Ar­ray shares surge as sec­ond chap­ter of its PhI­II can­cer com­bo sto­ry ends on an up­beat note

Ar­ray Bio­phar­ma stock got a bounce out of the up­beat as­sess­ment of the sec­ond part of its Phase III study of binime­tinib com­bined with en­co­rafenib, demon­strat­ing their abil­i­ty to sig­nif­i­cant­ly im­prove pro­gres­sion free sur­vival rates for pa­tients with BRAF-mu­tant ad­vanced melanoma. The top-line re­sults lay the foun­da­tion for an NDA, the com­pa­ny adds, which is ex­pect­ed to be de­liv­ered to the FDA this sum­mer.

Ar­ray CEO Ron Squar­er

Ar­ray’s shares $AR­RY surged 20% on Wednes­day as in­vestors and an­a­lysts got a chance to con­sid­er the da­ta on the MEK/BRAF in­hibitors. And while some of the an­a­lysts cov­er­ing the biotech felt that the Phase III news was a def­i­nite plus, there was a feel­ing that a sub­se­quent­ly an­nounced part­ner­ship with Mer­ck in­volv­ing Keytru­da — in which the phar­ma gi­ant will sim­ply con­tribute a quan­ti­ty of their check­point drug for a study — was a bit of a let­down af­ter spec­u­la­tion that a mon­ey deal was in the works.

In Phase III part 2, in­ves­ti­ga­tors looked at a com­bi­na­tion of 45 mg binime­tinib twice dai­ly plus 300 mg en­co­rafenib dai­ly against the con­trol arm of 300 mg en­co­rafenib alone. The com­bi­na­tion achieved a bet­ter me­di­an PFS — 12.9 months vs. 9.2 months; HR = 0.77.

The surge in the stock price helped re­pair some of the dam­age done a cou­ple of months ago when CEO Ron Squar­er had to walk back a promise that they had the da­ta need­ed for its first ap­proval of binime­tinib for NRAS-pos­i­tive melanoma.

Not­ed Leerink’s Michael Schmidt:

Giv­en the pos­i­tive out­come of COLUM­BUS tri­al Part 1 & 2, the like­li­hood of ap­proval of the binime­tinib/en­co­rafenib com­bi­na­tion in mid-2018 re­mains high which was ex­pect­ed by most in­vestors.

Part 1 was a 3-arm tri­al de­sign in 577 pa­tients with a 450 mg en­co­rafenib dose com­bined with binime­tinib com­pared to Zelb­o­raf. The me­di­an PFS rate for Ar­ray’s com­bo was 14.9 months vs. 7.3 months.

Schmidt was less im­pressed with Ar­ray’s deal with Mer­ck to com­bine binime­tinib with Keytru­da for col­orec­tal can­cer in an ear­ly study to test its po­ten­tial.

While this is in­cre­men­tal­ly pos­i­tive for AR­RY, we think a po­ten­tial deal (or even a buy-out of AR­RY) was wide­ly ex­pect­ed by in­vestors.

“The to­tal­i­ty of the COLUM­BUS re­sults, in­clud­ing es­ti­mat­ed pro­gres­sion free sur­vival, ob­jec­tive re­sponse rate, dose in­ten­si­ty and tol­er­a­bil­i­ty of the com­bi­na­tion, pro­vide a strong and con­sis­tent theme across mul­ti­ple end­points, un­der­scor­ing the promise of binime­tinib plus en­co­rafenib as an at­trac­tive treat­ment op­tion for pa­tients di­ag­nosed with BRAF-mu­tant melanoma,” said Kei­th T. Fla­her­ty, di­rec­tor of the Ter­meer Cen­ter for Tar­get­ed Ther­a­py, Mass­a­chu­setts Gen­er­al Hos­pi­tal.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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