- Potential to revolutionise the current treatment paradigm and become the cornerstone therapy for patients with suspected acute coronary syndrome
- Enables accelerated development of HY-073 (IV acetylsalicylic acid), bringing the anticipated FDA submission date forward to end 2023
- Initially targeting a total addressable patient population of ~2 million in the
U.S.
Liège,
Coronary heart disease (CHD) is a common term for the build-up of plaque in the heart’s arteries, and is the leading cause of mortality in the
“Rhoshan Pharmaceuticals believes that the clinical impact of injectable Aspirin could be tremendous, starting in the cardiovascular setting. Every minute is critical when treating a suspected myocardial infarction, and this product has the potential to save precious time in this hyperacute setting,” said Hitha Palepu, Chief Executive Officer of Rhoshan Pharmaceuticals. “Our partnership with Hyloris aligns our development expertise with their experience in commercialisation, and we look forward to the collective impact we can have on making healthcare better, together.”
Under the terms of the agreement with Rhoshan, Hyloris acquires an exclusive worldwide license to all intellectual property rights, knowhow, and technical proprietary information in relation to the IV formulation technology (
About coronary heart disease (CHD), acute coronary syndrome (ACS) and Aspirin IV
CHD occurs when the heart’s blood supply is blocked due to the build-up of fatty substances in the arteries around the heart. This can lead to blood clots that restrict blood flow and cause ACS, including unstable angina, acute myocardial infarction, and even cardiac arrest. Patients with symptoms of ACS are admitted to the hospital emergency room and oral aspirin therapy (162 to 325 mg per day) should start as soon as possible and be continued to delay and prevent further blood clotting.3 Each minute after a heart attack, more heart tissue deteriorates or dies, so restoring blood flow quickly and effectively helps prevent heart damage. However, it takes on average 1-2 hours for oral aspirin to reach peak effectivity and there can be material variabilities which can result in significant delay, or even lack of, effect in subgroups of patients. Moreover, many patients with ACS symptoms are not eligible for oral administration due to their acute condition.
Aspirin IV
About Rhoshan Pharmaceuticals
About
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. Outside of its core strategic focus, the Company also has 3 high barrier generic products in development and registration phase. Two products are currently in initial phases of commercialisation 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,
For more information, please contact
investorrelations@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
2 Premier Healthcare Database; Malik et al, Annals of Translational Medicine, 2018
3 AHA Guidelines; Circulation 2013
Attachment
- 211113 Hyloris Press Release Aspirin IV_ENG
Source:
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