- Privately-held Virginia biotech Kaleo says it will relaunch EpiPen rival Auvi-Q in early 2017 on its own.
- Kaleo is promising low-cost and quality manufacturing – both things that typically bring out the skeptics. Even so, the company provided no details on price.
- Auvi-Q was originally launched by Sanofi in 2012, but was recalled from the market in 2015 after the device raised safety concerns about proper dosing. The French pharma pulled out of the partnership once the auto-injector was taken off the market.
Small biotech Kaleo is taking advantage of the pricing backlash that Mylan has been facing for the cost of its anaphylaxis treatment, hoping to worm its way into the market.
The specialty pharma has come under siege from both payers and Congress due to the price hikes that Mylan has initiated over the last several years since acquiring EpiPen in 2007, raising the price from about $60 to over $600 for a two-pack of the allergic reaction medication.
Mylan has since taken steps to reign in the cost by offering a 50% discount to patients who are uninsured or underinsured, as well as saying it will offer a generic version at half price. The generic has yet to come out.
"We believe that patients should have options when it comes to epinephrine auto-injectors for life-threatening allergic reactions," said Spencer Williamson, president and CEO of Kaleo. "When a health care practitioner prescribes Auvi-Q, determining that it is best for a patient, we believe that the patient should be able to obtain the product without insurance barriers or being subjected to a high out-of-pocket cost."
Yet, when Auvi-Q was on the market previously, Sanofi kept on pace with Mylan, increasing the price of the device to more than $500.
Meanwhile, Kaleo might not be able to penetrate the market as quickly as it thinks. Despite Mylan's flawed pricing strategy, the company has done solid work educating people about the dangers of allergic reactions and has made the EpiPen a staple in schools across the U.S.
Auvi-Q, on the other hand, lost the faith of both consumers and its former partner Sanofi when the device raised safety issues about the accurate dosing level being delivered. It's going to be an uphill battle to convince parents to rely on a device that might not save their child in a life-threatening situation.
"After regaining the rights to Auvi-Q, Kaleo conducted a thorough manufacturing assessment and invested in new technology and quality systems to ensure accurate, reliable and consistent delivery from the product. Auvi-Q is manufactured on an intelligent, high-tech, 100% automated robotic production line with more than 100 automated quality checks on each Auvi-Q, ensuring a streamlined and consistent production process," promised the company in a statement.