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.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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