Too slow to warn: Sanofi in­dict­ed over old an­ti-epilep­tic drug tied to birth de­fects

Sanofi has been for­mal­ly charged over De­pakine — a decades-old ther­a­py for epilep­sy that caus­es birth de­fects and im­pedes neu­ro­log­i­cal de­vel­op­ment when tak­en dur­ing preg­nan­cy.

Ev­i­dence that the com­pound — sodi­um val­proate — was as­so­ci­at­ed with neu­rode­vel­op­men­tal risks emerged in the lat­ter half of the 20th cen­tu­ry. In 2014, the EMA re-eval­u­at­ed the drug, and a year lat­er rec­om­men­da­tions that prac­ti­tion­ers should no longer pre­scribe the treat­ment for women of child­bear­ing age or preg­nant women were en­forced.

In 2015, the French so­cial af­fairs in­spec­tion agency (IGAS) chid­ed French health au­thor­i­ties and Sanofi over their re­sponse to the risks re­lat­ed to the drug and its de­riv­a­tives. Soon af­ter, the French pros­e­cu­tor kicked off a pre­lim­i­nary in­ves­ti­ga­tion in­to the ap­proval and sale of De­pakine in Oc­to­ber 2016, Reuters re­port­ed.

The com­pound — which is on the WHO list of “es­sen­tial med­i­cines” — has been on the mar­ket since 1967 to treat epilep­sy and bipo­lar dis­or­der. Sanofi learned of the risk of fe­tus mal­for­ma­tion in the 1980s. In 2003, the com­pa­ny be­came aware of the drug’s im­pact on the neu­ro­log­i­cal de­vel­op­ment of the fe­tus, with a risk of autism or learn­ing dif­fi­cul­ties, ac­cord­ing to the wire agency.

“It’s fi­nal­ly a great vic­to­ry!” tweet­ed Ma­rine Mar­tin, pres­i­dent of the As­so­ci­a­tion for the as­sis­tance of par­ents of chil­dren suf­fer­ing from an­ti-con­vul­sant syn­drome (APE­SAC), which was set up in 2011. “My de­ter­mi­na­tion paid off, we will have our big crim­i­nal tri­al !!!”

The crim­i­nal in­ves­ti­ga­tion was ini­ti­at­ed by APE­SAC, and forms of part of the process of the pend­ing crim­i­nal in­ves­ti­ga­tion on De­pakine be­fore the Ju­di­cial Tri­bunal of Paris, a Sanofi spokesper­son told End­points News.

“This (in­dict­ment) sta­tus will al­low us to as­sert all of our means of de­fence and demon­strate that the com­pa­ny has com­plied with its no­ti­fi­ca­tion oblig­a­tion,” the spokesper­son said.

IGAS has es­ti­mat­ed that be­tween 425 to 450 ba­bies suf­fered con­gen­i­tal birth de­fects or were still­born fol­low­ing ex­po­sure to De­pakine from 2006 to 2014, ac­cord­ing to es­ti­mates cit­ed by Reuters.

Af­ter par­ents of suf­fer­ers crit­i­cized the French state and Sanofi for be­ing too slow to warn about the side ef­fects of the drug — in 2017, a com­pen­sa­tion scheme for vic­tims was set up. Rough­ly 6.5 mil­lion eu­ros has been pro­vid­ed in com­pen­sa­tion to 31 vic­tims, al­though near­ly 2,000 claims have been filed, ac­cord­ing to the French me­dia group fran­ce­in­fo.

Sanofi is not par­tic­i­pat­ing in this fund, the spokesper­son told End­points.

In a 2016 in­ter­view with Reuters, Sanofi said it would ac­cept any blame at­trib­uted by a court over the drug.

On Tues­day, Sanofi in a state­ment that it will “prove it has al­ways com­plied with its du­ty to in­form and been trans­par­ent.”

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOS moved from 8% to 9.8%.

Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Scott Got­tlieb in the run­ning for pos­si­ble coro­n­avirus czar; The drug Van­da sued the FDA over fails a piv­otal study

→ Former FDA commissioner Scott Gottlieb is among a handful of candidates being considered for coronavirus czar, a new role that the Trump administration may set up to oversee the US’s response to the spreading outbreak, Politico reported. The president has yet to make the final decision, but has announced a press conference later today upon his return from India.

→ Days after a court ruled against Vanda in its lawsuit against the FDA over a partial clinical hold on tradipitant, the biotech said the drug has failed a Phase III study for pruritus associated with atopic dermatitis. While the neurokinin 1 antagonist missed the primary endpoint of reducing itching among all patients, Vanda pointed to “robust” antipruritic effect in the mild AD subpopulation as a reason to remain optimistic and said it will reassess its second, ongoing late-stage study.

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.