SUDA Pharmaceuticals Signs Licence & Supply Deals for ZolpiMist™ & Feasibility & Option Agreement with Pfizer

KEY TAKEAWAYS: 

• Signed a licence and supply deal for ZolpiMist™ (plus an additional licence and supply deal after the reporting date).
• Feasibility and option agreement with a major pharma company.
• ArTiMist marketing application submitted to TGA
• New provisional patent for the permeation-enhancing technology.

Signed licencing deals for ZolpiMist™

• 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 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.
• Teva Pharmaceuticals International GmbH (post balance sheet date) On 4 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 distribute and market 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.

Feasibility and Option agreement with major pharma company

In March 2017, SUDA entered into a feasibility and option 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.

ArTiMist marketing application submitted to TGA

In late 2016, SUDA made a pre-submission to the Australian Therapeutic Goods Administration (TGA) and subsequently submitted the Marketing Authorisation Application (MAA) for ArTiMist® (artemether sublingual spray) for the treatment of children with severe malaria. In April 2017, the TGA has accepted the dossier for evaluation. The TGA is expected to complete its review and provide an opinion, including potential approval of ArTiMist, in the first half of 2018.

New provisional patent for permeation-enhancing technology

SUDA filed a provisional patent application with IP Australia for a novel mucosal permeation-enhancing 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 in-vitro, 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 and ex-vivo 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 the delivery of therapeutic drugs across the oro-mucosal membrane.

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About SUDA Pharmaceuticals Ltd (ASX: SUD)

SUDA Pharmaceuticals Ltd (ASX: SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia.

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