GlobeNewswire

Hyloris Announces Launch of Maxigesic® IV, a Novel Non-Opioid Pain Treatment, in Key European Markets

Share

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

Liège, Belgium – 8 July 2021Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that Maxigesic IV is now available in Germany, the largest European pharmaceutical market, and Austria.

Maxigesic IV is a novel, patented, non-opioid treatment for post-operative pain and is a unique combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion. Hyloris’ partner AFT Pharmaceuticals works together with distribution partners with strong local presence to commercialise the product globally.

Maxigesic IV is currently licensed in more than 100 countries across the globe, and it has been registered in 24 countries. Following the launch in Germany and Austria, the product is now available in 5 countries: Australia, New Zealand, The United Arab Emirates, Germany, and Austria.

Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: We are pleasedthat AFT and its partner Ever Pharma have now launched Maxigesic IV in Germany and Austria.We are convinced that Ever Pharma is the ideal partner to make this valuable new non-addictivepain treatment available to patients in Germany and Austria given their strong footprint in key European markets, and their expertise with complex injectables in multiple therapeutic areas, including anaesthesia.We look forward to continuing to update the market as we,and our partner AFT,make further progress in theregulatory activities, launches and further roll-out ofMaxigesic IV across the globe.

Annually, over 5.2 million surgical procedures are performed in Germany, and the market for postoperative pain in Germany is expected to grow to $166.5 million by 2028 at a CAGR of 11.58% from 2017-2028.1

About Maxigesic® IV

Maxigesic IV has been developed under the development collaboration agreement signed in 2012 between Hyloris and AFT Pharmaceuticals. Maxigesic IV is a unique combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion 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<0.005).2 In addition, the safety and tolerability of repeated doses of Maxigesic IV over an extended period was assessed in an open-label, multi-centre, single arm study in 232 patients undergoing orthopaedic or plastic surgery. This extension study demonstrated that Maxigesic IV, administered 6-hourly as a 15-minute infusion between 48 hours to 5 days was safe and well-tolerated, and was perceived positively by study participants, supporting a favourable risk benefit profile.3 Under the terms of the collaboration agreement with AFT, Hyloris is eligible to a high minority share of Maxigesic IV related income generated by AFT, excluding income generated in Australia and New Zealand.

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. 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 Vermeersch
VP Investor Relations and Corporate Communications
M: +32 (0)479 490 603
marieke.vermeersch@hyloris.com

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

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

FLSmidth to acquire thyssenkrupp’s Mining business – creating a global industry leader in mining technology29.7.2021 12:39:04 CEST | Press release

Company Announcement No. 7 2021 FLSmidth and thyssenkrupp Industrial Solutions AG (a fully owned subsidiary of thyssenkrupp AG, "thyssenkrupp") have reached an agreement that FLSmidth will acquire thyssenkrupp’s Mining business1 (TK Mining) for a total consideration (enterprise value) of EUR 325 million, corresponding to approximately DKK 2.4 billion. Closing of the transaction is expected in H2 2022 and is subject to customary approvals from relevant authorities. TK Mining is a leading full-line supplier of solutions for mining systems, material handling, mineral processing and services, which is highly complementary to FLSmidth’s offering. TK Mining has an asset light business model and is present in 24 countries with engineering and global service centres, and has close to 3,400 employees. In 20202, revenue was EUR 780 million (approximately DKK 5.8 billion) with around one-third deriving from services. The business delivered a high single-digit negative EBIT margin and is expected

Millicom to repurchase own shares29.7.2021 12:02:00 CEST | Press release

Millicom to repurchase own shares Luxembourg, July 29, 2021 – On May 4, 2021, the Annual General Meeting of Shareholders (“AGM”) of Millicom resolved to authorize (the “Authorization”) the Board of Directors of Millicom (the “Board”) to adopt a share repurchase plan. Based on the Authorization, the Board has decided to initiate a repurchase program comprising not more than 5,000,000 Swedish Depository Receipts representing the Company’s ordinary shares (“SDRs”). The purposes of the share repurchase plan may include: reduction of Millicom's share capital; meeting obligations for Board remuneration; and/or meeting obligations under Millicom’s share-based incentive plans or other compensation programs. The repurchase program will be implemented in accordance with the Authorization, the Nasdaq Nordic Main Market Rulebook for Issuers of Shares (“Nasdaq Rulebook”), and applicable law including the Luxembourg law of 10 August 1915 on commercial companies, as amended, and the EU Market Abuse R

