Bob Kramer, Emergent

The man­u­fac­tur­ing hold at Emer­gen­t's Bal­ti­more Bayview plant could be com­ing to an end — re­port

Mary­land’s Emer­gent BioSo­lu­tions has been forced to sit on its own hands for more than a month af­ter shut­ting down pro­duc­tion at a Bal­ti­more plant blast­ed for screw­ing up mil­lions of dos­es of two Covid-19 vac­cines. Now, with a laun­dry list of qual­i­ty is­sues ap­par­ent­ly solved, Emer­gent is re­port­ed­ly days away from get­ting its lines rolling once again.

J&J is ex­pect­ed to an­nounce that con­t­a­m­i­na­tion prob­lems at Emer­gent’s Bal­ti­more Bayview plant have been re­solved and pro­duc­tion is set to re­sume, The Wall Street Jour­nal re­port­ed Fri­day.

The deal with the FDA could free up al­ready man­u­fac­tured dos­es of the vac­cine that have been in quar­an­tine, and al­low for the pro­duc­tion of new ones. Dos­es of the vac­cine have been in lim­bo af­ter the FDA took over the plant in April, and Emer­gent an­nounced it would cease man­u­fac­tur­ing in light of the in­spec­tion tied to a vi­ral vec­tor mix­up.

That was on April 16, and soon af­ter the US saw the num­ber of dos­es al­lo­cat­ed for states fall from near­ly 5 mil­lion to 785,000. Cal­i­for­nia, Texas and Flori­da were slat­ed to re­ceive the dos­es, Reuters re­port­ed.

As a part of the arrange­ment, 60 mil­lion dos­es of the J&J jab could be cleared for use, the WSJ re­ports. Be­cause the jab is sin­gle-dose, that means 60 mil­lion peo­ple are el­i­gi­ble to be ful­ly vac­ci­nat­ed once dos­es be­come avail­able. An ad­di­tion­al 60 mil­lion dos­es of the As­traZeneca shot could be­come avail­able as well, ac­cord­ing to the WSJ, ready to vac­ci­nate 30 mil­lion peo­ple.

The mix­up wasn’t Emer­gent’s first. Ear­li­er in the man­u­fac­tur­ing process, the com­pa­ny was forced to trash mil­lions of ma­te­ri­als tied to As­traZeneca’s vac­cine, some­thing Kramer blamed on a flawed man­u­fac­tur­ing process sent over by the drug­mak­er.

A Form 483 from the FDA re­vealed un­san­i­tary con­di­tions at the plant and half-heart­ed at­tempts at keep­ing it clean. Mold, paint chip­ping off the walls and un­known black and brown sub­stances were all present, and some em­ploy­ees failed to de­con­t­a­m­i­nate bags of waste be­fore drag­ging them through the ware­house.

In an April 21 state­ment, Emer­gent said:

We deeply val­ue the re­la­tion­ship we have with our man­u­fac­tur­ing part­ners and with the FDA. The FDA’s feed­back will help us con­tin­ue to im­prove and strength­en the sup­ply chain for John­son & John­son’s COVID-19 vac­cine. While we are nev­er sat­is­fied to see short­com­ings in our man­u­fac­tur­ing fa­cil­i­ties or process, they are cor­rectable and we will take swift ac­tion to rem­e­dy them.

Kramer had pre­vi­ous­ly of­fered mixed mes­sages on what ex­act­ly hap­pened to lead to the mix­up, but clar­i­fied in front of a House sub­com­mit­tee in May that J&J qual­i­ty con­trol em­ploy­ees at its Lei­den, Nether­lands fa­cil­i­ty caught the mix­up. The cross con­t­a­m­i­na­tion oc­curred as a re­sult of ma­te­r­i­al ex­it­ing out of a fa­cil­i­ty and com­ing in close vicin­i­ty with me­dia pre­pared for a J&J run.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.