If you read the transcript att the last part of taking questions, how much does value does one see if dacogen is approved in the eu for aml ? Not sure and its on a name to name basis. so not only is the product confine to a certain subset group its on a name to name basis. Wow we should sell alot. I believe its why the stock is not up but will be down shortly.
You definitely having a reading problem. Do you undertstand the term "at this time?"
The person asking the question was trying to figure out if currently was dacogen being used in aml, if so then we wouldn't see any increase in sales, but by the answer it is clear that dacogen for aml is not being sold as of yet. Here is the actual question, maybe you should practice reading this a few times:
Boris Peaker - Oppenheimer & Co. Inc., Research Division
I have a couple of questions. Maybe let's start with AML, elderly AML. Could you give us a sense of if and how much use of Dacogen there may be in elderly AML in Europe at this time?
James S. J. Manuso - Chairman and Chief Executive Officer
At this time, it would only be on a named patient basis and perhaps Dr. Azab can address that.
AT THIS TIME....very important that you comprehend this. I guess you need the share price to fall, so you can buy it back.
with respect to numbers, it appears we,aka J&J Cilag, aka the sponsors, estimate less than 46,000. See the EMEA site:
What is the estimated number of patients affected by the condition*?
According to the information provided by the sponsor, acute myeloid leukaemia was considered to affect less than 46,000 persons in the European Union.
*Disclaimer: For the purpose of the designation, the number of patients affected by the condition is estimated and assessed based on data from the European Union (EU 25), Norway, Iceland and Lichtenstein. This represents a population of 59,700,000 (Eurostat 2004). This estimate is based on available information and calculations presented by the sponsor at the time of the application.
What are the methods of treatment available?
Treatment for leukaemia is complex and depends on a number of factors including the type of leukaemia, the extent of the disease and whether the leukaemia has been treated before. It also depends on the age, the symptoms, and the general health of the patient. The primary treatment of acute myeloid leukaemia is chemotherapy (using drugs to kill cancer cells). Several products were authorised for the condition in the Community at the time of submission of the application for orphan drug designation.
Decitabine might be of potential significant benefit for the treatment of acute myeloid leukaemia, because it may act in a different way than other medicines, which might potentially be easier to use in the older patient population. The assumption will have to be confirmed at the time of marketing authorisation. This will be necessary to maintain the orphan status.
<<According to the information provided by the sponsor, acute myeloid leukaemia was considered to affect less than 46,000 persons in the European Union.>>
How much does a month of Dacogen treatments cost? I have a vague recollection that it is in the $900 range.
So if all 46000 patients take Dacogen, JNJ would see 41 million of revenues per month and 120 million in a quarter. At 22.5% royalties, the company would see 28 million of royalties.
Now, these numbers are extreme and certain to be off. Let's say they are off by a factor of ten. That would give us 2.5 million of royalties in the quarter and increasing as sales pass 250 million annually.
That would lead to an annual revenue revision of greater than 10 million.
This would approach a 20% increase in revenues and more than 10 cents added to the bottom line.