Aeterna Zentaris Files International Patent Application for Novel Method of Manufacturing Zoptrex(TM)
Charleston, South Carolina / CRWEPRESSRELEASE / January 26, 2016 – Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the “Company”) today announced that it 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.”
Zoptrex™ represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptrex™ is the first intravenous drug in advanced clinical development that is considered to direct the chemotherapy agent specifically to LHRH-receptor expressing tumors, which then could result in a more targeted treatment with less damage to healthy tissue. Potential benefits of this targeted approach include better efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin alone. Aeterna Zentaris owns the worldwide rights to this compound except in China.
On December 1, 2014, the Company entered into a Master Collaboration Agreement, a Technology Transfer and Technical Assistance Agreement and a License Agreement with Sinopharm A-Think Pharmaceuticals Co., Ltd for the development, manufacture and commercialization of Zoptrex™ in all human uses in the Peoples Republic of China, including Hong Kong and Macau. Sinopharm A-Think is a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune's Global 500 list.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
Philip A. Theodore
Senior Vice President
Source: Aeterna Zentaris