Covid-19 man­u­fac­tur­ing roundup: Af­ter Emer­gent dis­as­ter, As­traZeneca in talks to move to Catal­ent plant — re­port; Sinopharm says it has ca­pac­i­ty to pro­duce 5B vac­cines

Af­ter months of pro­duc­tion of its vac­cine plagued by a mix­up at a Bal­ti­more Emer­gent plant that has been tak­en over by the FDA, As­traZeneca is in talks with the US gov­ern­ment to move pro­duc­tion to a fac­to­ry owned by Catal­ent, the New York Times re­ports.

The news comes just days af­ter news broke that J&J is ex­pect­ing to an­nounce that the con­t­a­m­i­na­tion prob­lems at the plant have been re­solved and pro­duc­tion is set to re­sume. Emer­gent an­nounced that af­ter a month of the FDA tak­ing over the Bayview site, a laun­dry list of is­sues has been solved, it said in a state­ment. With an agree­ment with the FDA, mil­lions of the dos­es of the J&J vac­cine that were quar­an­tined could be freed up for de­liv­ery and ad­min­is­tra­tion.

Catal­ent, a New Jer­sey-based CD­MO, will use its Mary­land fac­to­ry in which it al­ready pro­duces the drug sub­stances used in As­traZeneca’s jab to man­u­fac­ture the vac­cine, the Times re­ports.

Ear­ly in the man­u­fac­tur­ing process, Emer­gent was forced to trash mil­lions of ma­te­ri­als tied to As­traZeneca’s vac­cine, some­thing CEO Bob Kramer blamed on a flawed man­u­fac­tur­ing process sent over by the drug­mak­er.

The vac­cine has been ap­proved in sev­er­al coun­tries around the world, but not the US be­cause of a rare but se­ri­ous blood clot in the brain that has been re­port­ed in some who’ve re­ceived that vac­cine.

Mean­while, Emer­gent is now try­ing to over­come the ef­fects that come with shut­ting down op­er­a­tions for two months. Ma­te­ri­als from As­traZeneca’s vac­cine came in close con­tact with me­dia pre­pared for a J&J run, caus­ing cross con­t­a­m­i­na­tion. Lat­er, a Form 483 from the FDA re­vealed that the plant had un­san­i­tary con­di­tions, in­clud­ing black and brown sub­stances — and mold — present in the build­ing and a fail­ure to de­con­t­a­m­i­nate waste be­fore dis­pos­ing of them.

Kramer was called in front of the US House of Rep­re­sen­ta­tives Sub­com­mit­tee on the Coro­n­avirus Pan­dem­ic on May 19 and said that his plant would be good to re­sume op­er­a­tions with­in a few days if it was giv­en the OK by the FDA.

Sinopharm says it has ca­pac­i­ty to sup­ply 1B dos­es out­side Chi­na

Sinopharm has the ca­pac­i­ty to sup­ply the world with more than 1 bil­lion Covid-19 vac­cine dos­es out­side Chi­na, and has the ca­pac­i­ty to pro­duce 5 bil­lion dos­es an­nu­al­ly in to­tal, its chair­man Liu Jingzhen said Wednes­day.

Right now, two vac­cines from Sinopharm are be­ing used in Chi­na, and one of them has been grant­ed emer­gency use au­tho­riza­tion by the WHO. Sinopharm has al­so planned a man­u­fac­tur­ing fa­cil­i­ty for its third vac­cine, which is in ear­ly-stage clin­i­cal tri­als.

Liu would not say how many dos­es have been pledged to CO­V­AX, how­ev­er. In Feb­ru­ary, the Chi­nese gov­ern­ment pledged 10 mil­lion dos­es to the or­ga­ni­za­tion.

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.

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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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.

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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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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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Terrie Curran, Phathom CEO (Credit: Arcutis)

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

There’s no time for rest in biopharma — at least not at Phathom Pharmaceuticals. Just over a month after submitting two NDAs for its lead acid-fighter vonoprazan, the biotech is already lining up a third, and collecting an extra $50 million to push things along.

Vonoprazan met its primary non-inferiority endpoints in a Phase III study comparing it to standard-of-care Prevacid in a type of gastroesophageal reflux disease (GERD) called erosive esophagitis (EE). It also proved superior to the popular heartburn drug by multiple measures, including healing rate and maintenance of healing.

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.