SUDA Pharmaceuticals Ltd (ASX:SUD) passed a number of key milestones during the September quarter including approval from the Therapeutics Goods Administration (TGA) for the registration of the ZolpiMist® (zolpidem tartrate) treatment for short-term insomnia in adults.
Completion of the TGA review is expected in the current quarter and the company is in discussions to secure its Australian commercialisation partner.
SUDA CEO and managing director Dr Michael Baker said: “This has been a busy quarter and we are proud that SUDA has received its first TGA approval for ZolpiMist.
“The next step is to secure our Australian partner for commercialisation of the product and to continue to work with our existing partners for their regulatory submissions and commercialisation efforts.”
The TGA approval is expected to assist SUDA’s current partners, TEVA, Mitsubishi Tanabe Pharma Singapore and MTP Korea, with their submissions in their respective territories.
Australian patent for anagrelide
There were also two positive developments for the anagrelide project during the quarter.
Adding to the granted patents that the company has in Europe and Japan, the Australian Patent Office will grant SUDA’s Application No 2015370666 ‘Prevention and Treatment of Metastatic Disease in Thrombocytotic Cancer Patients’.
This patent has an expiry date of December 2035.
Another positive development for the anagrelide project was the receipt of the final report for the pharmacokinetic study completed at Covance Inc. in the UK.
The data revealed that one of the carefully selected oral spray formulations resulted in a statistically significant increase in bioavailability of anagrelide with a lesser increase in the levels of the unwanted cardiostimulatory intermediate - this means that patients may be able to take less of the drug and reduce their exposure to the cardiostimulatory intermediate.
These results support SUDA’s hypothesis that an oral spray version of anagrelide may provide a safer route of administration of the drug for the treatment of metastatic disease.
Dr Baker said: “It is also pleasing to have ticked off two important milestones for the anagrelide program, receiving notification that the Australian patent will proceed to grant and confirming the hypothesis that an oral spray version of anagrelide may provide a safer route of administration to treat patients with metastatic disease and elevated platelet levels.”
$4.1 million capital raising complete
The non-renounceable pro-rata entitlement offer which closed on July 29, 2020, was strongly supported by shareholders, including institutional shareholders, and closed heavily oversubscribed.
Applications for entitlements and additional top-up shares received from shareholders totalled $5.2 million and, accordingly, the company had to scale back top-up applications.
In total, SUDA raised $3.56 million (before costs) via the entitlement offer and issued 142,254,397 shares and 47,418,132 listed options.
In preparation for any shortfall that may have arisen for the entitlement offer, the lead manager Baker Young, received bids in excess of $3.4 million.
Due to the overwhelming demand, the company placed a further 21,338,159 fully paid ordinary shares at 2.5 cents per share raising an additional $533,453 to sophisticated investors.
The company is in a strong financial position to support commercialisation plans going forwards.