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.”

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.