FDA approval lets Foamix set its maiden acne therapy on course for US market launch
Months ago, Foamix leaned on its biggest shareholders — Perceptive Advisors and OrbiMed — to financially grease its wheels, ahead of the FDA decision date for its acne therapy. On Friday, that approval came in — and the topical formulation of the antibiotic minocycline is set for a January launch.
The therapy, Amzeeq (formerly known as FMX101), was approved to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older.
Minocycline, a second-generation tetracycline, was first synthesized in 1967 and made its maiden entry into the US market in 1972. It is a broad-spectrum antibiotic — employed as a weapon across a myriad of conditions including acne. But its use as an oral formulation has been limited in acne due to systemic side-effects. Scientists have struggled with engineering a topical version because the compound is typically unstable in such traditional formulations.
Foamix’s technology platform delivers minocycline in a foam formulation. It was tested in three pivotal studies that involved 2,418 patients altogether.
In the first two studies: trial 04 and trial 05, a total of 961 subjects with moderate-to-severe acne were randomized to either receive the Foamix foam or vehicle foam once daily for 12 weeks. The twin main goals of each study were: the absolute change in the number of inflammatory lesions (papules and pustules); and the proportion of patients securing an investigator’s global assessment (IGA) score of “clear” or “almost clear” and at least a two-grade improvement from baseline at week 12.
While the Foamix foam hit statistical significance on both endpoints in trial 05, the therapy did not make the cut in the IGA score in trial 04 — forcing a third late-stage trial, which succeeded on both counts.
The Israeli drug developer has a different minocycline foam formulation, called FMX103, for rosacea under FDA review — a decision is expected by early June. Meanwhile, the company is also testing a minocycline + adapalene formulation for acne — that combination is in mid-stage development.
Both Amzeeq and the rosacea therapy should see significant uptake and generate $250 million-plus in peak sales each, Cowen’s Ken Cacciatore wrote in a note, citing experts in the field.
“As for Amzeeq’s pricing, although the exact figure has not yet been disclosed, we expect that the potential for $200-400 net is reasonable and achievable, given Foamix’s initial positive interaction with payors and branded pricing of other differentiated acne options.”
Endpoints News has contacted Foamix $FOMX regarding its Amzeeq pricing plans.
The company has been building out its commercial infrastructure ahead of approval, with roughly 50+ sales reps focusing on 6,000 prescribers that cover roughly 75% of the acne prescription market, Cacciatore noted.
“This specific targeting will allow management to avoid a very costly launch approach that other companies have undertaken, which has resulted in overly broad, unfocused, all-territories marketing effort that has often burned significant capital with poor results. Instead, Foamix is expected to move regionally – and more thoughtfully – according to the managed care coverage timing,” he said.
“Clearly small company launches have had struggles of late, but we believe Foamix is going to thoughtfully incorporate the learnings (and mistakes) of other product introductions, especially in terms of the necessary co-pay support programs. We would also note that ‘103 — once approved for rosacea — will target nearly the exact same clinician base to leverage the Amzeeq relationship building and commercial platform.”
