In a rare block­buster per­for­mance for As­traZeneca, Tagris­so comes through on lung can­cer PhI­II

As­traZeneca CEO Pas­cal So­ri­ot

For a Big Phar­ma com­pa­ny that of­ten gets things wrong, Tagris­so has been As­traZeneca’s ace in the hole. Sped through the clin­ic to a first ap­proval in an as­ton­ish­ing two years, it was al­ready on the mar­ket when Clo­vis’ ri­val im­plod­ed on ar­rival at the FDA.

To­day, the phar­ma gi­ant is pulling back the veil off of new da­ta demon­strat­ing a 5.7-month im­prove­ment in pro­gres­sion-free sur­vival of non-small cell lung can­cer among pa­tients with an epi­der­mal growth fac­tor re­cep­tor (EGFR) T790M mu­ta­tion com­pared to plat­inum-based dou­blet chemother­a­py (10.1 months vs 4.4 months). And the PFS spread sig­nif­i­cant­ly fa­vored Tagris­so among the one-third of pa­tients with CNS metas­tases.

Tagris­so, As­traZeneca ex­ecs say now, is poised to be­come the stan­dard sec­ond-line treat­ment for lung can­cer pa­tients with this mu­ta­tion.

That is ex­act­ly the kind of thing As­traZeneca CEO Pas­cal So­ri­ot needs to hear a lot more about. So­ri­ot tapped Tagris­so as a $3 bil­lion an­nu­al earn­er, a key fea­ture in a big promise to de­liv­er $45 bil­lion in an­nu­al rev­enue in 2023.

The com­pa­ny has start­ed back­ing away from that over­all fig­ure, but ex­pand­ing the mar­ket for Tagris­so will go a long way to con­vinc­ing in­vestors there are bright spots in a year dom­i­nat­ed by set­backs.

As­traZeneca CMO Sean Bo­hen

Clo­vis helped. The biotech had played fast and loose with da­ta for its ri­val ro­ci, which at­tract­ed plen­ty of un­want­ed at­ten­tion at the FDA. The agency spurned the drug and Clo­vis opt­ed to re­struc­ture and dump the drug.

As­traZeneca CMO Sean Bo­hen had this to say:

“The con­fir­ma­to­ry Phase III da­ta sug­gest the po­ten­tial for Tagris­so to re­place chemother­a­py as the stan­dard of care for pa­tients who have pro­gressed fol­low­ing EGFR ty­ro­sine ki­nase in­hibitor treat­ment. As lung can­cer is the most com­mon type of can­cer to spread to the brain, it is al­so en­cour­ag­ing to see the ac­tiv­i­ty of Tagris­so in pa­tients with cen­tral ner­vous sys­tem metas­tases whose prog­no­sis is of­ten par­tic­u­lar­ly poor.”

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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