Gilead buy Ver­tex? A gold­en oldie in the M&A buzz cir­cuit gets fresh air time

This was the year M&A was sup­posed to make a big splash in bio­phar­ma. But we’ve seen on­ly a few rip­ples on this pond, and we’re at the halfway mark for the year now.

What bet­ter time for Ge­of­frey Porges, now at Leerink, to re­vive an old sug­ges­tion that Gilead $GILD buy Ver­tex $VRTX?

Ge­of­frey Porges, Leerink

Gilead, as we know, has been told by many an­a­lysts that it needs to do some­thing big in M&A more times than prac­ti­cal­ly any oth­er deal-hun­gry com­pa­ny in the in­dus­try, in­clud­ing Sanofi $SNY and Bio­gen $BI­IB. It has the mon­ey. They’re watch­ing the hep C cash cow start to dry up and CEO John Mil­li­gan could pull it off quick, land­ing a mar­ket-lead­ing cys­tic fi­bro­sis port­fo­lio with a fo­cused pipeline.

Ap­pro­pri­ate­ly ti­tling his note “Déjà vu…Why VRTX is still Gilead’s best op­tion,” Porges re­peat­ed some old lessons from 2015 and added that Gilead doesn’t have to try and nav­i­gate the white wa­ter field of on­col­o­gy buy­outs, as it ap­pears in­tent on.

There is an­oth­er way, notes Porges:

Gilead’s stock has been the worst per­former in biotech this year and faces po­ten­tial­ly dev­as­tat­ing rev­enue ero­sion in 2018. We be­lieve an ac­qui­si­tion of Ver­tex (VRTX, OP), which we have ad­vo­cat­ed in the past, would still pro­vide one of the few op­tions for GILD to off­set the risks and in­evitable ero­sion of their lega­cy prod­uct fran­chis­es. Gilead’s man­age­ment faces one of the great­est chal­lenges in re­cent bio­phar­ma­ceu­ti­cal in­dus­try his­to­ry, with the con­cen­tra­tion of their rev­enue in two very large, very prof­itable small mol­e­cule an­tivi­ral fran­chis­es fac­ing in­ten­si­fy­ing com­pet­i­tive threats. Their lack of progress to­ward de­ploy­ing the cash flow from those fran­chis­es has be­come a ma­jor frus­tra­tion to in­vestors, and man­age­ment’s com­ments con­tin­ue to sug­gest that the com­pa­ny’s fo­cus and in­ter­ests are away from Ver­tex, most ob­vi­ous­ly chas­ing the flood of cap­i­tal be­ing de­ployed in­to on­col­o­gy, but we would view an ac­qui­si­tion of a grow­ing and large­ly de-risked rev­enue stream, such as Ver­tex, much more pos­i­tive­ly than a com­pa­ra­ble in­vest­ment, or set of in­vest­ments, in­to the in­tense­ly com­pet­i­tive, and tech­no­log­i­cal­ly un­cer­tain field of on­col­o­gy.

Mil­li­gan has at­tract­ed wide­spread at­ten­tion and plen­ty of nod­ding ap­proval for a com­ment he made re­cent­ly, not­ing that while the buzz is all about tax re­form, big changes to health­care cov­er­age in Wash­ing­ton and so on, a com­pa­ny can on­ly fo­cus on its plan and ex­e­cute, ig­nor­ing the chat­ter.

So far, that at­ti­tude has ex­tend­ed to many an­a­lysts’ re­marks as well.

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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