Shankar Musunuri, Ocugen CEO

Ocu­gen hits an­oth­er snag in bring­ing its Bharat Biotech-part­nered Covid-19 vac­cine to the US

Back in Ju­ly, Ocu­gen and Bharat Biotech un­veiled some Phase III da­ta sug­gest­ing their Covid-19 vac­cine, Co­v­ax­in, was 77.8% ef­fec­tive at pre­vent­ing over­all dis­ease in In­dia. They’re now look­ing to launch an im­muno-bridg­ing study to see if those num­bers hold up in the US — but on Fri­day, the FDA said not so fast.

Reg­u­la­tors have placed a clin­i­cal hold on the part­ners’ IND, Ocu­gen shared on Fri­day. Ocu­gen’s stock $OCGN sank 9% on the news Fri­day, but was up al­most 7% in pre-mar­ket trad­ing on Mon­day.

“The FDA plans to iden­ti­fy the spe­cif­ic de­fi­cien­cies that are the ba­sis for clin­i­cal hold and in­for­ma­tion on how to ad­dress those de­fi­cien­cies,” the Malvern, PA-based com­pa­ny said in a state­ment. “The Com­pa­ny ex­pects to re­ceive for­mal writ­ten com­mu­ni­ca­tion with the ad­di­tion­al in­for­ma­tion from the FDA and plans to work with the FDA in an ef­fort to re­solve its ques­tions as prompt­ly as pos­si­ble.”

The news comes just a few weeks af­ter Ocu­gen filed for emer­gency use au­tho­riza­tion of the Bharat Biotech-part­nered shot for just pe­di­atric use based on an im­muno-bridg­ing study con­duct­ed in In­dia.

Co­v­ax­in, a whole-viri­on, in­ac­ti­vat­ed vac­cine, was de­vel­oped by Bharat Biotech along with the In­di­an Coun­cil of Med­ical Re­search. The World Health Or­ga­ni­za­tion grant­ed it an emer­gency use list­ing ear­li­er this month, stat­ing that the jab is “ex­treme­ly suit­able for low- and mid­dle-in­come coun­tries due to easy stor­age re­quire­ments.”

In Ju­ly, Bharat an­nounced that the vac­cine was 77.8% ef­fec­tive against Covid-19 of any sever­i­ty, and 93.4% ef­fec­tive against se­vere dis­ease in a Phase III tri­al with more than 25,000 par­tic­i­pants in In­dia. Few­er than 0.5% of pa­tients ex­pe­ri­enced se­vere side ef­fects, the In­di­an biotech said at the time.

Ear­li­er this year, Ocu­gen an­nounced plans to file for an EUA in the US in June. But when June rolled around, the com­pa­ny said it de­cid­ed to pur­sue a bi­o­log­ics li­cense ap­pli­ca­tion in­stead, up­on rec­om­men­da­tion by the FDA. At the end of Oc­to­ber, Ocu­gen filed an IND to con­duct a Phase III im­muno-bridg­ing study in “sev­er­al hun­dred” US adults who’ve nev­er been vac­ci­nat­ed, or re­ceived two dos­es of an mR­NA vac­cine at least six months pri­or.

Just a week lat­er, the com­pa­ny sub­mit­ted an EUA for use in kids ages 2 to 18 based on an­oth­er im­muno-bridg­ing study con­duct­ed in In­dia. Ac­cord­ing to Ocu­gen, an im­muno-bridg­ing study showed that neu­tral­iz­ing an­ti­body re­spons­es in the pe­di­atric group were equiv­a­lent to those seen in adults.

“Our re­search sug­gests that peo­ple are seek­ing more choic­es when se­lect­ing a vac­cine, es­pe­cial­ly for their chil­dren,” CEO Shankar Musunuri said. “Hav­ing a new type of vac­cine avail­able will en­able peo­ple to dis­cuss with their child’s physi­cian the best ap­proach for them to low­er their child’s risk of con­tract­ing COVID-19.”

The clin­i­cal hold may not be a good sign for Ocu­gen’s pe­di­atric EUA, though we’ll have to wait and see.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.

US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.

The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.