Mallinck­rodt bags an­oth­er mi­cro­cap biotech, pick­ing up Ocera’s failed drug in $117M buy­out

Back at the be­gin­ning of the year, Ocera looked like just about any oth­er small de­vel­op­er af­ter a head-on col­li­sion with bad da­ta. Its Phase IIb in he­pat­ic en­cephalopa­thy — trig­gered by chron­ic liv­er dis­ease — flopped on the pri­ma­ry, crush­ing its stock price and leav­ing an­a­lysts shak­ing their heads over the wreck­age.

Lin­da Grais

But CEO Lin­da Grais game­ly tout­ed ev­i­dence of ef­fi­ca­cy at the high dose, and that ul­ti­mate­ly gained the at­ten­tion of Mallinck­rodt $MNK, which has picked it up cheap af­ter go­ing biotech shop­ping in the bar­gain aisle. And now they’re shoot­ing for an OK on the IV for­mu­la­tion in 5 years, look­ing for a new way to low­er lev­els of am­mo­nia in the blood.

Mallinck­rodt snapped up the mi­cro­cap this morn­ing, bag­ging a Phase III-ready drug af­ter it was im­pressed by their lead drug’s abil­i­ty to re­duce am­mo­nia lev­els in the blood.

Ocera start­ed the day with a mar­ket cap at $26 mil­lion, mak­ing this a bite-sized buy­out for the likes of Mallinck­rodt. They’re pay­ing $42 mil­lion for the stock — at $1.52 each along with $75 mil­lion in con­tin­gent val­ue rights for the com­pa­ny.

Mallinck­rodt is the po­lar op­po­site of Ocera, with a $3 bil­lion mar­ket cap. A few months ago they bought out In­faCare for $80 mil­lion up­front, bag­ging a heme oxy­ge­nase in­hibitor de­signed to pre­vent jaun­dice by in­hibit­ing the for­ma­tion of biliru­bin.

The bio­phar­ma com­pa­ny re­cent­ly bowed out of PhRMA just be­fore the trade group im­posed new, high­er stan­dards for mem­ber­ship they were un­like­ly to meet.

Just a few months be­fore that, Mallinck­rodt had agreed to pay a $100 mil­lion fine to re­solve a probe of the long, rather sor­did his­to­ry be­hind Ac­thar, an in­fan­tile spasm drug which cost $28,000 a vial when Mallinck­rodt picked it up in the $5.6 bil­lion ac­qui­si­tion of Quest­cor. Quest­cor had been jack­ing up the price on Ac­thar when it paid No­var­tis $135 mil­lion to gain US rights to a ther­a­py that posed a di­rect threat to its drug fran­chise. And Mallinck­rodt was forced to pay the fine for il­le­gal­ly main­tain­ing a drug mo­nop­oly — not the kind of sanc­tion PhRMA likes to see for mem­bers.

Their com­ment this morn­ing:

Mallinck­rodt be­lieves that tri­al de­sign el­e­ments, in part, drove the pri­ma­ry out­come and, on ac­qui­si­tion, will in­vest to es­tab­lish the op­ti­mal dos­ing reg­i­men pri­or to ini­ti­at­ing a Phase III pro­gram. Mallinck­rodt will have con­tin­ued en­gage­ment with the U.S. Food and Drug Ad­min­is­tra­tion (FDA) to con­firm the reg­u­la­to­ry path­way to gain FDA ap­proval and sub­se­quent­ly launch the IV for­mu­la­tion, ex­pect­ed by 2022, and the oral for­mu­la­tion, ex­pect­ed by 2024.

Grais is more up­beat than ever about the drug’s prospects. She not­ed: “With this fo­cus, I’m con­fi­dent this im­por­tant treat­ment can be suc­cess­ful­ly brought to mar­ket.”

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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