Following a bruising EpiPen pricing scandal, Mylan’s lock on the epinephrine injector market may soon end. Privately held kaléo now plans to resurrect a popular rival product, Auvi-Q, in the first half of next year.
Kaléo's Auvi-Q relaunch would follow the product's collapse in the U.S. last year, when marketing partner Sanofi pulled the device on manufacturing and dosing issues. Kaléo will now go it alone to challenge EpiPen, a product that’s had a stranglehold on the market for years.
The first question is whether kaléo can pull it off; the second is price. The company hasn’t disclosed a prospective sticker--a number that will help determine its ability to steal market share. Mylan's years of significant price hikes on EpiPen have prompted intense criticism from lawmakers and the public in recent months, not to mention a settlement with the U.S. Justice Department.
Kaléo says it plans to make Auvi-Q an affordable alternative. "As we prepare to make Auvi-Q available once again in the United States, our priority is to return Auvi-Q to the market as an epinephrine auto-injector alternative that all patients can afford," CEO Spencer Williamson said in a statement.
It remains to be seen whether competition in the market will bring relief to consumers. As Forbes notes, that wasn't the case when Auvi-Q was previously on the market; its price increases from early 2013 to late 2015 were in line with those for EpiPen.
A few months after Auvi-Q injector faults triggered a recall last year, Sanofi cancelled its marketing deal with kaléo on the product, allowing Mylan to tighten its grip in the epinephrine injector arena. A potential generic from Teva also fell by the wayside earlier this year, when FDA officials flagged “certain major deficiencies” with that company’s offering.
Now, Richmond, VA-based kaléo is touting an “intelligent, high-tech” manufacturing process that’s completely automated. The new line uses more than 100 quality checks along the way.
The Auvi-Q injector is the size of a credit card with the thickness of a cell phone, and it incorporates voice instructions to guide users through the process.
Earlier this month, Mylan settled Justice Department claims that it overcharged Medicaid by misclassifying EpiPen, though it admitted no fault in the $465 million deal. Now, shareholders are coming after the company for damages in a class-action suit.
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