AFT Pharmaceuticals (NZX: AFT; ASX: AFP), today announces that the US Food and Drug Administration (FDA) has issued a tentative approval for Scomara (rapamycin 0.5% cream) for treatment of Facial  Angiofibromas in Tuberous Sclerosis (FA in TSC).

The quality, efficacy and safety data has been evaluated, and subsequent product labelling and claims have  been tentatively approved but the  launch and commercialisation is subject to existing  ‘orphan exclusivity’ for another product that was granted in 2022 and expires on 22 March 2029. 

FA in TSC affects between 15,000 to 30,000 patients in the US.
Orphan  exclusivity  in  some  countries  is  a  regulatory  incentive  granted  to pharmaceutical  companies to encourage the development of treatments for rare diseases. In the United States, it  provides seven years of market protection during which the FDA cannot approve any other application 
for the same drug for the same rare disease indication.

However, the orphan exclusivity granted in the US does not apply in many other significant markets  around the world, where FDA approval will support regulatory approval. These markets include  Canada, Australia, New Zealand, where AFT operates directly itself, and many markets in Asia.

In these markets AFT believes Scomara will have a competitive advantage over the existing orphan  product because the medicine is only applied once a day and it is stored at ambient temperature. In contrast, the competing product must be refrigerated and is applied twice per day.

AFT Managing Director Dr Hartley Atkinson said, “We are pleased to achieve this tentative approval 
following FDA review of our regulatory application but are disappointed that the US launch will be delayed at least until 22 March 2029. However, the tentative approval is a catalyst for AFT to  develop new and significant markets for the medicine outside the US which is positive.”

AFT has not forecast any revenue from the medicine in its budgets so this decision does not impact AFT’s forecast for FY27. AFT receives a 65% share of the earnings from the opportunity world-wide after the recovery of development costs. AFT also separately receives a royalty for the use of its 
proprietary technology in the medicine which is due prior to any profit share calculations.

The remaining 35% of profits accrues to the 35% owner of AFT Orphan Pharmaceuticals

Released for, and on behalf of, AFT Pharmaceuticals Limited by Stuart Houliston, Chief Financial Officer

Source: https://www.aftpharm.com/news/