GlobeNewswire

Hyloris Announces Major Commercial Partnership in the U.S. for Maxigesic® IV

Share

Hikma Pharmaceuticals, a leading supplier of complex, injectable hospital products in the U.S., to commercialise Maxigesic IV in the U.S.

Hyloris is eligible to receive $4 million in regulatory based milestones as well as commercial milestones and a share of net profit

Maxigesic IV has potential to combat the opioid epidemic in pain management

Liège, Belgium 28April 2021Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to bringing innovative treatments that offer added value to underserved patient populations, today announces that its partner for Maxigesic IV, AFT Pharmaceuticals (“AFT”), has signed an exclusive license and distribution agreement with Hikma Pharmaceuticals (“Hikma”) for the U.S. commercialisation of Maxigesic IV, a novel, patented, non-opioid treatment for post-operative pain.

Under the terms of the agreement with AFT, Hikma will have exclusive rights for the sales, marketing, and distribution of Maxigesic IV in the U.S. Hyloris is eligible to receive $4 million in regulatory based milestones as well as commercial milestones plus a share of any additional product-related income received by AFT in the U.S.

Hikma (LSE: HIK.L) is a global pharma company focused on complex and differentiated branded generics and generic pharmaceuticals and is a leading supplier of injectable hospital products in the U.S. across a broad range of indications, including respiratory, oncology and pain management. The Company generated group revenue of $2.34Bn in 2020.

Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: This partnership marks a major milestone for Hylorisand represents an important step forwardin bringing much needed innovation in post-operative pain management to patients and physicians in the U.S.Hikma’s large U.S. footprint, their scale,network and business valuesmake them an ideal partner for the successful rollout of Maxigesic IV in the U.S.The misuse of and addiction to opioids is a major public healthissue with nearly 50,000 deaths annually in the U.S. due to opioid-involved overdoses. There is an urgentneed for safer and more effective non-opioid pain treatments in the post-operative hospital setting, and thanks to its unique, dual mode-of-action, Maxigesic IV has the potential to become a valuable pain treatment option without the side effects and risk of addiction associated with opioids.

Globally, approximately 1.2 billion vials1 are sold per year in the non-opioid analgesic space and the market for post-operative pain is growing rapidly and is forecasted to reach $1.7 billion in 2028 in the U.S., up from $745 million in 20192. In 2019, 51 million surgical procedures were performed in the U.S. and the overall treatment of post-operative pain has not substantially improved over the past 20 years, with the misuse of opioids remaining a key public health issue. The Centers for Disease Control and Prevention estimate that the total economic burden of prescription opioid misuse in the U.S. alone is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

About Maxigesic® IV

Maxigesic IV has been developed under the development collaboration agreement signed in 2012 between Hyloris and AFT Pharmaceuticals, and is to date, licensed in >90 countries, approved in 20 countries and marketed in three countries. Maxigesic IV is a unique combination of 1000mg paracetamol with 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)3. An additional exposure study has demonstrated Maxigesic IV’s efficacy and safety in an expanded population group over a longer treatment period4. Maxigesic IV is protected by several granted and pending patent applications. The preparations to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) by AFT are progressing well.

About Hyloris Pharmaceuticals

Hyloris is a specialty biopharma company identifying and unlocking hidden potential in existing medications for the benefit of patients and the healthcare system. Hyloris applies its knowhow and technological innovations to existing pharmaceuticals and has built a broad proprietary product pipeline that has the potential to offer significant advantages over currently available alternatives. Hyloris currently has two partnered, commercial-stage products: 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 IQVIA
2 DelveInsight Market Research Report (2020)
3 Daniels et al, 2019, Clinical Therapeutics
4 Maxigesic IV Phase 3 exposure study. Study ID No AFT-MXIV-11. NCT04005755. Submitted for publication


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

Mandalay Resources Corporation tillkännager resultatrapporten för första kvartalet 202115.5.2021 14:02:50 CEST | Pressemelding

TORONTO, May 15, 2021 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation (”Mandalay” eller ”bolaget”) (TSX: MND, OTCQB: MNDJF) tillkännager resultatrapporten för kvartalet som slutade den 31 mars 2021. Bolagets sammanfattade och konsoliderade delårsrapporter för kvartalet som slutade den 31 mars 2021, tillsammans med ledningens diskussion och analys (”MD&A”) för samma period, finns tillgängliga under bolagets profil på www.sedar.com och på bolagets webbplats www.mandalayresources.com. Alla valutor i detta pressmeddelande avser US-dollar om inget annat anges. Höjdpunkter för första kvartalet 2021: Kvartalsintäkter på 52,6 miljoner USD, de högsta sedan andra kvartalet 2016;Justerad EBITDA på 26,1 miljoner USD, det tredje högsta i bolagets historia;Justerat nettoresultat på 5,6 miljoner USD (0,06 USD eller 0,08 CAD per aktie); ochKonsoliderat nettoresultat på 25,5 miljoner USD (0,28 USD eller 0,35 CAD per aktie). Dominic Duffy, styrelseordförande och CEO på Mandalay, kommenterar: ”Mandala

Antal aktier i Nexstim Abp efter första momentet i processen för att minska antalet aktier14.5.2021 20:00:00 CEST | Pressemelding

