Yesterday, Danish company Veloxis presented positive data from a pivotal phase III study of main asset, LCP-Tacro. And, although analyst Thomas Bowers, Danske Markets, said the results were expected, it is nevertheless a significant milestone.
“They made it with this study. On the face of it, it is no surprise. We have seen previous data sets that also pointed heavily in this direction, for example last year’s phase III study. In a way, it was expected, but it is naturally a very important milestone for the company. Now, they have taken a crucial step closer to final approval and the possibility of marketing the product.”
Friday morning the share reacted heavily to the news, jumping 50 %. But before noon it had dropped back to DKK 0,75 – an increase of 25 %.
As good as approved
“Someone has traded the share up, but I cannot really comment on why the share rises like this. From my point of view, this result is very good and an important milestone, but it is also data which is in line with my expectations,” the analyst says about the drug, which is aimed at preventing organ rejection in kidney transplants, adding:
“This was the biggest hurdle to push past. It was the study that U.S. authorities had said according to the SPA agreement was crucial for the approval or denial of the product. And, as I said, they made it. So based on the data before us – and assuming no unexpected surprises crop up, as they dig deeper in the data – it currently looks like a product that is as good as approved.”
Important events are scheduled for next month, which Thomas Bowers says might have an even bigger significance for the company.
A rival-drug from Japanese company Astellas Pharma is due to receive a decision from the FDA on its registration application on July 21.
“It is their once-daily product, Advagraf, which they have marketed in Europe over a number of years and are now trying to win approval for in the U.S. This is their fourth or fifth go at it, but now they have a data pack with five years of safety data, so presumably there is a good chance authorities will grant approval. Of course, that can be crucial to Veloxis’ product launch,” he says, elaborating:
“We see Advagraf as an inferior once-daily, and the company has had some problems with it, which is why U.S. authorities are not exactly thrilled with it. But you should bear in mind that Astellas markets the leading product, Prograf, and it is Big Pharma, so they naturally have a certain impact on the market.”
If approved in July, everything points to a launch this year, says the analyst, which means the product will have about a year’s head start.
“But you also have to keep in mind that Chiesi has struck a deal with Veloxis on the European market, although Astellas’ product has been in Europe for years. They are of course a rival, and all things considered they will take market shares from Veloxis. We know that the drug works and the profile looks good – the greatest risk is commercial.”
- translated by Martin Havtorn Petersen
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