SUDA Pharmaceuticals has productive few months with ZolpiMist™ and spray version of anagrelide

SUDA Pharmaceuticals Ltd (ASX:SUD) (FRA:E4N) has had a productive few months progressing its short-term insomnia treatment in adults, ZolpiMist™, and an oral spray version of anagrelide. The oro-mucosal drug delivery company said its current focus areas were oncology and the central nervous system, with its lead product in each area being anagrelide and ZolpiMist™. SUDA’s chief executive officer and managing director Dr Michael Baker said: “We are committed to building our presence in these areas, in addition to executing on the programs that we have underway. “We have a strong balance sheet, TGA approval for our lead product and positive progress for our cancer program.” Australian commercialisation partner The company said the July approval from the Therapeutic Goods Administration to proceed with the registration of ZolpiMist™, also included the supplemental API supplier and final product manufacturer. This allows the company to supply the product at a more competitive price and potentially allows it to target additional territories. Baker added: “It is the first step to bringing a product to market and we are excited to have reached this milestone. “We are in discussions, looking to select our Australian commercialisation partner.” It already has partners in place for some regions, including TEVA covering Brazil, Chile and Mexico; Mitsubishi Tanabe Pharma Singapore covering Singapore, Malaysia and the Philippines; and recently added Mitsubishi Tanabe Pharma Korea for South Korea. “We are continuing to pursue partnerships to cover additional territories in line with commercialising the product across the globe.” Positive results for anagrelide The company is continuing to optimise and enhance the formulation for anagrelide, which is being repurposed for the treatment of metastatic disease in patients with solid tumour cancers. Once the formulation has been refined, it will complete pre-clinical toxicology studies, prior to initiating clinical trials. As anagrelide has previously been approved by both the Food and Drugs Administration (FDA) and the European Medicines Agency (EMA), it expects a much-reduced package of preclinical testing will be required for the future development of the formulation. Results from the pharmacokinetic study performed at Covance Inc, analysing several oral spray formulations of anagrelide have been positive, supporting the concept that it could provide patients with lower doses of the drug, while at the same time reducing their exposure to the cardio-stimulatory intermediate. Also, it reinforces the belief that an oral spray formulation of anagrelide could provide a safer means by which the drug could be more safely administered to patients for the treatment of metastatic disease. Project director Dr Richard Franklin said: “We are delighted that one of the formulations tested leads to increased bioavailability and could reduce exposure to the cardio-stimulatory immediate.” Suitable cancer target In other work, the company has looked at a number of different cancer types that could be candidates for clinical trials, given the incidence of increased platelet levels (thrombocytosis), the use of combination immunotherapies and the targetable pool of patients suffering from the particular cancer. SUDA is now performing additional work to further define the most suitable cancer target. Anagrelide patent The company is continuing efforts to secure grants for the patent in additional markets, including North America. Recently the Australian Patent Office accepted its patent application and the patent will now proceed to grant status, with an expiry date of December 2035. It already has patent approval in Europe and Japan. Search for additional technologies SUDA is continuing its efforts to secure additional technologies that it plans to develop internally and fit within its current focus areas. Preliminary searches have identified a number of interesting technologies that it believes could enhance its current portfolio of products. Maintain focus SUDA currently has a number of products under development using its OroMist® platform, in addition to anagrelide, which it is deliberately developing internally. To maintain focus, SUDA has put a number of its legacy programs on hold. ArTiMist has been put on hold and the company will not be committing any further resources toward Midazolam, Ondansetron and Sildenafil. Nevertheless, it will still look to opportunistically enter into co-development partnerships for these products. Financially more than comfortable Baker said the company was financially “more than comfortable for the next year’s operation”, following the entitlement offer that was heavily oversubscribed and saw the raising of a total of $4.09 million.