AFT notes FDA approval for Pascomer alternative

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





5 April 2022
AFT notes FDA approval for Pascomer alternative
AFT Pharmaceuticals (NZX: AFT, ASX: AFP) today notes the US Food and Drug
Administration (FDA) has approved a topical treatment indicated for facial
angiofibroma (FA) associated with Tuberous Sclerosis Complex (TSC) developed by
Japan’s Nobelpharma
1
.
The active ingredient in Nobelpharma’s medicine is rapamycin, which AFT and its
development partner, the US-based Timber Pharmaceuticals, are also developing as
a treatment for FA in TSC and other larger non orphan indications under the brand
Pascomer.
Nobelpharma’s medicine has also been granted orphan status for FA in TSC. This
means that Nobelpharma will gain exclusivity for a period of seven years in USA which
will prevent AFT filing its Pascomer for this orphan indication with the FDA during this
period.
AFT notes that the clinical study results for its study of rapamycin for the FA in TSC
orphan indication will be available in mid-2022. It confirms that its clinical trial program
for non-orphan drug Pascomer indications will continue.
Furthermore, AFT notes it has been granted a significant formulation patent for
Pascomer in Australia until November 2040 which will form the basis of further patent
filings around the world
2
. The Nobelpharma product is only stable under refrigerated
conditions for 12 months whilst the AFT proprietary formulation has resulted in a
product stable at room temperature for 36 months.
AFT Managing Director Dr Hartley Atkinson said that the company does not expect
that the FDA’s approval of Nobelpharma’s medicine will affect the $12.5 million
carrying value of the Pascomer assets in the company’s accounts. He also confirmed
that AFT retains its guidance for an operating profit for the year to 31 March 2022 of
$18 million to $23 million.
AFT will report its results for the 2022 financial year in late May.
“AFT is disappointed that Nobelpharma has secured FDA approval ahead of us. As
we noted in our 2021 annual report, we always maintained there were significant

1
https://www.prnewswire.com/news-releases/fda-approves-nobelpharmas-hyftor-sirolimus-topical-gel-0-2-
301516272.html

2
Australian patent (Patent Number 2020277132) Pascomer formulation patent

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

uncertainties associated with both conclusion of the clinical trials and the successful
registration of Pascomer with orphan status,” Dr Atkinson said.
“It was for these reasons that we adopted a conservative valuation of the Pascomer
assets. We continue to believe Pascomer has strong potential for non-orphan
indications and the potential market for these is potentially larger than the market for
FA in TSC.”
In 2019 AFT and Timber agreed an out-licensing and development agreement for the
USA, Canada & Mexico for rapamycin under the brand Pascomer. Last year it also
licensed the technology in Europe to Germany’s Desitin Arzneimittel GmbH, a
specialist pharmaceutical company based in Hamburg, Germany.
“AFT is consulting with its development partner and licensees to assess the implications
of the FDA’s approval of Nobelpharma’s medicine. We will update the market as
more information becomes available,” Dr Atkinson said.
For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial
Officer.
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 company that develops, markets, and
distributes a broad portfolio of pharmaceutical products across a wide range of
therapeutic categories which are distributed across all major pharmaceutical
distribution channels: over the counter (OTC), prescription and hospital. Our product
portfolio comprises both proprietary and in-licensed products, and includes patented,
branded, and generic drugs. Our business model is to develop and in-license products
for sale by our own dedicated sales teams in our home markets of Australia and New
Zealand and to out-license / distribute our products to local licensees and distributors
to over 125 countries around the world. For more information about the company, visit
our website www.aftpharm.com.