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.
