Ex­or­cis­ing Mar­tin Shkre­li’s ghost, Kalo­Bios steps out of Ch. 11 and back in­to the biotech busi­ness

Six months af­ter Mar­tin Shkre­li’s brief, tur­bu­lent role as the con­tro­ver­sial sav­ior of the trou­bled Kalo­Bios end­ed in Chap­ter 11 and near ex­tinc­tion, new CEO Cameron Dur­rant is turn­ing the last page on that chap­ter of pulp fic­tion dra­ma.

This morn­ing Kalo­Bios says it has emerged from bank­rupt­cy with $14 mil­lion in fi­nanc­ing, a new­ly re­or­ga­nized board and a com­plet­ed deal with Sa­vant Ne­glect­ed Dis­eases to de­vel­op ben­znida­zole for the treat­ment of rare cas­es of Cha­gas dis­ease.

Cameron Dur­rant, Kalo­Bios CEO

“We re­al­ly see this as a clean slate,” Dur­rant tells me. “And it was pret­ty much dead twice over.”

The first near death ex­pe­ri­ence came af­ter a se­ries of big clin­i­cal set­backs in the com­pa­ny left in­vestors won­der­ing what man­age­ment was think­ing. Backed in­to a cor­ner, ex­ecs threat­ened to file for bank­rupt­cy un­less they could work out a deal.

And then Shkre­li ar­rived on the scene, bring­ing a horde of jour­nal­ists in his wake.

The biotech CEO had been boot­ed out of Retrophin and start­ed Tur­ing, grab­bing an old drug called Dara­prim and jack­ing up the price more than 5000%. But rather than duck­ing out a back door in the face of an on­line lynch mob, a de­fi­ant Shkre­li fa­mous­ly of­fered a one-fin­ger salute to all of his crit­ics, in­clud­ing me and every oth­er jour­nal­ist who ques­tioned his ac­tions. In short or­der he en­gi­neered a takeover of Kalo­Bios and ev­i­dent­ly was look­ing to re­peat his price goug­ing with ben­znida­zole.

Mar­tin Shkre­li at the De­vel­op­ments in the Pre­scrip­tion Drug Mar­ket: Over­sight hear­ing, 2016

In­stead, he was ar­rest­ed, perp walked and charged with bla­tant fi­nan­cial fraud, which he has de­nied. Kalo­Bios was kicked off Nas­daq and left in a sham­bles. Now Dur­rant wants to make it clear that Shkre­li has no role left at the com­pa­ny—and hasn’t since the blow up last De­cem­ber—had his eq­ui­ty stake in the biotech cut to 14% and that the com­pa­ny is work­ing on get­ting that back as well.

While Shkre­li may be long gone, some of the ba­sic build­ing blocks he had been as­sem­bling will be key to the biotech’s re­cov­ery. Dur­rant is work­ing with the FDA on es­tab­lish­ing a de­vel­op­ment plan for ben­znida­zole, look­ing to win a po­ten­tial pri­or­i­ty re­view vouch­er from the FDA that by it­self could be worth a for­tune on the bio­phar­ma mar­ket.

“We’re hop­ing for a 505(b)(2) ap­proach,” says Dur­rant, re­fer­ring to an ab­bre­vi­at­ed clin­i­cal de­vel­op­ment plan that can use da­ta from oth­er stud­ies the com­pa­ny didn’t con­duct it­self. But they need to spend some time work­ing that out with the FDA.

Dur­rant al­so wants to get its an­ti­body KB003, a GM-CSF an­tag­o­nist, in the clin­ic for chron­ic myelomono­cyt­ic leukemia. And he’ll look for part­ners to take over 004 and 002.

The new CEO is work­ing on ar­rang­ing some fresh fi­nanc­ing and has lots on his plate. But Dur­rant al­so wants to ex­or­cise the ghost of Mar­tin Shkre­li once and for all, vow­ing a new ap­proach on drug pric­ing that is the po­lar op­po­site to the pro­tag­o­nist’s role Shkre­li played.

As for Shkre­li, he’s as un­re­pen­tant as ever. Just yes­ter­day, he had this to of­fer me.

https://twit­ter.com/Mar­tin­Shkre­li/sta­tus/748476570789109760

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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