Hyloris Announces Earlier than Expected PDUFA Date for Maxigesic® IV
15 November 2021 - 07:00AM
Hyloris Announces Earlier than Expected PDUFA Date for Maxigesic®
IV
- PDUFA date set on 30 June 2022,
ahead of the August to September 2022 timeframe initially
expected
Liège, Belgium –
15 November
2021, 7:00 am
CET – Hyloris Pharmaceuticals SA (Euronext
Brussels: HYL), a specialty biopharma company committed to
addressing unmet medical needs through reinventing existing
medications, today announces that the U.S. Food and Drug
Administration (FDA) has set the Prescription Drug User Fee Act
date (PDUFA) for the New Drug Application (NDA) for Maxigesic® IV
on 30 June 2022. The PDUFA date is the date by which the FDA must
respond to an NDA.
Maxigesic IV is a novel, unique combination of
1000mg paracetamol and 300mg ibuprofen solution for infusion,
indicated for the relief of mild to moderate pain and for the
management of moderate to severe pain as an adjunct to opioid
analgesics, where an intravenous route of administration is
considered clinically necessary. Maxigesic IV has been developed
under the collaboration agreement between Hyloris and AFT
Pharmaceuticals and is currently licensed in over 100 countries
across the globe, has been registered in 28 countries and is now
launched in 5 countries. Maxigesic IV is protected by several
granted patents and pending patent applications.
Stijn Van Rompay, Chief Executive
Officer of Hyloris, commented: “We are extremely pleased
that the PDUFA date comes earlier than expected, which offers the
potential for earlier registration and commercialisation in the
U.S. Together with our partners, we are looking forward to working
with the FDA during the review process and to further executing on
our global commercial rollout. Upon approval in the U.S., Maxigesic
IV will be commercialised by Hikma Pharmaceuticals, a leading
supplier of complex, injectable hospital products in the U.S.”
The NDA for Maxigesic IV was based on positive
data from two Phase 3 studies of Maxigesic IV: i) a randomised,
double-blind, placebo-controlled efficacy trial in 276 patients
following bunionectomy surgery; and ii) an open-label,
multi-centre, single arm, multiple dose safety study in 232
patients undergoing general, orthopaedic, or plastic surgery. As
previously reported, 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)1. 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 safe and well-tolerated, and was perceived positively by
study participants, supporting a favourable risk benefit
profile.2 About Hyloris
Pharmaceuticals Hyloris is a specialty biopharma company
focused on innovating, reinventing, and optimising existing
medications to address important healthcare needs and deliver
relevant improvements for patients, healthcare professionals and
payors. Hyloris has built a broad, patented portfolio of 14
reformulated and repurposed value-added medicines that have the
potential to offer significant advantages over available
alternatives. Outside of its core strategic focus, the Company also
has 3 high barrier generic products in development and registration
phase. Two products are currently in initial phases of
commercialisation with partners: Sotalol IV for the treatment of
atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative
pain treatment. The Company’s development strategy primarily
focuses on the FDA’s 505(b)2 regulatory pathway, which is
specifically designed for pharmaceuticals for which safety and
efficacy of the molecule have already been established. This
pathway can reduce the clinical burden required to bring a product
to market, and significantly shorten the development timelines and
reduce costs and risks. Hyloris is based in Liège, Belgium. For
more information, visit www.hyloris.com and follow-us on
LinkedIn.
For more information, please
contact: Hyloris Pharmaceuticals, Investor Relations and
Mediainvestorrelations@hyloris.com Disclaimer and
forward-looking statementsHyloris means “high yield, lower
risk”, which relates to the 505(b)(2) regulatory pathway for
product approval on which the Issuer focuses, but in no way relates
or applies to an investment in the Shares.Certain statements in
this press release are “forward-looking statements.” These
forward-looking statements can be identified using forward-looking
terminology, including the words "believes", "estimates,"
"anticipates", "expects", "intends", "may", "will", "plans",
"continue", "ongoing", "potential", "predict", "project", "target",
"seek" or "should", and include statements the Company makes
concerning the intended results of its strategy. These statements
relate to future events or the Company’s future financial
performance and involve known and unknown risks, uncertainties, and
other factors, many of which are beyond the Company’s control, that
may cause the actual results, levels of activity, performance or
achievements of the Company or its industry to be materially
different from those expressed or implied by any forward-looking
statements. The Company undertakes no obligation to publicly update
or revise forward-looking statements, except as may be required by
law.
1 Daniels et al, 2019, Clinical Therapeutics2 Gottlieb et al,
2021, Biomedicine & Pharmacotherapy
- 211115 Hyloris Press Release Maxigesic PDUFA_ENG
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