Hyloris Announces Further Extension of Maxigesic® IV Footprint
21 Settembre 2021 - 07:00AM
- Regulatory approvals in South
Korea, the fourth largest pharma market in Asia, and Panama
- Maxigesic® IV provides a
non-opioid, dual mode-of-action pain management alternative to
traditional analgesics
Liège, Belgium – 21 September
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 global
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 South Korea, the fourth largest pharmaceutical market
in Asia, and Panama, thereby increasing the number of countries in
which Hyloris’ partner AFT Pharmaceuticals obtained regulatory
approval for Maxigesic IV to 26 countries, from 24 countries at the
end of March 2021.
Kyongbo Pharmaceuticals Co., the licensee for
the South Korean market, is now gearing up to commence sales in
early 2022. The licensee for Panama, Pharma Bavaria International,
which has a license agreement for Maxigesic IV in 17 countries in
Latin, Central America, and the Caribbean, is planning to launch
the product later this year in Panama. The commercial rollouts
represent the first launches of Maxigesic IV in Asia and Latin
America.
Stijn Van Rompay, Chief Executive
Officer of Hyloris, commented: “Maxigesic IV is a
breakthrough non-opioid post-operative pain treatment, offering
clinicians a well-tolerated and effective alternative to highly
addictive opioids. We are very pleased that Maxigesic IV is gaining
further international momentum with additional regulatory approvals
in key markets. Meanwhile, we and our partners are also making good
progress with the regulatory submission process in the U.S., and we
look forward to updating the market on further achievements over
the next period.”
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 26 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 products that have the potential to offer significant
advantages over currently available alternatives. Two products are
currently commercialised 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 CommunicationsM: +32 (0)479 490
603investorrelations@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.
- 210921 Hyloris Press Release Maxigesic International
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