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"Approval of our first product is an important corporate milestone andvalidates our accelerated development model, which allowed us to moveNEXTERONE from licensing to FDA clearance in less than three years and aheadof the PDUFA target date," said Dr. Warren D. Cooper, President and CEO ofPrism. "We developed NEXTERONE to overcome solvent-based limitations ofconventional intravenous amiodarone and to improve patient care and overallmedication management in the setting of life-threatening cardiac arrhythmias."
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NEXTERONE represents the first product to successfully overcome the longrecognized solubility issues of amiodarone by removing the original cosolventspolysorbate 80 and benzyl alcohol. As a result of removing these cosolvents,NEXTERONE does not have many of the product administration limitationsregarding 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 offatal gasping syndrome in newborn infants because it does not contain benzylalcohol.
Improving medication safety in the hospital environment is an area ofsignificant and current attention. This agenda is being driven by entitiessuch as The Joint Commission, which is responsible for the accreditation ofhospitals, and the Institute for Safe Medication Practices. Providinginjectable 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 NEXTERONEsupplied in vials and a prefilled syringe, the changes in the compatibilityand stability profile of NEXTERONE, brought about by the removal ofpolysorbate 80 and benzyl alcohol, present the opportunity to formulateintravenous amiodarone for the first time in premixed, ready to useconfigurations."
Prism is currently implementing a full scale manufacturing developmentprogram with the Medication Delivery business of Baxter HealthcareCorporation, a world leader in premix technologies. Prism intends to submit asupplemental NDA for the premixed configurations which will form the focus ofthe commercial launch of NEXTERONE as a complete product line. Health-SystemPharmacists hold the primary management responsibility for improvements inmedication safety in hospitals and this will be a key target customer groupfor NEXTERONE.
"We intend to commercialize NEXTERONE ourselves in the US with partnersthat are well positioned in the hospital marketplace and will seek to licensethe ex-US worldwide rights," said Dr. Cooper. "As we round out the NEXTERONEproduct line with the premixed bag configurations, we are concurrentlydefining the best approach to launch the brand, drive rapid conversion andoptimize the value of NEXTERONE to pharmacists, clinicians, patients and theCompany. I believe NEXTERONE can rapidly replace generic Amiodarone IV whenit becomes available and has the potential to eventually render conventionalAmiodarone IV obsolete."
The FDA approval of NEXTERONE triggers a second $10M milestone paymentfrom Paul Capital. This long range financing agreement, established inSeptember 2006, provides Prism with non-dilutive capital to enable the companyto 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 27th AnnualJP Morgan Healthcare Conference on January 13, 2009 at 7:30 a.m. PST/10:30a.m. EST. A webcast of the presentation will be available onhttp://www.prismpharma.com.
About Ventricular Fibrillation and Ventricular Tachycardia
Ventricular fibrillation is a condition in which the heart's electricalactivity becomes disordered. When this happens, the heart's lower (pumping)chambers contract in a rapid, unsynchronized way. (The ventricles "flutter"rather than beat.) The heart pumps little or no blood. Ventricularfibrillation is very serious. Collapse and sudden cardiac death will follow inminutes unless medical help is provided immediately.
Ventricular tachycardia is a fast or rapid heart rate that starts in theheart's lower chambers (ventricles). Ventricular tachycardia may result fromserious heart disease and usually requires prompt treatment.
Important Safety Information About NEXTERONE
The most important treatment-emergent adverse effects associated withintravenous amiodarone therapy in clinical studies were hypotension,asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenicshock, congestive heart failure, bradycardia, liver function testabnormalities, ventricular tachycardia, and atrioventricular block. Overall,treatment was discontinued for about 9 percent of the patients because ofadverse effects. The most common adverse effects leading to discontinuationof intravenous amiodarone therapy were hypotension (1.6 percent),asystole/cardiac arrest/EMD (1.2 percent), ventricular tachycardia (1.1percent), and cardiogenic shock (1 percent).
NEXTERONE is contraindicated in patients with known hypersensitivity toany of the components of NEXTERONE, including iodine, or in patients withcardiogenic shock, marked sinus bradycardia, and second- or third-degree AVblock unless a functioning pacemaker is available.
NEXTERONE is for hospital use only. NEXTERONE should be administered onlyby physicians who are experienced in the treatment of life-threateningarrhythmias, who are thoroughly familiar with the risks and benefits ofintravenous amiodarone therapy, and who have access to facilities adequate formonitoring the effectiveness and side effects of treatment.
For more information about NEXTERONE, including full prescribinginformation, visit http://www.prismpharma.com.
About Prism Pharmaceuticals
Prism Pharmaceuticals, based in King of Prussia, Pennsylvania, is aspecialty pharmaceutical company committed to developing and commercializingacute care cardiovascular products. The product portfolio strategy is focusedon recognizing unfulfilled opportunities in existing compounds that addresscurrent unmet medical needs with a specific focus on medication safety in thehospital environment.
Prism was started in 2004 with a founding investment from Essex WoodlandsHealth Ventures (http://www.ewhv.com). In 2006 Prism secured a $68M layeredfinancing of equity from Essex combined with equity and a revenue interestagreement from Paul Capital (http://www.paulcap.com). This level of sustaininginvestment has enabled Prism to pursue an aggressive licensing and rapiddevelopment model resulting in the successful approval of NEXTERONE.
The worldwide rights to NEXTERONE were licensed in early 2006 from CyDexPharmaceuticals (http://www.cydexpharma.com). NEXTERONE is based on the CyDexpatent-protected CAPTISOL(R) technology platform. Prism and CyDex are alsodeveloping a novel injectable form of the blockbuster antiplatelet agentPLAVIX(R) (clopidogrel) for use in acute care situations overcoming thelimitations of the current product which is only available as an oral therapy.
For further information, visit http://www.prismpharma.com.
NEXTERONE(R) is a registered trademark of Prism Pharmaceuticals, Inc.Cordarone(R) and PLAVIX(R) are registered trademarks of sanofi-aventis.
SOURCE Prism Pharmaceuticals
