Posted by gpznos on February 7, 2013, at 7:10:29
This is a google translate from Danish, published yesterday. If something is too unclear I can explain it correctly as I am Danish (as Lundbeck, the manufacturer is):
Lundbeck: New antidepressant will come on the market
Pharmaceutical & Biotech:
"We will be mighty surprised if there is a problem," said Lundbeck's Executive Director on the company's next potential bestseller.
By Ritzau Finance
Published 06.02.13 at. 13:20
Lundbeck's confidence is great when it comes to the authorities' treatment of applications for registration of the company's next antidepressant Brintellix. The risk that the authorities impede the launch, management estimates that low.
"We will be mighty surprised if there is a problem," says CEO Ulf Wiinberg Wednesday at a press conference.
CFO Anders Götzsche adds:
"To get an approval in Europe, Canada and the United States, we consider not as a hurdle., There is nothing we can see in front of us who had to do that we do not get a permit. There are many times that mixed data do that you are in doubt, but here we are pretty confident. "
Antidepressant has a new unique mechanism of action that Lundbeck believes to be interesting for those patients who do not respond to the usual antidepressants of the SSRI type or SNRI. At the same time, the safety profile of Lundbeck advantageous. Among other things, reducing agent is not libido to the same extent as the usual antidepressants are known.
Launched in the coming years
Brintellix, developed in collaboration with Takeda, expected to be launched in late 2013 or in 2014.
Sales potential will depend among other things on whether Lundbeck able to show that Brintellix improves patients' cognition and ability to concentrate and focus. It has preclinical studies and a study in elderly patients shown.
"We also have a few other studies (in other patient groups, ed.), We get results this year, and it is clear that they fall also positive, so goes Brintellix from a common antidepressant to something the other can not. But we must first have the results, and then we discuss with the authorities how it will go with the leaflet, "explains Ulf Wiinberg.
Predicts blockbuster status
He predicts a topsalg of around 5 billion. million, or 1 billion. dollar if the cognitive improvements are not part of the package insert. Sales could reach double that if the studios are settling out.
"But I've been so long in the industry now, and the only thing that is certain is that every time you try to give accurate sales estimates before you know leaflet and have entered the market, it takes always wrong. Either you sell much more or much less, "says Ulf Wiinberg.
He says, moreover, that any kognitionsdata hardly comes into the first label for Brintellix. This is because the registration applications do not contain the necessary data. Therefore, it becomes a discussion that must be taken with the authorities later.