Hyloris announces the launch of Maxigesic® IV, a novel


Marks the first European launches of Maxigesic IV, a well-tolerated and effective non-opioid pain treatment

Cork, Belgium – July 8 2021Hyloris Pharmaceutical SA (Euronext Brussels: HYL), a specialty biopharmaceutical company committed to meeting unmet medical needs by reinventing existing drugs, today announces that Maxigesic IV is now available in Germany, Europe’s largest pharmaceutical market, and Austria.

Maxigesic IV is a new, patented, non-opioid treatment for postoperative pain and is a unique combination of 1000 mg paracetamol and 300 mg ibuprofen solution for infusion. Hyloris’ partner AFT Pharmaceuticals is working with distribution partners with a strong local presence to market the product globally.

Maxigesic IV is currently licensed in over 100 countries around the world, and it has been registered in 24 countries. After the launch in Germany and Austria, the product is now available in 5 countries: Australia, New Zealand, United Arab Emirates, Germany and Austria.

Stijn Van Rompay, CEO of Hyloris, said: We are delighted than AFT and its partner Ever Pharma have launched Maxigesic IV in Germany and Austria. We are convinced thatt Never Pharma is the perfect partner to make this precious news non addictive pain treatment available for patients in Germany and Austria given their strong footprint in the main European markets, and their experiencethis is with complex injectables in many therapeutic areas, including anesthesia. We are looking forward to keep updating the market as we, and our partner AFT, make further progress in the regulatory Activities, launches and continued deployment oF Maxigesic IV across the world.

Each year, more than 5.2 million surgeries are performed in Germany, and the postoperative pain market in Germany is expected to reach $ 166.5 million by 2028 at a CAGR of 11.58% from 2017 to 2028.1

About Maxigesic® IV

Maxigesic IV was developed under the development collaboration agreement signed in 2012 between Hyloris and AFT Pharmaceuticals. Maxigesic IV is a unique combination of 1000 mg paracetamol and 300 mg ibuprofen solution for infusion for use post-operatively. 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 and provided relief of greater pain than IV ibuprofen or IV paracetamol alone in the same doses. In addition, the superior analgesic effect of Maxigesic IV was supported by a range of secondary endpoints, including reduced opioid consumption compared to the IV paracetamol and IV ibuprofen treatment groups (P 2 In addition, the safety and tolerability of repeated doses of Maxigesic IV over an extended period was evaluated in an open-label, multicenter, single-arm study in 232 patients undergoing orthopedic or plastic surgery. This extension study demonstrated that Maxigesic IV, administered every 6 hours as a 15-minute infusion between 48 hours and 5 days, was safe and well tolerated, and was perceived positively by study participants, supporting a risk profile. favorable profit.3 Under the terms of the collaboration agreement with AFT, Hyloris is eligible for a high minority share of Maxigesic IV related revenues generated by AFT, excluding revenues generated in Australia and New Zealand.

About Hyloris Pharmaceuticals

Hyloris is a specialty biopharmaceutical company focused on innovating, reinventing and optimizing existing drugs to meet important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payers. Hyloris has built a large patented portfolio of 13 reformulated and reused value-added drugs that have the potential to offer significant advantages over available alternatives. Two products are currently marketed with partners: Sotalol IV for the treatment of atrial fibrillation and Maxigesic® IV, a treatment of non-opioid postoperative pain. The Company’s development strategy focuses primarily on the FDA 505 (b) 2 regulatory pathway, which is specifically designed for pharmaceutical products for which the safety and efficacy of the molecule have already been established. This route can reduce the clinical burden required to bring a product to market, dramatically shorten development times, 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 Pharmaceutical:

Marieke vermeersch
VP Investor Relations and Corporate Communication
M: +32 (0) 479 490 603
[email protected]

Disclaimer and forward-looking statements

Hyloris stands for “high yield, low risk”, which relates to the 505 (b) (2) regulatory pathway for product approval on which the Issuer focuses, but does not relate to or apply in any way. to an investment in the Shares.
Certain statements contained in this press release are “forward-looking statements”. These forward-looking statements may be identified using forward-looking terminology, including the words “believes”, “believes”, “anticipates”, “expects”, “intends”, “may”. , continue “,” in progress “,” potential “,” predict “,” plan “,” target “,” seek “or” should “, and include statements by the Company regarding the expected results of its strategy. 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 control of the Company, which may cause actual results, levels activity, performance or achievements of the Company or its industry is materially different from those expressed or implied by forward-looking statements.The Company assumes no obligation to publicly update or revise the forward-looking statements s, unless required by law.

1 Postoperative Pain Market Overview, Epidemiology and Market Forecast – 2028. DELVEINSIGHT
2 Daniels et al, 2019, Clinical Therapeutics
3 Gottlieb et al, 2021, Biomedicine & Pharmacotherapy

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