Amid a national shortage for Mylan’s EpiPen—and during a busy back-to-school season—competitors are making moves aimed at stealing share. After a recent Novartis deal to scoop up rights to Symjepi from Adamis, Kaléo Pharma has become the latest drugmaker to strike a deal aimed at making its product more widely available.
Under a new deal with Walgreens, Kaléo’s Auvi-Q will be available at pharmacies nationwide for the first time. Kaléo relaunched its drug last year and ran into pushback over its $4,500 price tag for two injectors, but the company says it’s now the only epinephrine injector not experiencing manufacturing delays. Since the relaunch, Auvi-Q has only been able to claim a 2% market share, according to a recent note from Wells Fargo analyst David Maris.
The Kaléo-Walgreens tie-up will work like this: If a Walgreens pharmacy is unable to provide a patient’s epinepherine injector as written, the pharmacist will work with the patient’s doctor to determine whether Auvi-Q is appropriate. If so, the pharmacist can dispense the injectors. It'll be the first time Auvi-Q will be available through pharmacies; until now, Auvi-Q was only available through a direct delivery program.
Sanofi previously marketed the drug but pulled it from the market due to manufacturing problems. Kaléo, which originally invented Auvi-Q, reacquired the rights and relaunched the injector last year. In a statement, Kaléo CEO Spencer Williamson said the 2% market share estimate "does not include sales through our direct delivery service, as that data is not captured by prescription data services." He said Auvi-Q is "the number one branded epinephrine auto injector prescribed by allergists."
Auvi-Q injectors carry a high list price at $4,500 for a two-pack—compared with EpiPen’s $600 for a two-pack—but patients are insulated from the cost. Under the program, patients with commercial insurance will have access to the med at no cost, according to Kaléo. For patients whose insurers block coverage, Kaléo will provide the injectors for free, the company has said.
“We are working with insurance providers to maximize coverage of Auvi-Q for as many patients as possible,” Phil Rackliffe, general manager of allergy and pediatrics at Kaléo, said in a statement.
The deal comes as Mylan and its manufacturing partner Pfizer struggle to keep up with demand for EpiPens. In response, the FDA recently extended expiration dates for certain EpiPens to help fight the shortage. The FDA last month approved the first EpiPen generic from Teva, and a representative said the company is “applying our full resources to this important launch in the coming months.” Impax's competitor is also on the FDA's shortage list.
In July, Novartis bought out rights to Adamis’ Symjepi prefilled epinephrine syringe for an undisclosed amount. The company is hoping to put its marketing heft behind the discounted product in order to grow share.
Editor's note: This story was updated with a statement from Kaléo CEO Spencer Williamson.