AcelRx Pharmaceuticals, Inc. announced the divestment of its FDA-approved drug, DSUVIA to Alora Pharmaceuticals (Alora). The agreement allows AcelRx to participate in the long-term value expected to be created by Alora as they expand the commercialization of DSUVIA.
The agreement provides AcelRx with a 15% royalty on commercial sales of DSUVIA, a 75% royalty on sales of DSUVIA to the Department of Defense, DSUVIA’s single largest customer, and up to $116.5 million in sales-based milestones. Closing of the transaction is expected by the end of the month, and AcelRx will provide, and be reimbursed for, transition services during a period of up to 6 months post-closing. In exchange for the 75% royalty on net sales to the DoD, AcelRx will lead the relationship to ensure continued engagement and expected expansion of sales to the DoD. Importantly, the divestment will allow for AcelRx to focus its operations and capital on its late stage, high-value asset programs, with specific prioritization of its lead nafamostat program, Niyad, as an anticoagulant for the extracorporeal circuit with peak sales potential of $200M.
AcelRx expects Alora will continue to build on AcelRx’s previous focus on procedural suites, with the employment of AcelRx’s existing sales representatives at closing, and the utilization of a number of their own existing sales representatives that will also expand into the hospital and surgery center settings, which both companies believe to be the largest market opportunity for DSUVIA.
“As stated previously, our goal has been to find a partner for DSUVIA who is better resourced and has the experience to expand the sales of DSUVIA to the hospital and surgery center markets and to build on our current momentum in the procedural suites. In addition, we believe the opportunity to maintain our relationship with the DoD will benefit all parties and leverage years of effort and education into incremental value for our shareholders,” stated Vince Angotti, Chief Executive Officer of AcelRx. “We believe that Alora is in a great position to deliver value given their expertise in commercializing products in hospitals, experience with manufacturing and selling controlled substances, and a seasoned commercial team across their group of companies of over 200 people.”
Mr. Angotti continued, “The divestment of DSUVIA marks a new chapter in the evolution of AcelRx enabling our laser focus on the advancement of our high-value, late-stage development assets led by Niyad. In particular, we have progressed our lead nafamostat product candidate, Niyad™ to prepare for an Emergency Use Authorization (EUA) submission in this first half of 2023. In addition, we expect to submit our first ephedrine pre-filled syringe NDA in the first half of this year. This transaction also allows us to continue to reduce operating expenses while sharing in the continued value of DSUVIA. We believe that the divestment of DSUVIA, plus the advancement of both our nafamostat and pre-filled syringe portfolio programs, builds long-term value for our shareholders and sets us on the path to a new era for the Company with multiple late-stage, and potentially commercial stage assets within the next 12 months.”
“We are proud to partner with AcelRx to continue the growth and distribution of DSUVIA to ensure access by patients. This product will help Alora Pharmaceuticals expand our pain management portfolio. DSUVIA provides an effective solution for patients in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, with management of acute pain severe enough to require an opioid analgesic,” said Art Deas, CEO of Alora Pharmaceuticals, LLC.