Progressing remarkably with the commercialisation of its insomnia drug ZolpiMistTM, the oro-mucosal drug delivery leader SUDA Pharmaceuticals Limited (ASX:SUD) has signed an additional licence agreement with one of the top Japanese pharmaceutical companies, Mitsubishi Tanabe Pharma Korea Ltd (MTPK).
MTPK is based in Seoul with the parent firm Mitsubishi Tanabe Pharma Corporation (MTPC), whose corporate philosophy is to provide support towards the healthier lives of people throughout the world via development of pharmaceuticals.
Under the agreement, SUDA has granted Mitsubishi Tanabe Korea an exclusive licence for, and supply of, its insomnia drug for South Korea, with a term of ten years from first commercial sale.
SUDA signed an exclusive license agreement with Mitsubishi Tanabe Pharma Singapore Pte Ltd (MTPS) in December 2018 for licence and supply of ZolpiMistTM in Malaysia, Singapore and Philippines.
Key Terms of the Agreement
As a part of the agreement, the Company will obtain an upfront fee of USD 100,000, in addition to:
- a milestone payment of USD 100,000 based on MTPK obtaining regulatory approval, and
- commercial milestone payments based on MTPK attaining sales targets of the product up to a maximum series of milestone payments of USD 300,000.
Moreover, the Company will receive a double-digit royalty of about 12 per cent based on net sales of the product in South Korea. SUDA is also obliged to register ZolpiMistTM with the Australian TGA and supply the product, for which SUDA will receive a handling fee.
Both the parties, MTPK and SUDA, will collaborate under a Joint Management Committee and a Joint Development Committee to supervise and coordinate activities to ensure the success of the product within South Korea. It is imperative to note that the agreement is subject to standard termination clauses.
Progressing Rapidly with its Key Project – ZolpiMistTM
The insomnia drug ZolpiMistTM approved by the US FDA, is SUDA’s most advanced product. It is a patented cherry-flavoured, zolpidem tartrate’s oro-mucosal spray formulation, which is supplied under the brand name of Stilnox® or Ambien®.
The Company has so far signed license and supply deals with various pharma players for ZolpiMistTM:
ZolpiMistTM clinical study results have demonstrated that the insomnia drug delivers sleep onset more rapidly than the tablet form of zolpidem based on efficacy and pharmacokinetics parameters.
Marketed in the United States, SUDA has rights to ZolpiMistTM outside of Canada and the US. SUDA has out-licensed ZolpiMistTM across Mexico, South Korea, Philippines, Malaysia, Singapore, Brazil and Chile. Moreover, the Company is also negotiating with pharma companies for other countries in South America as well as for China, Middle East and North Africa, UAE, Kuwait, Spain, Italy, France, Germany and Australia.
In 2020, the Company has planned for the global expansion of ZolpiMistTM, in addition to developing Anagrelide towards Phase 1 clinical trials, continuing work on the assets from its partnerships with Strides, Sanofi, Ordesa, Cann Pharma and Zelira Therapeutics, bringing in additional assets and managing costs.
SUDA’s latest agreement with Mitsubishi Tanabe Korea offers further evidence of the Company’s ability to build out the commercial potential for ZolpiMistTM. Moreover, the Company is in a unique position to leverage its robust network to tap significant target markets including insomnia, cancer, medical grade cannabis and migraine, supported by its staged business and marketing strategy.
SUDA last traded at $0.042 on 24 March 2020.
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