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.”

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