– USA, CA – AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced today the appointment of Howard B. Rosen as the Chief Executive Officer of AcelRx, effective April 1, 2016. Mr. Rosen has served as the interim CEO for AcelRx since April 1, 2015. Mr. Rosen is an experienced and technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Mr. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences, Inc. and ALZA Corporation. More recently he was interim CEO of Pearl Therapeutics which was subsequently acquired by Astra Zeneca for up to $1.15 billion in 2013. Mr. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra, Ltd. and two private biopharmaceutical companies.
“Howie has done a tremendous job over the past year helping the Company review and revise its priorities and in ensuring quality and timely execution of organizational goals. The Board determined that Howie is the best person to lead the Company in completing the NDA submissions for ARX-04 and Zalviso, and preparing the Company for the potential approval and commercialization of these important products,” commented Adrian Adams, Chairman of the Board of Directors of AcelRx.
“I appreciate the support of the employees, the Board of Directors and our shareholders during the past year as interim CEO. We have successfully transitioned ARX-04 into late-stage development, defined the regulatory pathway for ARX-04 and Zalviso in the U.S., seen the approval for Zalviso in Europe and strengthened our balance sheet,” commented Mr. Rosen.
“Now that we have received the necessary approvals from the Department of Defense and have initiated the two remaining Phase 3 studies for ARX-04, we have reviewed our resource needs and will focus our clinical, regulatory and commercial teams primarily on ARX-04,” stated Howie Rosen, CEO. Also, we were going to make the switch to commercial Zalviso supplies post-approval but by doing it now, we anticipate it will ultimately make the launch of Zalviso in the U.S. smoother.” Mr. Rosen affirmed, “Zalviso remains an important product for AcelRx and we look forward to updating the market on its progress toward NDA resubmission.”
The Company confirms its corporate objective that, assuming successful completion of the ongoing ARX-04 Phase 3 studies (SAP302 and SAP303) by the third quarter of 2016, the Company anticipates submitting the NDA for ARX-04 in the fourth quarter of 2016.
About AcelRx
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain. The Company’s late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg) designed for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso™ (sufentanil sublingual tablet system) designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index opioid, sublingually through a disposable, pre-filled, single-dose applicator. AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04 into studies in emergency room patients (SAP302) and post-operative patients 40 years and older (SAP303). Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. In response to the New Drug Application (NDA) AcelRx submitted to the U.S. Food and Drug Administration (FDA) seeking approval for Zalviso, AcelRx received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study (IAP312), which AcelRx is planning to initiate once supply testing is complete in order to support its NDA resubmission.
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