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.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.