Low sales, high cost: Melin­ta slash­es HQ re­search staff as it strug­gles to grow an­tibi­otics rev­enue

Look to Melin­ta Ther­a­peu­tics for the lat­est sign of eco­nom­ic trou­ble in the an­tibi­otics field.

Ex­act­ly a year af­ter the Con­necti­cut drug­mak­er ex­e­cut­ed a $270 mil­lion pact to buy out The Med­i­cines Co’s in­fec­tious dis­ease group — one in a string of pipeline ex­pan­sion deals — the com­pa­ny is re­port­ed­ly clos­ing down its head­quar­ters and lay­ing off 22 out of 25 staff and spin­ning out re­search projects, the lo­cal New Haven Biz re­port­ed last week. The bulk of the cuts were in R&D.

John John­son

While Melin­ta con­firmed the lay­offs to the pa­per, it de­clined to ver­i­fy the clos­ing date of No­vem­ber 30 cit­ed by the news site’s sources (say­ing “no fi­nal plans to shut­ter the New Haven lo­ca­tion had been made”) or elab­o­rate on the job cuts hap­pen­ing at its North Car­oli­na, New Jer­sey and Illi­nois of­fices.

Over the past year, Melin­ta’s share price $ML­NT has plunged 85%.

The com­pa­ny has not re­turned our re­quest for fur­ther in­for­ma­tion.

“In the face of an ex­treme­ly chal­leng­ing time for the an­tibi­otics in­dus­try, Melin­ta has made the dif­fi­cult de­ci­sion to sig­nif­i­cant­ly re­duce our in­vest­ment in dis­cov­ery re­search and are cur­rent­ly look­ing for strate­gic part­ners to take on these ac­tiv­i­ties, lo­cat­ed at our New Haven fa­cil­i­ty,” an emailed state­ment to New Haven Biz read.

Pe­ter Mil­li­gan

Melin­ta hint­ed at the re­or­ga­ni­za­tion in its Q3 call, in which in­ter­im CEO John John­son plain­ly ad­mit­ted to low­er-than-ex­pect­ed sales and high-than-ex­pect­ed costs. With the help of new­ly hired CFO Pe­ter Mil­li­gan, John­son is hop­ing to shed $50 mil­lion in op­er­at­ing ex­pens­es next year by look­ing to ex­ter­nal sources for in­no­va­tion and “re­fo­cus­ing the com­pa­ny on prod­uct launch­es.”

It’s yet an­oth­er alarm­ing con­fir­ma­tion of the com­mon wor­ry that an­tibi­ot­ic de­vel­op­ers face slim com­mer­cial prospects even af­ter they have over­come the of­ten lengthy reg­u­la­to­ry jour­ney. Big Phar­ma has large­ly bowed out of ba­sic re­search in the field, as ex­em­pli­fied in No­var­tis’ high-pro­file ex­it in re­cent months, though Genen­tech claimed a no­table ex­cep­tion with a pre­clin­i­cal can­di­date that its re­searchers say can rep­re­sent a new class for drug-re­sis­tant gram-neg­a­tive bac­te­ria.

In Melin­ta’s case, it took 17 years and sev­er­al CEOs to get an OK for Baxdela, which was launched this Jan­u­ary with “in­creas­ing mo­men­tum,” John­son said.

The ex­ecs, though, have toned down an­tic­i­pat­ed sales of Or­ba­tiv and Minocin — two of the three prod­ucts that came with the Med­i­cines Co deal — by a few mil­lion.

Ac­cord­ing to its web­site, Melin­ta was ap­ply­ing its dis­cov­ery plat­form on pro­grams in ac­ne and bac­te­r­i­al vagi­nosis as well as next-gen an­tibi­otics to com­bat “su­per­bugs” — a press­ing con­cern that the OECD warns will kill mil­lions glob­al­ly by 2050. Those pro­grams’ fate re­mains to be seen.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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