Avecho Biotechnology’s Vitamin K injectable gets pre-IND meeting with US FDA
Athenex is interested in commercialising Avecho’s TPM-enhanced phytonadione injectable drug.
Avecho Biotechnology (ASX: AVE) has had its TPM-enhanced phytonadione injectable drug presented to the US Food and Drug Administration in a pre-investigational new drug (pre-IND) meeting by global company Athenex Pharmaceutical.
Phytonadione is used to treat bleeding or clotting problems caused by issues such as Vitamin K deficiencies, reactions to certain medications, or other medical conditions which lead to thinning of the blood.
It is routinely administered to infants at birth as a prophylactic, providing protection against bleeding.
Development work
Feedback from the pre-IND meeting will define the amount of development work remaining before a new drug application is filed with the US FDA for formal review.
If the feedback is positive and the drug is deemed to be commercially feasible, Avecho and Athenex will proceed to a licencing agreement before development.
Athenex interest
Avecho chief executive officer Dr Paul Gavin said the company was encouraged to attract interest from Athenex.
“Athenex is a reputable partner for a legacy product in our portfolio, particularly one that can prime us for positive engagement with the US FDA,” he said.
“We are hopeful this will be the first of many injectable products we develop and enhance once the full capabilities of TPM and the viability of US commercialisation for phytonadione has been established.”
He said Athenex and Avecho were also in discussions to select a TPM-enhanced product for possible US commercialisation after phytonadione, where Athenex will hold first right of refusal for the product.
Insoluble oil
Phytonadione is comprised of an insoluble oil which needs to be formulated with excipients in order to dissolve and make it suitable for injection.
Excipients such as such as castor oil (Cremophor EL) or polysorbate are known to have poor safety profiles and are typically associated with adverse side effects once injected.
By comparison, TPM (or tocopheryl phosphate mixture) is reported to have an excellent safety profile and is being considered as an alternative.
TPM is derived from Vitamin E using patented processes and is proven to enhance the solubility and oral, dermal and transdermal absorption of drugs and nutrients.