Philadelphia, PA, Oct. 21, 2024 (GLOBE NEWSWIRE) -- SERB Pharmaceuticals, a global specialty pharmaceutical company, announced today the acquisition of Aurlumyn™ (iloprost IV), the only FDA approved treatment option for severe frostbite in the US, from CiVi Biopharma. Aurlumyn™ will be made available this coming winter season.
Arthur Pignot, Chief Strategy Officer at SERB, said: “Aurlumyn™ is set to become a gold standard treatment for frostbite, a rare yet debilitating condition, making it an ideal addition to our broad and diverse emergency care portfolio. This acquisition expands our leadership in rare emergency medicines and is a perfect fit for our US commercial capabilities.”
Studies show that thousands of people are hospitalized with severe frostbite in the US each year.[i] Frostbite can occur in several stages ranging from mild cases that don't require medical attention to severe frostbite where both the skin and underlying tissues freeze, cutting off blood flow. Frostbite is a high morbidity, high-cost injury that can lead to digit or limb necrosis requiring amputation.[ii]
Aurlumyn™ is a vasodilator (a drug that opens blood vessels) and inhibits platelet aggregation. Its efficacy in treating severe frostbite was primarily established in an open-label, controlled trial[iii]. Aurlumyn™ was granted priority review and orphan drug designation (ODD) and was approved by the FDA in February of 2024 for the treatment of severe frostbite in adults to reduce the risk of digit amputations. A published case series review showed that Aurlumyn™ can be effective up to 72 hours after rewarming of a frostbite patient begins.
The companies did not disclose specific financial terms. Today’s news follows the announcement in August that SERB acquired RSDL® (Reactive Skin Decontamination Lotion) kit.
About SERB Pharmaceuticals
SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB is a leading provider of essential acute care medicines, addressing unmet medical needs and supplying antidotes and medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. Learn more at https://SERB.com.
About Aurlumyn™ (OR-LOO-MIN)
Indication
AURLUMYN is a prostacyclin mimetic indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.
Important Safety Information
Warnings and Precautions
AURLUMYN is a systemic vasodilator and may cause symptomatic hypotension. Correct hypotension prior to administration of AURLUMYN. Monitor vital signs while administering AURLUMYN. Consider temporary discontinuation of concomitant vasodilator or other antihypertensive medications while administering AURLUMYN to reduce potential additive hypotensive effects. Consider downtitration or discontinuation of AURLUMYN if hypotension persists despite discontinuation of other antihypertensives and fluid resuscitation.
Adverse Reactions
Most common adverse events include headache, flushing, palpitations/tachycardia, nausea, vomiting, dizziness, and hypotension.
See full prescribing information (link).
[i] Endorf FW, Nygaard RM. Social Determinants of Poor Outcomes Following Frostbite Injury: A Study of the National Inpatient Sample. J Burn Care Res. 2021 Nov 24;42(6):1261-1265. doi: 10.1093/jbcr/irab115. PMID: 34139760.
[ii] Endorf FW, Nygaard RM. High Cost and Resource Utilization of Frostbite Readmissions in the United States. J Burn Care Res. 2021 Sep 30;42(5):857-864. doi: 10.1093/jbcr/irab076. PMID: 33993288.
[iii] Cauchy E, Cheguillaume B, Chetaille E. A controlled trial of a prostacyclin and rt-PA in the treatment of severe frostbite. N Engl J Med. 2011 Jan 13;364(2):189-90. doi: 10.1056/NEJMc1000538. PMID: 21226604.
