#United States #Fort Lee #Mezzion Pharmaceuticals #Udenafil #Fontan Patients

Mezzion Pharmaceuticals Announces Significant U.S. Patent Approval

Introduction
In a landmark development, Mezzion Pharmaceuticals, Inc. has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a critical patent concerning Udenafil (brand name JURVIGO). This patent marks a pivotal moment for Mezzion as it focuses on enhancing treatment options specifically for patients suffering from single ventricle congenital heart disease (SV-CHD) who have undergone the Fontan procedure. The approval underscores not only Mezzion's commitment to innovative therapies but also its strategic intent to carve out a sustainable path in the biopharmaceutical landscape for addressing rare disease needs.

Details of the Patent

The newly allowed patent, a continuation of the company’s 2020-filed FUEL patent family, encompasses method-of-use claims that are broad yet age-agnostic. This allows for chronic, twice-daily oral administration of Udenafil or its pharmaceutically acceptable salts to improve exercise capacity in Fontan patients. The comprehensive nature of the patent includes essential dependent claims that extend to multiple cardiopulmonary exercise testing (CPET) endpoints, pivotal for patient assessment.

With anticipated baseline expiration set for July 24, 2040, and potential patent term extensions subject to further FDA approvals, Mezzion is poised to gain substantial market exclusivity, potentially delaying generic competition into the late 2030s or early 2040s. This is particularly significant considering the alarming lack of FDA-approved therapeutic options for the approximately 70,000 individuals globally living with Fontan physiology.

Impact on Patients and the Company

Dean Park, Chairman and CEO of Mezzion, expressed optimism about the patent allowance. He remarked, "This allowance marks a pivotal milestone in our long-term strategy for JURVIGO. It reflects years of collaborative effort with investigators, families, and advocates within the Fontan community. The extended U.S. patent position will enable us to increasingly invest in our FUEL program and future innovations to serve this unique population better."

The urgency for effective therapeutic solutions in the Fontan community cannot be overstated, with this demographic facing devastating levels of morbidity and mortality. The economic burden associated with congenital heart disease is substantial, with estimates indicating an annual cost of roughly $74 billion in the U.S. alone, as per recent health-economic analyses. Therefore, having a reliable treatment like Udenafil could revolutionize the approach to care for these patients.

Current and Future Developments

In terms of immediate steps, Mezzion is actively enrolling patients for the global confirmatory Phase 3 FUEL-2 trial. This trial aims to gather critical data on the safety and efficacy of JURVIGO among adolescents and young adults with Fontan physiology. As of now, the study is underway in both the U.S. and Asia, with European sites soon to follow.

Despite the promising developments, it is essential to remember that Udenafil remains investigational, having not yet achieved FDA approval, meaning its safety and efficacy are yet to be established through clinical trials.

Conclusion

Ultimately, Mezzion's recent patent allowance for Udenafil represents a crucial stride toward meeting the unmet medical needs of individuals living with Fontan circulation. By combining scientific innovation with a clear understanding of market dynamics and patient welfare, Mezzion is strategically positioning itself to be a key player in the biopharmaceutical domain focused on rare diseases. The hope lies in not just uplifting the quality of life for these patients but also contributing positively toward the healthcare system as a whole.

About Mezzion Pharmaceuticals
Mezzion Pharmaceuticals, Inc. operates as a U.S.-based subsidiary of Mezzion Pharma Co., Ltd. (KOSDAQ 140410) and is committed to developing therapies aimed at rare and underserved diseases. With JURVIGO® at the forefront, Mezzion is aspiring to create a new standard of care for patients grappling with single ventricle congenital heart disease. For more information about the company and ongoing studies, please visit Mezzion's official site.

Forward-Looking Statements
This article discusses forward-looking statements regarding patent scopes, potential regulatory accomplishments, and the commercialization of Udenafil. Actual results may differ due to various risks and uncertainties.