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

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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