Eli Lil­ly took a hit Tues­day morn­ing as the phar­ma gi­ant re­vealed just how painful the with­draw­al of Lartru­vo will be for its on­col­o­gy op­er­a­tions while the Cialis fran­chise gets eat­en up by gener­ics. Less vis­i­ble was a de­ci­sion to dump two mid-stage drugs from its pipeline op­er­a­tions, both of which had fig­ured promi­nent­ly as two of its best longterm hopes in the field.

Out in the Q1 cleanup at Lil­ly is the CHK1 drug prex­as­ert­ib (LY2606368) and their Phase II PI3k/mTOR in­hibitor, LY3023414. Both of these drugs were spot­light­ed in the sum­mer of 2017 as Eli Lil­ly an­nounced plans to con­cen­trate their R&D group in on­col­o­gy on 7 key pro­grams they felt had the best shot at go­ing on to be­com­ing ma­jor play­ers in the mar­ket. 

The oth­er 5 projects were: TIM-3 MAb, PD-L1 MAb, ERK 1/2 in­hibitor, TGFb RI KI.

At the same time, Lil­ly al­so an­nounced plans to part­ner out 7 oth­er drugs.

Lil­ly to­day had to cut its 2019 earn­ings fore­cast by $3 bil­lion on its col­lec­tive headaches, drop­ping in­to the $22.0 to $22.5 bil­lion range. Its shares $LLY tum­bled 3% as an­a­lysts got a chance to chew over the un­ex­pect­ed re­ver­sal, which comes as Lil­ly’s di­a­betes fran­chise re­mains un­der in­tense pres­sure to rein in prices.

These pres­sures ar­rive af­ter Lil­ly has tak­en a se­ries of hits that have crimped its ex­pec­ta­tions. This morn­ing In­cyte not­ed that it de­cid­ed to cut any fur­ther R&D in­vest­ments on their part­nered pro­gram for baric­i­tinib, which on­ly man­aged to crawl to the mar­ket at a low­er dose than they had ad­vo­cat­ed for af­ter reg­u­la­tors raised safe­ty con­cerns for the JAK in­hibitor.

Im­age: Shut­ter­stock

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.

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

In­vestors are in no mood to hear biotechs tout the suc­cess of a “key” sec­ondary end­point when the piv­otal Phase III flunks the pri­ma­ry goal. Just ask Savara. 

The Texas biotech $SVRA went look­ing for a sil­ver lin­ing as com­pa­ny ex­ecs blunt­ly con­ced­ed that Mol­gradex, an in­haled for­mu­la­tion of re­com­bi­nant hu­man gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF), failed to spur sig­nif­i­cant­ly im­proved treat­ment out­comes for pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis, or aPAP.

Late-stage da­ta pre­sent­ed at the Amer­i­can Di­a­betes As­so­ci­a­tion an­nu­al meet­ing in 2010 pushed Eli Lil­ly to put a crimp on teplizum­ab as the phar­ma gi­ant found it un­able to re­set the clock on new­ly di­ag­nosed type 1 di­a­betes. At the same con­fer­ence but in dif­fer­ent hands nine years lat­er, the drug is mak­ing a crit­i­cal come­back by scor­ing suc­cess in an­oth­er niche: de­lay­ing the on­set of the dis­ease.

In a Phase II tri­al with 76 high-risk in­di­vid­u­als — rel­a­tives of pa­tients with type 1 di­a­betes who have di­a­betes-re­lat­ed au­toan­ti­bod­ies in their bod­ies — teplizum­ab al­most dou­bled the me­di­an time of di­ag­no­sis com­pared to place­bo (48.4 months ver­sus 24.4 months). The haz­ard ra­tio for di­ag­no­sis was 0.41 (p=0.006).