Adding value to healthcare systems Uncovering the hidden potential of existing drugs and reformulating established products to cure in unforeseen ways: this is the goal of Hyloris Pharmaceuticals. Founded in 2012, the company creates new formulas, new methods of administration and new indications to bring clear benefits to both patients and healthcare professionals.
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yloris’s development strategy is to create value for the healthcare system by developing reformulated products that the company believes offer significant advantages over alternatives currently on offer. To this end, Hyloris mainly relies on the FDA’s regulatory procedure 505(b)(2) for pharmaceuticals for which the safety and efficacy of the molecule have already been established. This strategy can help reduce the duration of clinical development until marketing authorization is obtained, as well as reduce the costs and risks compared to the development of a new molecule governed by the regulatory route 505(b)1.
the IV administration, a welcome solution given that up to 5% of patients that initiate a treatment with Sotalol risk triggering Torsades de Pointes. Sotalol IV has been launched in the US.
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For its part, Maxigesic® IV, is an intravenous nonopioid analgesic product for the treatment of pain. A phase III clinical trial has shown that the pain relief provided by Maxigesic® IV is in the order of double that of the current market leader IV paracetamol. It could therefore be indicated for the relief of mild to moderate pain or as an adjunct or alternative to IV opioids. It was also developed for patients who have a variety of factors that limit their ability to use oral pain relievers. Maxigesic IV, was developed by Hyloris with partner AFT Pharmaceuticals has been approved in more than 10 countries and is expected to launch in the US market in the next two years.
Hyloris assesses several criteria to identify the best product candidates for the 505(b)(2) regulatory Stijn Van Rompay, pathway: added value for patients, hospitals, CEO and reference shareholder of Hyloris Pharmaceuticals payors and other stakeholders in the healthcare system; products each solving a particular problem and having a clear utility; patent protection; the efficacy and safety of already established molecules ; and knowledge of the From 2021, Hyloris plans to move up a gear by initiating the development of 4 or more new product candidates per year clinical requirements to obtain authorizations. across its portfolio. Its objective remains the same: to add value for all shareholders, whether they are doctors, nurses, patients Hyloris has developed a portfolio of 14 products and product or investors. Improving the outcome of therapy is definitely part candidates covering three areas: cardiovascular IV drugs (for of Hyloris’ DNA! the treatment of atrial fibrillation, heart failure and coronary heart disease), other reformulations (outside the cardiovascular field) and established market products (development of generics with a high barrier to entry). Hyloris has two products at the initial stage of commercialisation. Sotalol IV is indicated for the treatment of atrial fibrillation, the most common type of irregular heart rate. This IV formulation of Sotalol, a commonly used antiarrhythmic drug, may reduce the length of hospital stay from three days to one. According to an article published in the Journal of American College of Cardiology, the potential cost reduction averages $3,123 for a two-day hospital stay, and $4,820 for a one-day hospital stay with this treatment. Additionally, side effects can be better controlled with
Hyloris Pharmaceuticals SA Boulevard Gustave Kleyer 17 - 4000 Liège Tel.: +32 (0)4 346 02 07 Email: contact@hyloris.com - https://hyloris.com 138