SUDA Shareholder Update; Negotiations with Licensing Partners & €6m Grant Application

8th February 2016, ASX Announcement

SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, today announces an update to shareholders describing the Company’s progress towards its business development goals and advancement of its pipeline of first- in-class oral sprays.

SUDA has started 2016 with real momentum behind its business development activities. The Company is negotiating financial terms with several prospective licensing partners and, in January 2016, received additional requests for term sheets. These negotiations span a number of the Company’s oral sprays and a range of territories.

ArTiMist™

The Company’s novel anti-malarial sublingual spray continues to attract attention from industry and also funding groups. Two major philanthropic funds have indicated their interest in funding the proposed clinical study to evaluate ArTiMist™ as an early interventional paediatric treatment in the pre-referral setting, before patients are admitted to hospital.

In addition, SUDA has applied for a European grant of Euro 6 million to support the study. The grant proposal received excellent reviews in the first stage of evaluation and has advanced to the second stage of assessment. The reviewers made comments such as: “A successful outcome to this trial could quickly lead to a policy change that would improve disease management.” And from another “The impact of ArTiMist™ could be substantial… There is a real need for an effective bridging treatment to sustain severely ill children in remote areas until full treatment can be administered at a referral facility…”.

The Company is also in dialogue with the World Health Organization (WHO) with regard to the inclusion of ArTiMist™ in the WHO’s Model List of Essential Medicines and their Standard Treatment Guidelines for malaria. This would lead to the provision of ArTiMist™ through the WHO’s large-scale procurement of antimalarial medicines for public health use in malaria-endemic countries.

SUD-001, SUD-002 and SUD-003

In 2015, the FDA acknowledged SUDA’s proposed development strategy for SUD-001 and requested minor justifications together with a paediatric study plan. The Company has submitted to the FDA the requested information regarding the trial design and is finalising the paediatric study plan. This will provide further clarity on the path to market for prospective licensees in the USA.

Having regained rights to SUD-002 ondansetron oral spray for nausea and vomiting in December 2015, SUDA is working with its regulatory advisors to request a meeting with the FDA. The outcome of this meeting will similarly de-risk the product by setting out the requirements for registration in the US market.

To download the full announcement, please click on the link below.