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.”

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

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.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

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.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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