Hyloris announces US FDA approval of Maxigesic® IV

  • Maxigesic IV, a strong non-opioid analgesic, is marketed in the US under the trade name Combogesic IV
  • First US sales expected early 2024, generating $2.1 million milestone payout

Lige, Belgium October 18, 2023 7am CET Regulated Information – Internal Information – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharmaceutical company committed to addressing unmet medical needs through the reinvention of existing medicines, today announced Maxigesic IV has been approved for the relief of mild to moderate and moderate to severe pain control as an adjunct to opioid analgesics in adults, where the intravenous route is considered clinically necessary.

The approval of the New Drug Application (NDA) is based on positive data from the Phase 3 program, where Maxigesic IV demonstrated that it was well tolerated and provided faster onset of action and high analgesia. than Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic IV was also supported by a series of secondary endpoints, including reduced rates of opioid use.

Stijn Van Rompay, CEO of Hyloris, commented: I am especially proud of what the Hyloris team has achieved with our development partner AFT Pharmaceuticals.

Delivering innovation by improving existing medicines highlights how Hyloris can improve patient outcomes, particularly by addressing the devastating opioid crisis in the world’s largest healthcare market gender.

Maxigesic IV demonstrates the potential of our strategy to bring product candidates to market according to our strict criteria: development time of 7 years or less and average R&D costs of less than 7 million EUR.first

An exclusive licensing and distribution agreement for the United States has been signed between Hyloris partners AFT Pharmaceuticals (AFT) and Hikma Pharmaceuticals (Hikma). Under the terms of the co-development agreement between Hyloris and AFT, Hyloris is eligible to receive a share of all product-related revenues, such as license fees, royalties, and milestone payments important that AFT received.

Distribution of Maxigesic IV in US hospitals will begin in early 2024. Following initial US sales, Hyloris will be entitled to a $2.1 million milestone payment. In addition, a payment of USD 1.5 million (approximately EUR 1.4 million) related to existing trade receivables is expected.

About the opioid epidemic in America

The development of chronic opioid use after surgery is one of the most common postoperative complications2 with particularly devastating consequences. In the US, the rate of new chronic opioid use after surgery is estimated to be nearly 6%.3.

Over the past 2 decades, prescription opioid use in the United States has contributed to more than 600,000 opioid overdose-related deaths, with the annual death toll increasing tenfold from 1999 to 2021 (80,000 deaths in 2021). Nearly 17,000 deaths linked to prescription opioids in 20214.

Patients requiring medical care related to opioid abuse account for approximately $11 billion in additional costs to the U.S. health care system annually or 1% of total hospital costs.5.

About pain after surgery

Postoperative pain is a normal response to surgical intervention and is the cause of delayed recovery and discharge from the hospital after surgery.

The global post-surgical pain medication market is worth $12.6 billion by 20236 and is predicted to grow at a CAGR of 4.7% to reach a value of USD 19 billion by 2032, with the US being the largest market.

About 50 million surgeries are performed in the US7 annual. Pain relief after surgery continues to be a major medical challenge with more than 80% of patients reporting acute pain after surgery.8. Medical professionals are increasingly aware of the societal impact of opioid abuse, as evidenced by the decline in the number of opioid prescriptions over the past decade in the US.9further increasing the need for powerful non-opioid alternatives.

Introducing Maxigesic IV
Maxigesic IV is a unique combination of 1000mg of Paracetamol with 300mg of Ibuprofen solution for infusion after surgery. Results from a randomized, double-blind, placebo-controlled Phase 3 trial in 276 patients after bunion surgery demonstrated that Maxigesic IV was well tolerated and had a faster onset of action as well as effective It is more effective in pain relief than using Ibuprofen IV or Paracetamol IV alone in the same dosage.
Furthermore, the superior analgesic effect of Maxigesic IV was supported by a series of secondary endpoints, including reduced opioid consumption compared to the Paracetamol IV and Ibuprofen IV treatment groups (p-value < 0.005).ten. Hyloris holds several patents for the US market, the latest of which expires in 2038.

Maxigesic IV is to date licensed in more than 100 countries, approved in more than 40 countries, and marketed in more than 20 countries.

Introducing Hyloris
Hyloris is a specialty biopharmaceutical company focused on innovating, reinventing and optimizing existing medicines to address critical healthcare needs and deliver tailored innovations for patients, healthcare professionals and payers. Hyloris has built a broad, patented portfolio of 16 innovative and repurposed value-added medicines that have the potential to deliver significant benefits over current alternatives. Have. In addition to its core strategic focus, the Company also has three high-barrier generic products in development.
Two products are currently in the early stages of commercialization with partners: Sotalol IV for the treatment of atrial fibrillation and Maxigesic IV, a non-opioid treatment for postoperative pain. The Company’s development strategy is primarily focused on the FDA’s 505(b)2 regulatory pathway, which is specifically designed for pharmaceutical products with established molecular safety and efficacy. This pathway can reduce the clinical burden required to bring a product to market and significantly shorten development time as well as reduce costs and risks. Hyloris is headquartered in Lige, Belgium. For more information, visit www.hyloris.com and follow us on LinkedIn.

For more information, contact Hyloris:
Stijn Van Rompay, CEO
+32 (0)4 346 02 07
Jean-Luc Vandebroek, Chief Financial Officer
+32 (0)478 27 68 42
Sven Wathy, Director of Communications & Investor Relations
+32 (0)499 71 15 29

Disclaimer and forward-looking statements
Hyloris means high return, lower risk, related to the 505(b)(2) regulatory pathway for product approvals on which the Company is focused, but not related or applicable to investments into Stocks. Certain statements in this press release are forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believe”, “estimate”, “anticipate”, “expect”, “project”. intend”, “may”, “will”, “plan”, “continue”, “ongoing”, “potential”, “anticipate”, “project”, “target”, “find earn” or “should” and includes statements the Company makes regarding the expected results of its strategy. These statements relate to future events or the future financial performance of the Company and involve known and unknown risks, uncertainties and other factors, many of which are beyond the Company’s control and could cause the Company’s actual results, level of activity, performance or achievements. The Company or its industry differs materially from that expressed or implied in any forward-looking statement. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

first Not adjusted for inflation and exchange rate differences
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7990836/
3 https://jamanetwork.com/journals/jamasurgery/fullarticle/2618383
4 Opioid data analysis and resources | Opium | CDC
5 Prime Minister | Opioid overdoses cost US hospitals about $11 (premierinc.com)
6 https://www.researchandmarkets.com/reports/5805706/global-postsurgical-pain-therapeutics-market
7 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388795
8 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5626380/
9 https://www.ama-assn.org/press-center/press-releases/report-shows-decrea-opioid-prescribe-increase-overdoses
ten Daniels et al., 2019, Clinical Therapy

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