Strides / Artimist / TGA, page-6

NDF Valuation of Artimist

Base case Optimistic case

6.2 ArTiMist (A$m) 18.8 49.6

From announcement dated 21 August 2014

The WHO has recommended that SUDA firstly seek registration of ArTiMist™ with the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) under Article 58.

Article 58 of Regulation (EC) No 726/2004 allows the EMA's Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with the WHO, on medicinal products for human use that are intended exclusively for markets outside of the European Union. In parallel, SUDA has been advised to pursue the WHO Prequalification of Medicines Programme (PQP) for ArTiMist™.

Every year, billions of US dollars worth of medicines are purchased by or through international procurement agencies – such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID – for distribution in resource-limited countries. PQP helps to ensure that medicines supplied by procurement ASX Release No. 731 21 August 2014 Page 2 of 3 agencies meet acceptable standards of quality, safety and efficacy. Based on these recommendations, SUDA is targeting US or European registration and WHO Prequalification of ArTiMist™ prior to a regional submission of the Common Technical Document in Africa.

The Company is coordinating its strategy with the WHO and MMV and plans to initiate dialogue with the FDA and EMA.

SUDA is making progress with its plan to expand the market of ArTiMist™ from the treatment of severe paediatric malaria to its use as an early interventional treatment when children first show signs of a malaria-like fever, before being referred to hospital.

This would represent a significant expansion of the patient population that could benefit from the product and would substantially increase the product’s commercial value. It is also an area of unmet medical need with no approved treatments.

As a result, it has drawn the attention of the MMV and the WHO. The MMV is supporting SUDA and the Company’s Clinical Advisory Board in the design of a clinical trial of ArTiMist™ in this pre-referral setting.

SUDA does not intend to initiate further trials without a partner, but will present the protocol to the WHO and philanthropic funds that have indicated an interest in supporting the clinical evaluation of ArTiMist™ as an early interventional treatment