IPXLE Impax Laboratories (MM)

By Jonathan D. Rockoff 

The maker of an EpiPen rival said its emergency allergy treatment would return to the market on Feb. 14, adding more competition to the market for the costly products.

Privately held Kaleo, the maker of the Auvi-Q injectors, said it had corrected the manufacturing problems that triggered a recall of the devices in 2015 and would list a twin pack for $4,500.

Critics have been clamoring for more competition for Mylan NV's EpiPen, whose $609 list price for a two-pack of the lifesaving treatments angered parents and prompted a hearing in Congress last September. In response, Mylan began selling an authorized generic for about $300 for a two-pack.

At Auvi-Q's list price, Kaleo could face obstacles securing reimbursement from health insurers and drug-benefit managers that don't want to pay so much. Last week, CVS Health Corp. said it would sell a twin-pack of the Adrenaclick auto-injector, from Impax Laboratories Inc., for $110.

Executives at Richmond, Va.-based Kaleo said on a conference call they expect multiple health plans will cover Auvi-Q, but declined to name them.

Company executives also said they were taking steps to limit the impact of the high list price on how much patients pay. They said Kaleo had put in place a program so that commercially insured patients, as well as uninsured patients with incomes less than $100,000, wouldn't pay anything out of pocket and other patients wouldn't pay more than $360.

"No epinephrine auto injector, branded or even generic, will cost a commercially insured patient less out of pocket than Auvi-Q," Kaleo Chief Executive Spencer Williamson said in a conference call.

The devices deliver a shot of epinephrine to treat potentially fatal allergic reactions. Dominating the market is the EpiPen, the list price of which Mylan raised nearly 550% in the years after acquiring the rights in 2007.

Auvi-Q was sold by Sanofi SA until the French drug company recalled the products in late 2015 after receiving reports the devices were delivering inadequate doses. At the time, Auvi-Q carried a list price of $509, according to Truven Health Analytics.

Kaleo regained the rights in February 2016 and upgraded Auvi-Q manufacturing, including installing more than 100 quality checks, to fix the problems that led to the dosing issues, said Eric Edwards, a Kaleo co-founder who is a vice president at the company.

Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com

(END) Dow Jones Newswires

January 19, 2017 16:12 ET (21:12 GMT)

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