AcelRx Pharmaceuticals, a California-based specialty pharma focused on development and commercialization of innovative therapies for the treatment of acute pain, has restructured its work force as part of a plan to reduce operating costs and focus its financial and development resources on working with the FDA to seek marketing approval for Zalviso, as well as to continue the development of ARX-04.
Zalviso is an investigational pre-programmed, non-invasive system to allow hospital patients with moderate-to-severe acute pain to self-dose with sufentanil sublingual tablets to manage their pain. Zalviso consists of sufentanil tablets delivered by the Zalviso System, a needle-free, handheld, patient-administered, pain management system.
This restructuring will reduce the company's workforce by 19 employees, or approximately 36% of its work force, primarily affecting the commercial team and field-based medical personnel, who were hired in preparation for a potential commercial launch of Zalviso.
AcelRx has appointed Howard B. Rosen as interim CEO, effective April 1. Rosen is a technically trained executive with over 25 years of success growing start-up and mid-sized biopharma companies. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development and R&D at Gilead Sciences and ALZA. Rosen has worked on the board of directors of AcelRx since 2008 and currently sits on the board of directors of Alcobra and several private biopharma companies.
"While we seek to get clarity from the FDA regarding the continued development of Zalviso, we are focusing on reducing operating costs and conserving our capital resources. In addition, our phase III development of ARX-04 is proceeding on schedule and is another exciting opportunity for the use of sublingual sufentanil in the management of moderate-to-severe acute pain. With the reduction in work force, we believe we retain the capabilities to continue work on both Zalviso and ARX-04 with the ultimate goal of gaining marketing approval for both products," said Rosen.
AcelRx estimates a charge of approximately $0.9 million associated with the reduction in force, including severance payments and medical and health benefits. The company anticipates that this charge will be reflected in the operating results for the quarter ending March 31, with payment in the second quarter of 2015. Following the one-time charges associated with this restructuring plan, AcelRx estimates savings of approximately $0.9 million per fiscal quarter attributable to the reduction in force.