Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug can­di­date lenaca­pavir got hit with a CRL over CMC is­sues in­volv­ing the type of vials planned for use. Now, the phar­ma is head­ed back to the FDA for round two.

Gilead an­nounced Mon­day af­ter­noon that it had re­filed its NDA sub­mis­sion filled with new CMC da­ta af­ter the FDA es­sen­tial­ly balked at borosil­i­cate glass vials, orig­i­nal­ly used for the non-oral form of lenaca­pavir. The drug can­di­date, which re­cent­ly won a pos­i­tive opin­ion from Eu­rope’s CHMP, is be­ing de­vel­oped for HIV-1 in­fec­tion “in heav­i­ly treat­ment-ex­pe­ri­enced (HTE) peo­ple with mul­ti-drug re­sis­tant (MDR) HIV-1 in­fec­tion.”

Many com­pa­nies have run in­to par­tic­u­late con­t­a­m­i­na­tion is­sues, and this is not the first time Gilead has such a prob­lem on its hands. Just last De­cem­ber, Gilead had to re­call two lots of Vek­lury due to glass con­t­a­m­i­na­tion is­sues.

Reg­u­la­tors pre­vi­ous­ly slapped a clin­i­cal hold on 10 tri­als — al­so last De­cem­ber — while study­ing in­jectable ver­sions of the ex­per­i­men­tal HIV-1 cap­sid in­hibitor, due to con­cerns that vials made of borosil­i­cate glass could lead to the for­ma­tion of tiny glass par­ti­cles seep­ing in­to the so­lu­tion. Gilead CMO Mer­dad Parsey said at the time that “We are com­mit­ted to work­ing dili­gent­ly with FDA to re­solve this glass vial com­pat­i­bil­i­ty qual­i­ty is­sue and re­sume in­jectable lenaca­pavir dos­ing in the af­fect­ed stud­ies in a time­ly fash­ion.”

That hold was lift­ed in May, two months af­ter the drug was ini­tial­ly re­ject­ed and af­ter Gilead found a new so­lu­tion with which the reg­u­la­to­ry agency was con­tent.

Jared Baeten

Gilead’s VP of HIV clin­i­cal de­vel­op­ment Jared Baeten said in a state­ment that “There are peo­ple with HIV who have se­vere­ly lim­it­ed treat­ment op­tions due to re­sis­tance to mul­ti­ple an­ti­retro­vi­ral ther­a­py class­es,” adding that the Cal­i­for­nia com­pa­ny is com­mit­ted to un­met needs.

Baeten tells End­points News that Gilead cur­rent­ly has no plans at look­ing at lenaca­pavir out­side of HIV treat­ment and pre­ven­tion. And with the new progress, Gilead has start­ed re-dos­ing pa­tients in mul­ti­ple clin­i­cal tri­als for HIV treat­ment — the ba­sis of Gilead’s NDA, ac­cord­ing to Baeten. On top of that, the restart­ed clin­i­cal tri­als in­clude lenaca­pavir in par­tic­i­pants as a pre-ex­po­sure pro­phy­lax­is, test­ing the drug as a method of HIV pre­ven­tion.

As for what makes the re­sub­mit­ted NDA dif­fer­ent from the first, Gilead said in a state­ment that “the NDA re­sub­mis­sion con­tains com­pre­hen­sive CMC da­ta to sup­port the com­pat­i­bil­i­ty of lenaca­pavir with an al­ter­na­tive vial type made from alu­mi­nosil­i­cate glass,” plus pre-clin­i­cal and clin­i­cal da­ta.

And now, the com­pa­ny is play­ing the wait­ing game to hear what FDA thinks, and whether the changes made are enough for the ap­pli­ca­tion to be ac­cept­ed, an­a­lyzed and run through a new, yet-undis­closed PDU­FA date. If it gets ap­proved, lenaca­pavir will be the first HIV-1 cap­sid in­hibitor on the mar­ket.

Lenaca­pavir has been billed as Gilead’s next big thing in its HIV ar­se­nal, giv­en the drug’s po­ten­tial to not on­ly al­low dos­ing just once every six months but block HIV-1 at mul­ti­ple stages of the virus’s life­cy­cle and work to both treat and pre­vent in­fec­tion. GSK’s Vi­iV Health­care is al­so in the long-act­ing HIV treat­ment game, with its pre-pro­phy­lax­is in­jectable cabote­gravir be­ing the first HIV treat­ment to pro­vide an al­ter­na­tive to a once-com­mon­place dai­ly pill reg­i­men.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

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

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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