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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.