Shire Pharmaceuticals: Anagrelide granted orphan drug status in EU
Shire Pharmaceuticals Group plc (LSE: SHP.L, NASDAQ: SHPGY) announces that the European Commission has granted orphan designation to anagrelide for the treatment of essential thrombocythaemia. This designation covers the EU, plus Norway and Iceland, and confers up to 10 years market exclusivity for the product following Marketing Authorisation Approval.
Orphan drug status already applies to anagrelide in the US, where market exclusivity is available until 2004 and in Japan where it will run for 10 years following marketing approval. Anagrelide is successfully marketed by Shire in the US and Canada under the Trade Mark, Agrylin. The product has also been registered and is available through distributors in South Korea, Switzerland, Israel, South Africa and Australia. It is under development for other markets and is currently at Phase III in Europe and Phase I in Japan.
Dr Wilson Totten, Group R&D Director of Shire, commented, “We are delighted with this grant of orphan designation for anagrelide in Europe. It means we now have valuable market exclusivity protection for the three major marketing regions of the world. Development work continues in Europe and Japan to gain the necessary marketing approvals and we look forward to being able to provide a new treatment for this debilitating and life threatening condition in these regions.”
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