It is a happy executive Medwatch is able to catch on the phone in the middle of his summer holidays; Jens Bager has just received positive news about the second pivotal phase III study with the company’s tablet vaccine against house dust mite allergy.
“It’s obviously positive, also in regards to the fact that we saw positive results from the other, very large study assessing the efficacy of the vaccine on allergy in the upper respiratory tract. And now we have also shown that the vaccine has a great effect on allergy in the lower respiratory tract. It reinforces the registration application we are able to submit to European authorities next years," he says, adding:
“We have a stronger product that can treat dust mite allergy in both the upper and lower respiratory tracts. That’s one of the positive aspects. The other is that it's positive in connection with the partners, who are investing a lot of effort and money in clinical studies in the U.S. and Japan at the moment. This offers a great indication that it probably also has a good chance of showing an effect in American and Japanese patients. So it reinforces our possibilities in Europe, but certainly also in the U.S. and Japan.”
Expanding the indication
The results of the first study were so strong that they alone could have led to an approval, the ALK chief believes.
“This is really an expansion of the indication. We add additional arguments to how patients and the general society can benefit from this treatment.”
In last week’s stock market release presenting the positive results, the company explained that it expects to apply for European approval in 2014 – and Jens Bager is not able to offer a narrower time frame than that.
“We are working as fast as humanly possible, and so far the guidance is that we will submit the application in Europe in 2014. I won’t narrow it down any more than that until our preparations are further along. Afterwards, we expect about a year of review time from the authorities, and then the product can be ready for launch in 2015.”
Greatest potential in the U.S.
The biggest potential for the tablet vaccine is in the U.S., followed by Japan, says the CEO.
“There is a very big, unused potential in Japan as well. There is also a great potential in Europe, but we probably view the opportunities for the house dust mite tablet as larger outside of Europe.”
In Japan, two phase III studies, designed to be similar to the European ones, will conclude next year. In the U.S., ALK’s partner, Merck, is in the process of recruiting patients for a major phase III trial aimed at allergy in the upper respiratory tract in children and adults. The 12-month study is due to be initiated at the end of this year or the beginning of the next.
Greater commercial opportunities
A few months back, U.S. partner Merck submitted registration applications for vaccines against ragweed allergy and grass pollen allergy.
“If you look at the number of patients on a global scale, the potential is far greater for the house dust mite vaccine than for the other two, as it is a global year-round condition. Pollen is partly seasonal and, while grass pollen is a North American and Northern European phenomenon, ragweed is common in North America, but very few other places in the world,” he says and adds:
“That’s also why we see this as something positive; because it gives the company greater commercial opportunities. It’s a really great announcement to receive. It’s a great present in the middle of the summer holidays.”
- translated by Martin Havtorn Petersen
Want to receive the latest news from Medwatch straight in your e-mail inbox? Sign up for our free english newsletter below.