Wednesday, February 25, 2015
Aeterna Zentaris, a specialty biopharmaceutical company based in Québec, and China-based Sinopharm A-Think Pharmaceuticals have signed of an exclusive license and technology transfer agreement for Aeterna Zentaris’ lead anti-cancer compound, zoptarelin doxorubicin, for the initial indication of endometrial cancer for the Chinese, Hong Kong and Macau markets (the territory). Zoptarelin doxorubicin, a novel synthetic peptide carrier linked to doxorubicin, currently is in a ZoptEC (zoptarelin doxorubicin in endometrial cancer) phase III trial in endometrial cancer.
Aeterna Zentaris, is a specialty biopharmaceutical company, has received a complete response letter (CRL) from the FDA for its NDA for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.
Aeterna Zentaris, a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology, has selected Charleston, S.C., for its North American business and global commercial operations. Over the next five years, Aeterna Zentaris will hire staff to support commercial operations, business development, regulatory and quality assurance, manufacturing management, clinical and product development, as well as various administrative functions. The Coordinating Council for Economic Development of South Carolina has approved job development credits to Aeterna Zentaris.
Aeterna Zentaris and Hikma Pharmaceuticals have signed an exclusive commercialization and licensing agreement for the registration and marketing of perifosine, Aeterna Zentaris’ lead anti-cancer compound, for the MENA (Middle East and North Africa) region. Perifosine, a novel oral Akt inhibitor, is currently in two phase III programs for the treatment of colorectal cancer and multiple myeloma in the United States and Europe.