AFT’s Scomara Cream Gains FDA Tentative Nod but US Sales Paused Until 2029
AFT Pharmaceuticals secures tentative FDA approval for Scomara cream to treat rare facial tumours but faces a US launch delay due to orphan drug exclusivity. The approval bolsters prospects in other markets where AFT expects competitive advantages.
- FDA issues tentative approval for Scomara cream
- US launch delayed until March 2029 due to orphan exclusivity
- Treatment targets Facial Angiofibromas in Tuberous Sclerosis
- Competitive edge in markets outside US with once-daily dosing
- No FY27 revenue forecast impact from Scomara
Tentative FDA Nod Delayed by Orphan Exclusivity
AFT Pharmaceuticals (NZX:AFT) has secured tentative approval from the US Food and Drug Administration for Scomara, a rapamycin 0.5% cream designed to treat Facial Angiofibromas in Tuberous Sclerosis Complex (TSC). While this marks a regulatory milestone, the US commercial launch is stalled until 22 March 2029 due to existing orphan drug exclusivity granted to a competitor in 2022.
Orphan exclusivity in the US confers seven years of market protection, preventing approval of the same drug for the same rare disease indication. This exclusivity affects an estimated 15,000 to 30,000 patients with FA in TSC. Despite the delay, the FDA’s tentative approval covers the product’s quality, efficacy, safety data, and labelling.
International Markets Offer Immediate Opportunities
Unlike the US, orphan exclusivity does not apply in key international markets such as Canada, Australia, New Zealand, and several Asian countries where AFT operates directly. The FDA’s tentative approval is expected to support regulatory submissions in these regions, where AFT anticipates a competitive advantage.
Scomara’s once-daily application and ambient storage contrast with the incumbent product’s twice-daily dosing and refrigeration requirements. This convenience factor may position Scomara favourably in these markets, potentially accelerating uptake.
Financial Impact and Profit Sharing Structure
AFT has not included revenue from Scomara in its FY27 forecasts, reflecting the US launch delay and ongoing regulatory processes. The company will receive 65% of worldwide earnings after development cost recovery, with the remaining 35% accruing to its partner, AFT Orphan Pharmaceuticals. Additionally, AFT collects royalties for its proprietary technology embedded in the medicine, payable before profit sharing.
Managing Director Dr Hartley Atkinson acknowledged the mixed news: "We are pleased to achieve this tentative approval following FDA review but are disappointed that the US launch will be delayed at least until 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."
This development follows AFT’s recent momentum, including a 22% revenue increase in FY26 and expansion to 87 countries, underscoring the company’s growing global footprint and diversified product portfolio.
Bottom Line?
While the US market remains on hold, Scomara’s tentative approval unlocks immediate strategic opportunities internationally where AFT’s formulation advantages could reshape treatment options for a rare disease.
Questions in the middle?
- How aggressively will AFT pursue regulatory approvals and market entry outside the US?
- What pricing and reimbursement strategies will AFT adopt given the competitive landscape in non-US markets?
- How might the expiry of US orphan exclusivity in 2029 affect competitive dynamics and AFT’s launch plans?
