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.”

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Mer­ck halts prostate can­cer study while re­port­ing pos­i­tive read­out in bil­iary tract can­cer

Merck is slamming the brakes on a late-stage Keytruda study in prostate cancer after an interim analysis showed no improvement in survival, the company announced on Wednesday. However, the pharma giant cushioned the blow with a positive look at a separate study in biliary tract cancer.

An independent data monitoring committee reviewing the Phase III KEYNOTE-991 trial saw no improvement in overall survival or radiographic progression-free survival in a Keytruda combination group compared to the control group, Merck said in a news release. The trial was conducted in more than 1,200 patients with metastatic hormone-sensitive prostate cancer (mHSPC), or those whose cancer is controlled by keeping testosterone levels as low as would be expected after castration.