Hyloris Announces Approval of Maxigesic® IV in the UK and Ireland
19 Ottobre 2021 - 7:00AM
Hyloris Announces Approval of Maxigesic® IV in the UK and Ireland
- Maxigesic® IV provides a
non-opioid, dual mode-of-action pain management alternative to
traditional analgesics
Liège, Belgium –
19 October 2021 – Hyloris
Pharmaceuticals SA (Euronext Brussels: HYL), a specialty
biopharma company committed to addressing unmet medical needs
through reinventing existing medications, today announces further
extension of the European footprint of Maxigesic® IV, a novel,
unique combination of 1000mg paracetamol and 300mg ibuprofen
solution for infusion, for the treatment of post-operative
pain.
Maxigesic IV has now obtained regulatory
approvals in the UK and Ireland, thereby increasing the number of
countries in which Hyloris’ partner AFT Pharmaceuticals obtained
regulatory approval for Maxigesic IV to 27 countries, from 21
countries at the end of March 2021. Kensington Pharmaceuticals
Ltd., the distributor for the UK, and Jed Pharma Ltd, the
distributor in Ireland, are now gearing up to commence sales in the
first quarter of 2022.
Annually, over 3.1 million surgical procedures
are performed in the UK and Ireland, and the market for
postoperative pain in these countries is expected to grow to $122.1
million by 2028 at a CAGR of 13.23% from 2017-2028.1
Stijn Van Rompay, Chief Executive
Officer of Hyloris, commented: “Maxigesic IV is a
breakthrough non-opioid pain treatment, offering surgeons a
well-tolerated and effective alternative to highly addictive
opioids. We are very pleased that Maxigesic IV is gaining further
momentum with additional regulatory approvals and together with our
partners, we look forward to making the product available in these
key markets.”
Maxigesic IV has been developed under the
collaboration agreement signed in 2012 between Hyloris and AFT
Pharmaceuticals. The product is currently licensed in over 100
countries across the globe, has been registered in 27 countries and
is now launched in 5 countries. Maxigesic IV is protected by
several granted patents and pending patent applications.
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 13 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: Marieke VermeerschVP Investor
Relations and Corporate
Communicationsinvestorrelations@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 Postoperative Pain Market Insights, Epidemiology and Market
Forecast – 2028 - DelveInsight
- 211019 Hyloris Press Release Maxigesic IV Approval UK_ENG
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