CYFENDUS Drug Profile

Summary for Tradename: CYFENDUS

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for CYFENDUS

Ingredient-type	Anthrax Vaccines Vaccines, Attenuated
Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Live Attenuated Bacillus Anthracis Vaccine

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 CYFENDUS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

CYFENDUS Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for CYFENDUS: The Anthrax Vaccine

Introduction

CYFENDUS, developed by Emergent BioSolutions Inc., is a significant player in the global anthrax vaccine market. This vaccine, formerly known as AV7909, has recently received full FDA approval, marking a crucial milestone in its market trajectory. Here, we delve into the market dynamics and financial aspects that shape the future of CYFENDUS.

Market Size and Growth

The global anthrax vaccine market, valued at USD 12.17 billion in 2022, is projected to grow at a CAGR of 4.59% from 2023 to 2030. This growth is driven by factors such as the increasing prevalence of anthrax, particularly in regions with high consumption of raw or undercooked meat from infected animals[1].

Key Drivers

Several factors are driving the demand for CYFENDUS and other anthrax vaccines:

• Increasing Anthrax Prevalence: The rising incidence of anthrax infections in both humans and animals is a primary driver.
• Government Initiatives: Recommendations for anthrax vaccinations and government support, such as the $75 million supply pact with BARDA, significantly boost market growth[4].
• Awareness and Immunization: Growing awareness among livestock caretakers about the importance of anthrax immunization also contributes to market expansion[1].

Distribution Channels

The anthrax vaccine market is segmented into hospital pharmacy, online pharmacy, and retail pharmacy. The retail pharmacy segment holds the largest market share due to the widespread availability of anthrax immunizations in these outlets[1].

Regional Market Dynamics

• North America: This region dominated the market in 2022, driven by increasing awareness and immunization efforts among livestock caretakers. Initiatives such as those by the South Dakota Animal Industry Board and Veterinarians from SDSU Extension have been instrumental in this growth[1].
• Asia-Pacific: Expected to witness the fastest CAGR over the forecast period, this region is influenced by high consumption of raw or undercooked meat and a significant anthrax load in developing countries[1].

Product Details and Approval

CYFENDUS is an anthrax vaccine absorbed (AVA) combined with an adjuvant, administered as two doses over 14 days. It is intended for post-exposure prophylaxis in adults aged 18 to 65. The vaccine received full FDA approval in July 2023, following four years of supply under a pre-emergency use authorization[4].

Financial Trajectory

Emergent BioSolutions has seen significant financial improvements driven by CYFENDUS and other medical countermeasures:

• Revenue Growth: In the first half of 2024, Emergent reported revenue of $555 million, up 11% from the prior year, largely driven by MCM (Medical Countermeasures) sales, including CYFENDUS deliveries to the U.S. government's Strategic National Stockpile[2].
• Segment Performance: Anthrax MCM sales increased by 155% year-over-year, contributing substantially to the company's revenue growth. For 2024, Emergent forecasts MCM product sales of $440 million to $490 million, reflecting strong demand for CYFENDUS[5].
• Profitability Metrics: Adjusted EBITDA for 2024 is forecasted to be between $125 million and $175 million, reflecting the impact of cost reduction actions and organizational changes. The total segment adjusted gross margin is expected to be between 44% and 47% for the full year[5].

Strategic Initiatives and Partnerships

Emergent BioSolutions has been actively engaging in strategic initiatives to enhance its market position:

• BARDA Partnership: The $75 million supply pact with BARDA for additional doses of CYFENDUS is a significant milestone. This partnership, initiated in 2016, has been crucial for the development and supply of the vaccine[4].
• Organizational Changes: Emergent has been focusing on stabilizing its financial position and executing a multiyear plan to remain a leader in global public health. This includes de-emphasizing its CDMO services business and focusing on core medical countermeasures like CYFENDUS[5].

Competitive Landscape

The anthrax vaccine market is competitive, with key players including Colondo Serum Company, Merck Co, Inc., Emergent BioSolutions Inc., and Proton Biopharma Ltd. These companies are involved in new product launches, collaborations, M&A activities, and other strategic alliances to gain market share[1].

Impact of Regulatory Approvals

The full FDA approval of CYFENDUS has been a game-changer for Emergent BioSolutions. This approval has enhanced the vaccine's credibility and expanded its market reach. As noted by Emergent, "The FDA signed off on Emergent’s vaccine—formerly known as AV7909—in July. Prior to the shot’s formal green light, Emergent had been furnishing the U.S. Department of Health and Human Services with the product since 2019"[4].

Conclusion

CYFENDUS, with its recent full FDA approval and robust market dynamics, is poised for significant growth. The vaccine's financial trajectory is bolstered by strong demand, government support, and strategic partnerships. As the global anthrax vaccine market continues to expand, CYFENDUS is likely to remain a key player.

Key Takeaways

• Market Growth: The global anthrax vaccine market is expected to grow at a CAGR of 4.59% from 2023 to 2030.
• Financial Performance: Emergent BioSolutions forecasts strong revenue and profitability metrics driven by CYFENDUS sales.
• Regulatory Approvals: Full FDA approval of CYFENDUS has significantly enhanced its market position.
• Strategic Initiatives: Partnerships with BARDA and other strategic moves are crucial for market expansion.
• Regional Dynamics: North America and Asia-Pacific are key regions driving market growth.

FAQs

1. What is CYFENDUS, and how is it administered? CYFENDUS is an anthrax vaccine absorbed (AVA) combined with an adjuvant, administered as two doses over 14 days for post-exposure prophylaxis in adults aged 18 to 65.

2. Who are the key players in the anthrax vaccine market? Key players include Colondo Serum Company, Merck Co, Inc., Emergent BioSolutions Inc., and Proton Biopharma Ltd.

3. What is the expected growth rate of the global anthrax vaccine market? The global anthrax vaccine market is expected to grow at a CAGR of 4.59% from 2023 to 2030.

4. What role does government support play in the market growth of CYFENDUS? Government initiatives, such as the $75 million supply pact with BARDA, significantly boost market growth by ensuring a steady supply of the vaccine.

5. How has the full FDA approval impacted CYFENDUS? The full FDA approval has enhanced the vaccine's credibility, expanded its market reach, and increased its supply to the U.S. government's Strategic National Stockpile.

Sources

1. Grand View Research - Anthrax Vaccine Market Size, Share & Trends Report, 2030
2. Investing.com - Earnings call: Emergent BioSolutions raises 2024 guidance
3. IQVIA - Biosimilars in the United States 2020–2024
4. FiercePharma - After Cyfendus' full approval, Emergent clinches $75M anthrax vaccine supply pact with US
5. Investing.com - Earnings call: Emergent BioSolutions raises 2024 profit outlook