- SUDA Pharmaceuticals (ASX:SUD) has recently published its October 2020 newsletter for shareholders, outlining developments around its key projects – ZolpiMist® and anagrelide.
- Lately, SUDA has made significant progress with regards to its key projects by attaining early TGA approval for ZolpiMist® and announcing positive pre-clinical trials on anagrelide.
- The Company has also marked a major breakthrough by receiving the Australian Patent Office’s approval on anagrelide patent application.
- SUDA is in the process of selecting its Australian commercialisation partner for ZolpiMist®.
- The Company is continuing with its efforts to attain grants for the anagrelide patent in additional markets, including North America.
- SUDA intends to finalise pre-clinical toxicology studies once the anagrelide formulation has been developed before starting clinical trials.
World-leading pharmaceutical company, SUDA Pharmaceuticals Limited (ASX:SUD) has recently published its October 2020 newsletter for shareholders. The letter focusses on SUDA’s developments around its key projects – ZolpiMist® and anagrelide – and discusses its strategy for 2020 and beyond.
SUDA’s current areas of focus are the central nervous system and oncology, with ZolpiMist® and anagrelide being the lead products. The Company is committed to building its presence in these areas in addition to executing on the projects that are presently underway.
Over the last few months, SUDA has made significant progress with regards to its key projects by attaining early TGA (Therapeutic Goods Administration) approval for the registration of ZolpiMist® and announcing positive pre-clinical animal trials on anagrelide.The Company has marked a major breakthrough by receiving the Australian Patent Office’s approval on anagrelide patent application.
Early Receipt of TGA Approval for ZolpiMist®- A Significant Breakthrough
In July 2020, SUDA obtained the TGA approval to proceed with the registration of ZolpiMist® while it was not expected until the last quarter of the year.
The approval also comprised the supplemental API (Active Pharmaceutical Ingredient) supplier and final product manufacturer. Consequently, it permits the Company to supply the product at a more competitive price and place it in good stead to target additional territories.
SUDA outlined multiple benefits of the TGA approval, which include:
- Enables commercialisation and sale of Zolpimist® within Australia.
- Demonstrates the Company’s good manufacturing practice and potential to attain regulatory approval for its products.
- Places it in a strong position to establish and further strengthen its credibility with its partners and help them in their submissions in their individual territories with the revised API supplier and manufacturer.
Currently, SUDA has multiple partners in place, comprising TEVA for Brazil, Chile and Mexico, Mitsubishi Tanabe Pharma Singapore for Singapore, Malaysia and the Philippines and Mitsubishi Tanabe Pharma Korea for the territory of South Korea. SUDA is also in the process of selecting its Australian commercialisation partner.
Besides, the Company continues to engage in other partnerships to encompass additional territories in accordance with commercialising the product worldwide.
Positive Results for Anagrelide – An Exciting Development
Recently, SUDA received positive outcomes from the pharmacokinetic study undertaken at Covance Inc., which analysed multiple oral spray formulations of anagrelide. The study results endorsed the idea that the Company could provide patients with lower doses of anagrelide drug while lowering their exposure to the cardiostimulatory intermediate at the same time.
The promising outcomes reinforced the Company’s belief that an oral spray formulation of anagrelide can potentially offer a safer means through which the drug can be more safely provided to patients for treating metastatic disease. In a nutshell, the results demonstrate that the Company’s approach of delivering drugs via an oral spray offers potential to be a safer and better way to dose patients relative to traditional delivery path of the capsule, tablet or pill.
SUDA has also recently secured the approval from the Australian Patent Office for its anagrelide patent application. The approval will now proceed to grant status, complementing the Company’s granted patents already in place in Japan and Europe.
SUDA is continuing with its efforts to attain grants for the anagrelide patent in additional markets, including North America. Additionally, it is in the process of optimzoising and enhancing the oral spray formulation for anagrelide to formulate a pharmaceutical grade product. Once the formulation is developed, the Company will finalise pre-clinical toxicology studies before starting clinical trials.
SUDA believes that a much-reduced package of pre-clinical testing will be needed for the future development of anagrelide’s unique formulation as the drug has already been approved by the FDA and EMA.
SUD traded at $0.040 on 14 October 2020 (12:17 PM AEST).
With the pandemic continuing to affect the globe, healthcare companies are evaluating their lead compounds for COVID-19 treatment. Future revenue for these stocks depends on the probability of launching an approved treatment in the market.