Cytori Updates On US Manufacturing And EU Approval Plans For ATI-0918

(RTTNews) - Cytori Therapeutics Inc. (CYTX) provided an update on its plans for US manufacturing and EU approval for its ATI-0918 liposomal doxorubicin product. ATI-0918 has been designed and developed to be bioequivalent to the market leading branded reference drug, Caelyx/Doxil (Johnson & Johnson).

Liposomal doxorubicin is a commonly used cytotoxic agent for recurrent breast and ovarian cancer, multiple myeloma and Kaposi's sarcoma. The global market is anticipated to grow to $1.4 billion by 2024.

Cytori said it intends to first seek European approval for its drug and has applied for and has received EMA approval to file for centralized European Union (EU) approval. Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body. Approval by EMA using a centralized procedure leads to approval of the product in all 28 EU Member States, Iceland, Liechtenstein and Norway.

All states of manufacturing of the product will be performed in the United States. More specifically, manufacturing of the cytotoxic liposomal formulation will be performed in Cytori's San Antonio Texas facility. Cytori's facility features a new manufacturing clean room and technology specifically designed for the manufacture of complex liposomal compounds integrating cytotoxic compounds. In addition, Cytori has in house analytical chemistry capabilities to ensure its products are manufactured to the highest quality standards.

Final sterile packaging and fill finish activities will also be performed in the United States by Bryllan, located in Brighton, Michigan. Bryllan is a premier commercial scale contract manufacturing organization capable of safely filling potent and cytotoxic compounds, hormones, antibodies and complex biologics, live viruses and vaccines. Bryllan features a state-of-the-art aseptic production facility using isolators as the core technology with the highest engineering standards of design and construction to meet US FDA and other global regulatory standards.