Schizophrenia Daily News Blog

Lundbeck Pharma Update

Excerpts from the Q1 2005 H. Lundbeck A/S Earnings Conference Call

DR. CLAUS BRAESTRUP, PRESIDENT AND CHIEF EXECUTIVE OFFICER,
H. LUNDBECK A/S
...

DR. CLAUS BRAESTRUP: I think that I will start, this is Claus Braestrup, on the question number 2 about Sertindole in the United States while somebody else is looking for some of the numbers you are asking for. And for Sertindole we have now achieved the approval in 25 European countries and in the United States we have at an earlier point and we've also stated that in public at a meeting with the FDA at which meeting the FDA stated that there would be nothing in principle against an approval of Sertindole in the United States but they would require certain further investigations and that they will also require a conclusion from the European Union regarding the reintroduction in Europe.

   With the reintroduction now decided in Europe we intend to return to the FDA and discuss potential plans of how we can introduce such Sertindole in the US. We have not yet decided whether these plans will be acceptable to us and whether we will follow that avenue. In case we follow the avenue of introducing Sertindole in the US, we will have to wait a couple of years before we will be in a position to do that and we have not made any predictions or expectations in regard to our potential revenues from the US.

   POUL LYKKESFELDT, ANALYST, ABN AMRO: The last question is will Bifeprunox and Gaboxadol can you tell us what time of the year we are likely to see clinical data from those two projects please?

   DR. CLAUS BRAESTRUP: And finally for Gaboxadol and Bifeprunox we have announced that we'll have data available in the second half of this year, which we certainly expect that we will have.

  
   ANNETTE RYE LARSEN, ANALYST, HSH GUDME: Yes it's Annette Rye Larsen from HSH Gudme I have two questions. The first question regards to Sertindole in Europe. Could you give us some flavor of what your own expectations are in terms of pricing of the product and also what kind of label we should expect? Will Sertindole get the same kind of black box warnings that we have seen on the other antipsychotics and then my second question relates to the R&D cost, if you could also give us some idea about the development the remaining quarters of the year, is that something in particular we should be aware of in terms of effects exceptional high R&D cost in any of the quarters? Thank you.

   DR. CLAUS BRAESTRUP: This is Claus Braestrup again the price for Sertindole will be at the same level as the other atypical antipsychotics. We don't have all the detailed prices but we have price in some countries. Regarding the label we will have the same warnings that other antipsychotics hold that's clear and then on top of that the label will indicate that doctors should use one other antipsychotic before they embark on the use of Sertindole and they should also make sure that the EKG or the cardiac rhythm of the patient doesn't hold a high QT level. With that restrictions we expect that Sertindole will be a very valuable product for a number of patients who will fare particularly well on Sertindole compared to others but we don't expect that Sertindole will take a major inroad in the antipsychotic market.

   HANS HENRIK MUNCH-JENSEN: Regarding the R&D cost, we would have see during the rest of this year that the R&D cost will be going up, we can't point to any particular quarters where the R&D cost will be unusually high, it depends on when the clinical trials are initiated deprive the patient recruitment through these trials so it will gradually over this remaining part of 2005 approach the level around to 20%.

   HENRIK SIMONSEN, ANALYST, ENSKILDA SECURITES: And also I was wondering on Serdolect have you had any and anecdotal feedback from psychiatrists to the possible return or to the return of Serdolect into the market?

   DR. CLAUS BRAESTRUP:

   For Sertindole it is very anecdotal what we have. But our contacts among psychiatrists in each individual country where the product was available the psychiatrists tells us that they have individual patients who were very well helped by that product and patients who were actually not in a position to do well with the disease with other products, and that means that we feel certain that there will be a number of patients that will have a major benefit out of Sertindol. But on the other hand the product will be more complicated to use than atypicals, which again means that there will be a restrictions to its use.

For more information: Serdolect and Bifeprunox

Lundbeck web site