Mayer Brown advises SERB Pharmaceuticals on the structuring of the acquisition of Aurlumyn®
- SERB Pharmaceuticals has acquired Aurlumyn, the only FDA-approved treatment for severe frostbite, with the legal assistance of Mayer Brown, facilitating improved frostbite care in the United States.
- Aurlumyn is a breakthrough treatment granted priority review and orphan drug designation by the FDA, significantly reducing the risk of digit amputations for severe frostbite patients.
- Mayer Brown's expertise was crucial in navigating the legal and regulatory aspects of the acquisition, ensuring Aurlumyn's availability to meet the urgent need for effective frostbite treatments as winter approaches.
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Title: "Mayer Brown Guides SERB Pharmaceuticals in Historic Acquisition of Aurlumyn for Severe Frostbite Treatment"
In a major move that is set to revolutionize the treatment of severe frostbite in the United States, global specialty pharmaceutical company SERB Pharmaceuticals has announced the acquisition of Aurlumyn® (iloprost IV), the only FDA-approved treatment option for severe frostbite. This significant acquisition was facilitated by the expert legal services of Mayer Brown, a leading global law firm known for its multidisciplinary approach to client needs.
The Breakthrough Treatment
Aurlumyn® is a prostacyclin mimetic specifically indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. This innovative drug has been granted priority review and orphan drug designation by the FDA, reflecting its critical role in addressing a rare yet debilitating condition. Studies have shown that thousands of people are hospitalized with severe frostbite each year, highlighting the urgent need for effective treatments like Aurlumyn.
The Acquisition Process
The acquisition of Aurlumyn was structured by Mayer Brown, leveraging their extensive experience in mergers, acquisitions, and healthcare regulations. This complex legal process involved ensuring compliance with all relevant FDA regulations and policies, as well as managing the financial aspects of the deal. The partnership between SERB Pharmaceuticals and Mayer Brown has been instrumental in bringing this critical treatment option to market, particularly as winter approaches and the risk of frostbite increases.
SERB Pharmaceuticals: A Leader in Emergency Care
SERB Pharmaceuticals is a global leader in specialty pharmaceuticals, focusing on emergency care and rare diseases. With a portfolio that spans essential acute care medicines and medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) risks, SERB has established itself as a trusted provider of critical treatments. The acquisition of Aurlumyn further expands SERB's leadership in emergency care, aligning with its mission to support clinicians, healthcare systems, and governments while offering hope to patients and their families.
The Significance of Aurlumyn
Aurlumyn's efficacy in treating severe frostbite was primarily established in an open-label, controlled trial. The drug works by acting as a vasodilator, opening blood vessels to improve circulation and reduce the risk of digit amputation. Its effectiveness has been demonstrated in young, healthy adults who suffered frostbite at high altitudes. A published case series review showed that Aurlumyn can be effective up to 72 hours after rewarming of a frostbite patient begins.
Regulatory Approvals
Aurlumyn received FDA approval in February 2024 for the treatment of severe frostbite in adults. This approval was granted after rigorous review, reflecting the drug's potential to significantly reduce the morbidity and high costs associated with frostbite injuries. Frostbite can occur in several stages, ranging from mild cases that do not require medical attention to severe cases where both the skin and underlying tissues freeze, leading to digit or limb necrosis and potentially requiring amputation.
Future Availability
SERB Pharmaceuticals has announced plans to make Aurlumyn available this winter season, coinciding with the peak risk period for frostbite. Arthur Pignot, Chief Strategy Officer at SERB, emphasized that Aurlumyn is set to become a gold standard treatment for frostbite, making it an ideal addition to their diverse emergency care portfolio. This acquisition underscores SERB’s commitment to addressing rare emergency medicines and leveraging its robust US commercial capabilities.
Mayer Brown’s Expertise
Mayer Brown’s role in structuring the acquisition highlights their expertise in healthcare mergers and acquisitions. The firm has a dedicated Emerging Companies & Venture Capital practice that advises healthcare companies through each stage of growth. Their comprehensive approach includes managing regulatory compliance, financial structuring, and transactional advisory services. This collaboration between Mayer Brown and SERB Pharmaceuticals ensures that the acquisition process is seamless, meeting all necessary regulatory requirements while securing a smooth transition for the new asset.
Conclusion
The acquisition of Aurlumyn by SERB Pharmaceuticals marks a significant milestone in the fight against severe frostbite. With Mayer Brown’s expert guidance, this transaction has set the stage for improved patient outcomes and reduced healthcare costs associated with frostbite injuries. As winter approaches, the availability of Aurlumyn will provide critical relief to those affected by this debilitating condition, aligning with SERB’s mission to make treating complex and life-threatening conditions possible.
