Pharmaceutical

Cytori Therapeutics (Nasdaq: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). As quoted in the press release: Liposomal doxorubicin is a commonly used cytotoxic agent for recurrent breast …

Cytori Therapeutics (Nasdaq: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).

As quoted in the press release:

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 $1.4B by 2024 (Grand View Research, Inc., 28 2nd Street, Suite 3036, San Francisco, CA, 94105, United States).

Cytori 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.

Click here to read the full press release.

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