Gilead rac­ing to FDA with a new HIV cock­tail boast­ing megablock­buster po­ten­tial

Gilead’s R&D team brought home a clean sweep for its four Phase III stud­ies adding the ex­per­i­men­tal drug bicte­gravir to its back­bone HIV ther­a­py.

Their cock­tail ther­a­py adding bicte­gravir to its main­stays emtric­itabine/teno­fovir alafe­namide (200/25mg) (FTC/TAF) proved non-in­fe­ri­or to do­lute­gravir and oth­er an­ti­retro­vi­ral ther­a­pies in the 4 late-stage stud­ies, set­ting up a new drug ap­pli­ca­tion in a mat­ter of weeks as Gilead races to a near-term mar­ket­ing OK.

That’s a clear win for Gilead, ac­cord­ing to some of the an­a­lysts who have been watch­ing this late-stage pro­gram ad­vance at a rapid pace. Gilead is a dom­i­nant play­er in HIV, and bicte­gravir is seen as a key piece in its megablock­buster mar­ket puz­zle for main­tain­ing its edge against a vi­brant Vi­iV, ma­jor­i­ty-owned by GSK.

Some GSK in­vestors, though, had been jit­tery that Gilead’s late-stage da­ta would re­flect su­pe­ri­or re­sults over do­lute­gravir (Tivicay). So when the da­ta came in as non-in­fe­ri­or, GSK back­ers let out a sigh of re­lief and drove up the phar­ma gi­ant’s shares 2.25% Tues­day morn­ing.

Gilead’s stock $GILD bare­ly edged up on the news, which met min­i­mum ex­pec­ta­tions.

Ge­of­frey Porges

Leerink’s bull­ish Ge­of­frey Porges ex­pects the big biotech, in bad need of some pos­i­tive R&D de­vel­op­ments af­ter a string of set­backs last year, will use a pri­or­i­ty re­view vouch­er to hus­tle this drug to a quick de­ci­sion at the FDA, which he now ex­pects to ar­rive be­fore the end of 2017.

Our fore­cast for bicte­gravir starts lat­er than this im­plied time­line (Q3 2018) but ramps to more than $10bn in glob­al sales based on the prod­uct’s con­ve­nience, safe­ty and tol­er­a­bil­i­ty and ef­fi­ca­cy. This dis­clo­sure ap­pears to be con­sis­tent with that po­ten­tial, and with the $12-13/share in val­ue con­tributed by bicte­gravir in our cur­rent com­pa­ny mod­el and val­u­a­tion.

Added Bar­clay’s Ge­off Meacham:

Bicte­gravir to­geth­er with TAF (a nu­cleotide re­verse tran­scrip­tase in­hibitor) are key dri­vers of Gilead’s strat­e­gy to pro­tect its HIV fran­chise against the head­winds of the up­com­ing TDF patent ex­piry and com­pe­ti­tion from do­lute­gravir, Vi­iV’s new in­te­grase in­hibitor.

Nor­bert Bischof­berg­er

“This in­ves­ti­ga­tion­al sin­gle tablet reg­i­men brings to­geth­er the po­ten­cy of an in­te­grase in­hibitor, bicte­gravir, with the demon­strat­ed ef­fi­ca­cy and safe­ty pro­file of the FTC/TAF back­bone,” said Nor­bert Bischof­berg­er, ex­ec­u­tive vice pres­i­dent, re­search and de­vel­op­ment and chief sci­en­tif­ic of­fi­cer, Gilead Sci­ences. “Based on the re­sults from these Phase 3 stud­ies, the com­bi­na­tion of bicte­gravir and FTC/TAF could rep­re­sent an im­por­tant ad­vance in triple-ther­a­py treat­ment for a broad range of HIV pa­tients, and we look for­ward to sub­mit­ting reg­u­la­to­ry ap­pli­ca­tions in the U.S. and EU this year.”

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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