CytRx Highlights Orphazyme’s Acceleration of Pre-Launch Activities for Arimoclomol
CytRx Corporation (OTCQB: CYTR) (“CytRx” or the “Company”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted that Orphazyme A/S (ORPHA.CO) (NASDAQ:ORPH) (“Orphazyme”) has announced new plans to accelerate commercial and other pre-launch activities during the fourth quarter of 2020 in preparation for potential approval of arimoclomol in Niemann-Pick disease Type C (“NPC”), which is currently under Priority Review by the U.S. Food and Drug Administration (“FDA”) with a target action date of March 17, 2021. CytRx has an agreement with Orphazyme that can yield potential milestone payments and future royalties paid on sales of arimoclomol.
According to Orphazyme, the organization’s reinforced financial position following a successful global stock offering has enabled it to commit additional resources to efforts pertaining to arimoclomol. Orphazyme stated that it will further invest in its Early Access Programs, additional API manufacturing, regulatory affairs and clinical safety activities. Orphazyme also expects continued costs through year-end for the ongoing trials in sporadic Inclusion Body Myositis and amyotrophic lateral sclerosis in order to provide home nursing and direct to patient distribution due to the COVID-19 pandemic. Orphazyme has stated that it wants to be well-situated to commercialize and launch arimoclomol for NPC if it receives FDA approval in 2021.
Orphazyme’s Chief Executive Officer, issued the following statement last week:
“There is real momentum here at Orphazyme as we move closer to potential approval of arimoclomol in the U.S. in its first indication of NPC and accelerating our preparatory efforts now will help ensure a smooth launch. There are currently no approved products for NPC in the U.S. and arimoclomol has the potential to make a significant difference to patients with this devastating disease, so our team is working expeditiously to ensure we are optimally positioned for a successful launch if approved.”
In September 2020, the FDA accepted Orphazyme’s New Drug Application (“NDA”) for arimoclomol for NPC, with priority review. The FDA set a target action date of March 17, 2021 under the Prescription Drug User Fee Act, or PDUFA, for completion of its review of the NDA. Orphazyme continues to expect to submit a Marketing Authorization Application, or MAA, to the European Medicines Agency in the second half of 2020.
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