Side­lined at the FDA, As­traZeneca watch­es as new team seizes ri­val drug in $1.5B Re­lyp­sa buy­out

Back in April, the M&A buzz in biotech swung its spot­light to Re­lyp­sa, a com­pa­ny that had field­ed Veltas­sa (patiromer), a hy­per­kalemia drug that grabbed an ap­proval by the FDA last fall. At the time the lat­est ru­mors sur­faced, it sound­ed like the frus­trat­ed bid­ders for ri­val ZS Phar­ma – out­bid at the auc­tion by As­traZeneca — were dri­ving the chat­ter. But this morn­ing we hear that it’s Re­lyp­sa’s Eu­ro­pean part­ners at Galeni­ca who were the most mo­ti­vat­ed to com­plete a deal.

The ac­qui­si­tion deal it­self is a straight, one-drug spe­cial­ty phar­ma pick­up. Galeni­ca is buy­ing Red­wood City, CA-based Re­lyp­sa $RLYP for $1.53 bil­lion, a hefty 59% pre­mi­um for a stock that had been pumped up al­ready by the buy­out ru­mors. The ther­a­py will be used to bol­ster its spe­cial­ty phar­ma group Vi­for, just ahead of a cor­po­rate split. And it’s at­trac­tive to Vi­for be­cause they get the com­mer­cial op­er­a­tions al­ready set up to sell the drug in the U.S.

But this sto­ry isn’t be­ing played out in a vac­u­um.

Vi­for has an op­por­tu­ni­ty to get it­self bet­ter es­tab­lished in the new mar­ket as As­traZeneca rest­less­ly deals with a set­back at the FDA. The phar­ma gi­ant, look­ing at the near-term col­lapse of its big Crestor fran­chise as gener­ics await a green light, bought out ZS Phar­ma for $2.7 bil­lion so it could get its hands on ZS-9, the ri­val hy­per­kalemia drug that quite a few an­a­lysts had tapped as an easy win­ner over Veltas­sa.

Veltas­sa comes with a black box warn­ing. But Re­lyp­sa, which strug­gled to build sales, has scored some new safe­ty da­ta that may sig­nif­i­cant­ly im­prove the drug’s ap­peal to doc­tors and pa­tients. While sales have been slow to pick up, there are al­so signs of grow­ing ac­cep­tance for Veltas­sa as the mar­ket gains some ex­pe­ri­ence with the first new drug in this field in decades. And they have a chance to po­si­tion the first-mover ahead of a ZS-9 roll­out be­cause As­traZeneca’s ap­pli­ca­tion was re­ject­ed back in May due to some prob­lems that came up on the man­u­fac­tur­ing side.

Now we have to wait through the de­lay to see what kind of la­bel ZS-9 will get – as­sum­ing ap­proval.

As­traZeneca de­scribed the de­lay to me as a “bump in the road,” with any new de­ci­sion post­poned un­til six months af­ter a re­sub­mis­sion. Some an­a­lysts made that out to be a year-long de­lay, so prob­a­bly some­time in 2017.

As­traZeneca, though, may find that its mar­ket op­por­tu­ni­ty has erod­ed some­what. The com­pa­ny pegged ZS-9 as a drug that could earn block­buster rev­enue of $1 bil­lion-plus, while most pro­jec­tions on Veltas­sa ini­tial­ly slid well be­low $1 bil­lion. Those pro­jec­tions, though, have now been creep­ing ever high­er.

That man­u­fac­tur­ing de­lay couldn’t have come at a worse time for As­traZeneca.

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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