Shire says that it has decided to withdraw a submission to regulators in Europe for Daytrana, its patch for attention deficit hyperactivity disorder.
The company says that the decision to pull its marketing authorisation application is due to the fact that regulators had requested an additional clinical study on Daytrana (methylphenidate) in a European patient population. Also, the recent acquisition of non-US rights to the instant- and extended-release versions of UCB’s ADHD drug Equasym (methylphenidate) has led to a shift in strategy.
Shire insisted that the decision to withdraw the MAA does not impact its commitment to Daytrana across the Atlantic where the product has been used as a paediatric treatment since 2006. The company believes that Equasym IR and XL will provide it with an entry to the European ADHD market once the 55 million euro deal is completed in the second quarter.
Equasym XL is currently available in countries including Denmark, Finland, Germany, Ireland, the Netherlands, Norway, Sweden and the UK, and a number of additional launches are planned in other European markets. The UCB deal also “establishes a solid bridge for Shire’s other ADHD treatments”, the firm said, notably Vyvanse (lisdexamfetamine dimesylate), and two European trials of the latter are being enrolled.
Barr sued over Fosrenol patents
Meantime, Shire has filed a lawsuit against Teva’s Barr Laboratories unit claiming infringement of three patents on its kidney disease drug Fosrenol (lanthanum carbonate). The move is in response to Abbreviated New Drug Applications filed by Barr and Mylan seeking approval in the USA to sell its generic versions of the drug which is used in the control of hyperphosphataemia in chronic renal failure patients on dialysis.
Because Shire filed its lawsuit within 45 days of receiving Barr and Mylan’s Paragraph IV notification letter, the US Food and Drug Administration cannot approve the ANDA for 30 months, starting from October 26 this year, or until a court finds that the patents are invalid or not infringed. Shire said that it is confident in its intellectual property portfolio protecting Fosrenol “and will enforce its patents against infringers to the fullest extent allowed by law”.
Patents on the compound run up to 2018-2024, Shire concluded. Fosrenol contributed $33.2 million to Shire’s fourth-quarter revenues.
