Neurocrine Biosciences exercises option to license Idorsia's novel treatment for rare pediatric epilepsy - Seite 2

About the license and collaboration agreement
In 2019, Neurocrine Biosciences paid a $5 million upfront fee to Idorsia for the option rights to
ACT-709478 and a preclinical research collaboration. In May 2020, upon Investigational New Drug (IND) application acceptance by the US Food and Drug Administration (FDA), Neurocrine Biosciences exercised the option to license ACT-709478. The exercise of the option triggered an upfront payment of $45 million in cash from Neurocrine Biosciences to Idorsia. In addition, Neurocrine Biosciences will provide an incremental $7 million in funding to Idorsia as part of the research collaboration to discover, identify and develop additional novel T-type calcium channel blockers.

The agreement is subject to the following terms:

• ACT-709478 milestones: In addition to the up-front payment, Idorsia may also receive up to $365 million in additional development and regulatory milestone payments. Furthermore, Idorsia may also be entitled to one-time commercial payments based on sales thresholds.
   
• ACT-709478 royalties: Idorsia will have the right to receive a tiered royalty ranging from the low double-digits to upper teen percentage in the US and a tiered royalty at slightly lower rates outside the US based upon aggregate global net sales.
   
• Preclinical research collaboration: The parties will work together to identify novel T-type channel blockers and explore their use in potential new disease states. Idorsia may be entitled to additional development, regulatory and commercial milestones as well as tiered royalties on annual sales for each product included in the research collaboration.

Notes to the editor

About ACT-709478
ACT-709478 is a potent, selective, orally-active and brain penetrating T-type calcium channel blocker in development for epilepsy. A Phase 1 clinical trial was completed in healthy adult subjects in 2019. The IND application was accepted by the FDA on April 30, 2020. A Phase 2 study in a rare pediatric epilepsy is planned for the second half of 2020.

Idorsia has received Rare Pediatric Disease designation from the US FDA for ACT-709478 for the treatment of a rare pediatric epilepsy. The FDA grants Rare Pediatric Disease designation for diseases that primarily affect children ages 18 years or younger and fewer than 200,000 persons in the US.

About Idorsia
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.