Med­i­ci­No­va flops in PhII metham­phet­a­mine de­pen­dence tri­al, stock slips

San Diego drug­mak­er Med­i­ci­No­va has flunked a mid-stage tri­al test­ing its lead drug can­di­date against metham­phet­a­mine de­pen­dence, send­ing the com­pa­ny’s stock quick­ly south in pre-mar­ket trad­ing.

Yuichi Iwa­ki

The com­pa­ny an­nounced Thurs­day that its Phase II clin­i­cal tri­al as­sess­ing MN-166, a drug called ibudi­last, failed to achieve the study’s pri­ma­ry end­point: metham­phet­a­mine ab­sti­nence dur­ing the last weeks of treat­ment.

Med­i­ci­No­va is hop­ing to get a lot out of ibudi­last, test­ing the drug in mul­ti­ple neu­rode­gen­er­a­tive and sub­stance de­pen­dence in­di­ca­tions, in­clud­ing MS, ALS, and opi­oid de­pen­dence. The drug has been around for a long time treat­ing post-stroke com­pli­ca­tions and bronchial asth­ma, and has been on sold in Japan and Ko­rea since 1989. Med­i­ci­No­va says ibudlilast’s an­ti-neu­roin­flam­ma­to­ry and neu­ro­pro­tec­tive ac­tions back up the com­pa­ny’s rea­son­ing for the drug’s use in neu­rode­gen­er­a­tive dis­or­ders and sub­stance abuse. In ad­di­tion to this flopped metham­phet­a­mine de­pen­dence tri­al, Med­i­ci­No­va has five oth­er on­go­ing Phase II tri­als of the drug.

Med­i­ci­No­va’s stock $MNOV was down 15% in pre­mar­ket trad­ing as of press time, trad­ing for $10.17 per share.

Med­i­ci­No­va’s pres­i­dent and CEO Yuichi Iwa­ki had this to say in a state­ment:

We will con­duct fur­ther analy­ses of the da­ta with UCLA re­searchers, which will help us to bet­ter un­der­stand how to op­ti­mize study de­sign and set­ting for any fu­ture clin­i­cal tri­als in sub­stance de­pen­dence.  We will dis­cuss the re­sults with NIH/NI­DA, who pro­vid­ed the fund­ing for this tri­al, the opi­oid de­pen­dence tri­als and the al­co­hol de­pen­dence tri­al.  We plan to meet with FDA af­ter we have da­ta from the on­go­ing study of MN-166 in metham­phet­a­mine use dis­or­der at Ore­gon Health & Sci­ence Uni­ver­si­ty.

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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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.

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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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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.