Mi­cro­bio­me play­er uBio­me puts founders on leave, in­ter­im CEO promis­es to as­sist in fed­er­al probe

When Joe Jimenez signed on to the board at uBio­me last fall, the new­ly ex-No­var­tis chief was clear­ly hop­ing to put the con­tro­ver­sy over his re­la­tion­ship with Pres­i­dent Trump’s per­son­al at­tor­ney — Michael Co­hen — be­hind him and start a new chap­ter in his sto­ried ca­reer.

Joe Jimenez

In­stead, he’s found him­self in­volved in a fresh scan­dal in­volv­ing an FBI in­ves­ti­ga­tion in­to uBio­me’s billing prac­tices. To­day, the com­pa­ny’s founders who re­cruit­ed Jimenez, Jes­si­ca Rich­man and Zac Apte, have been placed on leave while gen­er­al coun­sel John Rakow steps up as in­ter­im CEO in charge of an in­ter­nal in­ves­ti­ga­tion.

John Rakow

In a state­ment out Wednes­day af­ter­noon, Rakow said:

As in­ter­im CEO of uBio­me, I want all of our stake­hold­ers to know that we in­tend to co­op­er­ate ful­ly with gov­ern­ment au­thor­i­ties and pri­vate pay­ors to sat­is­fac­to­ri­ly re­solve the ques­tions that have been raised, and we will take any cor­rec­tive ac­tions that are need­ed to en­sure we can be­come a stronger com­pa­ny bet­ter able to serve pa­tients and health­care providers.

The Wall Street Jour­nal first re­port­ed a few days ago about the fed­er­al probe.

Jes­si­can Rich­man

Billing it­self as the “lead­ing mi­cro­bial ge­nomics com­pa­ny,” uBio­me was launched 6 years ago from its base in the Bay Area, mar­ket­ing a pair of con­sumer tests that can do at-home tests on your gut or the STDs that women face, like chlamy­dia and gon­or­rhea. When I talked to Rich­man last fall, the com­pa­ny said it had raised $83 mil­lion from ven­ture back­ers — led by OS Fund — in a new dri­ve to join the pack de­vel­op­ing mi­cro­bio­me ther­a­pies. 

A few months lat­er, though, uBio­me was al­ready lay­ing off em­ploy­ees from its staff of some 300, say­ing it want­ed to fo­cus more on drugs and part­ner­ships with drug com­pa­nies, where Jimenez could help.

Zac Apte

I nev­er got a chance to talk to Jimenez last fall, but he told one oth­er writer that he had put the Co­hen af­fair be­hind him and moved on. Dur­ing his last year as CEO, No­var­tis paid Co­hen $1.2 mil­lion for what it said was a brief con­sult­ing pe­ri­od as they sought to learn more about Trump’s health­care pol­i­cy.

The mon­ey, though, went in­to the same ac­count that paid porn ac­tress Stormy Daniels hush mon­ey. And when that emerged, the phar­ma gi­ant and Jimenez were caught in one of the ugli­est scan­dals to hit Wash­ing­ton DC.

Co­hen told law­mak­ers that No­var­tis had want­ed him to open a back door to the White House, seek­ing help in mak­ing con­nec­tions with the top play­ers in the ad­min­is­tra­tion. He re­fused, and while No­var­tis paid out the con­tract, they even­tu­al­ly stopped talk­ing. By that time, No­var­tis spokes­peo­ple had shut the win­dow on com­ments.

A new at­tempt to reach Jimenez this af­ter­noon has so far been un­suc­cess­ful.

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.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

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.

Ted Love. HAVERFORD COLLEGE

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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Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

The Wash­ing­ton Post man­aged to whip up the quick­est in­dus­try con­sen­sus I’ve ever seen that one of its re­porters was pur­vey­ing overblown non­sense with a sto­ry that Pfiz­er was sit­ting on da­ta sug­gest­ing that En­brel could be an ef­fec­tive treat­ment for Alzheimer’s. 

In cov­er­ing that bit of an­ti-Big Phar­ma fan­ta­sy — there are lots of rea­sons to go af­ter phar­ma, but this piece was lu­di­crous — I not­ed com­ments in the sto­ry from some promi­nent peo­ple in the field crit­i­ciz­ing Pfiz­er for not pub­lish­ing the da­ta. I sin­gled out Rudy Tanzi at Har­vard and then ap­plied some added crit­i­cism for the things he’s done to hype — in my opin­ion — high­ly ques­tion­able as­sump­tions. You can see it in the link. 

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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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.

Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

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.

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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