As­traZeneca looks to re­bound from pro­duc­tion de­lays for its Covid-19 vac­cine with new fill-fin­ish deal

The re­la­tion­ship be­tween As­traZeneca and the EU has been on edge in re­cent weeks af­ter pro­duc­tion de­lays have scut­tled roll­out plans for the British drug­mak­er’s Covid-19 vac­cine. Now, look­ing to squash wor­ries its pro­duc­tion can’t keep up with de­mand, As­traZeneca is bring­ing on a new part­ner it hopes can right the ship.

As­traZeneca has tapped Ger­many’s IDT Bi­ologi­ka to ramp up im­me­di­ate pro­duc­tion of its ade­n­ovirus-based Covid-19 vac­cine, dubbed “Covid-19 Vac­cine As­traZeneca,” and build long-term ca­pac­i­ty to han­dle fill-fin­ish work for the shot, the British drug­mak­er said Wednes­day.

The part­ners are look­ing at “op­tions to ac­cel­er­ate out­put” of As­traZeneca’s vac­cine as soon as next quar­ter, hop­ing to quick­ly fill its 300-mil­lion-dose or­der for the EU. The com­pa­ny be­gan ship­ping out dos­es late last week with the goal of dis­trib­ut­ing an ini­tial 17 mil­lion dos­es be­fore March.

The newest pact un­der­scores As­traZeneca isn’t mov­ing fast enough in sup­port­ing its EU or­der — and that doesn’t be­gin to ad­dress a po­ten­tial fu­ture OK in the US or oth­er parts of the world.

Even so, As­traZeneca is al­so tak­ing the long view with its part­ner­ship with IDT, pledg­ing to build long-term ca­pac­i­ty at the man­u­fac­tur­er’s Dessau site for fu­ture pan­demics. De­tails are still in the works, both com­pa­nies said, but As­traZeneca hopes to in­stall five 2,000-liter re­ac­tors at the site by the end of 2022 — enough ca­pac­i­ty to make “tens of mil­lions” of dos­es of the Covid-19 shot per month.

As­traZeneca and the EU have squab­bled for weeks over sup­ply con­straints for the vac­cine, with the EU at one point ac­cus­ing the British drug­mak­er of duck­ing a plan­ning meet­ing. As­traZeneca de­nied those claims, but did ad­mit that pro­duc­tion lags set back plans to meet their dis­tri­b­u­tion tar­gets.

As­traZeneca may have rea­son to dodge EU reg­u­la­tors af­ter the bloc pub­lished a heav­i­ly redact­ed ver­sion of the com­pa­ny’s con­tract with redac­tions over cost fig­ures that were eas­i­ly re­moved by in­ter­net sleuths. Among the most note­wor­thy find­ings was that the con­tract it­self was worth £870 mil­lion, or about $1.19 bil­lion for 300 mil­lion dos­es, in­clud­ing all di­rect and in­di­rect costs.

The drug­mak­er and its ade­n­ovirus vac­cine car­ry­ing the SARS-CoV-2 spike pro­tein pay­load have al­so fall­en be­hind the curve in terms of ef­fi­ca­cy com­pared with Pfiz­er and Bion­Tech and Mod­er­na, drug­mak­ers with mR­NA-based vac­c­cines that have hit the 90% ef­fi­ca­cy mark and high­er in pre­vent­ing se­vere dis­ease.

Just last week, As­traZeneca rolled out new da­ta for a two-shot reg­i­men show­ing 82.4% ef­fi­ca­cy in pre­vent­ing symp­to­matic dis­ease when giv­en giv­en 12 weeks apart, but months af­ter the FDA gave its emer­gency use nod to Pfiz­er and Mod­er­na, those re­sults and some squishy ear­li­er da­ta may not be enough to con­vince US reg­u­la­tors.

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.

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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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Avid Bioser­vices, with re­cent IPO and Covid-19 part­ner­ship in hand, launch­es 2nd phase of fa­cil­i­ty ex­pan­sion

California’s Avid Bioservices now has two simultaneous expansion projects underway as the CDMO’s projections for customer demand sparked the launch this week of the second phase of building out its Myford facility.

Avid expects construction on the second phase, which will be known as its Myford South facility to take 18 to 24 months to complete at a cost of roughly $45 million to $55 million, it said in a press release.

Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden wants a re­view of the API sup­ply chain. Will that par­lay in­to an ef­fort to 'on­shore' drug man­u­fac­tur­ing?

When former President Donald J. Trump was voted out of office Nov. 2, his gung-ho effort to “onshore” drug manufacturing was left mostly up in the air. Joe Biden has been mostly mum on whether he would continue that effort, but a new executive order could provide a clue — at least in a few months.

In an order signed Wednesday, Biden demanded a 100-day governmental review of key supply chains, including for active pharmaceutical ingredients (API) used in American drugs.

Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.