SAN DIEGO, April 30, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) (“Cytori” or “the Company”) today 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 $1.4B 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.
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.
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Cytori Nanomedicine™ is developing encapsulated therapies for regenerative medicine and oncologic indications using technology that allows Cytori to use the benefits of its encapsulation platform to develop novel therapeutic strategies and reformulate other drugs to optimize their clinical properties. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, statements regarding the approval pathway for ATI-0918, the expected growth in the global market potential for liposomal doxorubicin and Cytori Cell Therapy’s potential to provide benefits across multiple disease states, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties, which include inherent uncertainties in conduct of clinical studies and trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Nanomedicine), risks associated with clinical use of Cytori Cell Therapy in studies and trials not controlled by Cytori, risks to Cytori’s intellectual property portfolio are described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Cytori Therapeutics, Inc.