Joan Butterton, Merck Research Laboratories VP of global clinical development, infectious diseases (Merck)

Mer­ck­'s ex­per­i­men­tal HIV drug is­la­travir hits with a PhI­II com­bo win and FDA fil­ing plans

Back in March, Mer­ck and Gilead agreed to a part­ner­ship to chal­lenge Glax­o­SmithK­line on long-act­ing HIV meds — by com­bin­ing one drug from both Mer­ck and Gilead that had shown po­ten­tial. While Gilead brought its cap­sid in­hibitor lenaca­pavir, Mer­ck brought is­la­travir in­to the deal — a small mol­e­cule that the phar­ma ac­quired in 2012 from a small Japan­ese firm.

While that part­ner­ship is on­go­ing, is­la­travir is com­ing out of 2 Phase III piv­otal tri­als with back-to-back suc­cess­es and plans to beat a quick ad­vance to the FDA.

The phar­ma gi­ant re­vealed top-line re­sults this morn­ing from its piv­otal Phase III tri­als of a once-dai­ly oral pill com­bin­ing Mer­ck’s FDA-ap­proved an­ti-HIV treat­ment Pifel­tro with is­la­travir. The par­tic­i­pants, who are adults with HIV-1 in­fec­tion who are on two dif­fer­ent an­ti­retro­vi­ral ther­a­py pro­to­cols, in­clud­ing a bicte­gravir/emtric­itabine/teno­fovir triple, were com­pared at 48 weeks.

Mer­ck has main­tained a steady run­ner-up rep in HIV, a field dom­i­nat­ed by Gilead and then Vi­iV, ma­jor­i­ty owned by GSK. And no mat­ter what hap­pens with the Mer­ck com­bo now that it’s head­ed to reg­u­la­tors, an­a­lysts don’t ex­pect any­thing to beat out Gilead’s mar­ket leader. A few months ago Bern­stein’s Ron­ny Gal as­sessed the al­liance be­tween Mer­ck and Gilead, con­clud­ing:

For HIV treat­ment it will be hard to un­seat Bik­tarvy. HIV treat­ments have ef­fec­tive­ly reached the up­per-lim­it on ef­fi­ca­cy and tol­er­a­bil­i­ty. From here, new prod­ucts will try to dif­fer­en­ti­ate based on qual­i­ty-of-life en­hance­ments like less fre­quent dos­ing and low­er as­so­ci­at­ed weight gain. These val­ue propo­si­tions are re­al, but pa­tient turnover in HIV is rel­a­tive­ly low and we be­lieve it would a tough sell to switch vi­ral­ly sup­pressed pa­tients of Bik­tarvy. As a re­sult, we mod­el on­ly 30% peak mar­ket share for ISL/LEN com­bi­na­tions – ma­te­r­i­al, but less than Bik­tarvy.

Both of the Mer­ck tri­als met their pri­ma­ry end­point on the per­cent­age of par­tic­i­pants with HIV-1 RNA lev­els at or be­low 50 copies/mL — show­ing that an­tivi­ral ef­fi­ca­cy was com­pa­ra­ble be­tween the drug com­bo and an­ti­retro­vi­ral ther­a­pies, ac­cord­ing to a com­pa­ny state­ment.

For ref­er­ence, any lev­el of HIV-1 RNA be­low 50 copies/mL is con­sid­ered op­ti­mal for pa­tients — some­times that num­ber is con­sid­ered un­de­tectable in a blood test. A “low­er vi­ral load” is any num­ber be­low 10,000 copies/mL — and a high vi­ral load is con­sid­ered to be any­where from 100,000 to a mil­lion copies of RNA/per mL of blood.

The safe­ty and tol­er­a­bil­i­ty of the com­bi­na­tion drug were con­sis­tent with da­ta from Phase II stud­ies, ac­cord­ing to Mer­ck — and these re­sults will lead the way for “glob­al reg­u­la­to­ry ap­pli­ca­tions.”

“We are en­cour­aged by the re­sults from the Phase 3 IL­LU­MI­NATE SWITCH A and B tri­als, in which the DOR/ISL dual reg­i­men ef­fi­ca­cy was com­pa­ra­ble to cer­tain com­mon­ly used three-drug reg­i­mens,” said Joan But­ter­ton, VP of glob­al clin­i­cal de­vel­op­ment, in­fec­tious dis­eases at Mer­ck Re­search Lab­o­ra­to­ries. “We will con­tin­ue to study do­ravirine/is­la­travir in di­verse pop­u­la­tions of peo­ple liv­ing with HIV and look for­ward to shar­ing da­ta from these tri­als.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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