Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU

The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector

Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary

As reported in our previous post, at the end of last year, the European Commission published a draft amendment to Regulation No 847/2000 regarding the concept of “similar medicinal product” for the purposes of the Orphan Medicinal Products Regulation. Last week, the final Regulation was published: Regulation (EU) 2018/781. The new Regulation

On 22 March 2018, the European General Court handed down its judgment in Case T-80/16 Shire Pharmaceuticals Ireland v EMA.  Shire had sought annulment of the EMA’s decision refusing to validate its 2015 application for designation of its medicinal product Indursulfase-IT as an orphan medicinal product for the treatment of Hunter Syndrome. This decision is particularly important for innovator companies who invest in R&D for rare diseases, and will likely have an impact on incentivizing this type of research.

Background

In 2001, a Shire product containing the active substance idursulfase was designated as an orphan medicinal product for the treatment of Hunter Syndrome. This was followed in 2007 by the grant of a marketing authorisation for the medicinal product Elaprase, containing the active substance idursulfase, and administered as a solution for intravenous infusion. In parallel, Shire started developing another medicinal product containing the same active substance. However this product, Idursulfase-IT, could be delivered intrathecally, whereas Elaprase did not cross the blood-brain barrier. Intrathecal administration of the new product allowed treatment of cognitive disorders associated with a severe form of Hunter Syndrome.


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