Tech con­glom­er­ate buys Me­di­da­ta for $5.7B; Alexan­dria teams up with Co­lum­bia for sec­ond Launch­Labs; So­bi all in on ema­palum­ab

→ Clin­i­cal tri­al soft­ware provider Me­di­da­ta is get­ting ac­quired in a $5.8 bil­lion deal. The all-cash buy­er, Das­sault Sys­temes, is a French tech­nol­o­gy com­pa­ny that’s his­tor­i­cal­ly fo­cused on 3D de­sign and en­gi­neer­ing. “Life sci­ence is go­ing to go through an ac­cel­er­at­ed dig­i­ti­za­tion of its own process­es, ba­si­cal­ly,” Das­sault CEO Bernard Charles told CN­BC. Hav­ing pow­ered op­er­a­tions and da­ta analy­sis for hun­dreds of bio­phar­ma com­pa­nies, CROs and re­searcher cen­ters, Me­di­da­ta’s plat­form is poised to lead the vir­tu­al trans­for­ma­tion in the in­dus­try, he added.

→ Swedish rare dis­ease play­er So­bi is re­struc­tur­ing its op­er­a­tions to fo­cus on hema­tol­ogy and im­munol­o­gy. Dis­cov­ery, ear­ly re­search and part­ner R&D pro­grams out­side of those core ar­eas are be­ing axed, claim­ing 90 po­si­tions and a cou­ple of projects that will now be di­vest­ed. One of the stars of the pipeline will be Gam­i­fant (ema­palum­ab), an in­ter­fer­on gam­ma in­hibitor it had li­censed from Novim­mune but now de­cides to ac­quire out­right. The deal, which adds over $100 mil­lion to the $400 mil­lion orig­i­nal pact, al­so cov­ers em­ploy­ees in­volved in the pro­gram as well as a pri­or­i­ty re­view vouch­er.

→ Mar­quee bio­phar­ma re­al es­tate de­vel­op­er Alexan­dria is open­ing its sec­ond Launch­Labs in New York City, team­ing up with Co­lum­bia Uni­ver­si­ty to in­cu­bate star­tups emerg­ing from there and peer in­sti­tu­tions. As with Alexan­dria Launch­Labs, mem­ber com­pa­nies have ac­cess to of­fice and lab space, men­tor­ship and net­work­ing op­por­tu­ni­ties, as well as seed cap­i­tal to get things go­ing. The pre­vi­ous co­hort of 20 star­tups have gone on to raise more than $300 mil­lion in fi­nanc­ing, Alexan­dria said.

De­nali has scored or­phan drug and rare pe­di­atric dis­ease des­ig­na­tions for its pre­clin­i­cal pro­gram DNL310. The drug is de­signed to re­place the de­fi­cient IDS en­zyme in pa­tients with Hunter Syn­drome us­ing a re­com­bi­nant form of IDS en­gi­neered to cross the blood-brain bar­ri­er us­ing De­nali’s sig­na­ture tech. A Phase I/II is planned for next year.

Sor­ren­to is weigh­ing an IPO for Scilex, a re­con­fig­u­ra­tion of the biotech it ac­quired for $47.6 mil­lion back in 2016. Af­ter ZTli­do was ap­proved by the FDA, Sor­ren­to merged Scilex with an­oth­er sub­sidiary Sem­nur, which had a non-opi­oid cor­ti­cos­teroid gel in Phase III stud­ies, en­vi­sion­ing a com­mer­cial com­pa­ny fo­cused on pain man­age­ment.

→ Des­per­ate for a turn­around and still mired in dra­ma with its ex-CEO, MiMedx has se­cured a three-year loan from Blue Torch Fi­nance to­tal­ing $75 mil­lion. With the cash in­fu­sion, in­ter­im CFO Ed Borkows­ki said, ex­ecs can work on plan­ning and com­plet­ing the fi­nan­cial re­state­ment.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.