SUDA (ASX: SUD) Signs 2 Licencing Deals & a Feasibility Agreement with a Major Pharma Company

Key milestones for the 2017 financial year:

1. Signed 2 licencing deals for ZolpiMist
2. Feasibility agreement with major pharma company
3. ArTiMist marketing application submitted to TGA

New provisional patent for permeation-enhancing technology

1.Signed 2 licencing deals for ZolpiMist

i. Eddingpharm (Asia) Macao Commercial Offshore Limited (Eddingpharm)

In November 2016, SUDA entered into an exclusive license agreement with Eddingpharm, a leading Chinese pharmaceutical company, for the development and commercialisation of SUDA’s novel ZolpiMist™ oral spray of zolpidem tartrate 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.

Under the terms of the agreement, SUDA received an upfront cash payment of US$300,000 (approx. A$400,000) and is entitled to receive a further milestone payment of US$200,000 (approx. A$260,000) following registration of the product in China. In addition, once Zolpimist is registered for sale in China, SUDA will receive escalating tiered royalties on net sales in the territory. The total value of the deal could exceed US$26 million (approx. A$34 million) based on Eddingpharm’s forecast sales for the first 15 years from launch.

ii. Teva Pharmaceuticals International GmbH

In July 2017, SUDA entered into an exclusive licence and supply agreement with Teva Pharmaceuticals International GmbH, an affiliate of Teva Pharmaceutical Industries Limited (“Teva”), a leading global pharmaceutical company and the world’s largest generic medicines producer, for ZolpiMist™ in multiple countries. SUDA 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.

Under the terms of the agreement, SUDA receives an upfront payment of US$300,000 (approx. A$400,000) and is entitled to receive further licence fees, registration milestone payments and commercial milestone payments of up to US$1,750,000 (approx. A$2,300,000). In addition, once ZolpiMist is registered for sale in the territory, SUDA will supply the product to Teva and receive a double-digit royalty on net sales less the supply price.

2. Feasibility agreement with major pharma company

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

To date, SUDA has provided Pfizer with preliminary formulations and the parties are discussing next steps.

3. ArTiMist marketing application submitted to TGA

In April 2017, the Australian Therapeutic Goods Administration (TGA) accepted for review the Marketing Authorisation Application (MAA) for ArTiMist® (artemether sublingual spray) for the treatment of children with severe malaria.

In late 2016, SUDA made a pre-submission to the TGA and based on that filing the TGA has advised that the filing is complete and deemed the MAA submission to be effective and has accepted the dossier for evaluation.  The TGA now has 255 days to complete its review and provide an opinion, including potential approval of the ArTiMist Marketing Authorisation.

4. New provisional patent for permeation-enhancing technology

SUDA filed a provisional patent application with IP Australia for a novel mucosal penetration drug delivery technology. The application was filed under the international Patent Cooperation Treaty (PCT), which enables SUDA to seek patent protection for its technology in more than 145 countries.

The technical field of the provisional patent application is entitled: ‘A method for modifying the penetration of active agents through mucosal membranes using hydrotropes.’ It is based on positive results from ex-vivo and in-vivo studies evaluating SUDA’s new-generation formulation of SUD-003 sildenafil oral spray for erectile dysfunction, together with in-vitro data investigating the technology with a broad range of other molecular drug classes.

This permeation-enhancing technology is intended to overcome some of the challenges associated with delivery of therapeutic drugs across the oro-mucosal membrane (further discussed under OroMist Technology below).

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ABOUT SUDA LTD

SUDA Ltd (ASX: SUD) is a drug delivery 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.