Avecho Biotechnology Limited announced that its TPM®-enhanced Vitamin K (phytonadione) injectable product has been presented to the FDA by Athenex Pharmaceutical Division, LLC in a pre- Investigational New Drug (pre-IND) meeting request. Phytonadione (Vitamin K1) injections are used to treat bleeding or clotting problems caused by Vitamin K deficiency, reactions to certain medications, or other medical conditions that lead to
thinning of the blood. It is routinely administered to infants at birth as a prophylactic, providing protection against bleeding, and in 2021 the US had an overall adult and pediatric approximate market size of USD 87 million, with over 4.9 million units sold. Phytonadione is an insoluble oil that requires
formulation with an emulsifying agent in order to dissolve the drug in a formulation suitable for injection. These excipients are typically hydrogenated castor oil (Cremophor EL) or polysorbate, both of which are associated with adverse side effects when given by injection. In lieu of the adverse excipients traditionally used, Athenex has interest in commercialising Avecho's phytonadione formulation, that uses TPM® to dissolve and solubilise the drug. The FDA's feedback to the pre-IND submission will define the amount of development work remaining before a New Drug Application (NDA) for the product could be filed with the FDA for formal review. If the FDA response to the pre-IND submission is generally favorable, and the remaining development work is commercially feasible, the parties will proceed to a license and development agreement to complete the phytonadione product development work for the NDA submission to the US FDA and product commercialisation. The final commercial terms of a subsequent agreement will be determined once FDA feedback is received.