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

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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Mer­ck grows Keytru­da in­di­ca­tions with head and neck can­cer ap­proval

Mer­ck’s check­point star is shin­ing a lit­tle brighter to­day with two new ap­provals in head and neck squa­mous cell car­ci­no­ma.

The phar­ma gi­ant first clinched an ac­cel­er­at­ed ap­proval to use Keytru­da in re­cur­rent or metasta­t­ic cas­es in 2016, tar­get­ing pa­tients whose dis­ease pro­gressed on or af­ter plat­inum-based chemother­a­py.

On Tues­day the FDA con­vert­ed it in­to a full ap­proval right at the end of a pri­or­i­ty re­view pe­ri­od, and ad­di­tion­al­ly stamped its OK on Keytru­da as a front­line treat­ment for head and neck can­cer. That cov­ers both monother­a­py (in pa­tients whose tu­mor ex­press PD-L1) and a com­bi­na­tion with plat­inum and flu­o­rouracil, or FU (whole pop­u­la­tion).

With a sub­stan­tial dis­count to Cat­a­lyst's Fir­dapse, is Ja­cobus poised to win physi­cian, pay­er sup­port for off-la­bel adult LEMS use?

Weeks ago, the FDA en­dorsed a Lam­bert-Eaton myas­thenic syn­drome (LEMS) drug from fam­i­ly-run New Jer­sey-based com­pa­ny called Ja­cobus Phar­ma­ceu­ti­cals in pe­di­atric pa­tients, on the ba­sis of adult da­ta, to the sur­prise of Cat­a­lyst Phar­ma­ceu­ti­cals which on­ly last year got its pricey — yet sim­i­lar — treat­ment for the rare au­toim­mune dis­or­der across the fin­ish line in adults. It has now been re­vealed that Ja­cobus’ ver­sion car­ries a price that is less than half of Cat­a­lyst’s Fir­dapse — a move that could fu­el off-la­bel pre­scrip­tion in adults.

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.