French court rules against Sanofi in land­mark De­pakine case

Sanofi has faced a slew of al­le­ga­tions over the last sev­er­al years that its epilep­sy drug De­pakine caus­es birth de­fects when tak­en dur­ing preg­nan­cy. Last week, it suf­fered a sting­ing loss in a French court — but the phar­ma gi­ant’s le­gal trou­ble is far from over.

A court in Nan­terre — a city sev­er­al miles out­side of Paris — ruled last week that Sanofi must pay up to €450,000 in dam­ages to a fam­i­ly whose child suf­fered a form of autism af­ter ex­po­sure to De­pakine, mul­ti­ple sources re­port­ed. Ac­cord­ing to Reuters, plain­tiffs al­leged that Sanofi knew of the po­ten­tial risks to preg­nant women, and failed to no­ti­fy pa­tients.

“It’s dif­fi­cult when you at­tack a Big Phar­ma like Sanofi,” Ma­rine Mar­tin, who leads an or­ga­ni­za­tion for vic­tims called ​​APE­SAC, told End­points News. 

This rul­ing marks the first time a French court has ac­knowl­edged a link be­tween De­pakine and dis­or­ders like autism in a sin­gle case, ac­cord­ing to Mar­tin. Her own two chil­dren were af­fect­ed af­ter she took De­pakine every day for years, and she’s been bat­tling Sanofi in court for the last decade.

APE­SAC cel­e­brat­ed a win ear­li­er this year when a French court gave fam­i­lies the go-ahead to join a class ac­tion law­suit against the phar­ma gi­ant.

“We are very hap­py for this first vic­to­ry be­cause a lot of fam­i­lies want to be com­pen­sat­ed,” Mar­tin said of the re­cent rul­ing.

De­pakine, al­so known as sodi­um val­proate, has been on the mar­ket since 1967 for epilep­sy and bipo­lar dis­or­der. It’s on the WHO’s list of “es­sen­tial med­i­cines,” and is pre­scribed in over 100 coun­tries. Sanofi al­leged­ly learned of the risk of fe­tus mal­for­ma­tion in the 1980s, and in 2003, the French phar­ma re­port­ed­ly be­came aware that the drug can im­pact neu­ro­log­i­cal de­vel­op­ment, ac­cord­ing to Reuters.

The EMA re-eval­u­at­ed the drug in 2014, en­forc­ing rec­om­men­da­tions the fol­low­ing year that prac­ti­tion­ers not pre­scribe the treat­ment to women of child­bear­ing age. Now, the bot­tle even in­cludes the crossed-out im­age of a preg­nant woman, Mar­tin said, hold­ing a bot­tle up to her we­b­cam — mak­ing the warn­ing abun­dant­ly clear.

But many ar­gue the ef­forts came too late.

The APE­SAC web­site counts more than 7,800 vic­tims and 180 deaths as a re­sult of De­pakine — though French health au­thor­i­ties have es­ti­mat­ed that the drug is re­spon­si­ble for neu­ro-de­vel­op­men­tal de­fects in up to 30,400 chil­dren, Reuters re­port­ed.

Sanofi was for­mal­ly charged with manslaugh­ter back in 2020, and placed un­der for­mal in­ves­ti­ga­tion soon af­ter. At the end of the year, France’s Na­tion­al Med­i­cines and Health Prod­ucts Agency (ANSM), was in­dict­ed for “in­juries and manslaugh­ter by neg­li­gence” re­lat­ed to birth de­fects and still­born births al­leged­ly caused by the drug.

Sanofi main­tains that De­pakine is an ef­fec­tive op­tion for mil­lions of epilep­sy pa­tients, and plans on fil­ing an ap­peal, a spokesper­son told End­points on Mon­day.

“The Court not­ed that Sanofi had in­deed made sev­er­al de­mands of the Health Au­thor­i­ty to mod­i­fy the in­for­ma­tion doc­u­ments, in­clud­ing the pa­tient in­for­ma­tion leaflet. How­ev­er, in its de­ci­sion vis a vis Sanofi, the Court did not take in­to con­sid­er­a­tion the re­fusal of the health au­thor­i­ties at the time to take in­to ac­count the re­quest­ed changes,” the spokesper­son said.

For Mar­tin, the ver­dict rep­re­sents hope as she con­tin­ues to fight her own case.

“A small per­son can win against Big Phar­ma,” she said. “It’s pos­si­ble.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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No­var­tis takes Gilenya fight to Supreme Court as gener­ic com­pe­ti­tion looms

Novartis stands to lose more than a quarter billion dollars in sales this year if Gilenya generics are allowed to market. So it’s taking the fight all the way to the Supreme Court.

The Swiss pharma giant announced on Wednesday that a US federal appeals court has refused to rehear its Gilenya patent case against private Chinese biotech HEC Pharm. Next up? Novartis plans on petitioning the Supreme Court to uphold the validity of its patent No. 9,187,405, referred to in court documents as the ‘405 patent, covering a 0.5 mg dosing regimen of the multiple sclerosis drug.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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