Covid-19 roundup: Ox­ford Bio­med­ica and As­traZeneca ex­tend vac­cine deal; FDA wants boost­ers for new­er vari­ants

An Ox­ford Uni­ver­si­ty spin­out and one of the ma­jor play­ers in the phar­ma in­dus­try are ex­tend­ing their col­lab­o­ra­tion on its Covid shot.

Ox­ford Bio­med­ica and As­traZeneca on Fri­day an­nounced that they have signed a new three-year agree­ment on fu­ture man­u­fac­tur­ing for the As­traZeneca Covid-19 vac­cine. Ac­cord­ing to Ox­ford Bio­med­ica, this deal is an ex­pan­sion of the orig­i­nal agree­ment an­nounced be­tween the two com­pa­nies dur­ing the first waves of the pan­dem­ic in Sep­tem­ber 2020.

Un­der the ex­ten­sion, the man­u­fac­tur­ing of vac­cines at Ox­ford Bio­med­ica’s 84,000-square-foot fa­cil­i­ty, called Oxbox, will be avail­able to As­traZeneca on an as-need­ed ba­sis be­yond this year. The man­u­fac­tur­ing of Covid-19 vac­cines at Oxbox is ex­pect­ed to be com­plet­ed in the last quar­ter of 2022, as part of the orig­i­nal com­mit­ment.

For the batch­es that were al­ready man­u­fac­tured in the first half of 2022, it plans to have rev­enue of £30 mil­lion ($36.1 mil­lion) Ox­ford Bio­med­ica.

Roch Do­liveux

“While con­tribut­ing to the ef­forts to fight the pan­dem­ic, this has al­so demon­strat­ed Ox­ford Bio­med­ica’s abil­i­ty to ex­pand the scope of our in­no­v­a­tive process de­vel­op­ment ser­vices and de­liv­er high-per­form­ing man­u­fac­tur­ing so­lu­tions be­yond lentivi­ral vec­tors,” said Roch Do­liveux CEO of Ox­ford Bio­med­ica in a state­ment.

The orig­i­nal deal in 2020 was a five-year agree­ment to help man­u­fac­ture the Covid-19 vac­cine be­ing de­vel­oped by Ox­ford Uni­ver­si­ty’s Jen­ner In­sti­tute and As­traZeneca. The ade­n­ovi­ral vec­tor vac­cine us­es a weak­ened ver­sion of a com­mon cold-caus­ing virus to de­liv­er the gene for a coro­n­avirus in­to hu­man cells.

FDA up­dates its rec­om­men­da­tions for boost­er dos­es, ask­ing for pro­tec­tions against BA.4 and BA.5

The FDA is rec­om­mend­ing that Covid-19 boost­er shots should be up­dat­ed to pro­tect against not just the orig­i­nal Omi­cron vari­ant, but its more vir­u­lent strains.

VRB­PAC vot­ed in fa­vor of in­clud­ing an Omi­cron com­po­nent in Covid-19 vac­cines that would be used for boost­er dos­es in the US be­gin­ning in fall 2022, ad­vis­ing man­u­fac­tur­ers to up­date their shots to add a BA.4/5 spike pro­tein to cre­ate bi­va­lent boost­er vac­cines.

Out­side ex­perts that are on FDA’s ad­comm ini­tial­ly met on Tues­day to dis­cuss whether a change to the cur­rent com­po­si­tion of Covid-19 boost­ers is nec­es­sary for the fall and win­ter. While the vac­cines that have been ap­proved and au­tho­rized for emer­gency use have made a dif­fer­ence to pub­lic health and have saved lives, the virus has evolved sig­nif­i­cant­ly, with re­cent surges around at­trib­uted to vari­ants such as Omi­cron.

Pe­ter Marks, FDA

Ac­cord­ing to Pe­ter Marks, di­rec­tor of the CBER, re­sults from post-au­tho­riza­tion ob­ser­va­tion­al stud­ies have shown that the ef­fec­tive­ness of pri­ma­ry vac­ci­na­tion wanes over time against cer­tain vari­ants, in­clud­ing Omi­cron. And while ini­tial boost­er dos­es have helped re­store pro­tec­tion against se­vere dis­ease and hos­pi­tal­iza­tion as­so­ci­at­ed with Omi­cron, stud­ies have al­so in­di­cat­ed wan­ing ef­fec­tive­ness of first boost­er dos­es.

The FDA ex­pects this com­ing year to be a tran­si­tion­al pe­ri­od when the mod­i­fied boost­er vac­cine may be in­tro­duced, but the agency has not ad­vised man­u­fac­tur­ers to change the vac­cine for pri­ma­ry vac­ci­na­tion, since an ini­tial two-dose se­ries with the FDA-au­tho­rized and ap­proved vac­cines pro­vides a base lay­er of pro­tec­tion.

Glob­al reg­u­la­tors, un­der the um­brel­la of ICM­RA, al­so agreed ear­li­er this week to adapt vac­cines to tack­le the omi­cron and its sev­er­al vari­ants.

Zye­sa­mi’s EUA for Covid-19 patents is re­ject­ed 

The FDA on Fri­day re­ject­ed the EUA for Zye­sa­mi’s use for pa­tients with crit­i­cal stages of Covid-19 and who are at risk for im­me­di­ate death from res­pi­ra­to­ry fail­ure.

Ac­cord­ing to a re­lease from NRx Phar­ma­ceu­ti­cals, Zye­sa­mi, al­so known as avip­tadil, was be­ing in­ves­ti­gat­ed for use in a sub-group of pa­tients that in ad­di­tion to us­ing the drug al­so, re­ceived Remde­sivir and con­tin­ued to progress. NRx Phar­ma­ceu­ti­cals had sub­mit­ted this last EUA ap­pli­ca­tion us­ing da­ta from a post-hoc sub­group analy­sis.

“As pre­vi­ous­ly com­mu­ni­cat­ed, since the fu­til­i­ty news of the AC­TIV-3b / TESI­CO Study with ZYE­SA­MI®, our team has al­ready been high­ly fo­cused on the de­vel­op­ment of NRX-101 for bipo­lar de­pres­sion in pa­tients with Acute and Sub-Acute Sui­ci­dal­i­ty. Though dis­ap­point­ing, this de­ci­sion by the FDA is not un­ex­pect­ed, giv­en that they had al­ready re­cent­ly de­clined Break­through Ther­a­py Des­ig­na­tion for Zye­sa­mi. We will eval­u­ate the op­tions for Zye­sa­mi in Covid-19 res­pi­ra­to­ry fail­ure and oth­er lung dis­or­ders once we re­ceive the full da­ta set from the NIH,” said Robert Besthof, NRx’s in­ter­im CEO.

This is not the first time Zye­sa­mi has been looked at un­fa­vor­ably by the gov­ern­ment. In late May, there were more deaths in the treat­ment group than in the place­bo co­hort in an NIH study of Zye­sa­mi which was al­ready re­ject­ed, and the da­ta safe­ty board rec­om­mend­ed stop­ping the tri­al. In the treat­ment arm, the mor­tal­i­ty was 37% com­pared to 36% in the place­bo group.

This weight has brought down NRx’s stock price $NRXP through the floor, as it has dropped 87% since the be­gin­ning of the year.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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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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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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