No­var­tis CEO Vas Narasimhan: We can do bet­ter at R&D, but we need FDA’s help; J&J gets $2.1B bid for LifeS­can

→ Why has med­ical in­no­va­tion in car­dio­vas­cu­lar dis­eases stag­nat­ed even as oth­er ther­a­peu­tic ar­eas have thrived? No­var­tis CEO Vas Narasimhan thinks a shift from broad-based de­vel­op­ment strate­gies to a more fo­cused med­i­cines ap­proach is need­ed, and drug mak­ers, reg­u­la­tors and pay­ers all have a role to play.

Vas Narasimhan

In a col­umn pub­lished in For­tune this week, Narasimhan ar­gues that phar­ma com­pa­nies need to be bet­ter at pre­ci­sion med­i­cine in this field: cat­e­go­riz­ing pa­tients, track­ing bio­mark­ers, and us­ing more re­al world da­ta. They can’t, how­ev­er, do it alone; reg­u­la­tors must adopt their poli­cies to rec­og­nize “sci­en­tif­i­cal­ly ro­bust sub­group da­ta” for that to work. Last­ly, he wrote, pay­ers could make it eas­i­er for pa­tients by im­ple­ment­ing val­ue-based re­im­burse­ment strate­gies. Giv­en the case No­var­tis has been pitch­ing for canakinum­ab, Narasimhan has a stake in push­ing for all this: “There’s been much dis­cus­sion on this top­ic, but the time to act is now.”

J&J $JNJ has re­ceived a $2.1 bil­lion bid from se­r­i­al buy­out in­vestor Plat­inum Eq­ui­ty, which wants to snatch up the phar­ma gi­ant’s di­a­betes care com­pa­ny LifeS­can. A ma­jor mak­er of blood glu­cose mon­i­tor­ing prod­ucts, LifeS­can brought in $1.5 bil­lion in rev­enue for J&J in 2017. If Plat­inum takes over the op­er­a­tions, the com­pa­ny’s pres­i­dent Va­lerie As­bury would con­tin­ue lead­ing the busi­ness un­der new own­er­ship, Plat­inum said in a state­ment. Last year, J&J said it was eval­u­at­ing op­tions for its di­a­betes care com­pa­nies — specif­i­cal­ly LifeS­can, An­i­mas Corp, and Cal­i­bra Med­ical — as sales have been falling since 2012. J&J has un­til June to ac­cept Plat­inum’s of­fer.

→ Bavar­i­an Nordic signed a $36 mil­lion al­liance with the US De­part­ment of De­fense to de­vel­op a pro­phy­lac­tic vac­cine against the equine en­cephali­tis virus — a rare mos­qui­to-borne ill­ness. With fund­ing from the DoD, Bavar­i­an Nordic will use its MVA-BN plat­form to de­vel­op a vac­cine against var­i­ous strains of the virus.

With con­tri­bu­tion by John Car­roll.

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.