Hyloris Enters into Strategic Partnership with Vaneltix for
Treatment of Acute Pain in Interstitial Cystitis
Access to AlenuraTM, a dual mode-of-action
advanced clinical candidate for the treatment of acute pain in
interstitial cystitis/bladder pain syndrome (IC/BPS)
Addressable patient population of at least 6
million1 in the U.S.
Liège, Belgium
– 17
December 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 a strategic
collaboration with Vaneltix Pharma, Inc. for the development and
commercialisation of AlenuraTM as first-line drug treatment for
acute pain in interstitial cystitis /bladder pain syndrome
(IC/BPS).
AlenuraTM is a patented, innovative,
clinical-stage bladder instillation product candidate that combines
lidocaine, a well-established anaesthetic, in a new alkalinized
form with heparin, a component of mucous membranes2. Thanks to the
novel dual mode-of-action, AlenuraTM has the unique potential to i)
immediately relieve pain, and ii) augment the mucous layer of the
bladder. In previous clinical studies, AlenuraTM was well-tolerated
and demonstrated to be more effective in terms of pain relief,
urgency response and improvement of symptoms compared to placebo,
and lidocaine alone3.
Dr. Dan
Vickery,
Chief
Executive
Officer of Vaneltix
Pharma, commented:
“IC/BPS is a chronic bladder condition that results in recurring
discomfort or pain in the bladder and surrounding pelvic region.
Today, there is no cure available, and there are no products
specifically approved to treat acute bladder pain. We have
discovered and developed AlenuraTM to address these unmet medical
needs and are very excited to partner with Hyloris to further
develop AlenuraTM and bring much needed innovation to IC/BPS
patients.”
Stijn Van Rompay, Chief Executive
Officer of Hyloris,
added: “With AlenuraTM, we are
expanding our broad, patented value-added portfolio with a fourth
new asset this year, delivering on our promise. The partnership
with Vaneltix also perfectly fits within our strategy of increased
focus towards repurposed medicines and addressing unmet medical
needs to create a meaningful difference for patients. We are now
preparing the next steps and anticipate the start of a larger Phase
2 comparative study and a Phase 2 multidose study mid 2022 for
which the results could be available by late 2023.”
Under the terms of the agreement, Vaneltix will
be responsible for the further development, manufacturing,
regulatory affairs and commercialisation of AlenuraTM in
collaboration with Hyloris. In return, Hyloris will provide staged
investments of in total maximum USD 6.7 Mio for Phase 2,
manufacturing and regulatory related activities and a loan of USD
0.5 Mio. Hyloris will be eligible to receive a tiered percentage of
the product margin generated by Vaneltix.
About
Interstitial Cystitis
/Bladder Pain Syndrome
(IC/BPS)
and AlenuraTM
IC/BPS is a condition that results in recurring
discomfort or pain in the bladder and surrounding pelvic region.
The scientific team of Vaneltix, led by Dr. CL Parsons, a
distinguished Professor Emeritus, Urologist and Surgeon, believes
that ICS/BPS stems from an anatomical defect in the protective
bladder lining (the GAG mucous layer) which exposes nerve endings
to toxic components in urine. Patients often experience episodes of
severe intensity pain lasting hours to days (painful flares), which
requires treatment. IC/BPS is more prevalent in women, although men
can experience symptoms as well, and although underdiagnosed, it is
estimated at least 6 million1 people in the U.S. suffer from the
condition.
AlenuraTM is a unique, combination product of
alkalinised lidocaine and the glycosaminoglycan heparin.
Alkalinised lidocaine penetrates the transitional epithelial cell
layer and provides immediate pain relief. Whereas heparin sodium is
thought to augment the natural mucous layer of the bladder to
prevent further irritation of the bladder and prolong the
anaesthetic effect. AlenuraTM will be supplied as a prefilled
syringe for intra-vesicular administration to the bladder through
an installation procedure and is protected by multiple patents and
patent applications potentially providing exclusivity up to
2038.
About
Vaneltix
Vaneltix Pharma, Inc. is a specialty
pharmaceutical company dedicated to the development and
commercialization of therapeutic products focused on repurposed
products that can be developed through the FDA 505(b)(2) regulatory
pathway. Vaneltix’s development programs target significant unmet
medical need and major market opportunities in urology and women’s
health care. Vaneltix’s lead clinical program is AlenuraTM, a
proprietary combination of the approved drugs lidocaine and heparin
that is instilled into the bladder, and targets IC/BPS, an unmet
medical need which affects at least 6 million 1 men and women in
the US. For further information, please visit Vaneltix's website at
http://www.vaneltix.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 15 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, Investor Relations and
Mediainvestorrelations@hyloris.com
For further information on the agreement with
Vaneltix, please consult the public announcement in accordance with
Article 7:97, §4/1 of the Code of Companies and Associations, which
is available on the Hyloris
website: https://hyloris.com/wp-content/uploads/2021/12/RP-Vaneltix.pdf
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.
- 211026 Hyloris Press Release Alenura_ENG_Final
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