- 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.
Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that it has entered into an exclusive, worldwide licensing agreement with Rhoshan Pharmaceuticals Inc. (“Rhoshan”), to develop, manufacture and commercialize intravenous acetylsalicylic acid (previously known as Hyloris’ HY-073) for the treatment of patients with suspected acute coronary syndromes (ACS). Acetylsalicylic acid IV is currently not available in the U.S. and Hyloris anticipates commercializing the product in the U.S. with its own future sales force targeting cardiologists in the hospital setting.
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 U.S.1 CHD can lead to ACS, life-threatening conditions that account for 50% of all cardiovascular disease-related deaths, including acute myocardial infarction (heart attack), unstable angina (chest pain that may signal an impending heart attack) or sudden cardiac death. About 2 million patients with acute myocardial infarction and unstable angina are admitted to the hospital each year in the U.S.2
“Rhoshan Pharmaceuticals believes that the clinical impact of injectable Aspirincould is 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 commercialization, and we look forward to the collective impact we can have on making healthcare better, together.”
Stijn Van Rompay, Chief Executive Officer of Hyloris, added: “Developing an IV formulation of acetylsalicylic acid, the active ingredient of Aspirin, is a challenge due to its inherent chemical instability and poor solubility. We are very pleased to join forces with the team at Rhoshanand to implement their breakthrough, provenIV formulation technology to accelerate the development of-073, thereby shortening overall timelines. We expect to start the pivotal study early 2022, with the submission of the regulatory dossier to the FDAnowalready anticipated towards end 2023.”
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Under the terms of the agreement with Rhoshan, Hyloris acquires an exclusive worldwide license to all intellectual property rights, know-how, and technical proprietary information in relation to the IV formulation technology (U.S. patent granted on 31 March 2021) to develop intravenous acetylsalicylic acid in multiple indications. Hyloris will be responsible for the manufacturing and commercialization of the product, whereas Rhoshan will continue product development and regulatory affairs activities, and will bear the NDA submission costs. Rhoshan will receive an upfront payment of $750,000; and is eligible to receive $1.25 million development and regulatory milestones; commercial-based milestones, as well as a share of net profit. Hyloris will provide a maximum of $7.5 million in R&D funding up to, and including regulatory approval.
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.
Source: Biospace
