is a drug delivery company focused on oro-mucosal administration. The Company is publicly listed on the Australian Stock Exchange (ASX: SUD) and headquartered in Perth, Western Australia.

Our business model is based on the development of low-risk pharmaceuticals using novel formulations of existing drugs that are off patent. We re-formulate these drugs to provide patentable products or line extensions for existing franchises.

Our proprietary and patented drug delivery platform has broad potential to enhance many classes of existing drugs. We have established a rich pipeline of drug candidates in various stages of development, and we will continue to expand the pipeline through the application of our oro-mucosal technology and also through acquisitions.

Suda Ltd (ASX: SUD) is a drug delivery company utilising proprietary 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 most advanced product is a novel sub-lingual (under the tongue spray) treatment, ArTiMist™, for severe malaria in children. The active anti-malarial in ArTiMist™ is artemether, which is well understood and used globally. ArTiMist™ is an easy to use spray that has been shown to provide a more consistent dose response and avoids the first pass effect associated with other oral anti-malarials. It also reduces the reliance on trained medical staff and intravenous (IV) cannulation required with the current standard in Africa, IV quinine.

Suda has successfully completed a Phase III trial of ArTiMist™ in 150 children with falciparum malaria across multiple African countries. The Company is preparing regulatory submissions and aims to commercialise the programme through a partnership or trade sale.

In August 2013, Suda completed the acquisition of the NovaDel oro-mucosal technology, which included a broad portfolio of patented product candidates in various stages of development. This has provided Suda with a deep pipeline of new programmes, the most advanced of which are for the treatment of migraine, erectile dysfunction, and chemotherapy-induced nausea and vomiting.

Westcoast

In addition to the oro-mucosal pipeline, Suda has a fully owned subsidiary, Westcoast Surgical and Medical Supplies Pty Ltd (Westcoast), which provides medical supplies to West Australian leading hospitals, aged care facilities, pharmacies, mining companies and other healthcare providers. Westcoast generated revenues of approx. $4 million in FY2013 and, in the first quarter of FY2014, achieved revenues in excess of $3 million.

Click here for more information about Westcoast.

Strategy

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, we are pursuing collaborations to reformulate partner companies’ current or developmental drugs, or extend their life cycle by developing oro-mucosal formulations.

Products

Among the various routes of drug delivery, the oral route is perhaps one of the most studied and preferred by patients and clinicians. About 70% of drugs are administered orally, primarily in tablet or capsule form however, there are a number of disadvantages associated with oral administration such as hepatic first-pass metabolism and enzymatic degradation within the gastrointestinal (GI) tract, which cause a relatively lengthy onset time and/or erratic absorption patterns. Furthermore, patients must be conscious and able to swallow (40% of US adults and 54% of children (6-11 years) report swallowing difficulties) and in most cases need to have access to drinking water.

The oral mucosa is the moist epithelial lining of the oral cavity, which includes the tongue, cheeks, palate and gums. Drug delivery within the oral mucosal cavity is classified into five categories:

1. local delivery, which is drug delivery into the oral cavity;
2. sublingual delivery, which is systemic delivery of drugs through the mucosal membranes lining the floor of the mouth;
3. buccal delivery, which is drug administration through the mucosal membranes lining the cheeks (buccal mucosa);
4. lingual delivery is drug administration on the tongue; and
5. gingival delivery is drug administration through the gums.

Suda Ltd is utilising its delivery technology to reformulate well-characterised molecules with known and proven regulatory routes to develop innovative patentable products, which provide a solution to a current market need.

Company Website:  http://www.sudaltd.com.au/