Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is fac­ing a for­mal in­ves­ti­ga­tion on manslaugh­ter charges, due to ac­cu­sa­tions that its epilep­sy drug De­pakine caused birth mal­func­tions and slow neu­ro­log­i­cal de­vel­op­ment when tak­en dur­ing preg­nan­cy.

The French phar­ma was for­mal­ly charged in Feb­ru­ary, years af­ter ev­i­dence sur­faced that the drug, sodi­um val­proate, posed neu­rode­vel­op­men­tal risks. Sodi­um val­proate first hit the mar­ket in 1967 for the treat­ment of epilep­sy and bipo­lar dis­or­der, and is cur­rent­ly pre­scribed in more than 100 coun­tries.

Be­tween 2006 and 2014, France’s so­cial af­fairs in­spec­tion agency IGAF be­lieves that 425 to 450 ba­bies ex­posed to the drug suf­fered con­gen­i­tal birth de­fects or were still­born, ac­cord­ing to a Reuters re­port. The EMA re-eval­u­at­ed the drug in 2014, and the fol­low­ing year rec­om­men­da­tions were en­forced that prac­ti­tion­ers not pre­scribe the treat­ment for women of child­bear­ing age.

Sanofi de­nied the al­le­ga­tions. “All these el­e­ments do not in any way pre­judge the re­spon­si­bil­i­ty of the com­pa­ny,” the com­pa­ny wrote in a state­ment to Reuters.

The As­so­ci­a­tion for the as­sis­tance of par­ents of chil­dren suf­fer­ing from an­ti-con­vul­sant syn­drome (APE­SAC) ini­ti­at­ed the crim­i­nal in­ves­ti­ga­tion. To be­gin a for­mal in­ves­ti­ga­tion, an in­ves­tiga­tive judge had to deem the case se­ri­ous enough to war­rant a fur­ther look, ac­cord­ing to Reuters. — Nicole De­Feud­is

Beam inks CAR-T deal with Ox­ford Bio­med­ica

The gene edit­ing ex­perts at Beam Ther­a­peu­tics have added Ox­ford Bio­med­ica’s LentiVec­tor plat­form to its CART- reper­toire. The li­cense gives Beam ac­cess to the same tech­nol­o­gy No­var­tis and Juno have lever­aged to man­u­fac­ture their cell ther­a­pies.

By car­ry­ing out tar­get­ed base changes, Beam promis­es to knock out the ex­pres­sion of mul­ti­ple cell sur­face tar­gets on T cells at once.

Un­der the new deal, Ox­ford Bio­med­ica was paid an undis­closed up­front sum to kick off de­vel­op­ment and man­u­fac­tur­ing for one pre­clin­i­cal pro­gram. More pay­ments and mile­stones are to come. — Am­ber Tong

Red­Hill grabs full com­mer­cial­iza­tion rights to ex-As­traZeneca drug

When Red­Hill Bio­phar­ma bought Movan­tik, a treat­ment for opi­oid in­duced con­sti­pa­tion, from As­traZeneca in April, it al­so in­her­it­ed a co-com­mer­cial­iza­tion al­liance with Dai­ichi Sankyo. It’s now re­vised the deal to grab ex­clu­sive re­spon­si­bil­i­ty to mar­ket the drug and pay roy­al­ties to the Japan­ese phar­ma in­stead.

“The clos­ing of this new agree­ment with Dai­ichi Sankyo will al­low us to have full con­trol over brand strat­e­gy and com­mer­cial­iza­tion ac­tiv­i­ties for Movan­tik in the U.S. while al­so in­creas­ing our mar­gins,” Rick Scrug­gs, Red­Hill’s chief com­mer­cial of­fi­cer and head of US op­er­a­tions, said in a state­ment.

In ad­di­tion to a mid-teen roy­al­ty rate on net sales, Dai­ichi is en­ti­tled to three lump sums pay­ments from 2021 to 2023. They al­so re­ceived 283,387 Amer­i­can De­posi­tary Shares of Red­Hill’s stock $RDHL as part of a sub­scrip­tion agree­ment.

Movan­tik, a pe­riph­er­al­ly act­ing μ-opi­oid re­cep­tor an­tag­o­nist, gen­er­at­ed $96 mil­lion in the US last year. Red­Hill ac­quired glob­al rights to the drug ex­clud­ing Eu­rope, Cana­da and Is­rael. — Am­ber Tong

PPD en­ters three-year agree­ment with Pfiz­er 

Wilm­ing­ton, NC-based con­tract re­search or­ga­ni­za­tion PPD has inked a three-year agree­ment to help grow Pfiz­er’s port­fo­lio in “mul­ti­ple ther­a­peu­tic ar­eas.” The deal builds on the com­pa­nies’ cur­rent re­la­tion­ship, in which PPD of­fers lab ser­vices and clin­i­cal de­vel­op­ment ex­per­tise to fa­cil­i­tate drug de­vel­op­ment. PPD and Pfiz­er are cur­rent­ly keep­ing the fi­nan­cial terms un­der wraps.

Pfiz­er has 23 drugs in Phase III de­vel­op­ment, rang­ing from vac­cines to on­col­o­gy. It’s cur­rent­ly work­ing with BioN­Tech on four Covid-19 vac­cine pro­grams, two of which are be­ing fast tracked by the FDA. Their can­di­date BNT162b2 just en­rolled in a Phase II/III study, set­ting it up for reg­u­la­to­ry re­view as soon as Oc­to­ber. — Nicole De­Feud­is

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.