CRYSTAL RESEARCH ASSOCIATES, LLC QUARTERLY UPDATE PAGE 5 Potential Milestone for 2017
Product Development Macrilen™ (macimorilen): submit NDA in early 3Q17. If approved, Macrilen™ will be the only FDA approved drug for assessing AGHD, a disorder which affects about 75,000 adults in the U.S., Canada, and Europe, and is mostly caused by damage to the pituitary gland. The drug is pat ented through 2027 and has been granted Orphan Drug Designation. There is significant market expansion opportunity for traumatic brain injury (TBI) patients at risk of developing AGHD. The Company currently has 13 sales reps and anticipates scaling up to approximately 30 following approval. During the recent FDA meeting, the Agency stated that the clinical studies performed by Aeterna with respect to Macrilen™ address the prior deficiencies cited in the November 2014 complete response letter. This conclusion puts in place the Company’s ability to re‐submit an NDA for the drug, which Aeterna has stated could be filed in early 3Q17. This announcement brings the Company closer to commercializing Macrilen™ in the U.S. beginning in 2018. |