Chymopapain - Biologic Drug Details

Summary for chymopapain

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

Recent Clinical Trials for chymopapain

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Utah	Phase 4

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Recent Litigation for chymopapain

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC	2018-12-20

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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 chymopapain Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of Chymopapain

Introduction

Chymopapain, a biologic drug introduced in the 1960s, was used for the treatment of herniated discs through a procedure known as chemonucleolysis. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual decline.

Historical Context

Chymopapain was first introduced in July 1963 and gained widespread use in Europe, North America, and Australia for treating lumbar disc herniation[2].

Mechanism and Use

Chymopapain is injected directly into a herniated disc to dissolve part of the disc material, thereby relieving pain and pressure on nerves. This procedure was typically performed in a hospital setting under anesthesia[1].

Clinical Outcomes

Studies have shown that chymopapain was effective in reducing radicular complaints caused by disc herniation. A ten-year follow-up study on 268 patients indicated that 86% experienced less leg pain, and 82% were employed at a capacity equal to or greater than before the injection[4].

Market Peak and Revenue

During its peak, chymopapain was a significant player in the orthopedic and spinal treatment market. However, specific financial figures for chymopapain's revenue during its active years are not readily available. The drug's market presence was substantial enough to warrant extensive clinical studies and widespread adoption.

Side Effects and Safety Concerns

Despite its efficacy, chymopapain was associated with serious side effects, including paralysis of the legs, death, and severe allergic reactions such as anaphylaxis. These risks, particularly the allergic reactions which occurred more frequently in women, were significant enough to influence its market trajectory[1].

Regulatory and Commercial Challenges

The use of chymopapain was discontinued in the US in January 2003 due to nonscientific and commercial reasons. This decision was likely influenced by the drug's side effect profile and the emergence of alternative treatments[2].

Impact of Adverse Events

Reports of severe adverse events, including cauda equina syndrome and disc herniation due to the "digestion" of the annulus fibrosus, further eroded confidence in chymopapain. These complications led to a decline in its use and ultimately contributed to its withdrawal from the market[2].

Alternative Treatments

The discontinuation of chymopapain paved the way for other treatments, such as collagenase, although these alternatives also had their own set of limitations and side effects. The search for safer and more effective treatments has continued, with newer methods like percutaneous injection of radiopaque gelified ethanol being explored[5].

Financial Trajectory

While specific financial data on chymopapain is limited, its market presence and subsequent decline can be inferred from the broader context of biologic drugs. The biologic market, which includes drugs like chymopapain, has seen significant growth, but this growth is also subject to challenges such as the introduction of biosimilars and increased competition[3].

Market Dynamics Post-Discontinuation

The discontinuation of chymopapain did not significantly impact the overall biologic market, which has continued to grow. However, it did highlight the importance of safety and efficacy in biologic treatments. The biologic market has since diversified, with major growth areas including autoimmune, diabetes, and oncology treatments[3].

Lessons Learned

The story of chymopapain serves as a cautionary tale about the importance of balancing efficacy with safety. It also underscores the dynamic nature of the biologic market, where new treatments and technologies can rapidly replace older ones.

Key Takeaways

• Chymopapain was a biologic drug used for treating herniated discs but was discontinued due to serious side effects.
• Despite its efficacy, safety concerns led to its withdrawal from the market.
• The biologic market continues to grow, driven by other therapeutic areas.
• Safety and efficacy remain critical factors in the success of biologic treatments.

FAQs

What was chymopapain used for?

Chymopapain was used to treat herniated discs by dissolving part of the disc material to relieve pain and pressure on nerves.

Why was chymopapain discontinued?

Chymopapain was discontinued due to serious side effects, including paralysis, death, and severe allergic reactions.

What were the common side effects of chymopapain?

Common side effects included back pain, stiffness, soreness, and muscle spasms in the lower back. Serious side effects included paralysis and severe allergic reactions.

What replaced chymopapain in the market?

Alternative treatments such as collagenase and newer methods like percutaneous injection of radiopaque gelified ethanol have been explored and adopted.

How did the discontinuation of chymopapain affect the biologic market?

The discontinuation of chymopapain did not significantly impact the overall biologic market, which has continued to grow driven by other therapeutic areas.

Sources

1. Mayo Clinic - Chymopapain (injection route) - Mayo Clinic
2. MDPI - Chemonucleolysis with Chondroitin Sulfate ABC Endolyase for Treating Lumbar Disc Herniation: Exploration of Prognostic Factors for Good or Poor Clinical Outcomes
3. IQVIA - Disruption and maturity: The next phase of biologics
4. PubMed - The long-term results of chymopapain. Ten-year follow-up of 268 patients
5. AJNR - Percutaneous Injection of Radiopaque Gelified Ethanol for the Treatment of Herniated Lumbar Discs

Last updated: 2024-12-22