Hyloris Broadens Pipeline with new Product Candidate in Burning Mouth Syndrome
22 12월 2023 - 2:30AM
Hyloris Broadens Pipeline with new
Product Candidate in Burning Mouth Syndrome
- Equal
Partnership with AFT Pharmaceuticals for Development of a Novel
Locally-Acting Product Candidate in Burning Mouth Syndrome
(HY-090)
-
Strengthening Strategic Partnership with AFT Pharmaceuticals
Following the Success of the Maxigesic® IV Collaboration
Liège, Belgium – 21 December 2023,
06:30PM CET – Regulated information – Inside information - 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 a partnership with AFT Pharmaceuticals (AFT) to
co-develop HY-090, a novel locally-acting product candidate for the
treatment of Burning Mouth Syndrome (BMS).
Under the terms of this equal partnership
agreement, targeting co-development and worldwide
commercialisation, Hyloris is responsible for ensuring the product
formulation, manufacturing activities and the coordination of the
commercialisation in Europe. AFT is responsible for managing the
clinical trials, overseeing all aspects to ensure effective
planning, execution and monitoring throughout the trial lifecycle,
and the coordination of the commercialisation outside of Europe.
Parties are jointly responsible for commercialization in the United
States.
Stijn Van Rompay, Chief Executive Officer of Hyloris,
added: “This collaboration brings together the strengths
of Hyloris and AFT, combining strong internal R&D capabilities
and solid expertise in clinical trial management. Together, we
combine our expertise to drive innovation and aim to deliver
unparalleled value to patients. I look forward to the successful
outcome and positive impact that will result from this strategic
collaboration, as it aligns with the collective mission to provide
much-needed relief for individuals living with Burning Mouth
Syndrome.”
About Burning Mouth Syndrome 1
2Burning mouth syndrome (BMS) is characterized by burning pain in a
normal-appearing oral mucosa lasting at least four to six months.
The condition is idiopathic, and the underlying pathophysiology is
not well understood. Patients with burning mouth syndrome commonly
experience changes in gustatory function. The reported prevalence
ranges from 0.7% to 5% of individuals in the US3 and occurs more
frequently in women than men, with a female to male ratio of 7:1.
Prevalence increases with age in both men and women, with the
highest prevalence reported in postmenopausal women aged
60–69 years.
About AFT Pharmaceuticals AFT
(ASX: AFP, NZX: AFT) is a specialty pharmaceutical company that
operates primarily in Australasia but has product distribution
agreements across the globe. The company’s product portfolio
includes prescription and over-the-counter (OTC) drugs to treat a
range of conditions.
About Hyloris Pharmaceuticals
SAHyloris is a specialty biopharma company focused on
innovating, reinventing, and optimizing 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 17 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 1 approved high
barrier generic product launched in the U.S. and 2 high barrier
generic product candidates in development. Two products are
currently in initial phases of commercialization 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, contact
Hyloris:Stijn Van Rompay,
CEOStijn.vanrompay@hyloris.com+32 (0)4 346 02 07
Jean-Luc Vandebroek,
CFOJean-luc.vandebroek@hyloris.com+32 (0)478 27 68 42
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 https://www.ncbi.nlm.nih.gov/books/NBK519529/2
https://www.sciencedirect.com/science/article/pii/S27725596220000493
based on combination of different sources: population-based study,
clinical based study and key opinion leaders' estimation
Hyloris Pharmaceuticals (EU:HYL)
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Hyloris Pharmaceuticals (EU:HYL)
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