Wednesday, March 21, 2007

Rozerem Over There? Sic 'em Beav!

Abe and the Beav are off on a European vacation...or, should I say, invasion?

Just when Europeans thought they were safe and had no problems sleeping soundly -- except, perhaps for the UK (only nominally part of the EU) -- lo and behold! comes Takeda and its insomnia medication, ramelteon (aka, Rozerem here in the US).

"Takeda Pharmaceutical Company Limited (Takeda) today announced that, Takeda Global Research & Development Centre (Europe), Ltd. submitted a marketing authorization application for insomnia medication,ramelteon, to the European Medicines Agency (EMEA) through the centralized procedure." (Takeda Press Release)

Takeda goes on to claim that "Insomnia is a serious condition that affects the daily life of around 20% of the European population. There is an unmet need for effective treatment options..."

Statistics about the prevalence rate for insomnia -- like many other "life-style" "unmet" medical needs -- are difficult to come by and vary according to the source. I found this source interesting: "Wrong Diagnosis? See for Yourself." with a list of Worldwide prevalence rates for insomnia. That source cites 11.76% for the US.

20% vs 12% -- I knew that the afternoon siesta was being phased out in Spain, but who knew that EU citizens are twice as worried as US citizens and can't get enough sleep?!

The EU ramelteon marketing team, shown here on the left at a strategy meeting in Cannes, is contemplating how best to circumvent EU anti-DTC laws to promote the product directly to EU citizens.

They are being aided and abetted by the award-winning US agency for Takeda that has been so successful circumventing FDA regulations and PhRMA DTC Guidelines here in the US (see "Takeda -- Fire These Guys!").

"If my knowledge of history is correct," said Ken Erke, member of the Cramer Krasselt/AB Rozerem ad team, "Europe, and especially the UK, threatened old Abe with war during the US civil war. I hope the EU team takes our lead and uses Abe and Beav to soften the shores over there for the ramelteon invasion. Old Abe finally will get to settle an old score!"

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