Covid-19 roundup: Novavax’s manufacturing woes nearing an end?; FDA rejects coronavirus drug in NIH trial

The US gov­ern­ment’s $1.8 bil­lion in­vest­ment in­to No­vavax’s Covid-19 vac­cine may soon pay off as the com­pa­ny float­ed some pos­i­tive com­ments around the is­sues sur­round­ing the man­u­fac­tur­ing of its re­com­bi­nant pro­tein vac­cine, which could be added ear­ly next year to the world’s ar­se­nal of shots.

The com­pa­ny has strug­gled with its vac­cine can­di­date’s po­ten­cy and pu­ri­ty, push­ing back the tim­ing of sub­mit­ting its ap­pli­ca­tion to the FDA all sum­mer, and in June the US gov­ern­ment had to steer No­vavax, in­struct­ing the com­pa­ny to pri­or­i­tize align­ment with the FDA on its an­a­lyt­ic meth­ods be­fore con­duct­ing ad­di­tion­al US man­u­fac­tur­ing, and ‘fur­ther in­di­cat­ed that the US gov­ern­ment will not fund ad­di­tion­al US man­u­fac­tur­ing un­til such agree­ment has been made,’ the com­pa­ny said.

But now things are ap­par­ent­ly look­ing up.

‘As of No­vem­ber 2021, we val­i­dat­ed the po­ten­cy and pu­ri­ty of our as­says and are in the fi­nal process of test­ing our prod­uct us­ing these as­says. We ex­pect to sub­mit the com­plete reg­u­la­to­ry pack­age to the FDA by the end of 2021,’ No­vavax said in an SEC fil­ing Fri­day.

The com­pa­ny al­so said it’s in ‘con­tin­ued dis­cus­sions with the FDA’ about its sub­mis­sion and that it con­tin­ues to ad­dress and com­plete var­i­ous CMC re­quire­ments.

FDA re­jects Covid-19 treat­ment EUA for res­pi­ra­to­ry fail­ure

NRx Phar­ma­ceu­ti­cals said Fri­day that the FDA was un­able to is­sue an EUA for its treat­ment for peo­ple hos­pi­tal­ized with Covid-19 ‘at this time due to in­suf­fi­cient da­ta re­gard­ing the known and po­ten­tial ben­e­fits of the med­i­cine and the known and po­ten­tial risks of Zye­sa­mi in pa­tients suf­fer­ing from crit­i­cal COVID-19 with res­pi­ra­to­ry fail­ure.’

In its let­ter, ac­cord­ing to NRx, the FDA not­ed that so far, it has re­viewed safe­ty in on­ly 131 ran­dom­ized pa­tients treat­ed with Zye­sa­mi. The drug is al­so be­ing stud­ied as part of the NIH’s AC­TIV-3b tri­al, which is for se­vere­ly ill in­pa­tients. NRx said it will at­tempt to co­or­di­nate a re­view by the FDA of the 150 or more ad­di­tion­al pa­tients al­ready treat­ed in that tri­al.

Ocu­gen seeks EUA in kids for Co­v­ax­in vac­cine

Penn­syl­va­nia-based Ocu­gen said Fri­day that it sent a re­quest to the FDA for an emer­gency au­tho­riza­tion for its Covid-19 vac­cine can­di­date BBV152, known as Co­v­ax­in out­side of the US, for just pe­di­atric use.

The vac­cine can­di­date, which is a whole-viri­on, in­ac­ti­vat­ed vac­cine and re­cent­ly au­tho­rized by the WHO, was de­vel­oped by the In­di­an com­pa­ny, Bharat Biotech. For kids ages 2-18, Ocu­gen said the vac­cine was stud­ied in an im­muno-bridg­ing clin­i­cal tri­al con­duct­ed in In­dia.

‘The neu­tral­iz­ing an­ti­body re­spons­es against wild-type strain in the pe­di­atric age group of 2-18 years were equiv­a­lent to those seen in adults, ages 18+ years, in Bharat Biotech’s large Phase 3 ef­fi­ca­cy and safe­ty tri­al,’ Ocuegn said in a state­ment.

In terms of safe­ty, the com­pa­ny said that among the 526 study sub­jects in the pe­di­atric clin­i­cal tri­al, no se­ri­ous ad­verse ef­fects, such as deaths, hos­pi­tal­iza­tions, my­ocardi­tis, peri­cardi­tis, Guil­lain-Barre syn­drome, vac­cine-in­duced throm­bot­ic throm­bo­cy­tope­nia or ana­phy­lac­tic re­ac­tions were re­port­ed.

