Hyloris Announces Launch of Maxigesic® IV in the U.S. and approval
In Canada
Hyloris Announces Launch of Maxigesic® IV
in the U.S. and approval In Canada
-
Maxigesic® IV, a Potent Non-opioid Painkiller, Marketed in the U.S.
under the Tradename Combogesic® IV
-
Maxigesic® IV approved in Canada
Liège, Belgium – 27 February 2024, 06:00
PM CET – Non-regulated information – Hyloris Pharmaceuticals SA
(Euronext Brussels: HYL), a specialty biopharma company
committed to addressing unmet medical needs through reinventing
existing medications, today announces that Hikma Pharmaceuticals
(Hikma) has launched Maxigesic® IV in the U.S. under the tradename
Combogesic® IV.
Stijn Van Rompay, Chief Executive
Officer of Hyloris, commented: “I am delighted with
the rapid marketing launch by our partner Hikma Pharmaceuticals, a
leading supplier of injectable medicines globally. The initial
feedback from the market is encouraging. Combogesic® IV represents
a significant innovation in pain management, offers effective pain
relief and importantly provides clinicians a valuable alternative
to opioid analgesics.”
Hyloris is entitled to a milestone payment of
USD 1,1 million, in addition to the USD 1 million that became due
upon product manufacturing, which occurred in December 2023.
Approval of Maxigesic® IV in
Canada
Maxigesic® IV has recently been granted
marketing authorization by Health Canada.
Canada1 is facing a significant
public health crisis related to opioid use with debilitating
consequences for individuals, families, and communities. 22
Canadians die on average each day from apparent opioid toxicity.
Between 2022 and 2023, health systems have seen an 11% year over
year increase in the number of opioid-related hospitalizations.
Beyond the human toll, the opioid crisis has significantly impacted
Canada's economy, costing an estimated CAD 3,5 billion across
healthcare, law enforcement, and lost productivity.
Stijn Van Rompay added:
“When launched, it will fill the critical need for
post-surgical pain management between inadequate non-steroidal
anti-inflammatory drugs (NSAIDs) and habit-forming
opioids.”
About the opioid pandemic in the
U.S.
The opioid pandemic in the U.S. is a critical
healthcare issue, with chronic opioid use after surgery being one
of the most common post-operative complications2. The
devastating consequences are reflected in the prevalence of new
chronic opioid use post-surgery in the U.S. In the past 2 decades,
prescription opioid usage in the U.S. contributed to over 600,000
deaths related to opioid overdoses, with the annual death toll
rising tenfold between 1999 and 2021. In 2021 alone approximately
80,000 deaths were attributed to opioid overdoses, with nearly
involving prescription opioids. The economic impact is also
substantial, as patients requiring medical attention related to
opioid abuse contribute around USD 11 billion in added costs to the
U.S. healthcare system annually, constituting 1% of all hospital
costs.
About Maxigesic® IV
Maxigesic® IV is a unique combination of 1000mg paracetamol with
300mg ibuprofen solution for infusion (in a 100 ml bottle) for use
post-operatively. Results from a randomised, double-blind,
placebo-controlled Phase 3 trial in 276 patients following bunion
surgery demonstrated that Maxigesic® IV was well-tolerated and 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 consumption compared to the Paracetamol IV and Ibuprofen IV
treatment groups (p-value < 0.005). Hyloris holds several
patents for the U.S. market, with the latest expiring in 2038.
Maxigesic® IV is, to date, licensed in over 100 countries,
approved in over 40 countries and marketed in over 20
countries.
About Hyloris Pharmaceuticals
SA
Hyloris is a specialty biopharma company focused
on innovating, reinventing, and optimizing existing medications to
address important healthcare needs and deliver relevant
improvements for patients, healthcare professionals and payors.
The Company’s development strategy primarily
focuses on leveraging established regulatory pathways, such as the
FDA’s 505(b)2 pathway in the U.S or equivalent regulatory
frameworks in other regions which are specifically designed for
pharmaceuticals for which safety and efficacy of the molecule have
already been established. This approach can reduce the clinical
burden required for market entry, and significantly shorten the
development timelines, leading to reduced costs and risks.
Hyloris has built a broad, patented portfolio of
18 reformulated and repurposed value-added medicines that have the
potential to offer significant advantages over existing
alternatives. Two products are currently in early phases of
commercialization in collaboration with commercial partners:
Sotalol IV for the treatment of atrial fibrillation, and Maxigesic®
IV, a non-opioid post-operative pain treatment. In addition to its
core strategic focus, the Company has 1 approved high barrier
generic product launched in the U.S. and 2 high barrier generic
products in development.
Hyloris is based in Liège, Belgium. For more
information, visit www.hyloris.com and follow-us
on LinkedIn.
For more information, contact
Hyloris:
Stijn Van Rompay, CEO
Stijn.Vanrompay@hyloris.com
+32 (0)4 346 02 07
Jean-Luc Vandebroek, CFO
Jean-luc.vandebroek@hyloris.com
+32 (0)478 27 68 42
Jessica McHargue, Investor Relations & Communications
Jessica.mchargue@hyloris.com
+1 (919) 451 4740
Disclaimer and forward-looking
statements
Hyloris 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
https://health-infobase.canada.ca/substance-related-harms/opioids-stimulants/
https://pubmed.ncbi.nlm.nih.gov/33279425/
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7990836/
https://jamanetwork.com/journals/jamasurgery/fullarticle/2618383
Opioid Data Analysis and Resources | Opioids | CDC
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