SUDA Ltd Announces that TGA Accepted for Review ArTiMist®

SUDA Ltd (ASX:SUD), a leader in oro-mucosal drug delivery, announces that the Australian Therapeutic Goods Administration (TGA) has accepted for review the Marketing Authorisation Application (MAA) for ArTiMist® for the treatment of children with severe malaria.

KEY TAKEAWAYS:

• In late 2016, SUDA, made a pre-submission to the TGA and based on that filing the TGA has advised that the filing is complete and deemed the MAA submission to be effective and has been accepted for evaluation.
• The TGA has 225 days to complete its review and provide an opinion, including potential approval of the ArTiMist Marketing Authorisation.
• SUDA is continuing discussions with parties in relation to a trade sale or partnering agreement as part of the product commercialisation strategy.

In parallel with this, SUDA has commenced pre-planning for a product launch. This has included negotiations around manufacture and supply chain logistics, pricing models and distribution channels. A number of parties with a distribution footprint and extensive experience in Africa have expressed interest in entering into distribution arrangements with SUDA.

Mr Stephen Carter, SUDA’s CEO and Managing Director, commented: “Based on the positive results from our clinical studies in paediatric patients and our discussions with the World Health Organisation and other groups, we believe that pursuing a marketing authorisation in Australia will accelerate access to ArTiMist for patients in malaria-endemic countries. The acceptance of this filing brings us one step closer to addressing the unmet medical need of severe malaria. It is a debilitating condition that can cause long-term neurological problems and death. Children under five years of age are one of most vulnerable groups affected by severe malaria because they lack immunity to the parasite.”

SUDA is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist® technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time.

SUDA’s most advanced development-stage product, ArTiMist®, is a novel sublingual malaria treatment for children. In a Phase III trial, ArTiMist® was shown to be superior to intravenous quinine. Other products in development include oral sprays for the treatment of migraine headache, chemotherapy-induced nausea and vomiting, erectile dysfunction and pre-procedural anxiety.

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