AFT welcomes US FDA Complete Response Letter

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com





Market and media release 9 November 2020

AFT welcomes US FDA Complete Response Letter
AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces it has received a US Food
and Drug Administration (FDA) complete response letter (CRL) covering its application
for the approval of a tablet version of its Maxigesic
®
pain relief medication.
In the letter, the US regulator said an FDA Good Manufacturing Practice (GMP)
inspection of the tablet production facilities – delayed due to COVID-19 related travel
disruptions – was the “only deficiency” with AFT’s application.
A CRL indicates the FDA has completed its review of a new drug application. The
letter covered AFT’s application for prescription Maxigesic tablets, branded
Combogesic
®
in the US, for treatment of mild to moderate acute pain.
The FDA also requested minor labelling changes and asked for updated global safety
data.
AFT Managing Director Dr Hartley Atkinson said the CRL indicated AFT had cleared a
significant hurdle on its path towards the commercialisation of the Maxigesic pain
relief family of medicines in the world’s largest pharmaceutical market.
“This is a very pleasing result. The letter shows a prescription version of Maxigesic is
approvable in the US and that AFT is well on the way to approval of its patented
medicine in the US market.
“The labelling and safety data are simple to address. The GMP inspection of the
manufacturing site which is located outside the US and has previously held FDA GMP
approval will take longer to resolve due to present COVID19 travel bans. We will need
to await lifting of these restrictions to organise the site inspection. However, a remote
GMP inspection has already been requested which is an alternative solution. Presently
the precise timing cannot be confirmed.”
Dr Atkinson said it was too early to say when the medicine would be approved for
sale in the US. In addition to final approval from the FDA, AFT still needed to licence
the medication to a distributor.
“Talks with potential licensees are ongoing, and a positive CRL was a major endpoint,
we now look forward to progressing these discussions, and the one final outstanding
regulatory requirement in the coming months,” Dr Atkinson said.
For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial
Officer.

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com


For more information:
Investors Media
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9488 0232

About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical business with a broad range of
products, both developed itself and in-licensed from third parties. AFT’s products
cover all major pharmaceutical distribution channels: over-the-counter, prescription
and hospital. Historically, AFT’s home markets have been Australia, New Zealand and
South-East Asia. However, the company is out-licensing its own products to licensees
and distributors to sell in an increasing number of countries around the world. The
company’s intensive Research and Development program forms the basis of its
international sales strategy. For more information about the company, visit our website
www.aftpharm.com
.