The new CEO at trou­bled AM­AG be­gins his bat­tle against an ar­ray of threats by ax­ing staff and slash­ing costs

Scott My­ers stepped in­to his new job as CEO of trou­bled AM­AG 2 weeks ago, and he has his work cut out for him.

Scott My­ers

In their Q1 call with an­a­lysts on Mon­day, My­ers out­lined a plan to slash costs, lay­ing off 140 staffers — 30% of the to­tal — as Covid-19 bites in­to its sales op­er­a­tions and de­rails clin­i­cal tri­als. The goal is to cut costs by $100 mil­lion. And he still has to find out whether the FDA will force the com­pa­ny to pull Mak­e­na off the mar­ket af­ter a ma­jor­i­ty of the mem­bers on an FDA ad­vi­so­ry com­mit­tee pushed for that in the wake of their failed con­fir­ma­to­ry study.

In his open­ing state­ment, My­ers sized up the chal­lenge ahead:

Many peo­ple have asked me why would you join AM­AG now, with the broad­er im­pacts of COVID and giv­en AM­AG’s pre­vi­ous­ly an­nounced changes? The last sev­er­al com­pa­nies that I’ve helped lead al­so had a myr­i­ad of chal­lenges, span­ning their en­tire en­ter­prise and we found so­lu­tions. I be­lieve that will be the case here as well.

For now, the FDA is re­buff­ing AM­AG’s re­quest for a meet­ing on Mak­e­na, telling the com­pa­ny it is “pre­ma­ture” to sched­ule a call as they’re still re­view­ing the sit­u­a­tion.

Nine years ago the FDA of­fered an OK for the drug, sup­posed to pre­vent preterm births and re­place a com­pound­ed drug, re­quir­ing a con­fir­ma­to­ry study that took years to as­sem­ble and ex­e­cute. That study showed no dif­fer­ence be­tween the drug and a place­bo, trig­ger­ing the neg­a­tive pan­el vote and threat­en­ing AM­AG’s key prod­uct.

In the mean­time, AM­AG is look­ing to of­fload two drugs to raise cash: In­trarosa (pras­terone) and Vyleesi (breme­lan­otide in­jec­tion). And their work to come up with new prod­ucts has been se­vere­ly ham­pered by the pan­dem­ic.

From their Q1 re­port:

The AM­AG-423 Phase 2b/3a clin­i­cal tri­al is a hos­pi­tal-based tri­al and all sites have paused new pa­tient en­roll­ment. The com­pa­ny has had to pause ini­ti­a­tion of new sites due to the pan­dem­ic, sig­nif­i­cant­ly im­pact­ing re­cruit­ment and en­roll­ment. AM­AG con­tin­ues to work with the FDA to ini­ti­ate the cira­paran­tag Phase 2b tri­al in healthy vol­un­teers in the U.S. How­ev­er, the COVID-19 pan­dem­ic has forced the clin­i­cal tri­al sites where the com­pa­ny ex­pect­ed to con­duct the tri­al to close.

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

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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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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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.