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10 10  
11 11  In addition to the development for renal diseases, Ardelyx has developed tenapanor for the treatment of patients with IBS-C. In 2017, the company completed the T3MPO program for this indication, including two Phase 3 studies, both of which achieved statistical significance for the primary endpoint, and a long-term safety extension study. The company believe that data from the T3MPO program collectively demonstrated the ability of tenapanor to provide sustained relief of constipation and reduced abdominal pain with a generally favorable tolerability profile. Based on the results of the T3MPO clinical program in IBS-C, Ardelyx is preparing to submit its first New Drug Application, or NDA, to the United States Food and Drug Administration, or FDA, in the second half of 2018 for tenapanor for the treatment of IBS-C.
12 12  
13 -= Commercial Strategy =
13 +==== Commercial Strategy ====
14 14  
15 15  The company aim to build a multi-product company that commercializes its renal products in the United States. The company's strategy is to leverage ex-U.S. collaborations with established industry leaders to efficiently bring its renal medicines to patients outside the United States. Additionally, its goal is to bring tenapanor for IBS-C to market by leveraging domestic and ex-U.S. collaborations.
16 16  
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18 18  
19 19  In December 2017, the company entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., or Fosun Pharma, providing Fosun Pharma with the exclusive rights to develop and commercialize tenapanor in China for the treatment of patients with hyperphosphatemia related to CKD and patients with IBS-C. Under the terms of the agreement, the company received an upfront payment of $12 million and are eligible to receive additional milestones of up to $113 million, as well as tiered royalties on net sales ranging from the mid-teens to 20%.
20 20  
21 -== Proprietary drug discovery and design platform ==
21 +==== PROPRIETARY DRUG DISCOVERY AND DESIGN PLATFORM ====
22 22  
23 23  In line with its overall strategy and transition to focus solely on its renal pipeline, Ardelyx has shifted its research focus to support its preclinical and clinical development candidates including tenapanor and RDX013, as well as other potential renal opportunities. The company intend to continue to utilize its unique discovery and design platform to help elucidate first-in-class mechanisms of action, as with tenapanor, and to inform preclinical experiments to help advance its product candidates. The company also use its platform to further support the potential commercialization of its programs, which is valuable to it and future partners. The company believe that its platform, and early pipeline, represent additional collaborative opportunities, market potential and downstream value-creation.
24 24  
25 25  Using its platform, Ardelyx has been able to discover targets found in the GI tract that regulate important processes in the body and design products candidates that act upon those targets to take advantage of the gut’s ability to communicate with other organs. The company's platform integrates two critical concepts: (i) its proprietary chemistry capabilities that enable it to design and optimize gut-restricted compounds that can provide a higher margin of safety than systemically absorbed compounds, and (ii) its stem cell-based translational technology called the Ardelyx Primary Enterocyte and Colonocyte Culture System, or APECCS, that enables it to discover targets in the GI tract which control health and disease processes, to optimize drug candidates and to understand their mechanisms of action. The company's platform can be applied across the entire GI tract, allowing for the broadest evaluation of disease targets to develop medicines optimized for specific diseases. The predictive ability of its platform enables it to better assess, at a very early stage, the potential for small molecule compounds to treat specific diseases.
26 26  
27 -= Product Pipeline =
27 +==== PRODUCT PIPELINE ====
28 28  
29 29  **Tenapanor**: A New Approach for Treating Hyperphosphatemia in ESRD Patients on Dialysis
30 30  
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183 183  
184 184  In addition to tenapanor for IBS-C, Ardelyx has an early GI pipeline comprised of RDX8940, a minimally absorbed, oral TGR5 agonist for which the company submitted an investigational new drug application, or IND, in late 2016; RDX011, its second-generation NHE3 inhibitor; and its RDX023 program for the development of gut-biased farnesoid X receptor, or FXR, agonists. While Ardelyx is not currently actively developing these programs, they represent potential collaboration opportunities to support their continued development.
185 185  
186 -= INTELLECTUAL PROPERTY =
186 +==== INTELLECTUAL PROPERTY ====
187 187  
188 188  The company's commercial success depends in part on its ability to obtain and maintain proprietary protection for its drug candidates, manufacturing and process discoveries, and other know-how, to operate without infringing the proprietary rights of others and to prevent others from infringing its proprietary rights. The company's policy is to seek to protect its intellectual property by, among other methods, filing U.S. and foreign patent applications related to its proprietary technology and inventions that are important to the development and operation of its business. The company also rely on trade secrets and careful monitoring of its proprietary information to protect aspects of its business that are not amenable to, or that the company do not consider appropriate for, patent protection.
189 189  
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205 205  
206 206  Ardelyx has patent applications pending in the United States and internationally that cover the compositions and methods of using its TGR5 agonists, its FXR agonists and compounds in its RDX013 program.
207 207  
208 -= MANUFACTURING =
208 +==== MANUFACTURING ====
209 209  
210 210  To date, Ardelyx has relied upon third-party contract manufacturing organizations, or CMOs, to manufacture both the active pharmaceutical ingredient and final drug product dosage forms of its potential drug candidates used as clinical trial material. The company expect that the company will continue to rely upon CMOs for the manufacture of its clinical trial materials and for its commercial product requirements, when and if regulatory approval is received. The company's license agreements with KHK and Fosun Pharma require it to supply active pharmaceutical ingredient and final drug product dosage forms of tenapanor for their use in the development of tenapanor in each of their respective territories, and Ardelyx is further obligated to continue to supply active pharmaceutical ingredient to support their commercialization of tenapanor in each of their territories. The company expect that the company will use CMOs to satisfy its supply obligations to its collaboration partners.
211 211  
212 -= EMPLOYEES =
212 +==== EMPLOYEES ====
213 213  
214 214  As of December 31, 2017, the company had 75 full-time employees, including a total of 15 employees with Ph.D. degrees. Within its workforce, 54 employees are engaged in research and development and the remaining 21 in general management and administration, including finance, legal, and business development. None of its employees are represented by labor unions or covered by collective bargaining agreements. The company believe that the company maintain good relations with its employees.
215 215  
216 -= RESEARCH AND DEVELOPMENT =
216 +==== RESEARCH AND DEVELOPMENT ====
217 217  
218 218  The company's research and development costs were $75.5 million, $94.2 million and $39.9 million in the years ended December 31, 2017, 2016 and 2015, respectivel
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