Thumbs Up/Thumbs Down: No­var­tis's re­treat leaves plen­ty of ca­su­al­ties; Bio­gen or­ches­trates a shame­ful me­dia show, and more


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


No­var­tis ex­e­cutes a messy with­draw­al on CAR-T

What­ev­er No­var­tis’s PR Team has come up with to ra­tio­nal­ize its de­ci­sion to dis­band its 400-mem­ber cell and gene ther­a­py unit, make no mis­take that this move marks a sig­nif­i­cant pipeline re­treat on the phar­ma gi­ant’s part. Two years ago the com­pa­ny couldn’t say enough about its com­mit­ment to CAR-T de­vel­op­ment, but these new ac­tions speak much loud­er than words. That’s not to say that No­var­tis is out of the game, but it is clear­ly falling by the way­side as a much faster set of play­ers at Kite is left in sole pos­ses­sion of front place. (Juno’s re­cent prat­fall se­ri­ous­ly de­layed its en­try.)

Bio­gen is feast­ed af­ter re­heat­ing some old Alzheimer’s da­ta

Bio­gen ex­ecs knew ex­act­ly what they were do­ing when they her­ald­ed the pub­li­ca­tion of ear­ly Alzheimer’s da­ta for ad­u­canum­ab. By push­ing some very thin re­sults from a small study back in­to the spot­light, old claims about cog­ni­tive trends were trans­formed in­to new head­lines about a cure. The com­pa­ny, which has been strug­gling to spark fresh en­thu­si­asm for its risky pipeline, wasn’t able to get any boost out of it from Wall Street, where an­a­lysts were acute­ly aware of the sham. Pa­tients and fam­i­lies, though, were like­ly tricked by the dog and pony show in­to be­liev­ing some new won­der drug lay just on the hori­zon. The whole thing was shame­ful, and Bio­gen is com­plic­it in spurring the me­dia show.

Medi­va­tion’s David Hung makes out like a ban­dit – and that’s a good thing

When you look for an ac­coun­tant to han­dle the books, chances are you ex­pect to save more on your tax­es than what you’re pay­ing your num­ber crunch­er. The same prin­ci­ple ap­plies to what you pay your CEO when it comes time to sell the com­pa­ny. For Medi­va­tion’s David Hung, that’s a prince­ly sum of $354 mil­lion. Sound ex­pen­sive? Per­haps. But when you dig in­to the auc­tion he per­formed for Medi­va­tion be­fore sell­ing to Pfiz­er for $14 bil­lion, you get the im­pres­sion that he earned it. Hung set a stan­dard on deal­mak­ing in biotech M&A. Let’s all raise our glass­es and make a toast. A win is a win.

Mar­tin Shkre­li makes his fi­nal ex­it at Kalo­Bios

Mar­tin Shkre­li has spe­cial­ized in defin­ing the worst about biotech. Greed al­ways trumped the pub­lic in­ter­est. Con­fused ep­i­thets were coined and tossed out to the mass­es via Twit­ter. And his let-the-in­sur­ers-pay-for-it de­fense — trot­ted out once again in an ef­fort this week that would ul­ti­mate­ly help vil­i­fy My­lan — in­cit­ed a mob of an­gry crit­ics. His char­ac­ter is so tox­ic that now that he’s cut his fi­nal ties to Kalo­Bios, the biotech has re­spond­ed by vow­ing to be a mod­el of trans­paren­cy while it seeks to ham­mer out a fair way to price drugs. We could on­ly hope that the rest of the in­dus­try is shamed in­to the same po­si­tion. Be­cause the next drug pric­ing scan­dal is right around the cor­ner. In­no­va­tors have to learn how to sep­a­rate them­selves from the prof­i­teers, or every­one will be “re­formed” the same way in the back­lash to come.

No­var­tis proves it can still be the leader in biosim­i­lars

This week, No­var­tis’s biosim­i­lars crew at San­doz won a key FDA ap­proval on its biosim­i­lar of En­brel, Am­gen’s $5 bil­lion drug. Once again, the agency was ready to ex­trap­o­late the da­ta for one in­di­ca­tion and ap­ply it across the board. That will all help blaze a clear trail for oth­ers to fol­low at the agency. Of course, as the FDA be­comes part of the so­lu­tion, the courts re­main ready to throw up road­blocks for long and tor­tu­ous patent lit­i­ga­tion. And there’s no sign of that end­ing any­time soon.

RIP Roger Tsien [1952-2016]

By all ac­counts, UC San Diego’s Roger Tsien il­lu­mi­nat­ed many lives through his work, and not just by his ground­break­ing work on flu­o­res­cent pro­teins. His un­time­ly death is a cause of sad­ness, tru­ly, but we should all cel­e­brate a life well lived and the fact that his work will con­tin­ue to ben­e­fit peo­ple for some time to come.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat a 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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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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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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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.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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