Fobi Wallet Pass For Ticketing And Global Fan Engagement Powers bdG Sports “Baha Mar Hoops” Tournament Featuring 19 NCAA Men’s And Women’s Basketball Teams, Including US Thanksgiving Nationally Televised Events29.7.2021 12:00:00 CEST | Press release

After multiple event successes with bdG Sports, Fobi is now adding ticketing and admissions capabilities to live and digital fan engagement to deliver a comprehensive solution for the “largest early season event in all of college basketball” at Baha Mar Hoops in The Bahamas VANCOUVER, British Columbia., July 29, 2021 (GLOBE NEWSWIRE) -- Fobi AI Inc. (formerly Loop Insights Inc.) (TSXV: FOBI) (OTCQB: FOBIF) (the "Company" or "Fobi"), is pleased to announce it will once again be supporting bdG Sports for college basketball’s largest early season event. The invite-only global event at Baha Mar Convention Center in Nassau, The Bahamas will take place from November 22-27, 2021 and will use Fobi’s Wallet Pass platform for ticketing, admission, and fan engagement both live and at home. Fobi will earn significant revenue from this event through the event license, ticket fees and fan activations both live and at home, including nationally televised and digital audiences across the United States

Building momentum and delivering results29.7.2021 12:00:00 CEST | Press release

Building momentum and delivering results Luxembourg, July29, 2021– Millicom is pleased to announce its second quarter 2021 results. Please find below links to the Q2 2021 Earnings Release and H1 2021 Interim Condensed Consolidated Financial Statements. Millicom Chief Executive Officer Mauricio Ramos commented: "We had an outstanding Q2. We built on our robust Q1 performance and delivered double-digit growth in both service revenue and EBITDA. In Colombia, we now have the best mobile network, and we capitalized on this in Q2 by leading the market in portability and by adding a record number of new postpaid customers. Our rapid customer and revenue growth is a direct result of our unwavering commitment to delivering the best customer experience, including network quality and reliability. With that in mind, and considering our healthy cash flow generation, we have accelerated investments that we expect will help us drive faster growth in all our businesses going forward. In light of our s

Summary of AB Klaipedos nafta webinar29.7.2021 11:30:00 CEST | Press release

On the 29th July 2021, AB Klaipedos nafta (KN) held an investor conference webinar where KN Chief Executive Officer Darius Šilenskis and acting Chief Financial Officer Indrė Kisielienė commented Company’s financial results for the six months of 2021. Webinar recording is available online at: https://youtu.be/BmHfUpOVmEM The presentation demonstrated during the webinar is attached to this announcement. Indrė Kisielienė, Acting Chief Financial Officer, +370 686 16276 Attachment KN_activity results for_2021_Q2

Correction: AB Klaipėdos nafta financial information reporting dates in 202129.7.2021 10:15:00 CEST | Press release

Correction: AB Klaipedos nafta interim financial information for the 6 months of 2021 has been released on 29 July 2021. AB Klaipėdos nafta (further – KN) informs that it plans to release financial information in 2021 according to the following schedule: DateReporting informationWithin first 5 working days of every month of 2021KN preliminary revenues for the previous month29 January 2021Interim financial information for the year 20207 April 2021Audited financial statements for the year 202030 April 2021Interim financial information for the 1st quarter of 20218 June 2021Social responsibility report for the year 202029 July 2021Interim financial information for the 6 months of 202129 October 2021Interim financial information for the 3 quarters of 2021 On 30 April 2021, the Company plans to convene an Ordinary General Meeting of Shareholders. Indrė Kisielienė, Acting Chief Financial Officer, +370 686 16276.

Hexagon Digital Wave signs new equipment and service agreement with Linde29.7.2021 09:00:00 CEST | Press release

Hexagon Digital Wave, a business of Hexagon Composites has signed an agreement with Linde, a leading industrial gas and engineering company. The agreement covers the supply and service of Ultrasonic Examination (UE) testing equipment. The estimated total value of the agreement is USD 2 million (approx. NOK 17 million) and designates Hexagon Digital Wave as a long-term partner. Driving energy transformation “We are excited to extend our relationship with the great team at Linde”, says Keith Fountain, UE international Sales Manager Hexagon Digital Wave. “Over the past 14 years we have provided our equipment to one of the market leaders in the industrial gas environment and helped to improve the safety of their cylinders.” About the market The non-destructive UE test and process enables the recertification of the cylinders without removing the internal product which improves the safety and allows a number of ESG requirements to be accomplished. Positive environmental impacts are accomplis