Athenex takes Avecho’s Vitamin K injection to FDA pre-IND meeting
Avecho Biotechnology Limited (ASX:AVE) its TPM® enhanced Vitamin K injectable product (phytonadione) has been presented to the FDA in a pre-IND meeting request by Athenex Pharmaceutical Division, LLC.
Athenex is a global biopharmaceutical company based in the United States. Their pharmaceuticals division specialises in delivering high quality injectable products to the US market, working with a network of global partners.
Pending a favourable response form the FDA, Athenex will sign a license and development agreement with Avecho, and complete the remaining development work for US registration.
Avecho CEO, Dr Paul Gavin, said:
“It is encouraging to attract interest from a reputable partner for what we consider a legacy product in our portfolio – particularly one that can prime us for positive engagement with the FDA. We are hopeful that this will be the first of many injectable products we develop and enhance in partnership with Athenex, once they have a chance to assess the full capabilities of TPM® and the viability of commercialisation for our Vitamin K product with the FDA.”