Aeterna Zentaris Inc. has filed an international patent application as well as national patent applications in selected countries including the US, China, Taiwan, Japan and India. These applications seek to protect the novel method of manufacturing Zoptrex™ (zoptarelin doxorubicin), and were filed in addition to a European patent application filed last year. The company decided to file patent applications in additional territories after the European Patent Office issued a search report for the European patent application that the Company considers to be favorable.
Dr. Richard Sachse, Senior Vice President and Chief Scientific Officer/Chief Medical Officer of the Company stated, “Zoptrex™ passed a significant hurdle last fall when the independent Data and Safety Monitoring Board recommended that we continue with our pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 clinical study of the compound in women with advanced, recurrent or metastatic endometrial cancer who have progressed and who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or first-line treatment). We expect to complete the ZoptEC trial in Q3 of 2016 and, if the results of the trial warrant doing so, to file the NDA and MAA for Zoptrex™ in 2017.”
Jude Dinges, Senior Vice President and Chief Commercial Officer of the Company added, “We are now moving forward with our planning to commercialize Zoptrex™, looking toward commercial launch of the product in 2018, if our NDA and MAA are granted. The claimed manufacturing process is expected to result in a significant reduction in our cost of manufacturing Zoptrex™, providing what should be a stronger competitive position for the Company and discouraging competition from generic manufacturers after our five-year period of data exclusivity expires.”
Zoptarelin doxorubicin is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is a Luteinizing Hormone Releasing Hormone (“LHRH”) agonist, a modified natural hormone with high affinity for the LHRH receptor. The design of the compound allows for the specific binding to the LHRH receptor and is believed to facilitate the selective and targeted uptake of the cytotoxic agent by LHRH receptor-positive tumors.
David A. Dodd, Chairman, President and Chief Executive Officer of the Company explained the significance of the new synthesis process: “We believe that Zoptrex™ has the potential to become the first approved therapy in the U.S. for treating women within the endometrial indication targeted in the ZoptEC trial, as well as additional cancers that we might evaluate in the future. Our commitment is to do our best such that patients and their physicians have such therapies that can potentially improve and extend the quality of lives. Zoptrex™ could be a very important oncology tool if our ZoptEC Phase 3 study achieves its endpoints. By reducing the complexity of production and the cost of the compound, we will have greater flexibility in potentially ensuring that patients on a worldwide basis have access to and can benefit from this therapy. We believe this patent family, if granted, could provide that advantage by giving us what should be a significant production and cost advantage in support of further development in additional indications. Along with our existing partner, Sinopharm A-Think in China, Hong Kong and Macau, as well as other parties currently evaluating the licensing of Zoptrex™ for other geographic territories, we look forward to the possibility of successful commercialization of this product and the benefits it might deliver to patients and their health care providers.”
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