Amevive Rejected in Europe.!

[peterb]

Biogen psoriasis drug rejected in Europe
Reuters, 02.20.03, 9:21 AM ET
NEW YORK (Reuters) - Biogen Inc. said Thursday that its drug for the skin disorder psoriasis, which was recently approved in the U.S., has been rejected by European regulators, who requested additional information that could take the company several years to gather.

Biogen, which is based in Cambridge, Massachusetts, said the decision should have no impact on its 2003 financial results, but it will be evaluating the impact on its financial projections for 2004 and beyond.

The drug, Amevive, is the second product that Biogen has had approved in the U.S. Its flagship product is the multiple sclerosis drug, Avonex.

Analysts had hoped sales of Amevive could offset declining sales of Avonex, which is suffering amid increased competition.

[Gary]

Just an observation.

I feel that the "seal of approval" from the NPF, which is widely known as America's largest educator on psoriasis, was one of the reasons Amevive went from being a year or so away from approval in the US - to only about four months.

Even though some may think their reach is worldwide, the NPF is just a *national* non-prof, they really don't hold much clout when it comes to convincing other countries about accelerating the release of a potentially dangerous biological treatment.

[Nick]

I couldn't agree more Gary.
It has to be remembered that the NPF is directed to the US environment and, as you say, has little influence outside that.

Also, here in the UK we have a little known of body called the Medicinces Control Agency . It's a government body that overseas every new drug for introduction into the UK market place and they have a reputation for being incredibly strict, even on domestic brands.

Add to that then the additional line of beaurocracy that EMEA adds and it's a wonder we even managed to get Aspirin admitted.

[Philip]

... and then we in the UK also have those nice people at NICE http://www.nice.org.uk who then provide guidance on whether a drug can be obtained on the NHS.

Although I'm disappointed, I agree that sometimes the FDA are just a little too quick to license things ...

[Gary]

Also, here in the UK we have a little known of body called the Medicinces Control Agency .

Is that the UK equivalent of the FDA (sans the Food)?

[Nick]

Is that the UK equivalent of the FDA (sans the Food)?

That's right Gary, only these guys wear Bowler hats, carry umbrellas even in the middle of summer and live in Surbiton or Kensington -  what! what! what!  

Usually they answer to the name of Gerrald or Peers, are members of a "club" and insist on calling their mother "Mater".