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Headquartered in Western Australia, SUDA Pharmaceuticals Ltd (ASX: SUD) is a drug-delivery pharmaceutical company that develops low-risk, innovative pharmaceuticals to improve the health and lifestyle of patients, by utilising its OroMist® oro-mucosal drug delivery proprietary technology.
A wide range of drug classes can be provided using SUDAâs OroMist® Oral Spray technology through either the gums, tongue, cheeks or floor of the mouth. The technology can be provided in either unit containers or multi-dose (in either pump or propellant-driven form) based on marketing requirements and the medical need.
The Companyâs focus is on re-formulating existing products, utilising the regulatory and development advantages of USFDA 505(b)2 and EMEA Chapter 10(3) to achieve significant patient benefits and enhancing shareholder benefits.
SUDA has obtained a Good Manufacturing Practice licence from the Therapeutic Goods Administration which signifies the companyâs high standards of principles and procedures to ensure that the therapeutic goods are of high quality.
Product Pipeline
The product pipeline of SUDA Pharmaceuticals contains several well-characterised, market-leading drugs that are in various stages of development and registration.
An exclusive licence and supply agreement was signed between the company and Teva Pharmaceuticals International GmbH for ZolpiMist⢠in multiple countries in July 2017. SUDA granted a license to Teva for the distribution and marketing of ZolpiMist in Brazil, Mexico and Chile. Besides this, an 18-month option was provided by SUDA to license the product in Australia, Argentina and Israel.
Product Development Update
A few days ago, the company released its product development update as follows:
- Sumatriptan Oral Spray â SUDA has developed a Sumatriptan medication (SUD001) and entered into a fully funded agreement with Strides (India) for the development of a 2nd generation sumatriptan spray (SUD019) utilising the companyâs Hydrotrope technology for the US market.
- Ondansetron â The company developed an oral spray equivalent to Zofran® - a medication used to prevent nausea and vomiting caused by cancer radiation therapy, chemotherapy or surgery. SUDA is looking for a collaboration to fund the relevant stability studies.
- Sildenafil (Viagra) for erectile dysfunction (ED) (SUD003) and Pulmonary Arterial Hypertension (PAH) (SUD004) â SUDA has developed two families of patents covering both ED and PAH caused by the use of anti-depressants.
- Midazolam (SUD005) â The company is carrying out the development of Midazolam (increasingly used for the treatment of epilepsy).
- ZolpiMist (SUD014) â SUDA is striving to create ZolpiMist⢠into a future long-term recurring revenue stream. Recently, SUDA submitted its Marketing Authorisation file for ZolpiMist⢠to the Australian TGA. The administration has considered and accepted the file for evaluation.
- Cannabinoids (SUD020) â SUDA has entered into a fully funded agreement with Zelda Therapeutics for the development of various cannabis-based oral sprays to be used in several therapeutic indications.
The company also informed the market that it had completed three commercial transactions* in this financial year.
The below In licensing/Asset Purchase deals brought the number of transacted deals to 11 for Suda.
In its third quarter update for 2019, the company notified that it had received income of 331,000 dollars in relation to its licence and feasibility study agreements. The companyâs bank balance as at 31 March 2019 was $ 1.7 million.
Board Restructuring
Mr Paul Hopper was recently appointed as the Non-Executive Chairman of the SUDA Pharmaceuticals Ltd following which the company restructured its board. As per the recent restructuring, Mr David Phillips took the role of the executive director from Chief Business Officer, to lead the business development activities, and Mr Joseph Ohayon stepped down as the director. Mr. Andrew Curtis continues in the role as Vice President of Business Development and Alliance Management.
SUD is trading at AUD 0.006 (As at 2:55 PM AEST, 29 May 2019). The stock has delivered a return of 133.33% per cent in the last one month (As on 28 May 2019).
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