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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources.