Monday 1st November 2021
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AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces the US Food and Drug Administration (FDA) has confirmed acceptance of the New Drug Application (NDA) for Maxigesic IV®, the intravenous form of its patented pain relief medicine which was filed in August this year.
The US regulator is expected, in due course to confirm the Prescription Drug User Fee Act (PDUFA) action date for the filing. The PDUFA date – the date at which the FDA must respond to the application will be notified later this year and is estimated to be between August and September 2022.
As disclosed in April, the licensing of Maxigesic IV to our US partner Hikma Pharmaceuticals and the filing with the FDA triggers milestone payments in aggregate of US$3.6 million, which will be recognised in the first half of the current financial year.
In total the licensing agreement with Hikma, the US’ third largest supplier of generic injectable medications by volume, will see AFT benefit from upfront, regulatory and commercial milestone payments of up to US$18 million and a profit share from in-market product sales.
AFT Managing Director Dr Hartley Atkinson said: “The NDA acceptance marks an important milestone for our company. It is a major step towards bringing much needed innovation in non-opioid, post-operative pain management and addressing the current opioid crisis, which is responsible for many deaths in the U.S. each year.
“Together with our EU-based development partner Hyloris Pharmaceuticals and Hikma, we are looking forward to working with the FDA and to further executing on our global commercial rollout of Maxigesic IV.”
The NDA submission is based on positive data from two Phase 3 studies of Maxigesic IV: a randomised, double-blind, placebo-controlled efficacy trial in 276 patients following bunionectomy surgery and an open-label, multi-centre, single arm, multiple dose safety study in 232 patients undergoing general, orthopaedic, or plastic surgery.
Treatment with Maxigesic IV was well-tolerated, had a faster onset of action and offered higher pain relief compared to ibuprofen IV or paracetamol IV alone in the same doses.
Moreover, the superior analgesic effect of Maxigesic IV was supported by a range of secondary endpoints, including reduced opioid usage rates compared to the paracetamol IV, ibuprofen IV and placebo treatment groups (P<0.005).
The open-label Phase 3 safety study demonstrated that Maxigesic IV, administered 6-hourly as a 15-minute infusion over an exposure period of 48 hours to 5 days, was well-tolerated, and was perceived positively by study participants, supporting a favourable risk benefit profile.
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