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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.