Doxorubicin Hydrochloride Cytori – First Intended for European Market

San Diego, CA (Press Release) – Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it officially filed a formal new drug appli­ca­tion pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori. 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.

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.

About Cytori Therapeutics, Inc.

Cytori is a thera­peutics com­pany devel­op­ing regenerative and onco­logic ther­a­pies from its pro­pri­e­tary cell ther­apy and nanoparticle plat­forms for a variety of medical con­di­tions. 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. Cytori Nano­medicine™ is devel­op­ing liposome encapsulated ther­a­pies for regenerative med­i­cine and onco­logic indi­ca­tions. 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, conduct of clin­i­cal trials involving our tech­nology, clin­i­cal per­for­mance, and prod­uct approvals, are all subject to risks and un­cer­tain­ties that could cause our actual results and financial position to differ ma­teri­ally. Some of these risks and un­cer­tain­ties in­clude, but are not limited to, in­her­ent risk and uncertainty in the protection intellectual property rights, regu­la­tory un­cer­tain­ties, risks in the conduct of clin­i­cal trials, risks in the collection and results of clin­i­cal data, final clin­i­cal out­comes, dependence on third party per­for­mance, per­for­mance and acceptance of our prod­ucts in the mar­ket­place, as well as other risks and un­cer­tain­ties described under the heading "Risk Factors" in Cytori's Securities and Exchange Com­mis­sion Filings on Form 10-K and Form 10-Q. We assume no re­spon­si­bil­ity­ to update or revise any forward-looking state­ments to reflect events, trends or cir­cum­stances after the date they are made.

Source: Cytori Therapeutics.