Hyloris enters pact with Rhoshan to develop, manufacture & commercialise intravenous acetylsalicylic acid to treat acute coronary syndromes

Liège, BelgiumThursday, October 14, 2021, 17:00 Hrs  [IST]

Hyloris Pharmaceuticals SA, a specialty biopharma company, announces that it has entered into an exclusive, worldwide licensing agreement with Rhoshan Pharmaceuticals Inc. (Rhoshan), to develop, manufacture and commercialise 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 US and Hyloris anticipates commercialising the product in the US 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 US. 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 US.

“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.”

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 Rhoshan and implement their breakthrough, proven IV formulation technology to accelerate the development of HY-073, thereby shortening overall timelines. We expect to start the pivotal study early 2022, with the submission of the regulatory dossier to the FDA now already anticipated towards end 2023.”

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 (US patent granted on 31 March 2021) to develop intravenous acetylsalicylic acid in multiple indications. Hyloris will be responsible for the manufacturing and commercialisation 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 maximum $7.5 million in R&D funding up to, and including, regulatory approval.

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. 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 US is a first-in-class IV formulation of acetylsalicylic acid that could significantly improve treatment outcomes of patients with ACS based on its potential life-saving benefits: i) a fast and more pronounced onset of activity (5 minutes to reach maximum peak concentrations) and a sustained effect over a few hours; ii) less intra- and interindividual metabolisation variabilities as it is given intravenously and thus has 100% bioavailability.

Rhoshan Pharmaceuticals, Inc is a specialty biopharmaceutical company focused on bringing the first injectable aspirin to US market.

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.