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This level of sustaining investment has enabled Prism to pursue an aggressive licensing and rapid development model resulting in the successful approval of NEXTERONE.
The worldwide rights to NEXTERONE were licensed in early 2006 from CyDex Pharmaceuticals, Inc.
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 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.
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.
The FDA approval of NEXTERONE triggers a second $10M milestone payment from Paul Capital.
The development and approval of NEXTERONE has been Prism's greatest achievement," said Warren Cooper, CEO of Prism Pharmaceuticals.
NEXTERONE Premixed Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
Prism's success in advancing this new, premixed IV bag formulation of NEXTERONE demonstrates not only the role Captisol can play in the development of novel products for intravenous therapy in the hospital setting, but also the productivity of this longstanding licensing relationship.