Parents looking for relief from Mylan's (MYL) pricey EpiPen should not be holding their breath. The EpiPen will continue to dominate the epinephrine auto-injector market even as Democratic presidential candidate Hillary Clinton has unveiled a plan to address "excessive" increases in drug prices -- and that's because its one-time rival, Auvi-Q, remains off the market.
Auvi-Q was a novel epinephrine auto-injector that provided audio and visual cues for patients at risk for life-threatening allergic reactions. The product, created by twins Eric and Edward Edwards who formed pharmaceutical company Intelliject (which changed its name to kaléo in 2014), was considered superior to Mylan's EpiPen. According to a study published in The Journal of Allergy and Clinical Immunology, Auvi-Q was preferred over EpiPen on all study end points, which included method of instruction, preference to carry, device size and share.
Auvi-Q was in Sanofi's (SNY) pipeline of products since 2013. But in 2015, Sanofi had to issue a nationwide recall of all Auvi-Q after the product had been found to potentially have inaccurate dosage delivery. Sanofi estimated an initial negative impact of approximately 100 million euros on the business's net income. Shortly after the recall, on Feb. 23, 2016, Sanofi announced that the license and development deal between Sanofi and kaléo would be terminated and returned Auvi-Q's rights to kaléo.
So with the product back in the hands of its developer, where is it?
"Kaléo is in the process of evaluating when and how to bring Auvi-Q back to individuals and families living with life-threatening allergies," said Mark Herzog, kaléo's Vice President of Corporate Affairs, via an email to Real Money. Herzog gave no timeline for the return to market, nor did he indicate what the price would be when Auvi-Q returns.
But given that people and families across America are clamoring for an alternative to the EpiPen, which carries a $600 price tag (or $300 for its generic two-pack carton), kaléo is missing out on a huge opportunity -- which it seems to acknowledge. "We are aware of the access challenges that patients have faced and we are monitoring the news media and conversation very closely," Herzog said.
Sanofi is also missing out, having just terminated a deal for EpiPen's more-preferred rival. Real Money's calls to Sanofi regarding the Auvi-Q product and whether the company would be interested in it again were not immediately returned.
But as kaléo works to return Auvi-Q to market, there are several dark horses trying to enter the epinephrine auto-injector race, such as Imprimis Pharmaceuticals (IMMY) and Adamis Pharmaceuticals (ADMP) .
Mark Baum, CEO of Imprimis Pharmaceuticals (IMMY) has plans to unveil a $100 alternative to the EpiPen. In an interview with CNNMoney on Aug. 30, Baum says his version of EpiPen would not cost much to make. He said that one milligram of epinephrine, which is three times more than what's in an EpiPen, costs just a couple of dollars. Furthermore, the auto injector is available at a cost between $3 and $7.
"Access should be the number one government policy, and right now, when you have monopolies that are artificially created, when there isn't competition prices go up and you have limited access for people," Baum said.
While Baum's $100 alternative has yet to hit the shelves and Auvi-Q's return remains in the works, parents will likely have to pay the market leader's price for the life-saving drug for now. Then again perhaps that will change come November, depending on who is sitting in the Oval Office.