Företagsmeddelande,Helsingfors, 14.5.2021 kl. 21.00 (EEST) Antal aktier i Nexstim Abp efter första momentet i processen för att minska antalet aktier Bolagsstämman av Nexstim Abp (NXTMH:HEX, NXTMS:STO) (”Nexstim” eller ”bolaget”) fattade 11 maj 2021 beslut om att minska antalet aktier i bolaget utan att minska aktiekapitalet genom att vederlagsfritt ge ut nya aktier till aktieägarna, och genom att vederlagsfritt lösa in bolagets egna aktier så att hundra (100) nuvarande aktier i bolaget ska motsvara en (1) aktie efter att arrangemangen för att minska antalet aktier i bolaget har genomförts. Som en del av arrangemangen med avseende på de aktieägare som på transaktionsdagen (enligt definitionen nedan) är registrerade i Nexstims aktieägarförteckning hos Euroclear Finland Ab fattade bolagsstämman beslut om att bolaget ska 14 maj 2021 (”transaktionsdagen”) vederlagsfritt emittera högst 1 000 000 nya aktier så att antalet aktier per värdeandelskonto som ägs av dessa aktieägare är delbart med

Quantity of shares in Nexstim Plc after completion of the first phase in reducing the quantity of shares14.5.2021 20:00:00 CEST | Press release

Company announcement,Helsinki, 14 May 2021 at 9 PM (EEST) Quantity of shares in Nexstim Plc after completion of the first phase in reducing the quantity of shares Annual General Meeting of Nexstim Plc (NXTMH:HEX, NXTMS:STO) (“Nexstim” or “Company”) resolved on 11 May 2021 to reduce the quantity of Nexstim's shares without reducing share capital by way of issuing new shares to its shareholders without consideration, and by redemption of Company's own shares without consideration, in such a way that each current 100 shares of the Company shall correspond to one share of the Company after the arrangements related to the reduction of the quantity of Company's shares are completed. As a part of the arrangements in respect of shareholders registered on the Transaction Day (as defined below) in the shareholders’ register of Nexstim held by Euroclear Finland Ltd, the Annual General Meeting resolved that the Company shall issue on 14 May 2021 (the "Transaction Day") a maximum of 1,000,000 new s

IMCD Colombia expands into new markets through the acquisition of Siliconas y Químicos14.5.2021 20:00:00 CEST | Press release

ROTTERDAM, The Netherlands (14 May 2021) – IMCD N.V. (“IMCD” or “Company”), a leading distributor of speciality chemicals and ingredients, today announces that IMCD Colombia acquired the Colombian speciality distributor, Siliconas y Químicos S.A.S. (“Siliconas y Químicos”). “We are delighted to further expand our presence in Latin America with the acquisition of Siliconas y Químicos,” said Marcus Jordan, Americas President, IMCD. “The company’s strategy of being ‘Specialists in Specialities’ closely aligns with IMCD and its expertise in personal care, coatings, silicones, and other speciality industrial markets perfectly complements our existing pharmaceuticals, food and nutrition business in Colombia.” Based in Bogotá, Siliconas y Químicos has experienced steady growth since its inception in 2000, generated a revenue of USD 9 million in 2020, and adds 25 employees to the IMCD Colombia team. Siliconas y Químicos is ISO 9001:2015 certified and operates across Colombia with strategic out

Touax: Q1 2021 restated revenues from activities14.5.2021 17:45:00 CEST | Press release

PRESS RELEASE Paris, 14 May 2021 – 5.45 p.m. YOUR OPERATIONAL LEASING SOLUTION FOR SUSTAINABLE TRANSPORTATION Q1 2021 restated revenues from activities Restated revenues from activities amounted to €24.6m in Q1 2021, stable in constant dollars compared to the same period in 2020.Favourable outlook with a significant order book New segmentation of revenues betweenownedactivities and management activities. In order to enable a more detailed and more accurate reading of its activities, the Group decided to update the key indicators of its quarterly report: Revenues from activities are restated in order to present ownedactivities separately from management activities. For management activities, leasing revenue from investor-owned equipment is replaced by management fees, which correspond to the net contribution of the leasing management activity to the Group's performance. This presentation showssyndication fees, sales feesand now management fees, grouped together under management activity

CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER14.5.2021 16:20:00 CEST | Press release

Bid procedure, 2021-05-19CertificateCommercial paper issued in SEK by non-financial companies with their registered office in Sweden and with a remaining maturity of up to six months on the Bid date. i.e. with the latest maturity date as of 2021-11-19 Delivery may not be made in commercial paper purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Special terms, i.e. the purchase may not have been made after 2021-05-07 BidsCounterparties may make one bid per Credit rating class and maturity class. Bids are made to tel 08-696 69 70 and confirmed by e-mail to EOL@riksbank.se.Bid date2021-05-19Bid times09.00-09.30 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 4 billionHighest permitted bid volume (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed SEK 4 billion. No bid may contain Commercial paper in excess of SEK 250 million issued by the s

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS14.5.2021 16:20:00 CEST | Press release

Bid procedure, 2021-05-21BondsSWEDISH GOVERNMENT: 1053. SE0002829192. 2039-03-30 SWEDISH GOVERNMENT: 1063, SE0015193313, 2045-11-24 Bid date2021-05-21Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)1053: 750 mln SEK +/-350 mln SEK 1063: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)1053: 750 mln SEK per bid 1063: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2021-05-25Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-05-14 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions c