Satellos Receives Rare Pediatric Disease Designation from the U.S. FDA for SAT-3247 for the Treatment of Duchenne Muscular Dystrophy

Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX: MSCL, OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to SAT-3247 for the potential treatment of Duchenne muscular dystrophy (“Duchenne” or “DMD”) after receiving Orphan Drug Designation earlier this year. SAT-3247 is a first-in-class oral small molecule therapeutic designed to restore the innate muscle regeneration and repair process, independent of dystrophin and regardless of exon mutation status.

“Obtaining the Rare Pediatric Disease and Orphan Drug Designations for SAT-3247 from the FDA are important milestones for Satellos as we continue to progressively build value in our DMD program,” said Frank Gleeson, CEO and Co-founder of Satellos. “The Rare Pediatric Disease Designation for SAT-3247 highlights the continued need for new disease modifying therapeutic options for pediatric patients with Duchenne, a need which we believe SAT-3247 has the potential to address.”

The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may be eligible for a voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product or sold to another sponsor for priority review of their marketing application.

The FDA grants Orphan Drug Designation to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including the potential for a seven-year market exclusivity upon regulatory approval, exemption from FDA application fees, tax credits for qualified clinical trials, and a priority review voucher.

About SAT-3247
SAT-3247 is an oral, small molecule drug candidate designed to target the root cause of muscle loss in degenerative diseases, initially in Duchenne. SAT-3247 presents a novel mechanism of action to restore impaired muscle regeneration caused by the absence of functional dystrophin.