It is going to be an eventful summer for the Danish biotech company Veloxis, and the most crucial event will be data from the 3002-study with the drug candidate LCP-Tacro – data which determines whether or not the FDA will approve the drug for the US market.

“We still have not set a date for when we will submit applications to EMA and FDA. We are working on it and we are still busy preparing the application. We expect data in the summer, and from our point of view that is a huge event,” CFO Johnny Stilou tells Medwatch.

And it also seems to be a huge event to investors and analysts.

Crucial study

“It is crucial to the investment case that this pivotal study delivers, and that is what we are all waiting for,” says analyst Thomas Bowers from Danske Markets.

The active substance in LCP-Tacro, tacrolimus, is already known from Astella’s drug, Prograf, so the analyst will be very surprised, if the candidate – for treating side effects from kidney transplants – will face any setbacks in the study.

“It is crucial that they can differentiate it from Prograf, and that remains to be seen in marketing studies later on. I see no great risk of this study not providing the positive data we hope for. Especially because it is a double-blinded study, so there will be no potential bias from doctors.”

Veloxis managed to secure 405 million kroner (USD 72 million) through stock dilution in November of 2012, just as the company has signed a partnership deal with the company Chiesi concerning marketing and distribution of LCP-Tacro on the European market.

Walking a tightrope

“Our strategy entails us marketing LCP-Tacro on the North American markets ourselves, while we enter into partnership deals, like the one with Chiesi, in Europe and the rest of the world,” Johnny Stilou explains.

But the strategy is dependant on the US launch going as planned, says Thomas Bowers.

“If they manage to market the product in the US according to the base case-scenario, it is likely that they can see it through without securing additional funds. But if the US launch is slower than anticipated, it will also take longer for them to reach a break-even cash flow. They are walking a tightrope at the moment,” he says and elaborates:

“Of course the Chiesi deal helps, as there are milestone payments, royalties and other guaranteed payments along the way.”

- translated by Martin Havtorn Petersen