Aquavit Files Two IND's For Its Botulinum Toxin With FDA

Announces its IND Submissions to FDA for Aquatox™ at the Annual American Academy of Dermatology 2023

NEW YORK, NY, USA I March 17, 2023 I Aquavit Holdings, the exclusive licensee of Huons Global's Botulinum Toxin in the USA and Canada, will officially unveil the Aquatox™ program at the Annual American Academy of Dermatology - 2023, the world's largest dermatology conference scheduled from March 17-21, 2023, in New Orleans, LA.

Aquatox™ (DTX-023) is a botulinum toxin type A drug product intended for the treatment of primary axillary hyperhidrosis (IND filing number 1) and for the treatment of palmar hyperhidrosis (IND filing number 2). Aquavit is exhibiting at AAD-2023 (Booth Number: 1558) and invites all esteemed attendees to visit the booth as it showcases its Aquatox™ program along with AQUAGOLD®, its renowned microchannel microinjector and other cutting edge technologies.

According to The Aesthetic Society and the Global Market Insights, botulinum toxin has been the #1 non-surgical aesthetic procedure since 1999 and is still growing rapidly with only 4 companies with approved botulinum toxin in the US. The North American botulinum toxin market alone was valued at $3.19B in 2019. With a projected CAGR of 7-9%, the global botulinum toxin market in 2026 is expected to be $8.9B. For several years, Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin. With Aquavit's proven track record of developing and launching a global brand such as AQUAGOLD®, combined with its knowledge of the botulinum toxin and network of physicians, Aquavit is poised to make a significant impact in the fast-growing multi-billion-dollar neurotoxin market.

"Hyperhidrosis is extremely debilitating with significant impairment of patient's activities of daily life, social interactions, occupational activities and a major cause of patient burden. Through our endeavors we will be providing appropriate and necessary access to a biologic to this vulnerable population." Churl-Su Kwon, CMO Aquavit.

DTX-023 is a highly purified and clinically tested injectable neuromodulator with a 900 kDa protein complex derived from neurotoxins produced by Clostridium botulinum. Aquavit is initiating Phase-II clinical trials soon with IND submissions with the FDA for the treatment of primary axillary hyperhidrosis and palmar hyperhidrosis. Additionally, Aquavit is currently evaluating all other potential therapeutic indications of botulinum toxins. Microtox™ (DTX-022) is developed to be a first-of-its-kind, pan-facial microinjection of neurotoxins. DTX-022 features a novel route of administration (RoA) of DTX-021 combined with Aquavit's innovative microchannel delivery system, a first-of-its-kind use of botulinum toxin intended for the pan-facial microinjection delivery. DTX-022 offers precision delivery with proven higher patient compliance and lower systemic toxicity. Aquavit is open for collaborations and is seeking interested and experienced investigators to be a part of the clinical trials of DTX-023.

"We are thrilled to showcase DTX-023 at this year's AAD. Aquavit's proven track record of developing and launching a global brand such as AQUAGOLD®, combined with our network of physicians and knowledge of botulinum toxins, we are poised to make a significant impact in the fast-growing botulinum toxin industry. We plan to introduce the most innovative botulinum toxin products, uplift and modernize the treatment paradigm" said Sobin Chang, CEO of Aquavit.

About Aquavit
Aquavit is a high-tech pharmaceutical company that provides a comprehensive range of innovative pharmaceutical, biotech and medical device technologies. Aquavit focuses on personalized medicine to improve patients' health, maximize the efficiency of our medical community, and support the pharmacoeconomics of payers.

SOURCE: Aquavit Holdings

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