Cenegermin-bkbj - Biologic Drug Details

Summary for cenegermin-bkbj

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for cenegermin-bkbj

Established Pharmacologic Class	Recombinant Human Nerve Growth Factor
Chemical Structure	Nerve Growth Factor

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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

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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 cenegermin-bkbj Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for cenegermin-bkbj Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for cenegermin-bkbj Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Cenegermin-bkbj (Oxervate)

Introduction to Neurotrophic Keratitis and Cenegermin-bkbj

Neurotrophic keratitis is a rare and debilitating eye condition characterized by corneal nerve damage, which impairs healing and can lead to corneal ulcers. The introduction of cenegermin-bkbj ophthalmic solution 0.002% (Oxervate), a recombinant human nerve growth factor (rhNGF), has revolutionized the treatment of this condition.

Market Size and Growth Projections

The neurotrophic keratitis market has seen significant growth, driven largely by innovative therapeutic approaches and increasing clinical research. As of 2023, the market size was valued at USD 137.5 million. Looking forward, the market is expected to reach USD 248.0 million by 2034, exhibiting a Compound Annual Growth Rate (CAGR) of 5.51% during the period 2024-2034[1].

Key Drivers of Market Growth

Development of Regenerative Therapies

The advancement of regenerative therapeutics, particularly the introduction of cenegermin-bkbj, has been a major driver of the neurotrophic keratitis market. Cenegermin promotes nerve regeneration and corneal repair, addressing the underlying cause of neurotrophic keratitis. Clinical trials have shown that cenegermin accelerates corneal healing, improves corneal sensitivity, and reduces the risk of recurrent ulcers and vision loss[1][2][4].

FDA and Regulatory Approvals

Cenegermin-bkbj received FDA approval in August 2018, following a "Breakthrough Therapy" designation that fast-tracked its review and approval. This approval, along with approvals from the European Medicines Agency (EMA) in 2017 and the National Medical Products Administration (NMPA) in 2020, has significantly boosted the market[3].

Clinical Efficacy

Studies have demonstrated the efficacy of cenegermin-bkbj in treating neurotrophic keratitis. For instance, corneal healing was achieved in up to 72% of patients at week 8, and nearly 80% of patients who healed during the 8-week cycle remained healed at the 1-year follow-up[2]. Additionally, treatment with cenegermin has shown a significant increase in total, main, and branch nerve densities, as well as improved corneal sensation[4][5].

Market Segmentation and Key Players

Geographic Markets

The major markets for neurotrophic keratitis treatments include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. The United States has the largest patient pool and represents the biggest market for the treatment, attributed to innovative research, increased awareness, and robust healthcare infrastructure[1].

Key Players

Dompé Farmaceutici is a key player in the neurotrophic keratitis market, primarily due to its groundbreaking treatment, Oxervate (cenegermin-bkbj). The company's industrial-scale biotech production process at its L’Aquila manufacturing plant in Italy has been crucial in making this treatment widely available[1][3].

Production and Distribution Challenges

The production of cenegermin-bkbj is complex and requires highly skilled technicians and biotechnologists. The active ingredient must be kept at very low temperatures within specially designed cold stores, and a cold chain is necessary to ensure the drug is distributed to patients in containers kept at -20°C[3].

Financial Trajectory

The financial trajectory of the neurotrophic keratitis market, driven by cenegermin-bkbj, is promising. With a projected market size of USD 248.0 million by 2034, the market is expected to grow steadily over the next decade. This growth is supported by the increasing adoption of cenegermin-bkbj as a standard treatment for neurotrophic keratitis, as well as ongoing research into its potential applications in other ocular diseases[1].

Future Outlook and Research Directions

Exploring Other Ocular Diseases

Dompé Farmaceutici is currently investigating further applications of cenegermin-bkbj in other ocular diseases. This expansion of research efforts into neurotrophins, including manufacturing, formulation, and administration, aims to better understand their potential for patients and could lead to additional market opportunities[3].

Incremental Innovation

The success of cenegermin-bkbj in treating neurotrophic keratitis is seen as a stepping stone for further innovation. Incremental advancements in the field of regenerative therapeutics and neurotrophins are expected to lead to innovative solutions, potentially expanding the market further[3].

Key Takeaways

• The neurotrophic keratitis market is expected to grow from USD 137.5 million in 2023 to USD 248.0 million by 2034, with a CAGR of 5.51%.
• Cenegermin-bkbj (Oxervate) is a groundbreaking treatment that promotes nerve regeneration and corneal repair.
• FDA and regulatory approvals have significantly boosted the market.
• Clinical efficacy studies have shown promising results in treating neurotrophic keratitis.
• The United States is the largest market for this treatment.
• Dompé Farmaceutici is a key player in the market due to its innovative production and distribution processes.

FAQs

Q: What is the current market size of the neurotrophic keratitis market? A: As of 2023, the neurotrophic keratitis market size was valued at USD 137.5 million[1].

Q: What is the projected growth rate of the neurotrophic keratitis market? A: The market is expected to grow at a CAGR of 5.51% during 2024-2034[1].

Q: What is cenegermin-bkbj, and how does it treat neurotrophic keratitis? A: Cenegermin-bkbj is a recombinant human nerve growth factor (rhNGF) that promotes nerve regeneration and corneal repair, addressing the underlying cause of neurotrophic keratitis[1][2][4].

Q: Who are the key players in the neurotrophic keratitis market? A: Dompé Farmaceutici is a key player, primarily due to its groundbreaking treatment, Oxervate (cenegermin-bkbj)[1][3].

Q: What are the future research directions for cenegermin-bkbj? A: Research is currently being expanded into other ocular diseases and further applications of neurotrophins[3].

Sources

1. Biospace: Neurotrophic Keratitis Market to Reach USD 248.0 Million by 2034...
2. Modern Optometry: Neurotrophic Keratopathy: A Practical Approach to Diagnosis and Management
3. Dompé: Nerve Growth Factor
4. Optometry Times: ASCRS 2023: Cenegermin 0.002%: Effective for corneal nerve regeneration in neurotropic keratitis
5. Ophthalmology Times: ASCRS 2023: Cenegermin 0.002%: effective for corneal nerve regeneration in neurotropic keratitis