Marketing assets

CytRx Comments on Orphazyme’s Update on European Union Regulatory Review of Arimoclomol in Niemann-Pick Type C Disease

Notes The main assets of CytRx are not affected by the evaluation of arimoclomol by the European Medicines Agency

Highlights positive developments regarding the company’s key assets, including aldoxorubicin

LOS ANGELES–(BUSINESS WIRE)– CytRx Corporation (OTCQB: CYTR) (“CytRx” or the “Company”), a biopharmaceutical company focused on research and development in the categories of oncology and neurodegenerative diseases, today commented on Orphazyme A /S (NASDAQ: ORPH) (“Orphazyme”) announced an update on the pending review of the marketing authorization application for its investigational product candidate, arimoclomol, for the treatment of Niemann-Pick disease type C (“NPC”) by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”). CytRx licensed arimoclomol to Orphazyme in exchange for milestone and royalty payments.

While Orphazyme was encouraged by the positive feedback from the ad hoc expert group meeting held on February 17, 2022, Orphazyme was notified by the CHMP of a negative trend vote on the MA for arimoclomol in NPCs following an oral explanation. The trend vote indicates that the current direction of the CHMP is not to approve arimoclomol when it is convened by the end of March 2022. Orphazyme considers that this position is unlikely to change before the formal vote is undertaken. next month. Orphazyme expects to continue discussions with the United States Food and Drug Administration regarding its planned resubmission of a New Drug Application for arimoclomol for the treatment of NPC.

As part of the news, CytRx released the following statement:

“While we are disappointed with the CHMP’s regulatory position regarding arimoclomol for NPCs in the European Union ahead of the formal vote next month, it is important to note that arimoclomol is an entry/exit license not essential for CytRx and is not part of the valuable core assets built from our LADRMT Technology. We are pleased to see recent positive clinical developments from ImmunityBio, Inc.’s study of aldoxorubicin, the first generation of our LADRMT technology, and are excited about the development of the next generation of LADRMT chemotherapeutics from our pipeline. As previously reported, CytRx has licensed aldoxorubicin to ImmunityBio through a deal that can yield royalties on sales and up to $343 million in potential milestones. ImmunityBio is currently studying aldoxorubicin in late-stage clinical trials in pancreatic cancer and in early-stage clinical studies in glioblastoma, triple-negative breast cancer, and head and neck cancer. We look forward to advancing CytRx Clinic’s other potentially life-saving cancer therapies using our LADRMT Technology.”

About CytRx

CytRx Corporation (OTCQB: CYTR) is a biopharmaceutical company focused on the discovery and development of novel therapies primarily to treat patients with cancer and neurodegenerative diseases. CytRx’s newest advanced drug conjugate, aldoxorubicin, is an improved version of the widely used cancer drug doxorubicin, and has been licensed to ImmunityBio, Inc. Additionally, CytRx’s drug candidate, l arimoclomol, was sold to Orphazyme A/S in exchange for milestone payments and royalties. Orphazyme is developing arimoclomol in two indications, including Niemann-Pick type C (NPC) disease and Gaucher disease. The CytRx Corporation website is www.cytrx.com.