25th Jun 2014 12:56
LONDON (Alliance News) - Shire PLC got a big boost Wednesday when a US District Court ruled that patents protecting its best-selling drug, its Vyvanse treatment for Attention Deficit Hyperactivity Disorder, had been infringed by five pharmaceutical manufacturers looking to bring out generic competitors.
The ruling means Shire's exclusivity over the treatment is protected until the patents end in 2023, unless the generic competitors successfully appeal.
The five manufacturers - Actavis, Amneal Pharmaceuticals, Mylan Pharmaceuticals Inc, Roxane Laboratories Inc, and Sandoz Inc - had filed applications seeking permission to be allowed to launch generic versions of the drug.
The ruling covered patents over Vyvanse's active ingredient, lisdexamfetamine dimesylate, and a method of using lisdexamfetamine dimesylate for the treatment of Attention Defecit Hyperactivity Disorder.
The ruling is a boost for the pharmaceutical company as it fends off a takeover approach from US-based AbbVie Inc. It has so far rejected three approaches from its suitor, the last of which was worth GBP27.2 billion.
Vyvanse is the biggest seller in Shire's portfolio, netting sales of USD351 million in the first quarter to end-March. By securing exclusivity over the product for as long as possible, Shire improves its chances of bringing another big seller from its pipeline to commercialisation.
Shire recently received a request from the US Food and Drug Administration that the company study the potential use of Vyvanse for the treatment of ADHD in preschool-age children aged 4 to 5, which would allow it to get a six month extension to its patents for Vyvanse under the Best Pharmaceuticals for Children Act.
Shares in Shire were trading up 1.6% at 4,474.00 pence Wednesday afternoon.
By Alice Attwood; [email protected]; @AliceAtAlliance, and Hana Stewart-Smith; [email protected]; @HanaSSAllNews
Copyright 2014 Alliance News Limited. All Rights Reserved.
Related Shares:
Shire