Hyloris Broadens Pipeline with new Product Candidate for Vulvar Lichen Sclerosus (VLS)
January 18 2024 - 1:00PM
Hyloris Broadens Pipeline with new Product Candidate for Vulvar
Lichen Sclerosus (VLS)
Hyloris Broadens Pipeline with new
Product Candidate for Vulvar Lichen Sclerosus (VLS)
-
Equal Partnership with AFT Pharmaceuticals for Development of a
Drug Releasing Mucoadhesive Film for VLS (HY-091)
-
Limited Availability of Approved Treatment Options in VLS
Liège, Belgium – 18 January 2024, 07:00
PM 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
develop a novel mucoadhesive film for the treatment of Vulvar
Lichen Sclerosus. HY-091 targets to have an extended duration
release of a known molecular entity and to offer a convenient
application method, ensuring simplicity and improving
compliance.
Under the terms of the agreement, Hyloris and
AFT will co-develop HY-091 for the purpose of registration and
worldwide commercialization. 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: “I am pleased to announce an additional
co-development with AFT. This partnership and the recently
announced collaboration on HY-090 for Burning Mouth Syndrome are a
testament to our shared commitment to making a meaningful impact on
the healthcare system. By combining our resources and expertise, we
are poised to pioneer innovative solutions for patients suffering
from VLS.”
About Vulvar Lichen Sclerosus
123Vulvar Lichen
Sclerosus (VLS) is a chronic, distressing, inflammatory disease
with an enormous impact on quality of life. HY-091 is designed as a
user-friendly mucoadhesive film product with a convenient
application method that ensures simplicity and compliance, offering
targeted relief for patients experiencing the discomfort, itching,
and pain associated with Vulvar Lichen Sclerosus by reducing
inflammation and scarring in the affected area of skin and helping
in restoring the skin structure. There is no curative treatment for
VLS, which usually occurs in postmenopausal women, although
children and premenopausal women may be affected. Advanced
condition severely affects the quality of life and is associated
with increases risk of vulvar squamous cell carcinoma.
It is a massively under diagnosed condition, which affects 0.1% to
3% of the general population.
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. The
Company’s development strategy primarily focuses on leveraging
existing regulatory pathways, such as the FDA’s 505(b)2 pathway in
the U.S or similar regulatory frameworks in other region which is
specifically designed for pharmaceuticals for which safety and
efficacy of the molecule have already been established. This type
of regulatory 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 has built a broad, patented portfolio of 18 reformulated
and repurposed value-added medicines that have the potential to
offer significant advantages over available alternatives. Two
products are currently in early phases of commercialization with
partners: Sotalol IV for the treatment of atrial fibrillation, and
Maxigesic® IV, a non-opioid post-operative pain treatment. Outside
its core strategic focus, the Company also has 1 approved high
barrier generic product launched in the U.S. and 2 high barrier
generic products in development.
Hyloris is based in Liège, Belgium. For more information,
visit www.hyloris.com and follow-us on LinkedIn.
About AFT Pharmaceuticals
LtdAFT is a listed (NZE: AFT) and growing multinational
pharmaceutical company that develops, markets, and distributes a
broad portfolio of pharmaceutical products across a wide range of
therapeutic categories. Its business model is to develop and
in-license patented, branded and generic products which are
promoted through its dedicated sales teams in Australia, New
Zealand and selected Southeast Asian markets, and to out-license
its products to local licensees and distributors in over 125
countries around the world.
For more information, contact
Hyloris:Stijn Van Rompay,
CEOStijn.vanrompay@hyloris.com+32 (0)4 346 02 07Jean-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.uptodate.com/contents/vulvar-lichen-sclerosus-beyond-the-basics2
https://www.jogc.com/article/S1701-2163(21)00890-2/fulltext3
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5496281/
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