Pharma Focus America

AcelRx Pharmaceuticals Announces Divestment of DSUVIA® to Alora Pharmaceuticals

Wednesday, March 15, 2023

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company specializing in the development and commercialization of innovative therapies for use in medically supervised settings, has 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.

Under the agreement, AcelRx will receive a 15% royalty on commercial sales of DSUVIA and a 75% royalty on sales of DSUVIA to the Department of Defense (DoD), which is DSUVIA's largest customer. Additionally, AcelRx stands to earn up to $116.5 million in sales-based milestones. The transaction is expected to close by the end of the month, and AcelRx will provide transition services, which will be reimbursed, for a period of up to six months after the closing. In exchange for the 75% royalty on net sales to the DoD, AcelRx will maintain its relationship with the DoD, ensuring continued engagement and anticipated sales expansion to the DoD. The divestment will enable AcelRx to concentrate its operations and capital on its late-stage, high-value asset programs, with a particular focus on its lead nafamostat program, Niyad™, as an anticoagulant for the extracorporeal circuit, which has a peak sales potential of $200 million.

AcelRx expects Alora to build upon its previous focus on procedural suites, employing AcelRx's existing sales representatives and expanding into the hospital and surgery center settings, which both companies believe represent the largest market opportunity for DSUVIA.

Vince Angotti, Chief Executive Officer of AcelRx, expressed the company's goal of finding a partner for DSUVIA who has the necessary resources and experience to expand sales in the hospital and surgery center markets, as well as build upon the momentum in procedural suites. He highlighted the benefit of maintaining their relationship with the DoD, which will leverage years of effort and education into incremental value for shareholders. Angotti believes that Alora, with its expertise in commercializing products in hospitals, experience in manufacturing and selling controlled substances, and a seasoned commercial team of over 200 people, is well-positioned to deliver value.

Angotti further emphasized that the divestment of DSUVIA marks a new chapter for AcelRx, allowing them to focus on advancing their high-value, late-stage development assets, led by Niyad. The company has made significant progress in preparing their lead nafamostat product candidate, Niyad, for an Emergency Use Authorization (EUA) submission in the first half of 2023. They also anticipate submitting their first ephedrine pre-filled syringe New Drug Application (NDA) in the first half of this year. The transaction not only reduces operating expenses but also enables AcelRx to share in the continued value of DSUVIA. Angotti believes that the divestment of DSUVIA, coupled with the advancement of their nafamostat and pre-filled syringe portfolio programs, will create long-term value for shareholders and pave the way for a new era for the company, with multiple late-stage and potentially commercial-stage assets within the next 12 months.

Art Deas, CEO of Alora Pharmaceuticals, expressed pride in partnering with AcelRx to continue the growth and distribution of DSUVIA, ensuring patient access to the product. He noted that DSUVIA provides an effective solution for patients in medically supervised healthcare settings such as hospitals, surgical centers, and emergency departments, who require an opioid analgesic to manage acute pain. Deas sees DSUVIA as a valuable addition

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