Moleculin Biotech announced the expansion of Annamycin production commitments in response to management's assessment of positive AML clinical trial activity and the potential expansion of indications for use to include lung-localized tumors. The purchase commitment arranged through Davos Pharmaceuticals includes moving final production of Annamycin to a larger-scale suite within BSP Pharmaceuticals (BSP) in Latina, Italy. Until now, BSP has been producing the clinical supplies of Annamycin in a smaller pilot-scale suite.
"Our clinical trials of Annamycin in relapsed and refractory acute myeloid leukemia ("AML") have been going better than expected, as it now appears we will be able to reach a higher maximum tolerable dose than what was established in previous clinical trials," said Walter Klemp, Moleculin's Chairman and CEO. "That not only increases our chances for improved patient outcomes, it places a higher demand on drug supply. Coupled with the recent discovery in animal models that Annamycin may be well suited to treat lung-localized tumors because of its ability in such models to accumulate in the lungs at nearly 6 times the level of the current standard of care anthracycline, we are clearly going to need more drug."
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"With management's view of success in clinic and the expectation of wider demand resulting from additional clinical trials in lung-localized tumors, it's time for Moleculin to start preparing for an eventual drug approval process,” Dr. Donald Picker, Moleculin's Chief Science Officer said. “That requires the development and validation of commercial scale methods and this move with BSP marks the beginning of that process. In addition to increasing the scale of clinical supply production, we will be working with BSP and with our manufacturer of API to develop the commercial scale synthesis and drug production methods we will need to ultimately prepare for New Drug Approval."