Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

Ken Fra­zier Mer­ck

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

“Un­der­neath these pro­grams, un­der­neath these prod­ucts […] un­der­neath what Ken and Rob told you about the fu­ture of the com­pa­ny, there is this enor­mous­ly sta­ble plat­form and what you will hear this morn­ing is first of all our abil­i­ty to ex­e­cute clin­i­cal­ly and com­mer­cial­ly to bring these prod­ucts to life,” he said of the Mer­ck lega­cy be­fore turn­ing to Roy Baynes and Mike Nal­ly for a more de­tailed look on R&D.

Perl­mut­ter’s com­ments echo CEO Ken Fra­zier’s in­sis­tence that the team here can build a fran­chise like Keytru­da not just once or twice but re­peat­ed­ly, and come as the board is re­port­ed­ly scout­ing their suc­ces­sors.

Fra­zier ad­dressed the in­evitable tran­si­tion ques­tion dur­ing Q&A by say­ing this:

Every­thing we need to dri­ve the growth we talked about […] is al­ready in our hands and so for us it’s re­al­ly fo­cus­ing on ex­e­cut­ing in the mar­ket­place and fo­cus­ing in the de­vel­op­ment space to make sure we main­tain that lead­er­ship. As it re­lates to suc­ces­sion, the board is very much fo­cused on that is­sue. What I can say is I’m ex­treme­ly pleased by the breadth of the lead­er­ship tal­ent in the com­pa­ny.

Rob Davis Mer­ck

The take-home mes­sage: Mer­ck, now at a 52-week high mar­ket cap of $221 bil­lion, is go­ing to do just fine.

On the BD front, the com­pa­ny is stick­ing to bolt-on M&A deals and strate­gic col­lab­o­ra­tions, though CFO Rob Davis em­pha­sizes that “we have the ca­pa­bil­i­ty to pret­ty much do what we want.” He al­so promised a top-down, com­pa­ny-wide ef­fort to cre­ate a lean­er struc­ture, with an eye to be­gin cut­ting R&D ex­pens­es as a per­cent­age of sales — a stan­dard met­ric in phar­ma — be­gin­ning in 2021.

Roy Baynes Mer­ck

As much as ex­ecs hyped up the growth po­ten­tial across the en­tire pipeline, Keytru­da re­mains the foun­da­tion­al pro­gram as an un­prece­dent­ed, ex­treme­ly large prod­uct that’s “on­ly go­ing to get big­ger” ac­cord­ing to Fra­zier.

“I re­al­ly be­lieve we’re still in the ear­ly stages of the op­por­tu­ni­ty we have with Keytru­da,” added Frank Clyburn, chief com­mer­cial of­fi­cer. And if you take Lyn­parza and Lenvi­ma in­to ac­count, “we be­lieve over the next five years I want you to think about the op­por­tu­ni­ty for more than 50 ad­di­tion­al in­di­ca­tions.”

Source: Mer­ck

Click on the im­age to see the full-sized ver­sion

Frank Clyburn Mer­ck

The mas­sive net­work of tri­als cen­tered around Keytru­da has pushed over the 1,000 mark, Baynes, the head of clin­i­cal de­vel­op­ment, said, with more than 100 in ear­li­er lines of ther­a­py (be­fore or right af­ter surgery), up­wards of 600 com­bi­na­tions, and 75 reg­is­tra­tional stud­ies un­der­way.

Breast and prostate can­cers loom large among them. As monother­a­py ap­proach­es have proven weak, Mer­ck is look­ing at new com­bos and ear­li­er lines for po­ten­tial first-to-mar­ket op­por­tu­ni­ties. The PARP in­hibitor Lyn­parza might al­so play a big role in tack­ling those two mar­kets, while Mer­ck and part­ner As­traZeneca ex­plore 19 oth­er in­di­ca­tions for the drug.

Mike Nal­ly Mer­ck

As for the rest of the pipeline out­side on­col­o­gy — vac­cines and hos­pi­tal care be­ing the main pil­lars — the com­pa­ny is look­ing to both grow ex­ist­ing prod­ucts while steadi­ly push­ing a “rich pipeline.”

Chief mar­ket­ing of­fi­cer Mike Nal­ly high­light­ed two drugs in par­tic­u­lar: MK-8591, which “has a true po­ten­tial to be a game chang­er for pa­tients with HIV”; and gefapix­ant, a P2X3 and P2X2/3 re­cep­tor an­tag­o­nist first po­si­tioned for chron­ic cough.

A glob­al vi­sion will be cru­cial to achiev­ing all of this. In his pre­sen­ta­tion, CFO Davis de­scribed Mer­ck has the fastest-grow­ing multi­na­tion­al phar­ma in Chi­na, swelling 43% over the last 18 months when the av­er­age was 11% — thanks in part to prod­uct ap­provals from Keytru­da to the HPV vac­cine Gar­dasil.

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.

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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H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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