Challengers eye a piece of EpiPen market as pricing scandal engulfs Mylan

Amid a tidal wave of backlash from politicians, media, consumers and others over its prices for EpiPen, Mylan Monday said it would roll out a generic copy of the star product. But other products are aiming to hit the market--and they could trigger real competition in a field where Mylan has been playing solo.

Kaléo Pharma, the Richmond, VA-based maker of former competitor Auvi-Q, is on the task. So is Imprimis Pharmaceuticals, the compounding pharmacy that saved the day for Daraprim patients after Martin Shkreli’s Turing Pharmaceuticals sent the price of their med through the roof.

Kaléo, for its part, is “in the process of evaluating when and how to bring Auvi-Q back to individuals and families with life-threatening allergies.”

“We are very humbled by the outpouring of interest and support we have received from patients, family members and healthcare providers about the potential return of Auvi-Q to the market,” the company told FiercePharma in a statement.

When it came along in 2013, Auvi-Q was EpiPen’s first serious challenger in 25 years. With automated voice instructions to help users with injections--along with Big Pharma commercial muscle from marketing partner Sanofi--industry-watchers thought the newcomer might just be able to ruffle the feathers of Mylan’s blockbuster.

But last year, an injector fault triggered a widespread recall of the product. The French drugmaker balked, pulling the product altogether and walking out on Kaléo.

Now, if Kaléo wants to make a comeback, it’ll have to decide whether it can go it alone on the commercial front or try to lure another Big Pharma into a partnership--both of which can prove difficult tasks.

It's not the only one with an eye on breaking up Mylan’s market control, however. Imprimis has been working on a compounded EpiPen alternative for “several months,” CEO Mark Baum told FiercePharma in an interview, and it’ll be “significantly lower in cost” than the original.

What’s more, Baum said, his company intends to resolve one of EpiPen’s challenges. “The data out there shows that children are often overdosed or underdosed,” he said. “The product we intend to put out will be more customized based on the individual needs of the patient”--meaning a child who weighs 50 pounds won’t receive the same dose of epinephrine as a child who weighs 100 lbs.

And because Imprimis is a compounding pharmacy, its product--assembled from already FDA-approved components--won’t have make its way through an FDA approval process, the company says.

That would be a big leg up, considering the track record other challengers have faced: Generics giant Teva received a rejection from the agency for its generic version, with regulators citing “certain major deficiencies." And more recently, the FDA stopped Adamis--maker of a prefilled epinephrine syringe candidate--in its tracks with a request for more data.

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