SUDA Pharmaceuticals Ltd (ASX:SUD) (FRA:E4N) enjoyed a productive first half of FY21, securing TGA approval for its ZolpiMist insomnia treatment and receiving the patent for its anagrelide formation for the treatment of metastatic disease.
The company ended the period to December 31, 2020, well-funded with cash at bank of $5.5 million off the back of successful capital raises during the half year of $6.85 million to sophisticated and new investors.
These funds are being used to support ongoing research and the potential acquisition of new technologies in the fields of oncology and the central nervous system.
Medpharm to optimise anagrelide formulation
The company has this week contracted the services of MedPharm, which will perform formulation development work to assist in stabilising and optimising the oral spray formulation.
MedPharm is a world-leading Contract Development and Manufacturing Organisation (CDMO) that focus on topical and transdermal product design and development services.
SUDA CEO and managing director Dr Michael Baker said: “MedPharm has an excellent reputation for the development of transdermal products and we look forward to working together.”
The company’s patent for anagrelide was also granted during the period.
Oral spray development
During the six months prior to December 31, 2020, the company conducted an animal study at Covance Inc, UK, to test the hypothesis that an oral spray could provide a safer route of administration for anagrelide in treating metastatic disease in cancer patients by reducing exposure to the cardiostimulatory metabolite, 3-hydroxy anagrelide.
One of the formulations tested displayed a statistically significant increase in bioavailability over the capsule of 43%, with the same formulation showing an increase of only 28% in exposure to the cardiostimulatory metabolite relative to the capsule formulation.
According to Covance, this provides evidence that a proportion of the drug from this formulation reaches the bloodstream by crossing the lining of the cheek.
Once a pharmaceutical grade formulation is established, it will be assessed in formal pre-clinical toxicology studies prior to performing human trials.
As anagrelide has been approved and has been in clinical use for more than 20 years, a reduced toxicology package is expected, and the company expects this will reduce the timing and cost of this development stage.
ZolpiMist TGA approval
On July 29, 2020, SUDA announced that the Therapeutic Goods Administration (TGA) had approved the registration of the ZolpiMist (zolpidem tartrate) product for the treatment of short-term insomnia in adults.
The approval includes a supplemental active pharmaceutical ingredient (API) supplier and the final product manufacturer, which allows SUDA to supply the product at a more competitive supply price.
The benefits of TGA approval are:
- ZolpiMist is now included on the Australian Register of Therapeutic Goods and can be commercialised and supplied within Australia;
- It demonstrates SUDA’s compliance with good manufacturing practice and an ability to obtain regulatory approvals for its products; and
- It assists the company’s current partners, TEVA (covering Brazil, Chile and Mexico) and Mitsubishi Tanabe Pharma Korea (covering South Korea), in their submissions in their respective territories with the amended API supplier and manufacturer.
Future focus
Looking forward, the company is continuing to identify suitable territories to create additional partnerships for distribution of the ZolpiMist product.
SUDA will also continue to work on its development partnerships with current partners, Cann Pharma for the development of their medical grade cannabis product and Strides Pharma for development of Sumatriptan into an oral spray for the treatment of migraine.
In addition, the company is continuing to work with Sanofi to finalise the feasibility study for one of Sanofi’s active ingredients.