Market Update

Market release
17
th
February 2017

Market update

AFT Pharmaceuticals (AFT) has received confirmation that the United States Food and
Drug Administration (FDA) will accept filing of its New Drug Application for Maxigesic
tablets.

Additionally, AFT has received approval for a multi-million dollar fee waiver from the
FDA by virtue of this first US filing being from a small entity. Under FDA rules a “small
organisation” is defined as having less than 500 staff.

“We’re really pleased to complete the significant pre-filing requirements and also to
gain approval for the fee waiver,” says CEO Dr Hartley Atkinson. “The waiver itself is
significant and will save us approximately US$2.4M (around NZ$3.3M). Clearly now the
work will shift to finalising the approval. Our development and regulatory teams have
geared up for this important next step in getting
Maxigesic into the US market.”

Although AFT has been licensed in 111 countries around the world, the next leg is North
America comprising the US, Canada and Mexico. “North America is an important market
and accounts for around 37% of the global target pain market for Maxigesic,” said Dr
Atkinson. “Negotiations on licensing agreements for certain
Maxigesic products have
started for both the US and Mexico.”

AFT has already licensed
Maxigesic to Swiss-based pharma, Acino AG, in Central
America and the Caribbean. AFT also plans to file through Acino next month in these
countries: Belize, Costa Rica, Dominican Republic, Haiti, El Salvador, Guatemala,
Honduras, Nicaragua, Panama and Trinidad & Tobago.

On the local New Zealand market front, AFT was pleased to finalise termination and
settlement of its current sole supply
Metoprolol contract with the government drug
funding agency, PHARMAC. During the earlier supply shortage period, AFT purchased
additional
Metoprolol from other suppliers to help maintain continuity of supply for
patients across New Zealand. A final payment of NZ$900,000 will be paid in the next
financial year FY2018 to PHARMAC.

“Our ongoing relationship with Pharmac is important for our New Zealand based side of
the business so it’s good to have this settlement completed,” said Dr Atkinson.

The company expects to meet the analyst consensus revenue projections of around
$70m for FY2017. On this basis, it has exercised its option under the CRG term loan to
amend the revenue covenant to $67.5m for FY2017.

[End of Release]
For more information:
Hartley Atkinson
Managing Director, AFT Pharmaceuticals Ltd
Phone: +64 9 488 0232