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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.