Top sto­ries of the week: Thumbs up/Thumbs down

End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

Cel­gene taps its new biotech co-star

This was the per­fect week to an­swer a ques­tion I’ve been think­ing about re­gard­ing Cel­gene. The Big Biotech, which has spe­cial­ized in lin­ing up rich deals for star col­lab­o­ra­tors, has set­tled on Jounce as its lat­est pick for up-and-com­ing biotech with the most po­ten­tial. Cel­gene has been stitch­ing to­geth­er a whole pipeline of im­muno-on­col­o­gy drugs through its BD team, head­ed by George Golumbes­ki. Our chart on all its pacts, and the $3.2 bil­lion it spent on deals over the past two years, proved to be the most pop­u­lar part of the week. Those deals al­so il­lus­trate how in­dus­try part­ner­ships dri­ve new pro­grams. Im­por­tant point: It’s not over at Cel­gene.

What were they think­ing at Zaf­gen?

There aren’t many biotechs which han­dle set­backs well. Zaf­gen, though, has be­come a case study in clue­less­ness. Af­ter in­sist­ing for months that they had com­pelling piv­otal da­ta and an ef­fec­tive plan to get its obe­si­ty drug back on track af­ter the death of two pa­tients, Zaf­gen had to ac­knowl­edge this week that the drug is dead. But on­ly af­ter tout­ing pre­clin­i­cal da­ta for their new, un­known lead drug. By the end of this week, the com­pa­ny’s shares are trad­ing at half cash, not what you would call a ring­ing en­dorse­ment for the new plan or the way they han­dled them­selves in the cri­sis. There’s no ques­tion about the com­pa­ny’s sin­cer­i­ty—these are smart, ex­pe­ri­enced and com­mit­ted play­ers who lost their way–but as an­a­lysts turn their backs on Zaf­gen, that may not mat­ter much any­way. This is a teach­able mo­ment in cri­sis PR. Don’t waste it.

  The Scan­gos lega­cy is­sue

George Scan­gos ar­rived on the scene at Bio­gen six years ago as its sav­ior. He leaves as the com­pa­ny looks for a new mes­si­ah. But what a ride. He and his new team pushed Tec­fidera through, and made it a block­buster in the MS mar­ket. In the mid­dle of a biotech boom, Bio­gen could boast ma­jor league sta­tus along­side Gilead and Cel­gene. Then the sales weak­ened, pipeline set­backs tar­nished their im­age, an over­haul was in or­der and the com­pa­ny is now in line for a new makeover, it might even be ac­quired. Maybe Scan­gos stayed a year too long and trust­ed in home run swings too much. But no one can take away the win­ning years.

The bio­phar­ma mi­gra­tion to the hubs con­tin­ues

We’ve been gath­er­ing some fresh ev­i­dence this week on just how pop­u­lar the two big biotech hubs are in the U.S. Mer­ck has been prep­ping a big move in­to a new cam­pus in the Bay Area as more re­searchers are be­ing pulled in­to Boston/Cam­bridge. And Ger­many’s Mer­ck KGaA un­veiled its blue­print for a new cam­pus in Burling­ton, MA. Big bio­phar­ma R&D loves the hubs, as com­pa­nies look to put them­selves in the main­stream of all the best sci­ence. It doesn’t hurt that these two big hubs al­ready host most of the start­up com­pa­nies in biotech.

More un­cer­tain­ty in a new round of re­or­ga­ni­za­tions

But of course there’s a down side to every big trend. The lat­est re­or­ga­ni­za­tions com­ing hand in hand with down­siz­ing some op­er­a­tions, as Mer­ck made clear. As­traZeneca has al­so been culling its U.S. ranks in Mary­land and Mass­a­chu­setts. The biggest re­search groups be­gan to over­haul R&D about 7 or 8 years ago now. Mer­ck, Pfiz­er, As­traZeneca, Sanofi, Roche and oth­ers all took a big swing at their or­ga­ni­za­tions, look­ing to find some re­al ef­fi­cien­cies from the multi­bil­lion dol­lar op­er­a­tions com­mit­ted to drug de­vel­op­ment. These lat­est re­or­ga­ni­za­tions un­der­score the fact that any­one look­ing for job se­cu­ri­ty might want to find an­oth­er line of work, or a dif­fer­ent place to do it. If it’s not about down­siz­ing, there’s al­ways a re­jig in core fo­cus ar­eas. Still, few in­dus­tries of­fer the kind of short-term op­por­tu­ni­ties as bio­phar­ma R&D; ask any se­r­i­al en­tre­pre­neur in the field.

Brex­it blues

Per­haps it was an un­in­tend­ed con­se­quence, but the gov­ern­ment reshuf­fle fol­low­ing the Brex­it vote in the UK cost the in­dus­try its ded­i­cat­ed min­is­ter for the life sci­ences. George Free­man heads to big­ger and bet­ter things at a time the in­dus­try faces a cri­sis of con­fi­dence it can ill af­ford. Leav­ing the EU means wav­ing off EU re­search cash and tal­ent from the con­ti­nent, some­thing the Gold­en Tri­an­gle can miss bad­ly as it looks to es­tab­lish their life sci rep­u­ta­tion. On the oth­er hand, the UK con­tin­gent of biotech has a scrap­py un­der­dog side to it that will see it through to bet­ter days. Stay calm and car­ry on. It’s worked be­fore.

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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