UPDATED: Activaero readies hoped-for EU launch of its first drug/device treatment

BERLIN--I met up with Christian Pangratz recently at the stylish, ultramodern lobby of the Hilton Berlin, on the edge of the Gendarmenmarkt in Germany's capital.

The Gendarmenmarkt is a massive, historic square with separate French and German cathedrals that sit symmetrically on either side of a grand concert hall--pieces of an elegant part of the city dating back to the early 1700s that are now polished for the modern age. The Hilton where we met taps into that history, but also Berlin's growing status as a place in which biotech and med tech companies do business.

Pangratz is chief business officer of Activaero, a private German company based in Frankfurt, Munich and Dublin, OH. Activaero initially launched 15 years ago as Inamed, a CRO from which it was spun off several years ago. It already has two CE-marked inhalation nebulizer devices. But it is on the cusp of seeking European approval application for Flavorestin, a drug/device combination treatment that addresses severe, end-stage asthma--its first proprietary treatment in this space. 

Activaero Chief Business Officer Christian Pangratz

Pangratz enthusiastically told me that the company is in the process of raising a little over €13 million ($17.4 million) to support that work, with a goal of finishing the round by September. The idea is to target existing investors, many of whom took part in the company's €16.8 million ($22 million) Series A round a few years back. (Angel investors contributed more funding before that.) Plans are in place to file to seek European approval by year's end. Then there's this: Europe has an opening window for IPOs in the biotechnology, device and diagnostics spaces, Pangratz says. And Activaero is seriously considering going through that window itself.

"An IPO could be within the next two to three years, depending on market conditions," Pangratz told me.

Flavorestin would rely on one of Activaero's CE-marked, proprietary nebulization devices and liquid budesonide, a glucocorticoid steroid developed initially by AstraZeneca ($AZN). It is now generic in the European Union for child and adult use, and generic for children in the U.S. Flavorestin would be approved as a therapuetic, but the primary benefit comes from Activaero's inhalation system, with the device enabling the drug.

The company is bullish about Flavorestin's prospects, based in part on a multinational, double-blind, randomized placebo-controlled clinical trial completed at 27 centers throughout Europe. Results suggested Flavorestin was superior to placebo and active control, Pangratz and the company said.

Many asthma treatments are dosed in powder form, relying on standard inhaler devices. And Pangratz said those have a drug penetration of between 10% and 30%. Liquid nebulizer inhalation would go much deeper, he argued--as high as 90%. And having a proprietary nebulizer device could give Activaero an edge as it seeks approval for its combined product. Activaero anticipates that a stronger, more penetrating device to deliver the drug in liquid form could help save the EU healthcare system money and also generate serious revenue down the line.

Expectations are that the company could become profitable within three to 5 years if those approval and fundraising timelines are met as envisioned.

There's also a U.S. approval strategy. Activaero had a pre-IND meeting with regulators two years ago to learn what it needs to do to gain FDA approval, with plans to return to the FDA at the end of this year carrying its pivotal trial data and a revised development plan. The company expects U.S. approval could take another three to 5 years.

-- Mark Hollmer (email | Twitter)

Editor's note: This story has been updated to reflect that Activaero will seek approval for its combination product as a therapeutic, and not through the CE mark process.

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