SUDA Pharmaceuticals Ltd (ASX:SUD), in partnership with Teva Pharmaceuticals, has secured approval from the Chilean Ministry of Health to register lead product, ZolpiMist™ for the treatment of short-term insomnia in adults.
SUDA’s partner, Teva Pharmaceuticals, submitted a Marketing Authorisation Application (MAA) with the new supplemental API supplier and the Australian final product manufacturer to the Chilean authority for ZolpiMist™ in May 2021. Approval has been granted months earlier than expected.
Boost to commercialisation
Chile is the first territory among those targeted by Teva through its Latin American-focused subsidiary to achieve commercial approval, paving the way for commercialisation and supply within Chile while also demonstrating ZolpiMist™'s international regulatory compliance and good manufacturing practice.
“The Chile submission was a combined effort by SUDA and Teva Pharmaceuticals. Obtaining the approval indicates the calibre of SUDA’s team as well as that of our partner, Teva Pharmaceuticals and is a key benefit to our partners for ZolpiMist™,” SUDA CEO and managing director Dr Michael Baker said.
“We are delighted by the outcome and look forward to seeing the commencement of commercial sales in the foreseeable future.”
About the companies
SUDA Pharmaceuticals is a biotechnology company focused on developing therapies to treat human disease, with a focus on oncology and conditions that impact the central nervous system.
SUDA is developing its invariant natural killer T (iNKT) cell therapy platform from Imperial College London to treat blood cancers. The company is also developing low-risk oral sprays to reformulate existing pharmaceuticals.
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.
ZolpiMist™ is approved by the FDA and the TGA and is marketed in the USA. Other products in development include oral sprays to treat migraine headaches, motion sickness, and drug-resistant epilepsy.
Teva Pharmaceutical Industries (NASDAQ:TEVA) is an Israeli multinational pharmaceutical company with headquarters in Petah Tikva, Israel. Teva Pharmaceuticals International GmbH is a subsidiary of the company with licence to market ZolpiMist™ in Brazil, Mexico and Chile.