Topotarget A/S announces that the FDA has granted acceptance to file and priority review for the Beleodaqtm NDA for the treatment of relapsed or refractory PTCL.
In December 2013, Topotarget’s US partner, Spectrum Pharmaceuticals, submitted a New Drug Application (NDA) for BeleodaqTM in relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) to the US Food and Drug Administration (FDA). This NDA has now been granted acceptance to file and Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 9, 2014.
The acceptance to file triggers the first of two expected milestone payments related to the study of BeleodaqTM in R/R PTCL patients in the USA: Spectrum Pharmaceuticals is to pay Topotarget USD 10 million and 1 million Spectrum Pharmaceuticals shares.
“We are very pleased with this news. This is a significant milestone for BeleodaqTM for the treatment of R/R PTCL patients. Also, the Priority Review designation underlines our drug’s potential compared to available treatments. Upon the receipt of the related milestone payment, we will look forward to presenting our new corporate strategy within the near-term future”, says Anders Vadsholt, CEO of Topotarget in a press release.
As previously disclosed, an additional milestone cash payment from Spectrum Pharmaceuticals is triggered upon an NDA approval. Upon an approval, Topotarget will moreover be eligible to receive potential royalty payments and sales milestones.