Despite high customer hopes for a less-expensive alternative to the EpiPen epinephrine autoinjector, the Virginia-based company may encounter some resistance in its return to the market.
The product was created by Eric Edwards, a doctor, in addition to Evan Edwards, a mechanical in addition to systems engineer, twin brothers who both have serious food allergies.
“This specific is usually a product which’s very personal to Evan in addition to I,” Eric Edwards said. “We grew up with life-threatening food allergies, in addition to we have children with life-threatening food allergies.”
With the advice of professional engineers as well as patients who were eager to share their thoughts, the twins developed their idea for an epinephrine autoinjector through a company they co-founded, Intelliject Inc.
Their product incorporates previously unseen features from the industry. The “talking autoinjector” instructs a user through the entire process of injection. Auvi-Q, which is usually about the size of a credit card in addition to the thickness of a cell phone, also features a self-retracting needle system.
“A user never sees a needle before, during or after use,” Evan Edwards explained.
In 2009, Intelliject licensed the North American commercialization rights for Auvi-Q to pharmaceutical giant Sanofi while retaining rights for the rest of the entire world.
This specific agreement paved the way for the twins to achieve their dream. In August 2012, the Food in addition to Drug Administration approved Auvi-Q for emergency treatment of allergic reactions.
However, on October 30, 2015, the FDA announced Sanofi’s voluntary recall of the Auvi-Q. At the time, which was comparable in cost to the EpiPen.
“The products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug,” the FDA said at the time.
Then, in February 2016, Sanofi announced a termination of its commercial in addition to development licensing deal in addition to returned all rights to Kaleo, Sanofi spokeswoman Anna Robinson said.
Though devastated by the recall, the twins used which as an opportunity to improve the device, utilizing what they called their “unique advantage” in understanding how the product works.
A turning point
Because the returned rights included both research in addition to development in addition to manufacturing, the company saw This specific as an “amazing opportunity,” explained Evan Edwards. “Immediately, we invested in improvements to the manufacturing, specifically resolving the issues which were tied to the voluntary recall in addition to then generating process improvements to not only the manufacturing systems nevertheless also our quality systems.”
In real terms, This specific means “a 100% automated robotic production line with over 100 automated quality checks on each in addition to every Auvi-Q device so we can ensure consistent reliable production process,” he said.
is usually This specific enough to convince consumers?
“To be honest, I think which health care professionals are going to want to see additional data to assure themselves as well as their patients which the safety concerns have been adequately addressed,” said Tonya Winders, president in addition to CEO of the Allergy in addition to Asthma Network, a nonprofit patient organization founded in 1953.
“in addition to I think which will be coming. which’s my understanding they’re doing additional safety studies to demonstrate which consistency of dosing,” she said.
Auvi-Q may be able to capitalize on its chief rival’s failures with respect to consumer costs.
“We understand which cost is usually absolutely central to This specific conversation,” said Spencer Williamson, CEO of Kaleo. The company is usually in talks with all of the stakeholders, including “wholesalers, insurance companies in addition to pharmacy benefit managers,” he explained, in an effort to “implement an access program” which will provide availability in addition to affordability for patients wanting to use Auvi-Q.
The cost tag may very well be crucial to success in light of the firestorm which descended on Mylan Inc., maker of the EpiPen autoinjector, in August.
At which time, outraged consumers had protested rising costs: The cost of an EpiPen standard two-pack, which cost about $100 in 2009, had gradually increased to about $0 This specific year.
According to the Senate Judiciary Committee, the Centers for Medicare in addition to Medicaid Services warned Mylan on several occasions which which had misclassified the EpiPen. which misclassification allowed Mylan to underpay the government for Medicaid rebates, resulting in taxpayers in addition to states being overcharged for the product.
Beginning in late August, Mylan began to offer instant savings cards to defray up to $300 of consumers’ out-of-pocket expenses. Whether This specific move helped smooth things over with the customer base remains unclear.
Kaleo hasn’t said how much which will charge once Auvi-Q returns to the market. nevertheless the Edwards twins know which their product needs to be easy to use in addition to safe.
“We know which various other families in addition to their loved ones are going to be counting on the safety in addition to reliability of This specific epinephrine auto-injector,” Eric Edwards said. “which is usually why we’re striving for flawless manufacturing: knowing we may have to use This specific on our own child one day.”