Merdad Parsey, Gilead CMO

FDA slaps a hold on Gilead­'s in­jectable HIV treat­ment over con­cerns about po­ten­tial glass con­t­a­m­i­nants

The FDA is com­ing down on yet an­oth­er ther­a­py over con­cerns about glass par­tic­u­lates wind­ing up in drug so­lu­tion.

Reg­u­la­tors have slapped a clin­i­cal hold on 10 tri­als study­ing in­jectable ver­sions of Gilead’s ex­per­i­men­tal HIV treat­ment lenaca­pavir, due to con­cerns that vials made of borosil­i­cate glass could lead to the for­ma­tion of sub-vis­i­ble glass par­ti­cles in the so­lu­tion.

“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,” CMO Mer­dad Parsey said in a state­ment.

The dos­ing of oral for­mu­la­tions will con­tin­ue, ac­cord­ing to Gilead, and in­ves­ti­ga­tors will con­tin­ue mon­i­tor­ing the pa­tients who have al­ready been dosed with in­jectable for­mu­la­tions, as well as dose par­tic­i­pants in com­para­tor arms.

Gilead’s been work­ing on lenaca­pavir, an HIV-1 cap­sid in­hibitor, for both the treat­ment and pre­ven­tion of HIV-1 in­fec­tion. While most an­tivi­rals act on just one stage of vi­ral repli­ca­tion, the com­pa­ny says lenaca­pavir is de­signed to in­hib­it HIV-1 at mul­ti­ple stages of its life­cy­cle.

The drug is Gilead’s big next-gen an­tivi­ral. Back in March, the com­pa­ny signed a co-de­vel­op­ment pact to study the can­di­date in com­bi­na­tion with Mer­ck’s is­la­travir.

How­ev­er, Mer­ck slammed the brakes on its pro­gram in No­vem­ber af­ter in­ves­ti­ga­tors flagged a drop in im­mune cell counts that an ex­ter­nal com­mit­tee de­ter­mined was re­lat­ed to is­la­travir. The FDA placed an of­fi­cial clin­i­cal hold on the ex­per­i­men­tal treat­ment ear­li­er this month.

The clin­i­cal hold af­fects sev­er­al mid- and late-stage tri­als, in­clud­ing one Phase III as­sess­ing pre-ex­po­sure pro­phy­lax­is in cis­gen­der men, trans­gen­der women, trans­gen­der men, and gen­der non-bi­na­ry peo­ple 16 years or old­er; and an­oth­er Phase III look­ing at pre-ex­po­sure pro­phy­lax­is in ado­les­cent girls and young women in com­bi­na­tion with stan­dards of care emtric­itabine/teno­fovir alafe­namide.

This isn’t the first time Gilead has run in­to trou­ble with glass par­tic­u­lates. Ear­li­er this month, the phar­ma com­pa­ny re­called two lots of its Covid-19 treat­ment Vek­lury af­ter the ap­pear­ance of par­tic­u­lates. A cus­tomer com­plaint had been con­firmed by a Gilead in­ves­ti­ga­tion.

Over the last year, glass par­tic­u­lates have emerged as an in­dus­try-wide prob­lem. Back in Oc­to­ber, one lot of Mer­ck’s an­tibi­ot­ic Cu­bicin was re­called af­ter a piece of glass was found in a vial, rais­ing safe­ty con­cerns. And in June, the FDA is­sued a warn­ing let­ter to the Japan­ese man­u­fac­tur­er Toy­obo Co af­ter 12 batch­es of in­jecta­bles were found to have cel­lu­lose and glass fibers, stains, and par­ti­cles on vials, the FDA said.

This month, the FDA re­leased draft guid­ance aim­ing to help drug­mak­ers pre­vent the risk of par­tic­u­late con­t­a­m­i­na­tion.

While side ef­fects caused by the glass pieces de­pend on the route of ad­min­is­tra­tion, the pa­tient pop­u­la­tion, and the na­ture of the par­tic­u­lates them­selves (such as size or shape), the agency not­ed that some pa­tients could ex­pe­ri­ence in­fec­tion, ve­nous or ar­te­r­i­al blood clots, in­flam­ma­tion, or even em­boli, ab­scess­es, and gran­u­lo­mas in vis­cer­al or­gans.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News. 

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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