Hyloris announces US FDA approval for Podofilox Gel
04 Dicembre 2023 - 7:00AM
Hyloris announces US FDA approval for
Podofilox Gel
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Product previously referenced as HY-016, targeting genital and
perianal warts
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US Commercialization by partner Padagis to start in December
2023
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Second U.S. market approval of the year after Maxigesic® IV
Liège, Belgium – 04 December 2023 – 7AM 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 its partner Padagis US
LLC has received final approval from the United States Food &
Drug Administration (FDA) on its abbreviated New Drug Application
(ANDA) for Podofilox Gel, the first drug product generic to
Condylox Gel 0.5%® in the U.S.
Podofilox Gel is an antimycotic drug for the topical treatment
of external genital and perianal warts.
For the 12 months period ending December 2022, Condylox® Gel
0.5% had U.S. sales of approximately $9 million according to IQVIA
Health. The FDA has granted Competitive Generic Therapy (CGT)
exclusivity providing Padagis with a 180 day market exclusivity
period during which other generics may not be launched.
Commercialization by Padagis will commence in December 2023.
Stijn Van Rompay, Chief Executive Officer of Hyloris,
commented: “This is the second product approval of the
year in the U.S. supported by Hyloris, following our recent success
with Maxigesic® IV. We are excited to launch, with Padagis, the
first generic version of Condylox® Gel in the US. The availability
of the generic Condylox® Gel reinforces Hyloris' mission to make a
meaningful difference in the lives of patients by delivering
innovative and accessible pharmaceutical solutions. The company
remains focused on expanding its portfolio to address unmet medical
needs and contribute to a more sustainable healthcare system.”
About genital and perianal warts
Genital and perianal warts are caused by certain types of the
Human Papilloma Virus (HPV), the most common sexually transmitted
disease. Genital HPV infections have an estimated prevalence of 10%
to 20% and remain mostly asymptomatic. Around 1% of the sexually
active population in the U.S. presents with the most visible
manifestation of genital HPV infections, genital or perianal
warts1. Patients affected by genital warts can experience itching,
bleeding and mucus discharge.
A vaccine for HPV exists, but a cure does not2.
About HylorisHyloris 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 16
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 generics product launched in the U.S.
and 2 high barrier generic products 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 07Jean-Luc
Vandebroek, CFOJean-luc.vandebroek@hyloris.com+32 (0)478 27 68
42Sven Watthy, Investor Relations & Communications
managerSven.watthy@hyloris.com+32 (0)499 71 15 29Disclaimer
and forward-looking statementsHyloris means “high yield,
lower risk”, which relates to the 505(b)(2) regulatory pathway for
product approval on which the Company 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 Human Papillomavirus: Clinical Manifestations and Prevention |
AAFP2 Genital Warts - StatPearls - NCBI Bookshelf (nih.gov)
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