Ko­re­an reg­u­la­tors shut down Sam­sung Phar­ma man­u­fac­tur­ing af­ter find­ing ad­di­tives, false records

South Ko­rea’s health reg­u­la­tor has sus­pend­ed Sam­sung Phar­ma­ceu­ti­cal’s man­u­fac­tur­ing op­er­a­tions un­til mid-Feb­ru­ary af­ter the agency learned that a pro­duc­tion man­ag­er was tasked with re­spon­si­bil­i­ties of two dif­fer­ent plants. The rev­e­la­tion vi­o­lat­ed a law re­quir­ing each plant to be man­aged by one per­son.

Mon­day’s halt comes just months af­ter an in­spec­tion re­vealed a num­ber of vi­o­la­tions at one Sam­sung Phar­ma plant, in­clud­ing the use of ad­di­tives with­out per­mis­sion and false man­u­fac­tur­ing records, the Ko­rea Bio­med­ical Re­view re­port­ed.

Six drugs, in­clud­ing five of Sam­sung Phar­ma’s, have been sus­pend­ed from be­ing man­u­fac­tured. Geramin, Moarex, Com­bicin, and an Aprog­en Phar­ma­ceu­ti­cal drug Health­namine have all been halt­ed.

The com­pa­ny is in no way af­fil­i­at­ed with the South Ko­re­an elec­tron­ics gi­ant Sam­sung, or its sub­sidiary Sam­sung Bi­o­log­ics, a rep­re­sen­ta­tive for the com­pa­ny said.

In a state­ment on its web­site, Sam­sung Phar­ma at­trib­uted the er­ror to neg­li­gence, and care­less­ness in check­ing in on the man­ag­er’s work, and in­sist­ed that it was not a prob­lem with the qual­i­ty of prod­ucts shipped.

“Nev­er­the­less, (we are) deeply re­flect­ing on the in­con­ve­nience caused by not thor­ough­ly com­ply­ing with the stan­dards that we, as phar­ma­ceu­ti­cal man­u­fac­tur­ers, should abide by,” the state­ment said.

The three-month sus­pen­sion is the first step in a se­ries of po­ten­tial pun­ish­ments for com­pa­nies who vi­o­late the law that pre­vents the dou­ble-dip­ping of em­ploy­ees. The next is a six-month man­u­fac­tur­ing sus­pen­sion, and the third strike will see the agency re­voke a busi­ness­es li­cense, Ko­rea Bio­med­ical Re­view re­port­ed. The sus­pen­sion will start to­day and end on Feb. 14.

Ad­di­tion­al sanc­tions in­clude the halt of man­u­fac­tur­ing in­jec­tions for five weeks and a four-month sus­pen­sion of the five drugs un­der scruti­ny. In a pub­lic state­ment, the com­pa­ny an­nounced that the sus­pen­sion would cost the com­pa­ny 5.7 bil­lion won, or rough­ly $4.8 mil­lion.

In June, a tem­po­rary sus­pen­sion was or­dered af­ter vi­o­la­tions sur­faced, and the six drugs were forced to be re­called. Sam­sung Phar­ma il­le­gal­ly used ad­di­tives ar­bi­trar­i­ly and cre­at­ed false doc­u­ments to cov­er up the vi­o­la­tions. Reg­u­la­tors have al­so pun­ished com­pa­nies such as Vivo­zon and Binex for sim­i­lar vi­o­la­tions.

The news brought down the com­pa­ny’s stock in the South Ko­re­an mar­ket when it first broke in June. But shares fal­tered very lit­tle af­ter Mon­day’s news broke, still clos­ing high­er than the pre­vi­ous day.

In the state­ment, Sam­sung Phar­ma said that it would re­vis­it its found­ing phi­los­o­phy and fo­cus on its orig­i­nal du­ties as a phar­ma­ceu­ti­cal com­pa­ny.

“We will do our best to be­come a Sam­sung Phar­ma that can be trust­ed by share­hold­ers, cus­tomers, med­ical staff and pa­tients again by re­mov­ing the com­pla­cen­cy of the past,” it said.

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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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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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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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.

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.

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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.

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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