- 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, Belgium – 13
October 2021 – 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
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 U.S. and Hyloris anticipates commercialising 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 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 (U.S. 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.
About
coronary
heart
disease
(CHD), acute coronary syndrome
(ACS) and Aspirin IV
U.S.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 U.S. 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.
About Rhoshan
PharmaceuticalsRhoshan Pharmaceuticals, Inc is a
specialty biopharmaceutical company focused on bringing the first
injectable aspirin to US market. The company was founded by Nagesh
Palepu, a highly experienced formulator in the enhanced formulation
space. He has helped develop 3 505(b)(2) products in the past 17
years (and over 50 products in his career) and is the inventor of
over 150 patents worldwide. Rhoshan Pharmaceuticals’ team brings
centuries of experience in formulation, CM&C, clinical
development, and regulatory affairs. Rhoshan Pharmaceuticals is
headquartered in Chadds Ford, Pennsylvania. For more information,
visit www.rhopharma.com.
About Hyloris Pharmaceuticals
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, Belgium. For more information, visit
www.hyloris.com and follow-us on LinkedIn.
For more information, please
contact Hyloris
Pharmaceuticals: Marieke Vermeersch, VP
Investor Relations and Corporate
Communicationsinvestorrelations@hyloris.com
Disclaimer and forward-looking
statementsHyloris 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 Centers for Disease Control and Prevention; American Heart
Association, Heart Disease & Stroke Statistics (2019)2 Premier
Healthcare Database; Malik et al, Annals of Translational Medicine,
20183 AHA Guidelines; Circulation 2013
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