Moleculin Granted EMA Orphan Drug Designation for Leukemia Drug
Pharmaceutical company, Moleculin Biotech (Nasdaq: MBRX) has been granted Orphan Drug Designation for Annamycin in the treatment of acute myeloid leukemia (AML) by the European Medicines Agency (EMA). The company’s share price rose 6.31% following the news on Thursday.
Anthracyclines, which have been an integral component of induction chemotherapy for AML for more than 30 years, are known to cause cardiotoxicity. Annamycin, Moleculin’s next-generation anthracycline, has been designed to be non-cardiotoxic and has demonstrated non-cardiotoxicity in 82 subjects treated in multiple studies in the US and in Europe.
Walter Klemp, Chairman and Chief Executive Officer of Moleculin, commented, “Combined with the Orphan Drug Designation we already have in the US and with the new composition of matter patent just awarded by the US Patent and Trademark Office with coverage through 2040, we believe the commercial exclusivity of Annamycin is now very well protected.
“We continue to be encouraged by the growing body of promising interim clinical data demonstrated by Annamycin. We remain focused on advancing our clinical and regulatory strategies toward our next phase of development, including the planned commencement of a pivotal registration study as a second line therapy in AML before year end.”
Annamycin currently has FDA Fast Track Status and Orphan Drug Designation for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma lung metastases.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company’s lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. All interim and preliminary data discussed above is subject to change. For more information about the Company, please visit www.moleculin.com and connect on Twitter, LinkedIn and Facebook.
