Civi­ca nabs tri­al part­ner as it forges ahead to cre­ate more af­ford­able in­sulins

A non­prof­it drug man­u­fac­tur­er is mov­ing for­ward with plans to stem the ris­ing tide of in­sulin costs in the US.

Utah-based Civi­ca has se­lect­ed Ger­man-based re­search or­ga­ni­za­tion Pro­fil as its hu­man clin­i­cal tri­al part­ner to sup­port the de­vel­op­ment of Civi­ca’s af­ford­able in­sulins. Civi­ca is plan­ning to pro­duce three in­sulin biosim­i­lars – dubbed glargine, lispro and as­part – each of which will be avail­able both in vials and pre-filled pens.

Civi­ca has plans to sell the in­sulins at sig­nif­i­cant­ly low­er prices than what is cur­rent­ly avail­able on the mar­ket, al­though the House re­cent­ly passed a Pres­i­dent Joe Biden-backed cap on in­sulin prices at $35 per month. The Sen­ate has yet to vote on the bill.

“The need for af­ford­able in­sulin is ur­gent, es­pe­cial­ly for unin­sured and un­der­in­sured pop­u­la­tions. With its ex­ten­sive ex­pe­ri­ence and qual­i­ty track record, Pro­fil is the ide­al clin­i­cal tri­al part­ner for Civi­ca,” said Civi­ca CEO Ned Mc­Coy in a state­ment.

Found­ed in 1999, Pro­fil is a full-ser­vice CRO that be­gan as a spin-off from the Uni­ver­si­ty of Dus­sel­dorf. Since its found­ing, the com­pa­ny has en­gaged in sev­er­al stud­ies re­lat­ed to di­a­betes and obe­si­ty.

Civi­ca is plan­ning to set its prices at $30 per vial max and no more than $55 for a box of five pen car­tridges, with those prices avail­able to those who are both in­sured and non-in­sured. How­ev­er, Civi­ca’s plans are con­tin­gent on FDA ap­proval and the com­pa­ny is an­tic­i­pat­ing that its in­sulins will be avail­able for pur­chase be­gin­ning in 2024.

The is­sue of more af­ford­able in­sulin has be­come a ma­jor top­ic of dis­cus­sion as of late, while the price has con­tin­ued to steadi­ly rise over the past sev­er­al years.

For Civi­ca, the com­pa­ny has been on this path since its found­ing in 2018 and has been gain­ing mo­men­tum over the past year. In 2021, the com­pa­ny an­nounced plans to in­vest $124.5 mil­lion to build its first in-house man­u­fac­tur­ing op­er­a­tion in Pe­ters­burg, VA, which is ex­pect­ed to be open by 2024.

While those still pay­ing heady amounts for in­sulin wait for con­gress or Civi­ca, ac­cord­ing to GoodRx, the cheap­est in­sulin glargine vial is about $125, while the cheap­est in­sulin lispro vial is about $360, and the cheap­est in­sulin as­part pack of 5 pens is about $90.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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#AAO22 conference in Chicago (Photo credit: Associate editor Kyle LaHucik)

#AAO22: Iver­ic Bio, un­de­terred by loom­ing PDU­FA for com­peti­tor, touts sub­group da­ta on GA drug

CHICAGO — While its competitor is on the cusp of likely securing the first FDA nod, Iveric Bio is trudging ahead with its potential treatment for geographic atrophy, an advanced form of AMD, and has new data to support its upcoming NDA filing.

The biotech said its drug was more favorable than sham across all subgroups in the second Phase III study of the investigational complement C5 protein inhibitor, performing similarly to a previous, smaller late-stage trial.

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#AAO22 conference in Chicago (Photo credit: Associate editor Kyle LaHucik)

#AAO22: In bid for first FDA nod in ge­o­graph­ic at­ro­phy, Apel­lis claims an­oth­er first in eye dis­ease field

CHICAGO — Eight weeks before patients and industry find out if the FDA approves the first treatment for geographic atrophy, an advanced form of age-related macular degeneration, the biotech behind the drug is out with some new data on a secondary endpoint.

In what study investigator Charles Wykoff called the “first direct evidence of function preservation by slowing GA growth” in an investigational treatment, Apellis Pharmaceuticals’ drug pegcetacoplan led to less loss of retinal sensitivity versus sham  within 250 microns on either side of the GA lesion over 24 months.

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