Suda Pharmaceuticals Ltd (ASX:SUD) has submitted additional data to the Therapeutic Goods Administration (TGA) for its ZolpiMist™ oral spray for the treatment of insomnia.
SUDA submitted a Marketing Authorisation Application (MAA) to the TGA for ZolpiMist in April 2019.
Subsequent to the submission, SUDA made a strategic decision to register a supplemental active pharmaceutical ingredient (API) supplier and manufacturer which required an amendment to the submission.
Product quality supported
This new data supports the quality of product generated using the new API supplier and manufacturer, which is a well-known, global generics manufacturer of over the counter and generic prescription pharmaceuticals.
ZolpiMist will be manufactured and packaged by the Australian subsidiary of this global manufacturer.
The outcome of the strategic decision is a reduction of the costs of raw material and finished product, which will enable SUDA to create additional value over the medium to long-term from its existing partnerships as well as to establish additional partnerships across more territories.
Review completion in Q4
Given the change of manufacturer and based on feedback from the TGA, completion of the TGA review is expected in the December quarter of 2020.
The data submitted to the TGA is intended to be shared by the company with current and future partners to support their regulatory submissions.
SUDA continues to make progress for ZolpiMist, a first-in-class oral spray for zolpidem for insomnia, by securing additional licence and supply agreements with Mitsubishi Tanabe Pharma Korea.
The company is continuing discussions with parties covering a range of territories in line with the strategy for global commercialisation of the product.
SUDA enjoyed a productive March quarter and Dr Michael Baker, who began as chief executive officer on March 9, said the company continued to advance discussions with prospective partners for ZolpiMist for other territories.
He said: “This has been a busy quarter for SUDA signing a new licence agreement, kicking off two important projects, reviewing and reassessing current business operations as well as managing the implications from COVID-19.”
SUDA also kicked off feasibility studies with its partners Laboratorios Ordesa SL and Sanofi-Aventis Groupe during the quarter, both of which are progressing well.
New general manager
During the quarter, SUDA also appointed a general manager for Perth operations in Tony Macintyre.
Dr Baker said: “It is very pleasing to find an individual with such a strong technical, operations and regulatory background.
“We are delighted that Tony has joined the team at SUDA.”
Other products in the commercialisation pipeline include Sumatriptan, which is for the treatment of migraines, and Anagrelide, which could play an important role in cancer treatment.