SUDA Pharmaceuticals Ltd (ASX:SUD) remains focused on cementing its presence in Latin America and establishing further markets for lead product ZolpiMist™, an oro-mucosal spray formulation used for treating insomnia.
An important area for future focus is Asia after Mitsubishi Tanabe Pharma Korea (MTPK) indicated their intention not to proceed with a licence and supply agreement.
The Korean subsidiary of Mitsubishi Tanabe Pharma cited challenges with their regulatory body, the Ministry of Food and Drug Safety, as the reason for withdrawing from the agreement.
As a result, SUDA has agreed to terminate the agreement and notes that there is no immediate financial impact as a result of the termination.
MTPK’s decision follows a similar move by Mitsubishi Tanabe Pharma Singapore Pte Ltd (MTPS) earlier this year with that company citing a change in business strategy across the ASEAN region as their primary reason not to proceed.
Seeking partners
In a statement about the MTPK decision, the company said: “SUDA will continue to focus on its partnership with TEVA and look to secure additional partners for the ASEAN region and other territories.”
The agreement with Teva Pharmaceuticals International GmbH, an affiliate of Teva Pharmaceutical Industries (NASDAQ:TEVA) Ltd (TEVA), is a key part of SUDA’s commercialisation strategy for ZolpiMist, which is approved by the US FDA and the Therapeutics Goods Administration (TGA).
TEVA has a licence to market ZolpiMist in Brazil, Mexico and Chile.
SUDA is a biotechnology company focused on developing therapies to treat human disease and its two focus areas are oncology and conditions that impact the central nervous system.
The company’s product pipeline includes an oral spray for the platelet-lowering drug anagrelide to treat metastatic disease in the background of high platelets, and ZolpiMist, a first-in-class oral spray of zolpidem tartrate to treat short-term insomnia.