Duska Therapeutics, Inc., and DSM Pharmaceuticals, Inc., have entered into a preliminary agreement to collaborate on the manufacture of commercial batches of ATPace for Duska’s planned pivotal Phase 3 clinical trial in paroxysmal supraventricular tachycardia (PSVT). ATPace will be produced at DSM’s commercial facilities in Greenville, North Carolina. ATPace, a stable liquid formulation of adenosine 5′-triphosphate (ATP) for intravenous injection, is an investigational drug for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio- ventricular nodal conduction, has been shown in numerous published clinical studies to safely and effectively terminate re-entrant PSVT involving the atrio-ventricular node. Design of a pivotal Phase 3 clinical trial for ATPace in PSVT is in the planning stage. PSVT, one of the most common cardiac arrhythmias, is a rapid, regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases of PSVT per year and approximately 570,000 persons with PSVT in the United States alone. Currently, adenosine is the only approved treatment for PSVT in the United States. Duska believes that the initial dose of ATPace will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT. While both ATP and adenosine inhibit atrio-ventricular nodal conduction, ATP is believed to have dual inhibitory action; one mediated by adenosine, the product of its rapid enzymatic degradation, and the other a triggered vagal reflex. Vagal maneuvers aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia. Injectable formulations of ATP have been approved in Europe for over 50 years as safe and efficacious treatments for PSVT. Duska is in the process of modifying the proposed design of the Phase 3 clinical trial in accordance with the FDA’s comments and plans to submit a revised protocol to the FDA for Special Protocol Assessment procedure approval. Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace’s clinical safety and efficacy. Upon successful completion of the trial, Duska intends to file a New DrugApplication under section 505(b). “We chose DSM after a thorough analysis of their ability to manufacture ATPace according to our specifications and timeline, as well as meet all of the FDA’s requirements of a commercial drug manufacturer,” stated Amir Pelleg, PhD, Duska’s President and Chief Scientific Officer. “We believe that DSM has an excellent working relationship with the FDA, experience with injectable drug products, and a superior reputation in sterile manufacturing,” he added. “We are delighted to be supporting Duska Therapeutics in bringing this important potential new therapy to market,” said Hans Engels, President and Business Unit Director for DSM Pharmaceuticals, Inc. “Through our collaboration, we have experienced first-hand, Duska’s commitment to excellence in serving a market with the need for improved treatments.” “We are excited to add Duska to our customer base and look forward to the anticipated launch of this key product, as well as the potential future growth with Duska,” remarked Laura Parks, Senior Vice President, Marketing & Sales for DSM.