An­oth­er day, an­oth­er de­lay. On Mon­day, Roche re­vealed that in ad­di­tion to the US Fed­er­al Trade Com­mis­sion, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty is prob­ing the Spark Ther­a­peu­tics takeover deal, trig­ger­ing an­oth­er de­lay of the $4.3 bil­lion ac­qui­si­tion an­nounced in Feb­ru­ary.

Spark share­hold­ers now have un­til Ju­ly 31 to ten­der their shares.

Since its last up­date in mid-May, the per­cent­age of shares al­ready sold inched up to 21.1% from 21%, low­er than 26.1% and 29.4% reg­is­tered on pre­vi­ous dead­lines. These num­bers are still a far cry from the 50% re­quired to con­sum­mate the deal, but Roche has main­tained it’s not un­usu­al for “a sig­nif­i­cant por­tion of share­hold­ers” to wait un­til the last days of the of­fer pe­ri­od.

“We think this is ap­pro­pri­ate dili­gence by FTC but there is un­like­ly any ma­jor is­sue and the deal will close smooth­ly,” Jef­feries an­a­lysts wrote in a note, not­ing that he­mo­phil­ia mar­ket is crowd­ed and that the way a gene ther­a­py is en­gi­neered to work is a stark con­trast to Roche’s ex­ist­ing Hem­li­bra he­mo­phil­ia drug.

“If any­thing, the reg­u­la­tors should see the nu­mer­ous com­peti­tors as pos­i­tive for the mar­ket dy­nam­ics where­by price could po­ten­tial­ly come way down over time and all the play­ers will have to bat­tle for pa­tients (sim­i­lar to Hep C mar­ket in that re­spect)…For these fun­da­men­tal im­por­tant rea­sons, we don’t see how this will be an an­ti-com­pet­i­tive merg­er and un­der­stand the reg­u­la­tors are think­ing about it in the long-term,” they wrote.

Roche’s orig­i­nal dead­line for the deal clos­ing was set for the first half of 2019. “(I)t is un­like­ly that the trans­ac­tion will close dur­ing the first half of 2019. The par­ties ex­pect the trans­ac­tion to close in 2019,” a Roche spokesper­son tells End­points News.

Mean­while the UK’s CMA has al­so opened an in­ves­ti­ga­tion in­to the pro­posed takeover to de­ter­mine whether the deal could hurt com­pe­ti­tion in the UK. Pend­ing the out­come of its in­ves­ti­ga­tion, the CMA has is­sued an in­ter­im en­force­ment or­der  which pre­cludes Roche from in­te­grat­ing Spark in­to the com­pa­ny, and stip­u­lates the two main­tain and op­er­ate the two busi­ness­es sep­a­rate­ly — for now. Both firms are co­op­er­at­ing with the CMA, they said on Mon­day.

“The is­suance of an IEO does not of it­self mean that the CMA has sub­stan­tive con­cerns about the ac­qui­si­tion nor that the CMA has the le­gal pow­er to in­ter­vene to im­pose con­di­tions to the ac­qui­si­tion pro­ceed­ing,” the spokesper­son added.

Spark’s in­vestors ex­pressed their frus­tra­tion with the lat­est de­lay, as the com­pa­ny’s shares $ONCE tum­bled about 9% to $99.80 in ear­ly morn­ing trad­ing.

In a Feb­ru­ary Q&A doc­u­ment in­tend­ed to pla­cate em­ploy­ees, Spark sug­gest­ed that Roche in­tend­ed to al­low the Philadel­phia-based com­pa­ny to op­er­ate as an au­tonomous gene ther­a­py spe­cial­ist, while pour­ing in the re­sources to build a whole unit around it.

Im­age: Spark CEO Jef­frey Mar­raz­zo at an End­points News break­fast pan­el at the 2019 JP Mor­gan con­fer­ence in San Fran­cis­co – pho­to by Jeff Ru­mans for End­points News

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.

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

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).

These aren’t the typ­i­cal slides you’d see at End­points — no mol­e­cules, clin­i­cal pro­grams, or p-val­ues. In­stead, we’ll talk dig­i­tal and in­ter­net trends, fac­tors that elite glob­al brands — re­gard­less of in­dus­try — must first mea­sure and un­der­stand be­fore de­ploy­ing prod­ucts in­to the world. That’s a con­cept that most of our Big Phar­ma au­di­ence is in tune with. Dig­i­tal aware­ness is key to suc­cess in the dis­cov­ery, de­vel­op­ment, and mar­ket­ing of new bio­phar­ma­ceu­ti­cals, and most of the ma­jors now have a chief dig­i­tal of­fi­cer: No­var­tis, Sanofi, and Pfiz­er, just to name a few.