Prism Pharmaceuticals announced that the US Food & Drug Administration (FDA) has approved the new drug application (NDA) for Nexterone (amiodarone HCl) Injection, a novel, patent-protected, cosolvent-free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
"Approval of our first product is an important corporate milestone and validates our accelerated development model, which allowed us to move Nexterone from licensing to FDA clearance in less than three years and ahead of the PDUFA target date," said Dr Warren D Cooper, president and CEO of Prism. "We developed Nexterone to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias."
Nexterone represents the first product to successfully overcome the long recognized solubility issues of amiodarone by removing the original cosolvents, polysorbate 80 and benzyl alcohol. As a result of removing these cosolvents, Nexterone does not have many of the product administration limitations regarding compatibility and stability with plastics and ionic infusion fluids, which are included in the labeling of conventional intravenous amiodarone. Importantly, Nexterone does not carry the specific warning about the risk of fatal gasping syndrome in newborn infants because it does not contain benzyl alcohol.
Improving medication safety in the hospital environment is an area of significant and current attention. This agenda is being driven by entities such as joint commission, which is responsible 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 pre-filled 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 $10 million milestone payment 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 NDA review and commercial launch.
Dr Cooper will present the corporate strategy for Prism Pharmaceuticals, the commercial plans for Nexterone, and the product pipeline at the JP Morgan 27th Annual Healthcare Conference on January 13, 2009 at 7:30 am PST/10:30 am EST. A webcast of the presentation will be available on www.prismpharma.com.
Prism Pharmaceuticals, based in King of Prussia, Pennsylvania, is a specialty pharmaceutical company committed to developing and commercializing acute care cardiovascular products.