On March 7, 2019 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported that it officially filed a formal new drug application pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori (Press release, Cytori Therapeutics, MAR 7, 2019, View Source [SID1234534097]). This submission is the precursor to filing an Article 58 Application for a Marketing Authorization Application (MAA) via EMA’s centralized approval procedure. In June 2017, the EMA Committee for Medicinal Products for Human Use (CHMP) confirmed that Doxorubicin Hydrochloride Cytori was eligible for submission of a MAA via the centralized procedure.
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In addition, in late 2018, the EMA CHMP Name Review Group validated Doxorubicin Hydrochloride Cytori as the official invented name to replace ATI-0918. Doxorubicin Hydrochloride Cytori is a liposomal nanoparticle medicinal product being developed for cancer patients that contains the active substance doxorubicin, a widely used chemotherapy drug. Doxorubicin Hydrochloride Cytori is intended for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma.
"Liposomal doxorubicin is a commonly prescribed chemotherapeutic drug for patients with advanced breast and ovarian cancer as well as other indications," said Dr. Marc Hedrick MD, President/CEO of Cytori Therapeutics. "Bringing Doxorubicin Hydrochloride Cytori to market in Europe as an alternative to the branded drug is an important near-term corporate goal."
As a ‘hybrid medicine’, Doxorubicin Hydrochloride Cytori is intended to be similar to a ‘reference medicine’, Adriamycin, already authorized in the EU. Doxorubicin Hydrochloride Cytori is different than Adriamycin in that the active substance is encapsulated in tiny lipid nanospheres called liposomes that are coated in polyethylene glycol or PEG. Cytori believes that it has successfully completed all clinical development work for Doxorubicin Hydrochloride Cytori and is currently manufacturing the drug in its dedicated plant in San Antonio, Texas.
Cytori expects to receive assignment of a rapporteur and co-rapporteur, who will work with the company through the MAA submission and review process, by the end of April 2019. The MAA submission is planned for later in 2019 or early 2020.
Cytori’s MAA will present data from the scientific literature and from non-clinical studies, including comparisons with Janssen’s Caelyx, an authorized medicine containing doxorubicin in pegylated liposomal form. The company will also present the results of a completed clinical study intended to investigate whether Doxorubicin Hydrochloride Cytori is ‘bioequivalent’ to Caelyx, meaning that they both produce the same levels of the active substance in the body.
Janssen’s Caelyx first received a marketing authorization for the EU in 1996, is currently approved for the treatment of breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, and generated over €110M in sales across Europe in 2017. No generic versions of Caelyx are currently approved and available in Europe.