In April 2006, Susan Murray, Senior Editor with IMS Company Profiles, interviewed Andreas Barner, Head of R&D at Boehringer Ingelheim. This excerpt (the full interview is available in the Profile) focuses on some of Boehringer's key R&D projects.
IMS: "I imagine that you are very excited about dabigatran etexilate. It seems like a strong compound in major Phase III studies and, especially now that AstraZeneca's Exanta (ximelagatran) has failed, it seems that it will represent a major opportunity for Boehringer Ingelheim. Could you please tell us about this compound and its current status?"
Andreas Barner: "Dabigatran, our oral thrombin inhibitor, is in Phase III now and we are testing it in the indication of thrombosis in patients who have undergone surgery. We expect to file for registration in 2007. As far as we can judge, these Phase III trials are going well. We have also begun a large Phase III programme in the indication of stroke prevention in patients with atrial fibrillation. We have 27,000 patients all in all in the dabigatran trial, and 15,000 patients being tested for the stroke indication. It is a huge programme."
IMS: "Stroke represents a major unmet medical need, I think?"
AB: "Yes, stroke continues to be one of the most common causes of disability in all countries, and the problem is that the incidence of atrial fibrillation is increasing because of the ageing population. Treatment with parenteral medications like low molecular weight heparin is not feasible in the long term, and the alternative is the oral medication warfarin. This is a tricky issue for the physician and the patient because if you overdose, there is the problem of bleeding, and if you under-dose the atrial fibrillation parameters go up fairly rapidly.
“Therefore, people have been looking for quite a while for something which is easier, and that could be dabigatran. Now, we believe we have a distinct safety profile advantage over Exanta and this is why we are continuing with this programme. The real problem with Exanta was the hepatic events. The question which we have to address is whether our dabigatran etexilate is comparable to warfarin and in addition better and safer than Exanta. That is what we are now testing and want to demonstrate in a number of different indications [the prevention of DVT after knee/hip replacement surgery, acute DVT treatment and the secondary prevention of DVT].”
IMS: "And obviously, dabigatran has the potential to become another blockbuster for you?"
AB: "If you think that there are even further possible indications, we have a very special drug with a huge potential, which of course would also have been the case for AstraZeneca if things had worked out with Exanta."
IMS: "I also wanted to ask you about flibanserin, which is now also in Phase III trials for female sexual dysfunction or hyposexuality."
AB: "I think it is important to recognise that there are patients who need this type of drug, if you think about the fact that 30-40% of all couples don't have children even though they want to. Of those who want children, but don't have children, among this group, there is one subgroup of patients with hypoactive sexual desire for whom this drug would be valuable. And these, we hope that we can help. This is not a lifestyle drug. This is not a drug you take, then your desire changes and then you stop taking it. It will be for chronic use. It will be indicated chronically, purely for those patients who really need it. I am making this comment because it has to be viewed as being quite different to Viagra because of the mode of action, the chronic aspect of treatment and so on."
IMS: "In the future do you think the drug may also have applications in other indications as well?
AB: "No. We did look at it for various indications, but this is the indication we have decided to test it in."
IMS: "I also wanted to ask about Respimat, the new respiratory drug delivery product, and how it is progressing? I think Berodual Respimat has already been launched in Germany?"
AB: "Yes, Berodual Respimat has been launched in Germany and sales are progressing very nicely. This was an opportunity for us to see how this brand new modern delivery system would work with patients, and our experience has been very positive, we were very, very satisfied. Also, market development was very good in terms of market share. We plan to submit Respimat for Spiriva in Europe and the US this year."
IMS: "I also wanted to ask about the telmisartan and hydrochlorothiazide combination product (Micardis HCT/Micardis Plus), which I understand is being rolled out in a number of markets."
AB: "It is doing very well. This is an important product in the antihypertensive combination sector. The incidence of hypertension is increasing, with the ageing population and it is also important to note that a large percentage of patients are still uncontrolled with hypertension, or not well controlled, in many markets. Therefore, there is room for this market to develop and grow."
The full transcript of this interview is available in the latest IMS Company Profile on Boehringer Ingelheim, where Andreas Barner also talks about the potential impact of generic competition on NSAID Mobic.
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