SERB Pharma expands emergency care portfolio with Aurlumyn | Pharmaceutical | The Pharmaletter

Introduction

In a significant move to bolster its emergency care portfolio, Philadelphia-based SERB Pharmaceuticals has announced the acquisition of Aurlumyn, the only FDA-approved treatment for severe frostbite in the United States. This acquisition marks a major milestone for SERB, further solidifying its position as a leader in addressing rare and life-threatening conditions. Aurlumyn, a vasodilator that inhibits platelet aggregation, represents a groundbreaking solution for managing severe frostbite, a condition that can lead to debilitating consequences and hospitalizations.

The Problem of Severe Frostbite

Severe frostbite is a serious condition that affects thousands of people annually in the United States. It occurs when skin and underlying tissues freeze due to prolonged exposure to cold temperatures, cutting off blood flow to the affected area. Frostbite can range from mild to severe, with the latter posing significant risks, including digit or limb necrosis and the need for amputation. The high morbidity and cost associated with frostbite injuries highlight the urgent need for effective treatments.

Statistics on Frostbite

• Hospitalization Rates: Thousands of people are hospitalized each year due to severe frostbite.
• Cost and Resource Utilization: Frostbite injuries are a high-cost and high-resource injury, leading to significant readmissions and healthcare costs.
• Risk of Amputation: Severe frostbite can result in digit or limb necrosis, requiring amputation in some cases.

What is Aurlumyn?

Aurlumyn, developed by CiVi Biopharma, is a prostacyclin mimetic specifically indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Its effectiveness was established through an open-label, controlled trial, demonstrating its efficacy in treating severe frostbite up to 72 hours after rewarming of a frostbite patient begins.

Mechanism of Action

Aurlumyn works as a vasodilator, which means it opens blood vessels to improve blood flow to the affected area. Additionally, it inhibits platelet aggregation, which helps in reducing the risk of clot formation and further tissue damage. This dual action makes Aurlumyn a critical component in the management of severe frostbite.

The Acquisition

SERB Pharmaceuticals has acquired Aurlumyn from CiVi Biopharma, solidifying its commitment to emergency care and rare diseases. This acquisition aligns perfectly with SERB's broad and diverse emergency care portfolio, positioning it as a leader in addressing unmet medical needs.

Quotes from SERB

Arthur Pignot, Chief Strategy Officer at SERB, emphasized the significance of the acquisition: "Aurlumyn is set to become a gold standard treatment for frostbite, a rare yet debilitating condition. This acquisition expands our leadership in rare emergency medicines and is a perfect fit for our US commercial capabilities".

Impact and Availability

Aurlumyn is set to become available this coming winter season, providing healthcare professionals with a much-needed tool in managing severe frostbite cases. The FDA approval in February 2024 granted priority review and orphan drug designation, underscoring the drug's potential to address a rare and potentially life-threatening condition.

Availability Timeline

• Coming Winter Season: Aurlumyn will be made available this winter season to aid in the management of severe frostbite cases.

SERB Pharmaceuticals: A Leader in Emergency Care

SERB Pharmaceuticals has been at the forefront of emergency care and rare diseases for over 30 years. The company's commitment to supporting clinicians, healthcare systems, and governments in addressing complex and life-threatening conditions is evident through its extensive portfolio of medicines.

Company Background

• Founding: SERB began in the 1950s as Société d’Études et de Recherches Biologiques (Company for Biologic Study and Research).
• Global Reach: SERB operates in 18 countries directly and supplies its medicines to over 100 countries worldwide.
• Diverse Portfolio: The company boasts a broad portfolio, including medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) risks, as well as antidotes for various emergency situations.

Conclusion

The acquisition of Aurlumyn by SERB Pharmaceuticals marks a significant stride in the treatment of severe frostbite. This move not only underscores SERB's commitment to addressing rare and life-threatening conditions but also highlights the company's position as a leader in emergency care. With Aurlumyn set to become a gold standard treatment, healthcare professionals now have a powerful tool to manage severe frostbite cases effectively, potentially reducing the risk of digit amputations and improving patient outcomes.

References

1. SERB Pharmaceuticals Website: SERB Pharmaceuticals Homepage
2. Benzinga Press Release: SERB Pharmaceuticals Expands Leading Emergency Care Portfolio with Acquisition of Aurlumyn™ (iloprost IV) for Severe Frostbite
3. Biospace Press Release: SERB Pharmaceuticals Expands Leading Emergency Care Portfolio with Acquisition of Aurlumyn™ (iloprost IV) for Severe Frostbite
4. GlobeNewswire Press Release: SERB Pharmaceuticals Expands Leading Emergency Care Portfolio with Acquisition of Aurlumyn™ (iloprost IV) for Severe Frostbite

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This acquisition underscores the importance of rapid and effective treatments for severe conditions like frostbite. With Aurlumyn set to become a standard treatment, SERB Pharmaceuticals continues to lead the way in emergency care, providing hope and effective solutions to patients and their families affected by these life-threatening conditions.