Obiltoxaximab - Biologic Drug Details

Summary for obiltoxaximab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for obiltoxaximab

Recent Clinical Trials for obiltoxaximab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Elusys Therapeutics	Phase 1

See all obiltoxaximab clinical trials

Pharmacology for obiltoxaximab

Mechanism of Action	Anthrax Protective Antigen-directed Antibody Interactions
Established Pharmacologic Class	Anthrax Protective Antigen-directed 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

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 obiltoxaximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Obiltoxaximab

Introduction

Obiltoxaximab, previously known as Nyxthracis, is a biologic drug that was indicated for the treatment of inhalational anthrax due to Bacillus anthracis. Although its marketing authorization has been withdrawn, understanding its market dynamics and financial trajectory provides valuable insights into the challenges and opportunities in the biologic drug market.

Indications and Use

Obiltoxaximab was approved for use in combination with appropriate antibacterial drugs for the treatment of inhalational anthrax in all age groups. It was also indicated for post-exposure prophylaxis of inhalational anthrax when alternative therapies were not appropriate or available[1].

Market Authorization and Withdrawal

The marketing authorization for Nyxthracis (Obiltoxaximab SFL) was withdrawn at the request of the marketing-authorisation holder. This decision was made under exceptional circumstances, as the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use[1].

Financial Challenges in Antibiotic and Biologic Development

The development of antibiotics and biologics like Obiltoxaximab faces significant financial challenges. The high costs of bringing these drugs to market, combined with the poor return on investment due to limited use as a last resort, have led many large pharmaceutical companies to abandon this field. This has left small companies to fill the gap, often with limited financial resources[2].

Market Size and Forecast

Although specific market size and forecast data for Obiltoxaximab are not available due to its withdrawn status, the broader anthrax vaccine market provides some context. The global anthrax vaccine market is expected to grow at a CAGR of 6.7%, reaching a valuation of US$ 1,006.33 million by 2031. This growth is driven by increasing bioterrorism threats and growing awareness about the disease[5].

Revenue and Funding

For biologic drugs like Obiltoxaximab, revenue is often tied to government contracts and procurement agreements. For example, companies involved in anthrax vaccine development, such as those mentioned in the annual report of Emergent BioSolutions, receive significant funding from government agencies like BARDA (Biomedical Advanced Research and Development Authority) for the development and procurement of vaccines and therapeutics[3].

Regulatory Hurdles

The development and approval of biologic drugs like Obiltoxaximab are heavily regulated and involve rigorous testing. The process includes three-phase clinical trials and a biologics license application (BLA) to the FDA, which can be time-consuming and costly. These regulatory hurdles can significantly impact the financial trajectory of such drugs[5].

Economic Prospects and Funding Models

To address the economic challenges in antibiotic and biologic development, innovative funding models are being explored. For instance, the UK has implemented a subscription model where the country invests in antibiotics that meet specific clinical needs and reimburses companies regardless of the number of prescription sales. This model provides a predictable return on investment, incentivizing development programs[2].

Impact of Withdrawal on Market Dynamics

The withdrawal of Obiltoxaximab's marketing authorization has significant implications for market dynamics. It reduces the available treatment options for inhalational anthrax, potentially increasing the demand for alternative therapies. This can lead to a shift in market share towards other approved treatments and vaccines, such as cell-free PA vaccines, which have shown effectiveness and safety[5].

Global Health Implications

The lack of effective treatments for diseases like anthrax can have severe global health implications. According to the World Health Organization (WHO), if the current situation remains unchanged, 10 million people could die each year from infections previously easily treated with antibiotics by 2050. This underscores the need for continued investment in antibiotic and biologic research and development[2].

Industry Expert Insights

Industry experts highlight the critical need for new antibiotics and biologics. For example, in the field of oncology, access to effective antibiotics is crucial for patient care. The development of new antibiotics is hampered by the lack of a high-quality health technology assessment that could quantify the economic impact of novel drugs[2].

Future Outlook

Despite the withdrawal of Obiltoxaximab, the future outlook for biologic drugs targeting anthrax and other infectious diseases remains promising. The global anthrax vaccine market is expected to grow, driven by increasing awareness and government investments. However, addressing the financial and regulatory challenges will be crucial for the successful development and market entry of new biologic drugs[5].

Key Takeaways

• Market Authorization: Obiltoxaximab's marketing authorization was withdrawn due to insufficient data on efficacy and safety.
• Financial Challenges: High development costs and poor return on investment are significant hurdles in the biologic drug market.
• Regulatory Hurdles: Rigorous testing and approval processes are costly and time-consuming.
• Innovative Funding Models: New funding models, such as subscription models, are being explored to incentivize development.
• Global Health Implications: The lack of effective treatments can have severe global health implications.
• Future Outlook: The anthrax vaccine market is expected to grow, but addressing financial and regulatory challenges is crucial.

FAQs

Q: What was Obiltoxaximab indicated for? A: Obiltoxaximab was indicated for the treatment of inhalational anthrax in combination with antibacterial drugs and for post-exposure prophylaxis when alternative therapies were not appropriate or available[1].

Q: Why was the marketing authorization for Obiltoxaximab withdrawn? A: The marketing authorization was withdrawn at the request of the marketing-authorisation holder due to insufficient data on the efficacy and safety of the medicine under normal conditions of use[1].

Q: What are the financial challenges in developing biologic drugs like Obiltoxaximab? A: The high costs of development, poor return on investment due to limited use, and the need for significant funding from government contracts are major financial challenges[2][3].

Q: How are regulatory hurdles impacting the development of biologic drugs? A: Regulatory hurdles, including rigorous testing and approval processes, are time-consuming and costly, affecting the financial trajectory of these drugs[5].

Q: What innovative funding models are being explored to support biologic drug development? A: Models such as subscription models, where countries invest in antibiotics and reimburse companies regardless of sales volume, are being explored to provide a predictable return on investment[2].

Sources

1. European Medicines Agency - Nyxthracis (previously Obiltoxaximab SFL)
2. Science - The past, present, and future of antibiotics
3. Emergent BioSolutions - Annual Report 2020
4. Market Research Intellect - Obiltoxaximab Market Size and Forecast
5. Astute Analytica - Anthrax Vaccine Market Analysis & Forecast [2031]