Chuck Schumer, US Senate Majority Leader

Covid-19 man­u­fac­tur­ing roundup: Ri­ton­avir pro­duc­tion to reach 100M dos­es an­nu­al­ly; Schumer calls for a boost to do­mes­tic vac­cine sup­ply

Amid the spike in pos­i­tive Covid-19 cas­es thanks to the Omi­cron vari­ant, As­cle­tis will ex­pand its pro­duc­tion of the oral tablet ri­ton­avir to pro­duce 100 mil­lion dos­es a year. And the com­pa­ny is ready to in­crease that num­ber if the mar­ket calls for that.

ASC10 tar­gets RNA de­pen­dent RNA poly­merase, while ASC11 tar­gets 3-chy­motrypsin-like pro­tease. As­cle­tis cur­rent­ly owns the on­ly au­tho­rized ri­ton­avir tablet in Chi­na, which was ap­proved in Sep­tem­ber. A low dose ri­ton­avir oral tablet (100mg) is a com­po­nent of Paxlovid, Pfiz­er’s drug that re­cent­ly land­ed a con­tract with the Bel­gian gov­ern­ment for 10,000 cours­es.

“At the be­gin­ning of Covid-19 in 2020, based on its an­tivi­ral plat­form and R&D ex­pe­ri­ence, the com­pa­ny made the firm and rapid de­ci­sion to in­vest in oral di­rect-act­ing an­tivi­rals R&D against RdRp and 3CL­pro of SARS-CoV-2,” CEO Jinzi Wu said in a state­ment. “Mean­while, the com­pa­ny ac­cel­er­at­ed the de­vel­op­ment ef­fort to ob­tain the ap­proval of ri­ton­avir oral tablets in Chi­na and suc­cess­ful­ly achieved the au­tho­riza­tion by Chi­na NM­PA for ri­ton­avir oral tablets.”

In the US alone, the num­ber of dai­ly cas­es has jumped from around 170,000 on Dec. 17 to 1 mil­lion on Jan. 3. Chi­na, where As­cle­tis is lo­cat­ed, has not re­port­ed such a spike, but oth­er coun­tries, such as the Philip­pines and the UK, are ex­pe­ri­enc­ing the largest spikes since last year.

Schumer calls for a boost to do­mes­tic vac­cine sup­ply

US Sen­ate Ma­jor­i­ty Leader Chuck Schumer wrote a let­ter to the De­part­ment of HHS Wednes­day, call­ing for the fair con­sid­er­a­tion of an ex­pan­sion of man­u­fac­tur­ing ca­pac­i­ty in Oneon­ta, NY.

The ex­pan­sion at the Oneon­ta Life Sci­ences Fa­cil­i­ty, owned by Corn­ing Phar­ma­ceu­ti­cal Tech­nolo­gies, could pre­serve the ex­ist­ing 150 jobs at the site, and cre­ate 275 jobs in man­u­fac­tur­ing and con­struc­tion in what he calls an eco­nom­i­cal­ly dis­ad­van­taged area.

“In­no­va­tion plus fed­er­al in­vest­ment is how we bet­ter equip Amer­i­ca to deal with health threats,” he wrote. “Corn­ing’s pro­posed project would be a shot in the arm for the Up­state New York econ­o­my, cre­at­ing hun­dreds of jobs and would be a boost­er for the do­mes­tic med­ical sup­ply chain.”

In 2021, Corn­ing got $204 mil­lion in fed­er­al fund­ing to dou­ble its Big Flats fa­cil­i­ty.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

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.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.