Prism gets FDA app for Nexterone injection

The USA's Prism Pharmaceuticals has received Food and Drug Administration approval for Nexterone (amiodarone HCl) injection, a  novel co-solvent-free formulation of the anti-arrhythmic agent  amiodarone IV, originally marketed  by Wyeth as Cordarone Intravenous.

"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 chief executive Warren 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," he added.

The FDA approval of Nexterone triggers a second $10.0-million milestone  from Paul Capital. This long range financing agreement, established in  September 2006, provides Prism with non-dilutive capital to enable the  company to bring Nexterone through the period of New Drug Application  review and commercial launch.