Fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol - Biologic Drug Details

Summary for fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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1) High Certainty: US Patents for fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol Derived from Patent Text Search

No patents found based on company disclosures

Fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Fibrinolysin and Desoxyribonuclease Combined Ointment

Introduction

Fibrinolysin and desoxyribonuclease, when combined, form a potent enzymatic ointment used for wound healing. This article delves into the market dynamics and financial trajectory of this biologic drug combination, including its historical context, current market status, and future prospects.

Historical Context

The combination of fibrinolysin and desoxyribonuclease has been used for several decades in the treatment of minor burns, superficial wounds, ulcers, and superficial hematomas. Initially, this combination was sometimes paired with the antibiotic chloramphenicol to enhance its therapeutic effects. However, due to the severe side effects associated with chloramphenicol, such as aplastic anemia and death, these combinations were eventually withdrawn from the market[1][3].

Current Market Status

Approval and Availability

The ointment, marketed under the brand name Fibrolan by Pfizer, is approved in several countries, including Switzerland, but it is not approved in the USA. The approval in other countries is largely based on claimed good therapeutic experience, although adequate and well-controlled studies are still lacking[1][3].

Indications and Usage

Fibrinolysin and desoxyribonuclease are used exclusively as a local application ointment. Fibrinolysin attacks and inactivates fibrin molecules, while desoxyribonuclease targets and destroys DNA, particularly in necrotic tissue. This synergistic effect enhances wound cleaning and accelerates the healing process[1][3].

Pharmacokinetics

The enzymes are marginally resorbed into systemic circulation due to their high molecular weight and macromolecular structure. Their activity is almost completely exhausted after 24 hours, necessitating repeated applications every 6 to 8 hours until healing is complete[1][3].

Financial Trajectory

Cost and Pricing

The cost of biologic drugs like fibrinolysin and desoxyribonuclease can be significant. Although specific pricing data for Fibrolan is not widely available, biologic therapies in general are known to be expensive. For instance, other biologics used in different therapeutic areas can cost anywhere from $50,000 to $100,000 per year[2].

Market Demand

The demand for wound healing treatments is substantial, driven by the increasing incidence of chronic wounds, burns, and other skin injuries. The market for wound care products is growing, and biologic treatments like fibrinolysin and desoxyribonuclease are part of this expanding market.

Revenue and Sales

While exact revenue figures for Fibrolan are not publicly disclosed, the overall market for wound care products is projected to grow significantly. The synergistic effect of fibrinolysin and desoxyribonuclease, along with their efficacy in wound healing, positions them well in this growing market.

Competitive Landscape

Other Wound Healing Treatments

The wound healing market is competitive, with various treatments available, including conventional pharmaceuticals, other biologics, and advanced wound care products. Fibrinolysin and desoxyribonuclease must compete with these alternatives, which may offer different benefits and cost profiles.

Biologic Therapies

Biologic therapies, in general, face competition from conventional treatments that are often cheaper and sometimes equally effective. For example, in the treatment of osteoporosis, biologics like teriparatide are more expensive and less effective than conventional treatments like bisphosphonates[2].

Regulatory Environment

Approval Challenges

The lack of approval in the USA is a significant challenge for the widespread adoption of fibrinolysin and desoxyribonuclease. Regulatory bodies require robust clinical trials to approve new drugs, and the absence of such data hampers broader market access[1][3].

Safety and Efficacy

The combination of fibrinolysin and desoxyribonuclease has a favorable safety profile, with infrequent local reactions such as increased pain or a stitching/burning sensation. However, the historical association with chloramphenicol, which was withdrawn due to severe side effects, highlights the importance of rigorous safety evaluations[1].

Future Prospects

Clinical Trials and Research

To expand market access and improve the financial trajectory, conducting well-controlled clinical trials is crucial. These trials would provide the necessary evidence to support regulatory approvals and enhance the credibility of the treatment.

Market Expansion

Expanding into new markets, particularly in regions with growing healthcare needs, could significantly boost revenue. This would involve navigating local regulatory environments and potentially partnering with local healthcare providers.

Technological Advancements

Advancements in biotechnology could lead to more efficient production methods, reducing costs and making the treatment more competitive. Additionally, integrating these enzymes into new wound care products or delivery systems could enhance their market appeal.

Contraindications and Precautions

Hypersensitivity

The ointment should not be used in patients with a known hypersensitivity to any ingredient, particularly bovine proteins. It should also be used with caution in pregnant women due to the lack of human data[1][3].

Side Effects and Interactions

Local Reactions

Infrequent local reactions such as increased pain or a stitching/burning sensation can occur. However, systemic anticoagulant activity is not seen due to the exclusively local character of the treatment[1].

Key Takeaways

• Market Approval: Fibrinolysin and desoxyribonuclease are approved in several countries but not in the USA.
• Cost and Pricing: Biologic treatments are generally expensive, though specific pricing for Fibrolan is not widely available.
• Competitive Landscape: The wound healing market is competitive, with various treatments available.
• Regulatory Environment: Robust clinical trials are needed for broader market access.
• Future Prospects: Expanding into new markets and conducting clinical trials are key to improving the financial trajectory.

FAQs

What is the primary use of fibrinolysin and desoxyribonuclease combined ointment?

The primary use is for enzymatic wound cleaning to assist in the healing of minor burns, superficial wounds, ulcers, and superficial hematomas.

Why was the combination with chloramphenicol withdrawn?

The combination with chloramphenicol was withdrawn due to severe side effects associated with chloramphenicol, such as aplastic anemia and death.

Is the ointment approved in the USA?

No, the ointment is not approved in the USA but is approved in several other countries.

What are the common side effects of the ointment?

Infrequent local reactions such as increased pain or a stitching/burning sensation can occur.

How often should the ointment be applied?

The ointment should be applied every 6 to 8 hours until healing is complete, as its activity is almost completely exhausted after 24 hours.

Sources

1. Wikipedia: Fibrinolysin
2. NCBI: Comparing Clinical and Economic Outcomes of Biologic and Conventional Treatments
3. DrugBank: Fibrinolysin: Uses, Interactions, Mechanism of Action
4. MDPI: Excipient Development for Pharmaceutical, Biotechnology, and Cosmetic Applications
5. MDPI: Thrombolytic Enzymes of Microbial Origin: A Review