Symlin in the UK?

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Permalink Reply by Scott Strumello on March 27, 2008 at 11:30am

David, I know that Amylin Pharmaceuticals, via a subsidiary called Amylin Europe, Ltd. submitted Marketing Authorization Applications for SYMLIN(TM) (pramlintide acetate) to the European Agency for the Evaluation of Medicinal Products (EMEA) under the centralized European procedure for the authorization of medicinal products in May 2001, but so far, I am unsure whether it has been approved by the EMEA, as a search on their website using the term "pramlintide acetate" does not indicate anything. As for the UK's Medicines and Healthcare products Regulatory Agency (MHRA), I haven't investigated there, as its unclear if the EMEA and MHRA's roles overlap, although both are headquartered in London (you may have more knowledge on that).

Before the product can be sold in the UK, it must have regulatory approval, and so far, its unclear whether the company even has that. You might also try contacting Amylin Europe Ltd. at Mendelstrasse 11, D-48149 Münster, Germany (sorry, I don't have a telephone number).

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Permalink Reply by Scott Strumello on August 24, 2008 at 6:34pm

Just a follow-up here, I did read that Amylin Europe had filed a regulatory submission with the European Agency for Evaluation of Medicinal Products (EMEA) and Switzerland for pramlintide for the treatment of both type 1 and type 2 diabetes under the centralized procedure.

Amylin completed pivotal phase III clinical trials with pramlintide acetate (Symlin™) for the treatment of type 1 and type 2 diabetes mellitus in North America and Europe. However, in October 2002, Amylin announced that following consultation with the Committee for Proprietary Medicinal Products (CPMP) of the EMEA, it had found that additional information was necessary to proceed with review of the MAA for pramlintide for diabetes. However, since, the centralized procedure does not allow the adding of new information to the application that is already under review, Amylin decided to withdraw the MAA for pramlintide. The company was planning to continue discussions with the EMEA to clarify the information required for a resubmission of the application, so its unclear where thing stand presently. I would suggest visiting Amylin, Inc.'s Investor Relations website at http://investors.amylin.com/ for more information.

However, you should know that Byetta is the product Amylin is really pushing for approval in Europe; they see a potential goldmine with that, while Symlin is likely to be smaller, thus does not have the same level of company priority.

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