Further to what I have posted today and to roughly corroborate what riskman said, I received additional clarification from Astra by E-mail a short time ago.
>>I am sorry to say that I cannot give you an exact time schedule for the launch in Europe, but officially we have said that Muse will be
introduced/launched in most major European countries by 1999. On July 1 this year, it was launched in Sweden. According to the specialists here at Astra, the changes I mentioned to you - and other similar measures - are not uncommon. Since Muse got an OK in the UK (November 1997), this is our reference country. To save time, we have wanted to clear every detail/change with the British authorities before introducing Muse in too many countries. The process could take longer then. For now, this is what can be said in this matter. Exactly when the MR procedure will start/end is something I cannot comment on, but the admittedly vague time table mentioned above is not in danger.>>
This was not all completely clear to me so I have in addition phoned the EMEA:
Pfizer went for the Centralised procedure, Vivus/Astra for the Mutual Recognition (MR) procedure.
The former procedure is particularly useful for a new patented drug where the company wants Europe wide approval simultaneously for all countries. One risk is blanket rejection and delay, something that Vivus/Astra would have avoided going for MR.
Having in sight European approval, the centralised procedure is generally more rapid than MR. However getting the first country approval (UK for muse) with MR is generally more rapid than getting the pan-European approval with the centralised procedure. Thus the MR approach can be advantageous where a company identifies and wishes to exploit a single big national market within Europe, and this can often be useful when the drug is not patented. In the MR procedure the additional countries get approved as and when what national/EC criteria are satisfied. The timescale could be variable. So my understanding is that although there can be a very good expectation that all the EC country approvals will come shortly we cannot say exactly when.
So as far as I can see Vivus/Astra took a less risk free approach, getting UK sales going quickly, Astra could presumably get an idea of the potential, but on the downside overall EC approval is delayed.
In the end I think none of us can say with confidence that prior approval of viagra in a country will necessarily be a bad or good thing for muse sales. Who knows, could be good because muse sales could build up in an environment free of the negative perception created by loss of muse sales - just rambling/guessing.
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