Date: 2015-02-25
Type of information: Establishment of a new subsidiary in the EU
Compound:
Company: Avexis (USA - IL)
Therapeutic area: Rare diseases - Genetic diseases - Neurological diseases
Type agreement: establishment of a new subsidiary in the EU
Action mechanism:
Disease:
Details: * On February 25, 2015, AveXis, a biotechnology company focused on using gene therapy to transform the lives of patients with severe genetic and orphan diseases like Spinal Muscular Atrophy (SMA), announced the formation of its EU-based wholly-owned subsidiary, AveXis EU, Ltd. The subsidiary will allow AveXis to move forward with its plans to open clinical trials in the European Union and leverage European Medicines Agency’s programs, such as Orphan Medicinal Product Designation and the Micro-, Small-, and Medium-Sized-Enterprise (SME) program, to advance development.
AveXis is currently sponsoring a US-based Phase 1 open-label, single-dose, dose-escalation study, which will enroll nine infants under the age of nine months who have been diagnosed with SMA Type 1. The study is being conducted at The Research Institute at Nationwide Children’s Hospital. The trial is currently open for enrollment and recruiting candidates.
AveXis has also continued its efforts to grow awareness of the ongoing and upcoming clinical trials with the Contact All Neurologists (C.A.N.) ProgramTM. The C.A.N. ProgramTM has reached over 30 neurologists nationwide, informing them of clinical trials available to infants recently diagnosed with SMA Type 1.
Financial terms:
Latest news: * On March 19, 2015, AveXis announced that the European Medicines Agency (EMA) has granted AveXis’ wholly owned European subsidiary, AveXis EU Ltd., SME (Small and Medium Sized Business Entities) status.
