In com­bat mode, In­di­v­ior hun­kers down for a war with DoJ over multi­bil­lion-dol­lar fraud charges

In the lat­est le­gal saga sur­round­ing the US opi­oid epi­dem­ic, In­di­v­ior and the De­part­ment of Jus­tice have ex­changed their first round of shots on al­le­ga­tions that the UK drug­mak­er pock­et­ed bil­lions through fraud­u­lent mar­ket­ing of its opi­oid ad­dic­tion treat­ment.

Howard Pien

The grand ju­ry in­dict­ment, ac­com­pa­nied by a strong­ly word­ed state­ment, evis­cer­at­ed its stock price on the Lon­don Stock Ex­change (£36.4 at last check, down 65%). Hav­ing lost mil­lions in mar­ket val­ue — and fac­ing $3 bil­lion in de­mand­ed fines — In­di­v­ior has not con­ced­ed an inch, call­ing the DoJ “fun­da­men­tal­ly wrong” and vow­ing to “con­test charges vig­or­ous­ly.”

At the core of the in­dict­ment is an al­leged scheme in which In­di­v­ior de­ceived health­care providers about the ef­fects of the Sub­ox­one film on one hand, and lured pa­tients in­to get­ting pre­scrip­tions for the drug on the oth­er. The in­dict­ment states that In­di­v­ior pro­mot­ed Sub­ox­one Film as safer and less abus­able than its tablet form, “even though the com­pa­ny lacked any sci­en­tif­ic ev­i­dence to sup­port those claims”; used a “Here to Help” hot­line to di­rect pa­tients to doc­tors that it knew were pre­scrib­ing Sub­ox­one Film in a “care­less and clin­i­cal­ly un­war­rant­ed man­ner;” and even an­nounced it would dis­con­tin­ue the Sub­ox­one tablet with the pur­port­ed pur­pose of de­lay­ing gener­ic en­try.

“The De­part­ment of Jus­tice in­tends to hold ac­count­able those who are in po­si­tion to know the harm opi­oid abuse in­flicts, but in­stead choose to prof­it il­le­gal­ly from the pain of oth­ers,” prin­ci­pal deputy as­so­ciate at­tor­ney gen­er­al Jesse Panuc­cio said in the state­ment.

In­di­v­ior be­gan its four-page de­fense by dis­tanc­ing it­self from pain pill mak­ers, which it sub­tly points to as the re­al con­trib­u­tors to the opi­oid cri­sis. Board chair­man Howard Pien al­so cit­ed CDC re­search that it says demon­strate Sub­ox­one Film did re­duce pe­di­atric ex­po­sure, as well as cas­es where com­pa­ny rep­re­sen­ta­tives ed­u­cat­ed doc­tors and re­port­ed risky pre­scribers to the au­thor­i­ties.

In short:

Key al­le­ga­tions made by the Jus­tice De­part­ment are con­tra­dict­ed by the gov­ern­ment’s own sci­en­tif­ic agen­cies, they are al­most ex­clu­sive­ly based on years-old events from be­fore In­di­v­ior be­came an in­de­pen­dent com­pa­ny in 2014, and they are wrong. The de­part­ment has ap­par­ent­ly de­cid­ed it would rather pur­sue self-serv­ing head­lines on a mat­ter of na­tion­al sig­nif­i­cance than achieve an ap­pro­pri­ate res­o­lu­tion, but we will con­test this case vig­or­ous­ly and we look for­ward to the full facts com­ing out in court.

In­di­v­ior was spun out of Reckitt Benckiser in 2014 and has spent much of the last five years bat­tling gener­ic ri­vals en­cir­cling Sub­ox­one. The FDA has re­cent­ly ap­proved what the com­pa­ny hopes will be a block­buster re­place­ment: Sublo­cade, a once-month­ly in­jec­tion of buprenor­phine.

Im­age: Shut­ter­stock

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Ugur Sahin, BioNTech CEO

Covid-19 roundup: Pfiz­er-backed BioN­Tech plans to seek FDA OK for a new vac­cine 'as ear­ly as' Oc­to­ber — ahead of the elec­tion

BioNTech execs say they’re on track to get their late-stage data on a Covid-19 vaccine — partnered with Pfizer — into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they won’t be wasting any time in hustling that over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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