(News Bulletin 247) – The Food and Drug Administration (FDA) approved Maxigesic IV this Wednesday to treat pain and use fewer opioid analgesics. Which will trigger the first sales in early 2024 and result in a milestone payment of $2.1 million for the company.
European biotechs do not obtain marketing authorization in the United States every day, far from it. This is nevertheless what the Belgian company Hyloris, listed on the Brussels Stock Exchange, announced this Wednesday, with a high valuation for a biotech (around 350 million euros).
This company specializes in reformulating existing drugs to address unmet needs. Founded in 2012, it has a portfolio of 16 reformulated and reused products.
Among these products is Maxigesic IV, a combination of ibuprofen and paracetamol used as an analgesic and administered as an infusion to treat postoperative pain. Results from a phase III study (the last step before marketing) on 276 patients showed that this drug worked “more quickly and provided greater pain relief than IV Ibuprofen or IV Paracetamol alone at the same doses,” explains Hyloris. The molecule has been approved in 40 countries and marketed in more than 20 countries.
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$2 million milestone payment coming
It is on the basis of these phase III results that the Food and Drug Administration (FDA) approved the molecule. The American health authority has given the green light to Maxigesic IV in the treatment of mild to moderate pain in adults and that of moderate to severe pain in addition to opioid analgesics, in cases where the intravenous route of administration is considered clinically necessary.
The distribution of Maxigesic IV in American hospitals should begin in early 2024. Upon the first sales in the United States, Hyloris will receive a milestone payment of $2.1 million, as well as payment of $1. 5 million dollars, related to commercial debts.
The goal of Maxigesic is to treat post-operative pain while preventing opioid overdoses that have caused 80,000 deaths in the United States and $2 billion in hospital costs, according to data cited by the company.
On the Brussels Stock Exchange, the market ignored the news, with Hyloris shares closing down 2.4%.
In terms of its financial results, the Belgian biotech indicated in September that it had generated 2.4 million in revenue over the first six months of the year, for an operational loss of 7 million euros and a net cash disbursement of 4 .16 million euros.
At the end of last June, its net cash amounted to 39.2 million euros. However, in view of this amount and “assuming the continuation of the granting of strategic licenses, the commercial success of Maxigesic IV and Sotalol IV (used for the treatment of atrial fibrillation, a heart disorder, Editor’s note) additional financing non-dilutive and milestone payments, the company believes that it is sufficiently capitalized to finance all planned R&D expenses for current product candidates (14 product candidates and three generic products),” Hyloris explained at the time.
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