Man­u­fac­tur­ing roundup: So­ci­etal CD­MO nets new cus­tomers; Chime Bi­o­log­ics gets the OK to man­u­fac­ture an­ti­bod­ies

So­ci­etal CD­MO has been award­ed ser­vice con­tracts for three new cus­tomers. The agree­ments in­clude an ar­ray of man­u­fac­tur­ing ser­vices, for clin­i­cal tri­als, an­a­lyt­i­cal meth­ods, for­mu­la­tion de­vel­op­ment and cGMP man­u­fac­tur­ing.

For the first con­tract, So­ci­etal will sup­port the ini­ti­a­tion of a Phase II clin­i­cal study of an an­ti­de­pres­sant al­ready ap­proved for use in Eu­rope and Aus­tralia. So­ci­etal will be re­spon­si­ble for sourc­ing, prepar­ing, pack­ag­ing and la­bel­ing of both the study drug and match­ing place­bo for use in the tri­al. These ac­tiv­i­ties will be con­duct­ed in col­lab­o­ra­tion at its fa­cil­i­ties in Geor­gia and Cal­i­for­nia.

In ad­di­tion, So­ci­etal will help de­vel­op a liq­uid oral for­mu­la­tion, and then pro­duce and pack­age an ini­tial batch, of an in­ves­ti­ga­tion­al treat­ment for pe­di­atric pa­tients with di­etary re­stric­tions who al­so have neu­ro­log­i­cal and neu­ropsy­chi­atric dis­eases.

And in the third con­tract, So­ci­etal will sup­port an­oth­er clin­i­cal tri­al — a Phase II study of an an­ti­sense oligonu­cleotide be­ing test­ed in var­i­ous can­cers. So­ci­etal will la­bel, store and dis­trib­ute the can­di­date as part of the con­tract.

“These new agree­ments spot­light the full range of ser­vices that So­ci­etal CD­MO pro­vides its cus­tomers, start­ing with ef­forts in the ar­eas as an­a­lyt­i­cal method and process de­vel­op­ment, as well as for­mu­la­tion de­sign, and ad­vanc­ing in­to cGMP man­u­fac­tur­ing, pack­ag­ing, la­bel­ing, and dis­tri­b­u­tion. Im­por­tant­ly, two of these new agree­ments in­volve our clin­i­cal tri­al ser­vices busi­ness, which we view as a key dri­ver of growth for the com­pa­ny,” said So­ci­etal CD­MO’s CEO David En­loe in a state­ment.

Chime Bi­o­log­ics re­ceives a Chi­nese man­u­fac­tur­ing li­cense

Chime Bi­o­log­ics, which net­ted in­vestor cash in 2021 for a 15x man­u­fac­tur­ing ex­pan­sion, has re­ceived a com­mer­cial man­u­fac­tur­ing li­cense from the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) in Chi­na.

Ac­cord­ing to the com­pa­ny, af­ter an 18 month prod­uct de­vel­op­ment and man­u­fac­tur­ing col­lab­o­ra­tion with LEPU Bio­phar­ma, the com­pa­ny passed a pre-ap­proval in­spec­tion, in­clud­ing an on-site in­spec­tion and GMP com­pli­ance in­spec­tion.

Un­der the part­ner­ship with LEPU Bio­phar­ma, Chime will man­u­fac­ture an an­ti-PD-1 mon­o­clon­al an­ti­body dubbed Puy­ouheng, which has been con­di­tion­al­ly ap­proved for mar­ket­ing in Chi­na. The drug is ap­proved for pa­tients with un­re­sectable or metasta­t­ic mi­crosatel­lite in­sta­bil­i­ty-high or mis­match re­pair de­fi­cient (dMMR) ad­vanced sol­id tu­mors.

“This al­so marks the of­fi­cial en­try of Chime Bi­o­log­ics in­to the era of com­mer­cial pro­duc­tion ser­vice. Chime Bi­o­log­ics will work with Lepu side by side to pro­vide al­ter­na­tive med­ical so­lu­tions to can­cer pa­tients in Chi­na and the rest of the world,” said Chime CEO John Zeng in a state­ment.

Te­va hits sup­ply snag for its AD­HD med­ica­tion Adder­all

Te­va has hit a bump with its pop­u­lar AD­HD drug Adder­all.

Ac­cord­ing to the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists (ASHP), both 20mg and 30mg tablets of Adder­all are cur­rent­ly on back­o­rder in the US, as the com­pa­ny is eye­ing a re­lease date lat­er this month. The FDA drug short­age track­er doesn’t note a cur­rent Adder­all short­age. Ac­cord­ing to it, an Adder­all short­age has pre­vi­ous­ly been re­solved, but the site al­so warns that its data­base is ex­pe­ri­enc­ing tech­ni­cal dif­fi­cul­ties and may be out-of-date.

The ASHP said Te­va is ex­pe­ri­enc­ing back­o­rder is­sues with its gener­ic ver­sion of Adder­all as well. How­ev­er, the com­pa­ny is ex­pect­ed to re­lease more 10mg gener­ic tablets in Au­gust, fol­lowed by 15mg and 30mg tablets.

For Adder­all, Te­va is aim­ing to re­lease more 20 mg and 30 mg tablets in ear­ly- to mid-Au­gust, ASHP said.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.

BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.

No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

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%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.

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, less than two weeks after its supplemental BLA was accepted. 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.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,300+ biopharma pros reading Endpoints daily — and it's free.