AKAO 2017 Annual Report

22 • Demonstration of non-inferiority to meropenem at day 5 and statistically favorable outcomes compared to meropenem at day 17 in patients with cUTI/AP infections due to Enterobacteriaceae, including fluoroquinolone resistant and ESBL-producing isolates; • Improved efficacy, overall mortality and safety of plazomicin versus colistin in patients with serious bacterial infections due to CRE, based on results observed in the CARE study; • Potential to individualize patient dosing using an in vitro drug-monitoring assay to optimize efficacy and safety of plazomicin therapy in BSI or pneumonia; • Potential for more convenient administration as a once-daily, 30-minute IV therapy compared to other IV antibiotics administered multiple times per day with infusion times up to two hours; and • Potential to reduce the healthcare costs associated with the treatment of such infections. If we are unable to demonstrate these or other advantages of plazomicin over competing drugs and drug candidates, we may not be able to successfully commercialize plazomicin and our results of operations may suffer. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make plazomicin or any other product candidates that we develop obsolete. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or regulatory approval or discovering, developing and commercializing antibiotics before we do. Intellectual Property The proprietary nature of, and protection for, our product candidates and our discovery programs, processes and know-how are important to our business. We have sought patent protection in the United States and certain other jurisdictions for plazomicin, C-Scape, and certain other inventions to which we have rights, where available and when appropriate. Our policy is to pursue, maintain and defend patent rights, whether developed internally or licensed from third parties, and to protect the technology, inventions and improvements that are commercially important to the development of our business. We also rely on trade secrets relating to our proprietary technology platform that may be important to the development of our business. Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection for our current and future product candidates and the methods used to develop and manufacture them, as well as successfully defending these patents against third-party challenges. Patents, issued or applied for, can cover inventions ranging from research compounds and techniques to processes related to specific products to the products themselves. Our issued patents extend for varying periods according to the date of patent application filing or grant and the legal term of patents in the various countries where patent protection is obtained. The actual protection afforded by a patent, which can vary from country to country, depends upon the type of patent, the scope of its coverage as determined by the patent office or courts in the country, and the availability of legal remedies in the country. We have applications or patents on platform technologies and methods of using our products (in either case, that may relate to classes of products or methods), that may confer additional patent protection but are not necessarily a protection against competition. Our ability to stop third parties from making, using, selling, offering to sell, or importing our products depends in part on the extent to which we have rights under valid and enforceable patents or trade secrets that cover our activities. We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents that may be granted to us in the future will be commercially useful in protecting our product candidates, discovery programs and processes. For this and more comprehensive risks related to our intellectual property, see “Risk Factors—Risks Related to Intellectual Property.” We consider that in the aggregate our patent applications, patents and licenses under patents owned by third parties are of material importance to our operations. For our lead product candidate, plazomicin, we have identified in the following paragraph the patents that are owned or controlled by us having claims directed to product-specific compositions of matter. This paragraph does not identify all patents or applications that may relate to plazomicin but are not material. We also have pending patent applications or applications we continue to file that may give rise to new patents relating to plazomicin. In part due to the early stage of our other research and development, we do not