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Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia
Date:1/5/2009

for the accreditation of hospitals, and the Institute for Safe Medication Practices. Providing injectable products, especially those for critical care use, in premixed, ready to use forms is a high priority solution to minimize medication errors.

Dr. Cooper continued, "While this regulatory approval is for NEXTERONE supplied in vials and a prefilled syringe, the changes in the compatibility and stability profile of NEXTERONE, brought about by the removal of polysorbate 80 and benzyl alcohol, present the opportunity to formulate intravenous amiodarone for the first time in premixed, ready to use configurations."

Prism is currently implementing a full scale manufacturing development program with the Medication Delivery business of Baxter Healthcare Corporation, a world leader in premix technologies. Prism intends to submit a supplemental NDA for the premixed configurations which will form the focus of the commercial launch of NEXTERONE as a complete product line. Health-System Pharmacists hold the primary management responsibility for improvements in medication safety in hospitals and this will be a key target customer group for NEXTERONE.

"We intend to commercialize NEXTERONE ourselves in the US with partners that are well positioned in the hospital marketplace and will seek to license the ex-US worldwide rights," said Dr. Cooper. "As we round out the NEXTERONE product line with the premixed bag configurations, we are concurrently defining the best approach to launch the brand, drive rapid conversion and optimize the value of NEXTERONE to pharmacists, clinicians, patients and the Company. I believe NEXTERONE can rapidly replace generic Amiodarone IV when it becomes available and has the potential to eventually render conventional Amiodarone IV obsolete."

The FDA approval of NEXTERONE triggers a second $10M milestone payment from Paul Capital. This long range financing agreement, estab
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SOURCE Prism Pharmaceuticals
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