Aveo takes a big step for­ward as come­back plan de­liv­ers EU OK for ti­vo

Michael Bai­ley, Aveo

Four years af­ter Aveo On­col­o­gy $AVEO was hand­ed a hu­mil­i­at­ing re­jec­tion for its can­cer drug tivozanib, the Cam­bridge, MA-based biotech has turned an im­por­tant cor­ner in its dri­ve to re­ha­bil­i­tate it­self and turn the com­pa­ny around. The EU has sanc­tioned its lead drug tivozanib for mar­ket­ing, a de­ci­sion which trig­gers a $4 mil­lion bonus from its Eu­ro­pean part­ner with a big step to­ward an­oth­er $12 mil­lion laid out for re­im­burse­ment and reg­u­la­to­ry mile­stones.

EU­SA will roll out the drug, now ap­proved as a front­line ther­a­py for ad­vanced re­nal cell car­ci­no­ma. EU­SA com­mit­ted to a to­tal of $394 mil­lion in mile­stones when it struck the deal.

Aveo shares surged 9% this morn­ing.

Back in the spring of 2016 the new man­age­ment at Aveo agreed to pay $4 mil­lion to set­tle SEC charges that the biotech had mis­led in­vestors on ti­vo, fail­ing to di­vulge the crit­i­cal fact that reg­u­la­tors were de­mand­ing a sec­ond con­fir­ma­to­ry Phase III ahead of an ap­proval. Sep­a­rate from that deal are the fates of three for­mer top ex­ecs at the com­pa­ny — CEO Tu­an Ha-Ngoc, CFO David John­ston, and CMO William Slichen­my­er — in­volved in po­si­tion­ing the com­pa­ny as they al­leged­ly con­tin­ued to keep in­vestors in the dark as they raised fresh funds.

FDA on­col­o­gy chief Richard Paz­dur led a bru­tal slap­down of Aveo when he took to the floor dur­ing the pan­el re­view. He ar­gued ve­he­ment­ly against tivozanib, say­ing that a vote in fa­vor of a drug that had pro­duced da­ta of an in­creased risk of death would set a dan­ger­ous prece­dent. In the end, the pan­el vot­ed 13 to one against an ap­proval and the FDA soon for­mal­ly said no.

Now Aveo wants a do-over, and will like­ly get it.

“The Eu­ro­pean Com­mis­sion’s de­ci­sion is the first reg­u­la­to­ry ap­proval of tivozanib glob­al­ly, and a tremen­dous ac­com­plish­ment for Aveo and its part­ner, EU­SA Phar­ma. We are very pleased that tivozanib is now avail­able to pa­tients in Eu­rope,” said Michael Bai­ley, pres­i­dent and chief ex­ec­u­tive of­fi­cer of Aveo. “We al­so con­tin­ue to make progress on the next two pil­lars in our tivozanib strat­e­gy: U.S. reg­is­tra­tion, dri­ven by the piv­otal Phase III TI­VO-3 tri­al, which is ex­pect­ed to read out in the first quar­ter of 2018; and im­munother­a­py com­bi­na­tion tri­als, start­ing with the TiNi­vo tri­al, our Op­di­vo com­bi­na­tion tri­al.”

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.

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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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.