AVI BioPharma, Inc., a developer of RNA-based drugs, today announced that it received an orphan drug designation from the Committee for Orphan Medical Products of the European Medicines Agency (EMEA) for AVI-5038, a drug candidate being developed by AVI for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a genetic muscle-wasting disease caused by failure to produce dystrophin. The orphan drug designation potentially may provide AVI up to 10 years of market exclusivity if the drug candidate is approved for marketing in the European Union (EU). AVI-4658, another drug being developed by AVI for DMD, received European orphan drug designation in 2008, and also potentially may receive up to 10 years of marketing exclusivity if approved in the EU.
"The EMEA's granting of orphan drug designation to AVI-5038 provides important regulatory support for our continuing commitment to develop disease modifying drugs for DMD patients," stated Dr. Leslie Hudson, President and CEO, AVI BioPharma, Inc. "We look forward to the opportunity to report continuing progress in our DMD program throughout the year, particularly with respect to our lead DMD drug candidate, AVI-4658, which is in an ongoing Phase 1b/2 clinical trial."