SUDA Pharmaceuticals Ltd (ASX: SUD) is a drug-delivery pharmaceutical company utilising its proprietary OroMist® oro-mucosal drug delivery technology to develop low-risk, innovative pharmaceuticals that improve the health and lifestyle of patients. The many potential benefits of administering drugs through the oral mucosa, which is the moist lining of the oral cavity (ie: cheeks, tongue, gums and palate), include ease of use, lower dosage, reduced side effects and faster response time.

SUDA’s product pipeline includes ZolpiMist, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the Americas and South Africa. SUDA’s most advanced development-stage product is a first-in-class sub-lingual spray, ArTiMist®, for treatment of malaria in children. The active anti-malarial in ArTiMist® is artemether, which is widely used in other formulations. ArTiMist® has been shown to provide a more consistent dose response and avoids the first pass effect associated with oral artemisinin-based monotherapies. SUDA has successfully completed a Phase III trial of ArTiMist® in severe paediatric malaria across multiple African countries. The Company has submitted a Marketing Authorisation Application to the Australian Therapeutic Goods Administration and aims to commercialise the product through a partnership or divestment.

SUDA has IP covering over 300 widely-used APIs formulated into oro-mucosal sprays. The Company’s development pipeline includes oral sprays of sumatriptan for migraine (SUD-001); ondansetron for chemotherapy-induced nausea and vomiting (SUD-002); sildenafil for erectile dysfunction (SUD-003) and PAH (SUD-004); and midazolam for pre-procedural anxiety and epileptic seizures (SUD-005).

SUDA has an exclusive license agreement with Eddingpharm, a leading Chinese pharmaceutical company, for the development and commercialisation of the Company’s ZolpiMist™ oral spray to treat insomnia in China. Once approved by the Chinese Food and Drug Administration (CFDA), ZolpiMist™ would be the first imported fast-acting oral spray of zolpidem tartrate available in China. 

SUDA has also entered into an exclusive licence and supply agreement with Teva Pharmaceuticals International GmbH, an affiliate of Teva Pharmaceutical Industries Limited for ZolpiMist™ oral spray in multiple countries. Teva is a leading global pharmaceutical company and the world’s largest generic medicines producer. SUDA has granted Teva a licence to ZolpiMist in Brazil, Mexico and Chile, together with an 18-month option to license the product in Argentina, Israel and Australia.  

SUDA's novel SUD-002 oral spray for nausea and vomiting is licensed to Kwang Dong Pharmaceutical Co, a leading South Korean pharmaceutical company, for Korea. 

SUDA offers added-value development services to companies seeking to formulate APIs into proprietary oro-mucosal sprays with unique advantages.This includes:

- Full feasibility assessment of the API to be formulated into an oral spray;
- Detailed work plan of the formulation project with go/no-go decision points;
- Rigorous supervision and execution of the entire project; and
- Potential to generate new IP and/or use SUDA’s background IP.

SUDA's formulation services are valuable for Rx, OTC, veterinary, vitamin and nutraceutical oral sprays. The Company has a first class Quality Control system with ISO9001 certification and is a Registered Research Provider in Australia. The Company provides its formulation services on a contract basis or as part of a co-development agreement.

In March 2017, SUDA entered into a feasibility agreement with Pfizer Consumer Healthcare. Under the agreed work plan, SUDA will apply its proprietary OroMist® oro-mucosal spray technology to two over-the-counter (OTC) molecules for evaluation by Pfizer.


SUDA is building a pharmaceutical business based on reformulated products that demonstrate major cost, functional and effectual advantages over competitors, thereby securing patient demand. Each new drug formulation developed by SUDA must address an unmet market need and use well-characterised molecules that have been approved and accepted by healthcare regulatory authorities in the world’s major territories.

The Company’s commercial strategy is to add value to each programme through to a stage where it can secure licensing or collaborative development agreements or alternatively an outright sale of the respective asset. In addition, SUDA is pursuing collaborations to reformulate partner companies’ current or developmental drugs, or extend their life cycle by developing oro-mucosal formulations.