Limited2024-05-16
Acerta Pharma B.V. v. Sandoz Inc.2022-02-04
Acerta Pharma B.V. v. MSN Pharmaceuticals Inc.2022-02-03

See all ARZERRA litigation

PTAB Litigation
PetitionerDate
Sandoz Inc.2023-02-03

See all ARZERRA litigation

Pharmacology for ARZERRA
Mechanism of ActionCD20-directed Antibody Interactions
Established Pharmacologic ClassCD20-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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 ARZERRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for ARZERRA Derived from Patent Text Search

These patents were obtained by searching patent claims
Showing 1 to 6 of 6 entries

ARZERRA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Biologic Drug: ARZERRA

Introduction

ARZERRA, also known as ofatumumab, is a biologic drug developed by Genmab and initially marketed by GlaxoSmithKline (GSK) for the treatment of chronic lymphocytic leukemia (CLL). Here, we delve into the market dynamics and financial trajectory of ARZERRA, highlighting its rise, challenges, and eventual shift in market strategy.

Approval and Initial Market Performance

ARZERRA was approved by the US FDA in 2009 for the treatment of CLL in patients who were refractory to fludarabine and alemtuzumab. Initially, it showed promise, particularly after receiving Breakthrough Therapy designation in 2013 for its use in combination with chlorambucil for previously untreated CLL patients[2].

Peak Sales and Market Position

At its peak in 2013, ARZERRA generated approximately £75 million in sales for GSK, which, although not a top-seller, indicated a viable market presence. However, this figure was modest compared to the broader oncology portfolio of GSK, which totaled $1.85 billion in 2014[1][4].

Impact of New Competitors

The CLL market landscape significantly changed with the approval of AbbVie's Imbruvica (ibrutinib) in 2013. Clinical studies showed that Imbruvica offered superior progression-free survival and overall survival rates compared to ARZERRA. This led to a rapid shift in treatment preferences, with Imbruvica becoming a dominant player in the CLL market. By 2017, Imbruvica's global sales had reached nearly $1.9 billion, far surpassing ARZERRA's sales[1].

Novartis Acquisition and Market Strategy

In 2015, Novartis acquired the oncology assets of GSK, including ARZERRA, as part of a multibillion-dollar asset swap. Novartis invested heavily, up to $1 billion, to explore ARZERRA's potential in multiple sclerosis, hoping to diversify its revenue streams. However, this strategy did not yield the expected results, and ARZERRA's sales continued to decline[4].

Decline in Sales and Market Withdrawal

By 2018, ARZERRA's sales had fallen to marginal levels outside the US market. Novartis decided to transition ARZERRA to compassionate use programs in non-US markets, reflecting the drug's diminished market viability. This decision was accompanied by a $50 million payment to Genmab to compensate for lost milestones and royalties[1].

Financial Impact on Genmab

Genmab, the developer of ARZERRA, saw a significant reduction in royalty revenues from Novartis. In the first three quarters of 2018, Genmab recognized only about $6 million in royalty revenue from ARZERRA sales, a substantial drop from previous years[1].

Market Competition and Evolution

The CLL market has evolved rapidly with the introduction of newer, more effective treatments. Drugs like Imbruvica and Venclexta (venetoclax) have become preferred options due to their superior clinical outcomes. This competition has made it challenging for older drugs like ARZERRA to maintain market share[1].

Strategic Shifts and Future Outlook

Novartis's decision to focus on compassionate use programs for ARZERRA outside the US indicates a strategic shift towards more promising therapeutic areas. The company is now investing in other innovative therapies and expanding its portfolio in areas like multiple sclerosis and other hematological conditions[4].

Key Takeaways

  • Market Competition: The introduction of newer, more effective treatments like Imbruvica and Venclexta significantly impacted ARZERRA's market position.
  • Sales Decline: ARZERRA's sales declined substantially, leading to its withdrawal from commercial marketing in non-US markets.
  • Strategic Shift: Novartis shifted focus towards other therapeutic areas and innovative therapies.
  • Financial Impact: The decline in sales affected both Novartis and Genmab, with reduced royalty revenues for Genmab.

FAQs

What is ARZERRA used for?

ARZERRA (ofatumumab) is used for the treatment of chronic lymphocytic leukemia (CLL), particularly in patients who are refractory to fludarabine and alemtuzumab.

Why did Novartis stop commercial marketing of ARZERRA outside the US?

Novartis stopped commercial marketing of ARZERRA outside the US due to the rise of more effective treatments like Imbruvica, which led to a significant decline in ARZERRA's sales.

How much did Novartis pay Genmab for the transition of ARZERRA to compassionate use programs?

Novartis paid Genmab $50 million to compensate for lost milestones and royalties.

What other therapeutic areas is Novartis exploring for ARZERRA?

Novartis had explored the potential of ARZERRA in multiple sclerosis, although this strategy did not yield the expected results.

What is the current market status of ARZERRA in the US?

In the US, ARZERRA remains available, including an approval for previously untreated CLL patients in combination with chlorambucil, but its sales have been significantly impacted by newer treatments.

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