ACN 090 987 250

ASX Release

SUDA SIGNS LICENCE AGREEMENT WITH MITSUBISHI TANABE FOR ZOLPIMIST

  • Licence agreement with a major pharmaceutical company;

  • Territory includes Singapore, Malaysia and Philippines plus optional countries;

  • SUDA to receive an upfront fee of US$100,000 plus milestone and option payments up to US$880,000;

  • SUDA to receive a double-digit royalty;

  • SUDA to supply the product and receive a handling fee;

  • SUDA continues to meet milestone targets.

PERTH, AUSTRALIA - 19 December 2018: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that it has entered into an exclusive license agreement with Mitsubishi Tanabe Pharma Singapore Pte Ltd (MTPS), a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation ("Agreement").

SUDA continues to expand its coverage of ZolpiMist™, an oral spray treatment for insomnia, as outlined in the announcement of 13 November 2018, and meets its anticipated milestone as outlined in the investor presentation of 28 August 2018.

Key terms of the Agreement:

i. The Agreement is for an exclusive licence for, and supply of, ZolpiMist for the

Philippines, Malaysia and Singapore and options for Thailand, Indonesia, Vietnam, Myanmar, Cambodia, Laos and Brunei. The option period is for 12 months.

  • ii. SUDA will receive an upfront fee of US$100,000 and milestone payments based on MTPS obtaining regulatory approval of US$40,000 per country as well as commercial milestone payments based on MTPS achieving sales targets of the product with a maximum milestone payment of US$650,000.

  • iii. On exercising the option, MTPS will pay SUDA US$35,000 followed by milestone payments of US$25,000 per country based on MTPS obtaining regulatory approvals.

  • iv. SUDA will also receive a low double-digit royalty based on net sales of the product in the territory.

  • v. SUDA's obligations include the supply of ZolpiMist, for which SUDA will receive a handling fee, and the registration of ZolpiMist with the Australian TGA.

  • vi. SUDA and MTPS will work together under a Joint Development Committee and a Joint Management Committee to coordinate and oversee activities to ensure the success of the product within the territory.

  • vii. The agreement is subject to standard termination clauses.

Mr Stephen Carter, SUDA's Executive Chairman, commented: "We have been in discussion with Mitsubishi Tanabe for several months and are very excited with the prospect of this partnership which will expand ZolpiMist coverage across Asia.

"By completing another agreement with a major pharmaceutical company, reinforces the work and developments of the company. We continue to focus on out-licensing our ZolpiMist product and are progressing further negotiations in a number of countries."

Further information:

STEPHEN CARTER EXECUTIVE CHAIRMAN SUDA Pharmaceuticals Ltd Tel: +61 8 6142 5555 sjcarter@sudapharma.comNOTES TO EDITORS:

About SUDA Pharmaceuticals Ltd

SUDA Pharmaceuticals Ltd (ASX: SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist® technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced sideeffects and faster response time. SUDA's product pipelineincludes ZolpiMist,a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. SUDA has submitted a Marketing Authorisation Application to the Australian Therapeutic Goods Administration for ArTiMist®, its novel sublingual malaria treatment for children. In a Phase III trial, ArTiMist was shown to be superior to intravenous quinine. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; PAH; epileptic seizures and pre-procedural anxiety and cancer.

For more information,visitwww.sudapharma.com

About Mitsubishi Tanabe Pharma Corporation (MTPC)

Mitsubishi Tanabe Pharma Corporation, which was founded in 1678, has its headquarters in Doshomachi, Osaka, Japan, which is the birthplace of Japan's pharmaceutical industry. Mitsubishi Tanabe Pharma Singapore (MTPS) is based in Singapore with the parent company MTPC. The Mitsubishi Tanabe Pharma corporate philosophy is to "contribute to the healthier lives of people around the world through the creation of pharmaceuticals." This philosophy expresses how they have returned to the basics of the discovery of pharmaceuticals and puts the fundamental purpose into words. In line with this philosophy, they strive to be a global research-driven pharmaceutical company that is trusted by society. Going forward, in accordance with the Group's shared values that "everything we do is for the patients," we will work to fulfil our social mission as a life sciences company by creating pharmaceuticals that are useful to people around the world and delivering those pharmaceuticals to patients

For more information,visithttps://www.mt-pharma.co.jp/e/

About ZolpiMist

ZolpiMist is a first-in-class, US-approved, cherry-flavoured, fast-acting oral spray of zolpidem tartrate (marketed under the brand name of Ambien® or Stilnox®), a non-benzodiazepine prescribed for the treatment of insomnia. It provides a convenient and easy-to-use alternative route of administration, by delivering a therapeutic dose with one or two actuations of the spray into the oral cavity. The pivotal studies demonstrated bioequivalence of ZolpiMist 5mg and 10mg doses with the respective Ambien tablets. The time to therapeutic levels of both ZolpiMist doses were significantly shorter than the corresponding Ambien tablets and ZolpiMist showed a faster onset of drowsiness. ZolpiMist advantages include reduced sleep latency, patient convenience, and ease of use as it is administered without the need of water, unlike conventi onal tabl ets. Al so, i t can benefi t pati ents experi enci ng di fficulties i n swallowi ng and/ or sufferi ng with gastrointestinal (GI) disorders that restrict the absorption of drugs via the GI mucosa.

Attachments

Disclaimer

Suda Pharmaceuticals Ltd. published this content on 19 December 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 19 December 2018 00:59:03 UTC