MENOMUNE-A Drug Profile

Summary for Tradename: MENOMUNE-A

High Confidence Patents:	0
Applicants:	1
BLAs:	2

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 MENOMUNE-A Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for MENOMUNE-A Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for MENOMUNE-A Derived from Patent Text Search

No patents found based on company disclosures

MENOMUNE-A Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Menomune and Meningococcal Vaccines

Introduction to Menomune

Menomune, a quadrivalent meningococcal polysaccharide vaccine, was produced by Sanofi Pasteur to protect against serogroups A, C, Y, and W-135 of Neisseria meningitidis. However, the vaccine's production was discontinued in 2017 due to evolving market dynamics and manufacturing challenges.

Reasons for Discontinuation

The decision to discontinue Menomune was not based on the vaccine's safety, quality, or efficacy. Instead, it was driven by several key factors:

• Evolving Market Dynamics: There was an increased interest in quadrivalent meningococcal conjugate vaccines, which offered superior immune responses and longer-lasting protection compared to polysaccharide vaccines[1][2].
• Manufacturing Challenges: Maintaining Menomune production at the highest quality and regulatory standards became increasingly difficult, leading Sanofi Pasteur to focus its resources on more viable vaccine options[1].

Impact on the Market

The discontinuation of Menomune had significant implications for the market:

• Alternative Vaccines: Sanofi Pasteur recommended the use of quadrivalent meningococcal conjugate vaccines, such as Menactra, for patients who required meningococcal vaccination. Menactra is available for individuals from 9 months to 55 years of age[1][2].
• Age Group Affected: The discontinuation left a gap for individuals 56 years and older, as no meningococcal polysaccharide vaccines were available for this age group. These individuals were advised to receive quadrivalent meningococcal conjugate vaccines instead[2].

Current Market Landscape

The meningococcal vaccine market has continued to evolve with new developments:

• GSK's 5-in-1 Vaccine: GSK has been working on a 5-in-1 meningococcal vaccine candidate (MenABCWY) that combines the antigenic components of its licensed meningococcal vaccines, Bexsero and Menveo. This vaccine has shown promising results in phase III clinical trials, offering broad serogroup coverage and a simplified immunization schedule[3].
• Competitive Landscape: The market is dominated by major players such as Sanofi Pasteur and GSK, with other companies like Pfizer and Novo Nordisk also making significant contributions to the biopharmaceutical sector[4].

Financial Trajectory

The biopharmaceutical market, including meningococcal vaccines, is experiencing substantial growth:

• Global Biopharmaceutical Market: The global biopharmaceutical market is projected to grow from USD 284 billion in 2023 to USD 566 billion by 2032, with a CAGR of 8.2% during the forecast period. This growth is driven by the increasing demand for biopharmaceuticals and their broader adoption in treating various diseases[4].
• Segment Performance: The oncology segment has been a significant contributor to the biopharmaceutical market, driven by high demand for innovative cancer therapies. Monoclonal antibodies are expected to lead the market through 2023 to 2032 due to their widespread application in disease treatment[4].

Regional Market Share

The biopharmaceutical market is geographically diverse:

• North America: Led the market in 2022 with a revenue share of over 43%, driven by robust government support and healthcare investments[4].
• Europe: Contributed 23% to the global market’s revenue in 2022, reflecting its significant role in the biopharmaceutical sector[4].

Company Performance

Major pharmaceutical companies are making significant strides:

• Sanofi Pasteur: Focused on quadrivalent meningococcal conjugate vaccines like Menactra, ensuring ample supply to meet market demands[1].
• GSK: Announced positive phase III data for its 5-in-1 meningococcal vaccine candidate, which could provide the broadest meningococcal serogroup coverage and simplify immunization schedules[3].
• Other Players: Companies like Novo Nordisk, AbbVie, and Eli Lilly are also experiencing financial growth and making strategic acquisitions to enhance their portfolios[4].

Public Health Impact

The discontinuation of Menomune and the introduction of new vaccines have significant public health implications:

• Vaccine Effectiveness: Quadrivalent meningococcal conjugate vaccines offer higher initial vaccine effectiveness and longer durations of protection compared to polysaccharide vaccines. For example, the initial vaccine effectiveness for MenACWY is around 79% for the first dose and 99% for the second dose[5].
• Disease Incidence: Invasive meningococcal disease (IMD) remains a serious public health concern, particularly among children and adolescents. Effective vaccination strategies are crucial in reducing the incidence of IMD and its severe complications[3][5].

Key Takeaways

• Market Shift: The market has shifted towards quadrivalent meningococcal conjugate vaccines due to their superior immune responses and longer-lasting protection.
• New Developments: GSK's 5-in-1 meningococcal vaccine candidate promises broad serogroup coverage and a simplified immunization schedule.
• Financial Growth: The biopharmaceutical market, including meningococcal vaccines, is experiencing significant growth driven by increasing demand and broader adoption.
• Public Health: Effective vaccination strategies are essential in reducing the incidence of invasive meningococcal disease and its complications.

FAQs

1. Why was Menomune discontinued? Menomune was discontinued due to evolving market dynamics favoring quadrivalent meningococcal conjugate vaccines and manufacturing challenges in maintaining the highest quality and regulatory standards[1][2].

2. What alternatives are available for Menomune? Alternatives include quadrivalent meningococcal conjugate vaccines such as Menactra, which is available for individuals from 9 months to 55 years of age[1][2].

3. How does the new GSK 5-in-1 vaccine compare to existing vaccines? GSK's 5-in-1 vaccine candidate combines the antigenic components of Bexsero and Menveo, offering broad serogroup coverage and a simplified immunization schedule. It has shown promising results in phase III clinical trials and is well tolerated with a safety profile consistent with existing vaccines[3].

4. What is the current market size and growth projection for biopharmaceuticals? The global biopharmaceutical market is projected to grow from USD 284 billion in 2023 to USD 566 billion by 2032, with a CAGR of 8.2% during the forecast period[4].

5. How effective are the new meningococcal conjugate vaccines? Quadrivalent meningococcal conjugate vaccines offer high initial vaccine effectiveness and longer durations of protection. For example, MenACWY has an initial effectiveness of around 79% for the first dose and 99% for the second dose[5].

Cited Sources

1. Sanofi US News: Sanofi Pasteur Statement on the Discontinuation of Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined.
2. CDC: Menomune (meningococcal polysaccharide vaccine) discontinuation.
3. GSK: GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate.
4. Market.US: Biopharmaceutical Market Toward US$ 566 Billion By 2032.
5. CDC: National Center for Immunization & Respiratory Diseases - CDC.