Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

EU mis­tak­en­ly leaves key parts of As­traZeneca Covid-19 con­tract unredact­ed, re­veal­ing costs and So­ri­ot's 'best-ef­fort' claim

Ten­sions be­tween As­traZeneca and the EU re­gard­ing slowed vac­cine roll­out boiled over last week, when the bloc pub­lished a heav­i­ly redact­ed ver­sion of the com­pa­ny’s con­tract fol­low­ing crit­i­cism of its “best-ef­fort” pledges. But ea­gle-eyed in­ter­net sleuths and Ger­man jour­nal­ists found the blacked-out sec­tions could be eas­i­ly re­moved, prompt­ing the EU to pub­licly apol­o­gize.

Among the most note­wor­thy find­ings was that the con­tract it­self is worth £870 mil­lion, or about $1.19 bil­lion for the 300 mil­lion dos­es, in­clud­ing all di­rect and in­di­rect costs. There was al­so a par­tial­ly cut-off sec­tion that de­tailed how even though As­traZeneca is ob­lig­at­ed to sup­ply its dos­es at no prof­it, the com­pa­ny “shall not be re­quest­ed or re­quired to sup­ply the Vac­cine Dose…”

Ger­man mag­a­zine Der Spiegel was the first pub­li­ca­tion to pub­lish the rev­e­la­tions. The au­then­tic­i­ty of the redact­ed por­tions has been con­firmed by End­points News, though any­thing writ­ten af­ter “Dose” could not be re­cov­ered.

The con­tract al­so pro­vid­ed roadmaps for in­stances of es­ti­mat­ed costs ex­ceed­ing the £870 mil­lion fig­ure. There are two plans in place, should the ex­ceed­ed costs be ei­ther high­er or low­er than 20%, but the redac­tions block­ing out the plans them­selves could not be re­moved.

Ad­di­tion­al­ly, the doc­u­ment con­tained a pro­vi­sion for pro­vid­ing ad­di­tion­al dos­es at cost through Ju­ly 1, at which point As­traZeneca could de­ter­mine “in good faith” whether or not the pan­dem­ic was still go­ing on. That backs up re­port­ing from the Fi­nan­cial Times last Oc­to­ber say­ing the com­pa­ny can de­clare the pan­dem­ic over by that time and start mak­ing a prof­it on vac­cines de­liv­ered af­ter that date.

The redac­tion block­ing the pro­vi­sion it­self, how­ev­er, al­so could not be re­moved.

A Eu­ro­pean Com­mis­sion spokesman apol­o­gized to As­traZeneca at a press con­fer­ence Tues­day, say­ing “it was cer­tain­ly not our in­ten­tion for this to hap­pen,” per an EU­Ob­serv­er re­port. He added, “In or­der for those con­tracts to be con­clud­ed with the phar­ma­ceu­ti­cal com­pa­nies, it was agreed that cer­tain con­tracts would re­main con­fi­den­tial.”

The news comes af­ter a rau­cous week of back-and-forth be­tween one of the biggest drug­mak­ers in the world and the Eu­ro­pean gov­ern­men­tal body. As­traZeneca no­ti­fied the bloc late last month that it would de­liv­er more than 60% few­er dos­es than orig­i­nal­ly promised, blam­ing pro­duc­tion prob­lems at a Bel­gian fac­to­ry. That trig­gered fiery back­lash from the EU, which was al­ready deal­ing with de­lays of the Pfiz­er/BioN­Tech vac­cine and lags in vac­ci­na­tion.

Some crit­ics ac­cused As­traZeneca of sell­ing vac­cines in­tend­ed for Eu­rope to oth­er coun­tries at a high­er price. But CEO Pas­cal So­ri­ot main­tained the con­tract was based on a best-ef­fort de­liv­ery clause, a clause that has os­ten­si­bly been con­firmed by the re­moved redac­tions. That could ul­ti­mate­ly shield the com­pa­ny from le­gal ac­tion, as a hand­ful of mem­ber states like Italy and Poland have con­sid­ered su­ing Pfiz­er over sim­i­lar slow­downs.

The par­ties al­so en­gaged in a high­ly pub­lic tit-for-tat over whether or not a meet­ing be­tween the two would oc­cur. The EU had ac­cused As­traZeneca of pulling out of a meet­ing last Wednes­day, but it ul­ti­mate­ly went on as planned de­spite not re­solv­ing much.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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