Ar­ray shows off the pos­i­tive BEA­CON CRC da­ta that helped spur Pfiz­er's $11.4B buy­out of­fer

In­ves­ti­ga­tors took cen­ter stage at a sci­en­tif­ic con­fer­ence to­day to tout the pos­i­tive da­ta from the BEA­CON CRC tri­al of Ar­ray’s BRAF/MEK triplet for drug re­sis­tant colon can­cer that played a key role in at­tract­ing Pfiz­er’s $11.4 bil­lion buy­out bid.

The FDA had al­ready stamped its break­through des­ig­na­tion on the triple ther­a­py of (Braftovi) en­co­rafenib in com­bi­na­tion with (Mek­tovi) binime­tinib and ce­tux­imab be­fore Pfiz­er ex­ecs were pro­vid­ed a glimpse of the top-line re­sults in May — whet­ting their ap­petite for the ac­qui­si­tion dur­ing the fi­nal days of their ne­go­ti­a­tions. That’s when they learned that the triplet scored a me­di­an over­all sur­vival rate of 9 months among drug re­sis­tant pa­tients with BRAF V600E-mu­tat­ed cas­es of col­orec­tal can­cer com­pared to 5.4 months for the stan­dard of care. 

The ORR was 26% in the triple ther­a­py drug arm, com­pared to just 2% in the SOC group. And while there was a high, dose-re­lat­ed rate of ad­verse events — with Grade 3 or above AEs in 58% of pa­tients on triplet treat­ment and 50% of those in the dou­blet group — that still com­pared well with the 61% rate of Grade 3 or high­er AEs among those in the stan­dard ther­a­py group.

Ever­core ISI’s Umer Raf­fat took a look at the da­ta and couldn’t quite fig­ure whether the triplet or dou­blet would be pre­ferred — a ma­jor con­sid­er­a­tion while try­ing to fac­tor the rev­enue po­ten­tial for Pfiz­er.

I ac­knowl­edge that over­all sur­vival for ITT pop­u­la­tion still tracks 21% bet­ter (but not stat sig yet) for triplet vs dou­blet … how­ev­er, the con­sis­ten­cy of da­ta in first half of pts (331) vs next half is puz­zling … and PFS did not help ei­ther.  In a silio, I’d ar­gue that giv­en the cost dif­fer­ences + ques­tions on in­cre­men­tal ef­fi­ca­cy with triplet vs dou­blet, we may see lim­it­ed up­take of triplet.  How­ev­er, in prac­tice, physi­cian ex­pe­ri­ence of us­ing BRAF+MEK com­bo in melanoma like­ly ex­erts a very pos­i­tive ha­lo ef­fect over to CRC in­di­ca­tion al­so … and, the OS HR of 0.79 helps with an added dat­a­point.

The da­ta were pre­sent­ed at the ES­MO World Con­fer­ence on Gas­troin­testi­nal Can­cer.

“These are very ex­cit­ing re­sults be­cause we’ve been try­ing to tar­get BRAF-mu­tant col­orec­tal can­cer for many years. It’s en­cour­ag­ing to see such a sig­nif­i­cant im­prove­ment in over­all sur­vival and re­sponse in pa­tients with such ag­gres­sive tu­mor bi­ol­o­gy. Hope­ful­ly, this will soon lead to in­creased ac­cess to this treat­ment for pa­tients where there is cur­rent­ly such a large un­met need,” said study au­thor Scott Kopetz, from the MD An­der­son Can­cer Cen­ter, in a pre­pared state­ment.

These re­sults were cru­cial to Ar­ray’s ne­go­ti­a­tions with Pfiz­er, and they “shared high-lev­el top line re­sults da­ta” with the phar­ma gi­ant’s ex­ecs on May 17, 4 days ahead of the top-line an­nounce­ment, as out­lined in a re­cent SEC fil­ing. Twelve days lat­er Pfiz­er CEO Al­bert Bourla made his first hard of­fer at $44 a share, set­tling soon af­ter at $48.

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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