Irene Frachon at the courthouse. (Michel Euler via AP Images)

Servi­er be­gins manslaugh­ter tri­al over weight loss drug

French phar­ma Servi­er be­gins tri­al to­day, as the com­pa­ny stands ac­cused of manslaugh­ter and de­ceit over a di­a­betes weight loss drug linked to as many as 2,000 deaths.

The drug, Me­di­a­tor (ben­flu­o­rex), was pulled out of French phar­ma­cies in 2009 af­ter 33 years on the mar­ket. A year lat­er, the French med­i­cine safe­ty agency an­nounced the drug was sus­pect­ed of caus­ing mul­ti­ple deaths, spark­ing out­rage, a crim­i­nal in­ves­ti­ga­tion and a se­ries of re­forms to the coun­try’s sys­tem of reg­u­lat­ing the phar­ma­ceu­ti­cal in­dus­try.

Servi­er ac­knowl­edged the deaths and said it was work­ing on com­pen­sat­ing vic­tims, al­ready hand­ing out €132 mil­lion ($146 mil­lion) in pay­ments. But it de­nied the charges that it mis­led the pub­lic and lied about the drug’s side ef­fects. The French drug reg­u­la­tor is al­so on tri­al, ac­cused of le­nien­cy and a fail­ure to act to pre­vent pa­tient deaths. The agency has said it will co­op­er­ate with the tri­al.

All told, the tri­al will in­volve 21 de­fen­dants, in­clud­ing 14 peo­ple, among them a for­mer com­pa­ny vice pres­i­dent, civ­il ser­vants, a for­mer sen­a­tor and a pro­fes­sor of pe­di­atrics re­tained by Servi­er. The case con­trasts sharply with a US sys­tem where in­ves­ti­ga­tions of or­ga­ni­za­tion­al wrong­do­ing rarely re­sult in in­di­vid­ual pros­e­cu­tions. The tri­al is ex­pect­ed to last 7 months — one of the longest in Paris in decades — and in­volves 2,600 plain­tiffs.

Me­di­a­tor is an am­phet­a­mine-based ap­petite sup­pres­sant and though it was mar­ket­ed as a way to ad­dress ex­cess weight in di­a­bet­ics, it was re­port­ed­ly wide­ly pre­scribed as a weight loss drug, in­clud­ing to many healthy women. Au­thor­i­ties es­ti­mat­ed 5 mil­lion peo­ple took the drug be­fore it was pulled.

Some of these women found them­selves un­able to climb stairs and ex­posed to a host of car­dio­vas­cu­lar prob­lems. In ad­di­tion to the deaths, thou­sands are es­ti­mat­ed to be suf­fer­ing de­bil­i­tat­ing side ef­fects from the drug.

The drug, how­ev­er, re­mained on the mar­ket de­spite con­cerns and the re­moval of a sim­i­lar drug from the US mar­ket in 1997. Me­di­a­tor was pulled from sev­er­al coun­tries, in­clud­ing Italy and Spain, in the ear­ly 2000s, but didn’t leave the French mar­ket un­til 2009, two years af­ter French lung spe­cial­ist Irene Fra­chon re­viewed pa­tient records and found a link be­tween the drug and se­ri­ous heart and lung dam­age.

“The tri­al comes as huge re­lief,” Fra­chon told Reuters. “Fi­nal­ly, we are to see the end of an in­tol­er­a­ble scan­dal.”

Two main stud­ies were per­formed on the drugs’ neg­a­tive im­pact, one find­ing it caused 500 deaths. An­oth­er: 2,000 deaths. Servi­er dis­putes these fig­ures, say­ing there are on­ly three doc­u­ment­ed deaths clear­ly at­trib­ut­able to Me­di­a­tor and not oth­er ag­gra­vat­ing fac­tors.

The French in­dict­ment al­leges Servi­er “know­ing­ly con­cealed the med­ica­tion’s true char­ac­ter­is­tics,” ac­cord­ing to Reuters, and hid un­fa­vor­able med­ical stud­ies.

Servi­er is the coun­try’s sec­ond-largest phar­ma­ceu­ti­cal com­pa­ny be­hind Sanofi. It makes a broad set of gener­ics and re­search­es new treat­ments on Alzheimer’s and on­col­o­gy. Last year, it bought Shire’s on­col­o­gy unit for $2.4 bil­lion.

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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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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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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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.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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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

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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.