Summary

• Page properties (2 modified, 0 added, 0 removed)

Details

Page properties

Tags

...	...	@@ -1,0 +1,1 @@
	1	+US:ARDX

Content

...	...	@@ -2,12 +2,8 @@
2	2	{{toc/}}
3	3	{{/box}}
4	4
5		-= Paragraph 1 =
	5	+= Company overview =
6	6
7		-Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.
8		-
9		-==== Company overview ====
10		-
11	11	Ardelyx is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. The company's primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia; patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. Ardelyx has also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.
12	12
13	13	The company's portfolio is led by the development of tenapanor, a first-in-class inhibitor of NHE3. In its renal pipeline, tenapanor is being evaluated in a second Phase 3 trial for the treatment of hyperphosphatemia in patients with ESRD who are on dialysis. This registration trial follows a successful first Phase 3 trial completed in 2017, which achieved statistical significance for the primary endpoint. Ardelyx is also advancing a small molecule potassium secretagogue program, RDX013, for the potential treatment of hyperkalemia. The company believe that both tenapanor and RDX013 have the potential to provide treatment options that are differentiated significantly from binders, the current standards of care in both of these markets. The company believe its small molecule approach to treating these conditions could significantly reduce the pill burden for patients, leading to higher compliance, and offer completely new mechanisms of action that interact with receptors in the gut, potentially allowing improved efficacy in some patients.
...	...	@@ -14,7 +14,7 @@
14	14
15	15	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.
16	16
17		-==== Commercial Strategy ====
	13	+= Commercial Strategy =
18	18
19	19	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.
20	20
...	...	@@ -22,13 +22,13 @@
22	22
23	23	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%.
24	24
25		-==== PROPRIETARY DRUG DISCOVERY AND DESIGN PLATFORM ====
	21	+== Proprietary drug discovery and design platform ==
26	26
27	27	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.
28	28
29	29	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.
30	30
31		-==== PRODUCT PIPELINE ====
	27	+= Product Pipeline =
32	32
33	33	**Tenapanor**: A New Approach for Treating Hyperphosphatemia in ESRD Patients on Dialysis
34	34
...	...	@@ -187,7 +187,7 @@
187	187
188	188	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.
189	189
190		-==== INTELLECTUAL PROPERTY ====
	186	+= INTELLECTUAL PROPERTY =
191	191
192	192	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.
193	193
...	...	@@ -209,14 +209,14 @@
209	209
210	210	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.
211	211
212		-==== MANUFACTURING ====
	208	+= MANUFACTURING =
213	213
214	214	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.
215	215
216		-==== EMPLOYEES ====
	212	+= EMPLOYEES =
217	217
218	218	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.
219	219
220		-==== RESEARCH AND DEVELOPMENT ====
	216	+= RESEARCH AND DEVELOPMENT =
221	221
222	222	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