AFT gets first step of US approval for Maxigesic IV

AFT Pharmaceuticals [NZX: AFT] has crossed the first hurdle in getting the intravenous version of its patented combination painkiller Maxigesic approved by the US Food and Drug Administration.

The investigational new drug application (IND) for Maxigesic IV has been approved by the FDA, which is the first step toward getting approval in the US, the Auckland-based drugmaker says in a statement.

It will now conduct a clinical study in Christchurch, followed by one in the US, as part of the path to gaining approval.

"It is a pretty rigorous investigational programme, and the approval process isn't automatic," founder and managing director Hartley Atkinson says.

"We've got Maxigesic tablets on the market and registered in many countries, and what we're doing is developing additional dose forms, and this is one of those dose forms, we've got IV, oral liquid, etcetera."

Maxigesic IV is an injectable drug for post-operative use in adults, either by itself or to reduce the use of opioid analgesics, the company said in its product disclosure statement issued before its initial public offering last November.

AFT raised $33.2 million in its IPO, before listing on the NZX and ASX last December.

Global market estimated at $US832m
In that product disclosure statement, the company estimated the 2014 global market size for Maxigesic IV at $US832 million and said it expected to submit an IND at the end of 2016.

The intravenous drug is being developed in collaboration with an unnamed pharmaceutical company which owns or controls patent rights extending to 2034.

AFT has rights to commercialise the product, however the other company is entitled to a proportion of any revenue received from the sale of the intravenous formulation outside Australia and New Zealand.

"We said we were going to do this in our IPO document," Mr Atkinson says. "We're very much on track with doing what we said we were going to do. We're making good steady progress really."

In February, AFT announced it had made a deal with multinational pharmaceutical company Acino Pharma to out-license all formulations of Maxigesic to a further 69 countries in four geographic regions - Saudi Arabia and Yemen, Central America and the Caribbean, Africa, and North Africa and the Levant.

AFT narrowed its net loss of $6.37 million for the six months ended September 30. The IPO prospectus didn't provide any estimates of future financial performance, though the company had revenue of $56.4 million in the 2015 financial year and posted a net loss of $12.9 million.

Mr Atkinson and his wife Marree retained a 75% stake in the company and received $3 million of the IPO proceeds with the remaining $32.6 million going on accelerating global expansion and research and development, including clinical trials on a number of drugs and devices in its pipeline.

The shares were unchanged at $2.85, up from last year's initial public offering price of $2.80.

(BusinessDesk)