ZINBRYTA Drug Profile

Summary for Tradename: ZINBRYTA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ZINBRYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZINBRYTA

Recent Clinical Trials for ZINBRYTA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
AbbVie	Phase 3
Biogen	Phase 3
Hammersmith Hospitals NHS Trust	Phase 4

See all ZINBRYTA clinical trials

Recent Litigation for ZINBRYTA

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 ZINBRYTA litigation

PTAB Litigation

Petitioner	Date
	2017-12-20
	2012-09-25

See all ZINBRYTA 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 ZINBRYTA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for ZINBRYTA 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
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2033-03-11	Patent claims search
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2036-03-11	Patent claims search
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2033-01-08	Patent claims search
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029		2028-05-08	Patent claims search

ZINBRYTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of ZINBRYTA: A Comprehensive Analysis

Introduction

ZINBRYTA (daclizumab high-yield process) was a promising biologic drug developed jointly by Biogen and AbbVie for the treatment of relapsing forms of multiple sclerosis (MS). Despite its initial approval and promising clinical trial results, the drug's market journey was cut short due to significant safety concerns. Here, we delve into the market dynamics and financial trajectory of ZINBRYTA.

Approval and Initial Market Reception

ZINBRYTA received FDA approval in May 2016, marking a significant milestone in the treatment of MS. The drug was hailed as the first once-monthly, self-administered treatment for MS, demonstrating superior efficacy over widely used interferons like AVONEX in clinical trials such as DECIDE and SELECT[5].

Clinical Efficacy

The clinical trials showed that ZINBRYTA significantly reduced the annualized relapse rate (ARR) by 45% compared to AVONEX and by 54% compared to placebo. It also reduced the mean number of new or newly enlarging T2-hyperintense lesions by 54% compared to AVONEX[5].

Market Potential

Analysts had high hopes for ZINBRYTA, predicting maximum annual sales of up to $500 million. However, the actual sales figures were significantly lower, with the drug generating $107 million in the year prior to its withdrawal[1][2].

Safety Concerns and Regulatory Actions

The European Medicines Agency (EMA) launched an urgent review of ZINBRYTA following reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis. Seven cases were reported in Germany and one in Spain, prompting Biogen and AbbVie to voluntarily withdraw the drug from all global markets in March 2018[1][2].

Impact on Patient Safety

The decision to withdraw ZINBRYTA was driven by the companies' commitment to patient safety. Dr. Alfred Sandrock, Biogen’s Executive Vice President and Chief Medical Officer, emphasized that the voluntary withdrawal was in the best interest of patients, given the complexity and evolving benefit/risk profile of the drug[1][2].

Financial Implications

The withdrawal of ZINBRYTA had different financial implications for Biogen and AbbVie. For AbbVie, the impact was minimal, as the company had a robust pipeline and was pursuing several other potential blockbusters, particularly around Humira[2].

For Biogen, however, the withdrawal was more significant. Biogen had a thin pipeline dominated by a high-risk Alzheimer’s therapy, and the loss of ZINBRYTA revenue added to the company’s challenges. The drug had generated $53 million in the previous year, which, although not substantial, was still a contributing factor to Biogen’s revenue[2].

Market Reaction

The market reaction to the withdrawal was mixed. While it did not significantly impact AbbVie’s long-term outlook, Biogen faced fresh jitters over its future pipeline. The decision to add patients to their pivotal trial for the Alzheimer’s drug to account for data variability further heightened market concerns[2].

Competitive Landscape

The withdrawal of ZINBRYTA did not significantly impact the overall treatment strategies for MS, as multiple other disease-modifying treatments with favorable risk/benefit profiles remained available. Clinical providers noted that while losing access to a unique drug like ZINBRYTA was unfortunate, patient safety was the critical priority[1].

Regulatory Cooperation

Biogen and AbbVie worked closely with regulatory bodies and healthcare providers to ensure an effective withdrawal and support for patients transitioning from ZINBRYTA. This cooperation was crucial in managing the transition and minimizing disruption to patient care[1].

Lessons Learned

The ZINBRYTA case highlights the importance of continuous monitoring of drug safety post-approval. It also underscores the need for pharmaceutical companies to prioritize patient safety above commercial interests. The decision to withdraw the drug, though financially impactful, was a necessary step to protect patients from potential harm.

Key Takeaways

• Approval and Efficacy: ZINBRYTA was approved in 2016 and showed significant clinical efficacy in reducing MS relapses and brain lesions.
• Safety Concerns: The drug was withdrawn due to reports of serious inflammatory brain disorders.
• Financial Impact: The withdrawal had minimal impact on AbbVie but was more significant for Biogen.
• Market Reaction: The market reacted with concern over Biogen’s pipeline but saw minimal long-term impact on AbbVie.
• Regulatory Cooperation: Close cooperation with regulatory bodies was crucial in managing the drug’s withdrawal.

FAQs

Q: Why was ZINBRYTA withdrawn from the market?

ZINBRYTA was withdrawn due to reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, which prompted an urgent safety review by the European Medicines Agency.

Q: How did the withdrawal of ZINBRYTA affect Biogen and AbbVie financially?

The withdrawal had a minimal financial impact on AbbVie but was more significant for Biogen, which had a thinner pipeline and was more reliant on ZINBRYTA revenue.

Q: What were the clinical benefits of ZINBRYTA?

ZINBRYTA significantly reduced the annualized relapse rate and the mean number of new or newly enlarging T2-hyperintense lesions in MS patients compared to other treatments like AVONEX.

Q: How did the market react to the withdrawal of ZINBRYTA?

The market reaction was mixed, with concerns over Biogen’s future pipeline but minimal long-term impact on AbbVie.

Q: What lessons can be learned from the ZINBRYTA case?

The case highlights the importance of prioritizing patient safety and continuous monitoring of drug safety post-approval.

Sources

1. MSCare.org: Abbvie and Biogen pull multiple sclerosis drug Zinbryta following urgent EMA safety review.
2. BioSpace: Biogen and AbbVie Voluntarily Pull Multiple Sclerosis Drug Off the Market.
3. Abbvie Investor Relations: FORM 10-K.
4. Biogen Investor Relations: FDA Accepts Biologics License Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment of MS.
5. Abbvie News: Biogen and AbbVie Receive FDA Approval of Once-Monthly ZINBRYTA (daclizumab) for Multiple Sclerosis.