Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

Covid-19 roundup: Eu­ro­pean Com­mis­sion's le­gal bat­tle against As­traZeneca be­gins; Kaza­khstan gives green light to do­mes­tic vac­cine

The Eu­ro­pean Com­mis­sion’s le­gal case against As­traZeneca for fail­ing to de­liv­er the amount of vac­cine dos­es laid out in a con­tract be­gan in a Brus­sels court on Wednes­day, ac­cord­ing to Reuters. 

The EC re­quest­ed im­me­di­ate de­liv­er­ies from all fac­to­ries list­ed in the con­tract, in­clud­ing ones in Britain, the news agency re­port­ed. It’s been two days since the EC an­nounced it would take le­gal ac­tion.

The dis­pute be­gan back in Jan­u­ary, when As­traZeneca in­formed the EU that it wouldn’t be able to de­liv­er the promised num­ber of dos­es laid out in a sup­ply con­tract due to pro­duc­tion lags. The con­tract al­lowed for the pur­chase of 300 mil­lion dos­es, with an op­tion for 100 mil­lion more. But on­ly 30 mil­lion were de­liv­ered in Q1 2021, and As­traZeneca promised 70 mil­lion in Q2, as op­posed to the 180 mil­lion that had been promised.

The EU pub­lished a heav­i­ly redact­ed ver­sion of the con­tract in an ef­fort to fos­ter trans­paren­cy. But af­ter in­ter­net sleuths and Ger­man jour­nal­ists found the blacked-out sec­tions could be eas­i­ly re­moved, the EU pub­licly apol­o­gized.

CEO Pas­cal So­ri­ot has as­sert­ed the con­tracts are not legal­ly bind­ing due to a “best ef­fort” clause in the text.

As­traZeneca said in a state­ment Mon­day that al­most 50 mil­lion dos­es are com­ing by the end of April, which it said is “in line with our fore­cast.”

“As­traZeneca deeply re­grets the de­ci­sion of the Eu­ro­pean Com­mis­sion to start this le­gal ac­tion in re­la­tion with the COVID-19 sup­ply agree­ment. We hope to re­solve this dis­pute as soon as pos­si­ble,” com­pa­ny lawyer Hakim Boular­bah said in court, per Reuters.

Two more hear­ings are sched­uled on May 26, and a judge is ex­pect­ed to de­cide on the case in June, Reuters re­port­ed.

Kaza­khstan gives green light to vac­cine be­fore it com­pletes test­ing

Kaza­khstan is rolling out its own Covid-19 shot, dubbed Qaz­Vac, be­fore it has com­plet­ed Phase III test­ing.

“The first batch of Qaz­Vac vac­cine ar­rived in the re­gions of the coun­try,” pres­i­dent Kassym-Jo­mart Tokayev tweet­ed on April 23. “Vac­cine pro­duc­tion will be in­creased to make it avail­able to all cit­i­zens.”

The vac­cine, de­vel­oped by the Re­search In­sti­tute for Bi­o­log­i­cal Safe­ty Prob­lems, en­tered a Phase I/II tri­al in Kaza­khstan back in Sep­tem­ber. Sci­en­tist Lep­ek Ku­tum­be­tov re­port­ed­ly test­ed it on him­self, then told the state-owned me­dia or­ga­ni­za­tion Kaz­in­form it is “harm­less.”

Since then, the re­search in­sti­tute has said that all 222 par­tic­i­pants in the first two stages of test­ing have de­vel­oped im­mu­ni­ty, with no ma­jor side ef­fects, ac­cord­ing to Reuters. A 3,000-per­son Phase III tri­al is ex­pect­ed to wrap up in Ju­ly.

Near­ly a mil­lion cit­i­zens have al­ready been vac­ci­nat­ed with Rus­sia’s Sput­nik V, and the coun­try has or­dered a mil­lion dos­es of Chi­na’s Sinopharm vac­cine, Reuters re­port­ed.

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

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.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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