Keith Kleeman, Optimvia CEO

In pur­suit of bet­ter he­parin man­u­fac­tur­ing process, Gink­go teams up with an Ohio-based biotech

The man­u­fac­tur­ing process to make biosyn­thet­ic he­parin, a drug used for pre­vent­ing blood clots, is not a par­tic­u­lar­ly clean one.

In a slaugh­ter­house, some­one must re­move the in­tes­tine cas­ings from a pig. The mu­cos­al lin­ings are then scraped. The steps to get he­parin are enor­mous, and the process is com­pli­cat­ed.

“It’s not like you kill a pig and you have he­parin,” Ohio-based Op­ti­mvia CEO Kei­th Klee­man told End­points News in an in­ter­view. “It’s a filthy, dis­gust­ing place for a med­ica­tion to start. I can’t think of a more dis­gust­ing place for an im­por­tant med­i­cine to start.”

Ja­son Kel­ly

But Op­ti­mvia and Gink­go Bioworks will team up to try and im­prove that process. The two com­pa­nies an­nounced last week that they will part­ner and lever­age Gink­go’s cell and en­zyme en­gi­neer­ing plat­form and fer­men­ta­tion process to strength­en the sup­ply chain, make the drug more af­ford­able and sim­pli­fy the process.

He­parin is clas­si­fied as an es­sen­tial med­i­cine by the World Health Or­ga­ni­za­tion, and pro­duc­ing non-an­i­mal de­rived ver­sions of the drug is part of Op­ti­mvia’s goal. There are two big ben­e­fits from en­zy­mat­ic man­u­fac­tur­ing: pulling out a clean­er prod­uct, and cre­at­ing a more ro­bust sup­ply chain for med­i­cines, Gink­go CEO Ja­son Kel­ly said in an in­ter­view.

“It’s a clean­er prod­uct, you’re fail­ure ef­fects aren’t pulling in some strange thing from the pig, you have a more con­tained pro­duc­tion en­vi­ron­ment when you have just a sin­gle species of cell pro­duc­ing this prod­uct in a tank, which is what the biotech in­dus­try learned with all the pro­teins in the 80s,” he said. But then the sec­ond thing is how do we just have more ro­bust sup­ply chains for es­sen­tial med­i­cines. The more things we can make via fer­men­ta­tion, the more ro­bust the US sup­ply chain is. We can fer­ment things here. We’re good at it.”

That’s im­por­tant for sev­er­al rea­sons, but per­haps none more than this: There are 350 mil­lion pigs need­ed right now to meet glob­al de­mand, Klee­man said, and some­where be­tween 60% and 80% of the pigs are lo­cat­ed in slaugh­ter­hous­es in Chi­na. The lack of ge­o­graph­i­cal di­ver­si­ty means that any changes in trade reg­u­la­tions could send the sup­ply spi­ral­ing out of con­trol, and if some­thing bi­o­log­i­cal were to hap­pen — sim­i­lar to an out­break of Mad Cow Dis­ease or African Swine Fever — 100s of an­i­mals could be killed, and the prices of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents could sky­rock­et.

Back in 2008, con­t­a­m­i­nat­ed he­parin made in Chi­na end­ed up killing 81 peo­ple in the US, and left 785 se­vere­ly in­jured.

The process to man­u­fac­ture it is sim­i­lar to Amer­i­can au­tomak­ers’ ef­forts to re­place the car­bu­re­tor with fu­el in­jec­tors in the 1980s. The peo­ple who cre­at­ed the car­bu­re­tor weren’t suc­cess­ful at per­fect­ing the fu­el in­jec­tor, Klee­man said, and what helps Gink­go and Op­ti­mvia in their ef­forts to im­prove this process is the dis­tance it al­ready has from it.

“We’re not the first guys to look at this, peo­ple have been look­ing at this since 1990, and they’re still try­ing to fig­ure it out. So with­out giv­ing the keys to the king­dom away…we found a very crit­i­cal com­po­nent to the biosyn­thet­ic process that had al­ready been in play…(Sci­en­tists) haven’t cracked that code of repli­cat­ing the nat­ur­al process…So why us? Well, we looked at it from a dif­fer­ent an­gle.”

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

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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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.

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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.

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.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.