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.”

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Bris­tol My­er­s' CAR-T Breyanzi busts out a win in ear­li­er-line lym­phoma, po­ten­tial­ly crack­ing open an ex­pand­ed mar­ket

Despite being third to the field in B cell lymphoma, Bristol Myers Squibb has repeatedly argued its CAR-T Breyanzi could have the juice to overtake its older competitors. Going into earlier lines of therapy may be the golden ticket on that front, and now Breyanzi has a late-stage win to back up that effort.

Bristol Myers’s Breyanzi beat out physicians’-choice salvage therapy followed by high-dose chemo and a stem cell transplant — what the drugmaker called a “gold standard treatment” — in second-line patients with relapsed or refractory large B cell lymphoma, according to topline data from the Phase III TRANSFORM study released Thursday.