Almost exactly a year after pharmaceutical maker Sanofi recalled nearly 500,000 epinephrine injectors after finding they might not provide the correct dosage to patients, the product is gearing up for a comeback, potentially creating a less expensive competitor to the highly scrutinized EpiPen.
Kaleo, which regained the rights to Auvi-Q from Sanofi earlier this year, announced the intention in a statement Wednesday, allowing potential customers to opt-in to receive updates on when the product will be available during the first half of 2017.
CEO of Kaleo, Spencer Williamson, tells Bloomberg that the company has yet to settle on the price for the Auvi-Q injector when it relaunches.
The medication cost around $500 prior to its recall, Business Insider reports, putting it in line with the current EpiPen price. Still, Williamson says the company is doing all it can to create a lower-cost option for patients.
“We’re working with multiple stakeholders including wholesalers, pharmacy benefit managers, insurers, etc., to establish a comprehensive access program,” he said. “We’re focused on minimizing the out-of-pocket costs for the patient.”
The return of Auvi-Q comes as Mylan, the maker of the EpiPen, continues to face backlash for the 600% increase in the cost of its life-saving device since it acquired the rights to the product in 2007.
The auto-injector pen contains about a $1 dose of the drug epinephrine, yet somehow costs 400% more on the wholesale market, and the cost to insurance companies and patients forced to pay retail has probably increased even more.
While the EpiPen is a 25-year-old device, there is no direct generic equivalent — yet.
In addition to Auvi-Q’s planned return to the market, pharmaceutical maker Teva is reportedly working on a potential competitor for the EpiPen.
Teva’s product was initially delayed by an intellectual property lawsuit filed by Mylan (a lawsuit that is at the center of a separate antitrust investigation by the West Virginia attorney general), only to have the FDA reject that product in early 2016 for “major deficiencies.” Teva says it is trying again and hopes to have the item available before 2018, though there is no guarantee that will happen or that Teva, which recently sought to acquire Mylan, would price its product significantly lower than EpiPen.
by Ashlee Kieler via Consumerist