Aastrom Biosciences Inc gene/cell therapy, dermatology news
Aastrom will discontinue manufacturing of MACI matrix-induced autologous chondrocyte implant in Denmark. Aastrom said its U.S. manufacturing facility will serve as the exclusive manufacturing facility for the Cell Therapy and Regenerative Medicine business, which Aastrom acquired from Sanofi (Euronext:SAN; NYSE:SNY, Paris, France) last month. Until U.S. production is available, Aastrom will also temporarily cease sales of MACI in Europe. The company said sales of MACI in Europe were $1.6 million in 2013, or 4% of total 2013 sales, and net losses attributable to EU operations of Sanofi’s gene/cell therapy business were about $7 million in 2013. Thus, Aastrom expects the changes to reduce annual operating expenses by about $7 million. The company plans to meet with FDA to clarify the regulatory path for MACI, which is marketed in Europe for cartilage regeneration. ...