03:47 - Source: CNN

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Kaleo says it will reintroduce its an epinephrine autoinjector in the first half of 2017

The company says it has corrected manufacturing issues that led to a recall last year

CNN —  

Pharmaceutical company Kaleo said Wednesday that it will reintroduce its compact epinephrine autoinjector to the US market in the first half of 2017. Auvi-Q can be used to treat life-threatening allergic reactions, including anaphylaxis, by delivering epinephrine to help relax muscles, open airways and reduce swelling triggered when the body has an allergic reaction.

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.

Introduced in 2012, Auvi-Q was recalled in 2015 amid concerns that the product was not delivering an accurate dosage of epinephrine.

A personal stake

The product was created by Eric Edwards, a doctor, and Evan Edwards, a mechanical and systems engineer, twin brothers who both have serious food allergies.

“This is a product that’s very personal to Evan and I,” Eric Edwards said. “We grew up with life-threatening food allergies, and 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 in the industry. The “talking autoinjector” instructs a user through the entire process of injection. Auvi-Q, which is about the size of a credit card and the thickness of a cell phone, also has 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 world.

This agreement paved the way for the twins to achieve their dream. In August 2012, the Food and Drug Administration approved Auvi-Q for emergency treatment of allergic reactions.

Intelliject changed its name to Kaleo – from the Greek word for “purpose” – in 2014.

However, on October 30, 2015, the FDA announced Sanofi’s voluntary recall of the Auvi-Q. At the time, it was comparable in price 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 and development licensing deal and returned all rights to Kaleo, Sanofi spokeswoman Anna Robinson said.

Though devastated by the recall, the twins used it 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 and development and manufacturing, the company saw this as an “amazing opportunity,” explained Evan Edwards. “Immediately, we invested in improvements to the manufacturing, specifically resolving the issues that were tied to the voluntary recall and then making process improvements to not only the manufacturing systems but also our quality systems.”

In real terms, this means “a 100% automated robotic production line with over 100 automated quality checks on each and every Auvi-Q device so we can ensure consistent reliable production process,” he said.

Is this enough to convince consumers?

“To be honest, I think that health care professionals are going to want to see additional data to assure themselves as well as their patients that the safety concerns have been adequately addressed,” said Tonya Winders, president and CEO of the Allergy and Asthma Network, a nonprofit patient organization founded in 1953.

“And I think that will be coming. It’s my understanding they’re doing additional safety studies to demonstrate that consistency of dosing,” she said.

Winning customers

Auvi-Q may be able to capitalize on its chief rival’s failures with respect to consumer costs.

“We understand that price is absolutely central to this conversation,” said Spencer Williamson, CEO of Kaleo. The company is in talks with all of the stakeholders, including “wholesalers, insurance companies and pharmacy benefit managers,” he explained, in an effort to “implement an access program” that will provide availability and affordability for patients wanting to use Auvi-Q.

The price tag may very well be crucial to success in light of the firestorm that descended on Mylan Inc., maker of the EpiPen autoinjector, in August.

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At that time, outraged consumers had protested rising costs: The price of an EpiPen standard two-pack, which cost about $100 in 2009, had gradually increased to about $600 this year.

According to the Senate Judiciary Committee, the Centers for Medicare and Medicaid Services warned Mylan on several occasions that it had misclassified the EpiPen. That misclassification allowed Mylan to underpay the government for Medicaid rebates, resulting in taxpayers and 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 move helped smooth things over with the customer base remains unclear.

Kaleo hasn’t said how much it will charge once Auvi-Q returns to the market. But the Edwards twins know that their product needs to be easy to use and safe.

“We know that other families and their loved ones are going to be counting on the safety and reliability of this epinephrine auto-injector,” Eric Edwards said. “That is why we’re striving for flawless manufacturing: knowing we may have to use this on our own child one day.”