In adults, Co­v­ax­in pre­vi­ous­ly showed 77.8% vac­cine ef­fi­ca­cy against symp­to­matic Covid dis­ease, through eval­u­a­tion of 130 con­firmed cas­es, with 24 ob­served in the vac­cine group ver­sus 106 in the place­bo group.

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The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Every part of ‘normal’ day-to-day life has been disrupted. Clinical trials and the traditional way of conducting them has been no different. Flexibility became an immediate need for sponsors, CROs, clinical sites, and patients. Quick adjustments had to be made, along with finding new ways to make sure that patients had the appropriate care, oversight of the clinical sites continued to be managed, and drug supply and accountability were maintained. Many clinical sites found themselves acting as a shipping department, trying to make sure all of their patients received their drug safely and on time. CRAs performed remote oversight visits, virtual site tours, and virtual accountability audits. Sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.

After a fiasco surrounding the contamination of Covid-19 vaccine doses in its facilties — during a time in which vaccinating residents was dire to America’s return to normalcy — Emergent BioSolutions’ $600 million manufacturing deal with the US government has come to an end.

CEO Bob Kramer said that the two parties ‘mutually agreed’ to terminate the contract in an earnings call with investors Thursday, evaporating about $180 million in deal value.

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For the past 20 years, Novartis and Roche were more than cross-town rivals reigning over towering pharmaceutical dynasties. Novartis also holds a sizable chunk of Roche’s shares — amounting to a nearly one-third voting stake.

Now, Roche is buying that stake back for $20.7 billion.

‘After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment,’ Novartis CEO Vas Narasimhan said in a statement, adding that the cash will go toward purposes in line with current capital allocation.

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Albert Bourla, Pfizer CEO (John Thys, Pool/AFP via Getty Images)

Pfizer on Friday unveiled statistically significant efficacy data for its potential Covid-19 pill among people who haven’t been hospitalized with the virus. The data will likely lead to a quick EUA from the FDA and add to a growing field of effective, easy-to-use treatments.

Data from a scheduled interim analysis showed an 89% reduction in risk of Covid-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset. Pfizer said it halted enrollment in the trial because of the positive results, and in consultation with the FDA.

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DeepMind CEO Demis Hassabis

Last summer marked a major breakthrough in drug discovery when DeepMind, a predictive modeling startup from Google parent company Alphabet, offered the most accurate picture yet of the ‘protein folding’ problem. The Alphabet team is now propping up a unit focused solely on drug discovery, and it will look to leverage lessons learned from DeepMind’s example.

Alphabet has launched Isomorphic Labs, a London-based drug discovery startup leveraging the company’s AI and machine learning work, and lessons from DeepMind’s AlphaFold breakthroughs, CEO Demis Hassabis said in a blog post Thursday.

As Nitrome Biosciences — a biotech founded in 2017 to focus on a class of enzymes called nitrases — rebrands to Nitrase Therapeutics, the company is also bringing on a new CEO: Pierre Beaurang.

In Nitrase’s statement earlier this week announcing its new CEO, the biotech said that the founder and now-former CEO — Irene Griswold-Prenner — will stay on with Nitrase as the new CSO. And this new appointment comes in tandem with the biotech’s Series A expansion, where Bristol Myers Squibb became an investor alongside AbbVie and Sofinnova Partners, bringing the total amount raised to $45 million.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Amgen announced back in June that it would spend $365 million to build its manufacturing plant of the future in New Albany, OH, complete with self-driving vehicles and data-gathering tools to ensure efficiency. Today, that journey begins.

The California-based biotech will break ground today on its new assembly and packaging plant, which is estimated to create 400 new jobs in the area just 18 miles northeast of Columbus, according to a report by the Columbus Dispatch. The new facility will further Amgen’s capabilities to make medicines set for distribution in the US, it said in a statement a few months ago.

Catalent CEO John Chiminski (Jeff Rumans)

Just weeks after Catalent opened a newly acquired site in Shiga, Japan, the CDMO giant announced the opening of a new facility in San Diego to up its clinical packaging and distribution solutions on the West Coast.

The facility is 24,000 square feet and located within a mile of the company’s early-phase oral drug product center of excellence. It supports clinical studies for Phases I through III, and end-to-end services.

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WuXi Biologics CEO Chris Chen (Photographer: Anthony Kwan/Bloomberg via Getty Images)

WuXi Biologics’ latest project is open for business in the Chinese firm’s namesake city.

WuXi has pumped millions into the expansion of its manufacturing operations as of late, and on Sunday announced it successfully launched its new drug product facility in Wuxi. That marks the eighth drug production facility for WuXi Biologics.

The site will add another 60 million vials a year to WuXi’s commercial drug production operations and consolidate the company’s single-use and automation operations.

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