Ardelyx launches IBSRLA® in the second quarter of 2022

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– IBSRELA (tenapanor) the first and only NHE3 inhibitor approved for the treatment of IBS-C in adults

– Potential peak of IBSRLA net income greater than $ 500 million annually

– Large and well established IBS-C market in need of new therapeutic options

– Small specialized sales organization and targeted digital marketing to target large prescribers and dissatisfied patients

– Company continues to obtain approval for tenapanor in hyperphosphatemia

– The company will host a conference call today at 8:00 a.m.ET

FREMONT, California and WALTHAM, Mass., November 30, 2021 / PRNewswire / – Ardelyx, Inc. (Nasdaq: ARDX), a specialty biopharmaceutical company founded with a mission to discover, develop and commercialize first-class innovative drugs that address significant unmet medical needs, announced today It intends to launch IBSRELA, the company-approved treatment for irritable bowel syndrome with constipation (IBS-C) in adults, in the second quarter of 2022.

Ardelyx Logo (PRNewsFoto / Ardelyx) (PRNewsfoto / Ardelyx)

Mike raab, President and CEO of Ardelyx, said: “Over the past five years, the IBS-C market has grown to be large and concentrated, with 9,000 high-writing physicians representing approximately 50% of the nearly five million prescriptions written each year. for drugs indicated for the treatment of IBS-C. This market is ripe for the entry of a new therapeutic option like IBSRLA, as existing therapies do not adequately meet all of the treatment needs of patients. Our market research has clearly shown that treating physicians recognize the need for new treatment alternatives to address the unmet medical needs of patients currently in care for IBS-C. This same research shows great interest and intention to prescribe, IBSRLA for a subset of patients. By capturing even a modest, mid-to-high-number share of this large market, IBSRLA has the potential to generate at least $ 500 million in peak annual net income. We will use the next few months to build a commercial inventory and prepare the market for a launch in Q2 2022. We believe we have a clear line of sight to achieve ultimate balance and profitability of the product, which we believe hopefully, will create significant shareholder value. “

Guillaume Chey, MD, Nostrant Professor of Medicine at the University of Michigan School of Medicine, added, “It is now widely recognized that although people with IBS-C have similar symptoms, it is a disorder of heterogeneous pathogenesis. Over the past two decades, with the introduction and widespread adoption of GC-C agonists, it is not surprising that many patients continue to suffer. is exciting because it offers a unique mechanism of action with compelling clinical data, providing physicians with an important new tool to advance the care of patients with IBS-C. “

“IBSRELA, with its first-order mechanism and strong clinical data set, is an important new addition to the therapeutic arsenal of IBS-C,” said Laura A. Williams, MD, MPH, Chief Medical Officer of Ardelyx. “The approval of IBSRLA was based on two successful Phase 3 trials involving over 1,200 patients with IBS-C. Both trials met their primary and secondary endpoints. observed at week 1, with sustained improvement until the end of treatment. IBSRELA may play a significant role in the treatment of patients with IBS-C. “

“As we work to bring IBSRELA to patients, we remain committed to securing approval of tenapanor for hyperphosphatemia through the formal dispute resolution process with the FDA, and as a commercial organization, if it is. approved, we will be in a good position to bring this new therapy to patients, ”said Mike raab, Chairman and CEO of Ardelyx.

Conference Call Information

The company will host a conference call today, November 30, 2021 To 8:00 a.m.ET to discuss plans to launch IBSRLA for the treatment of IBS-C. To participate in the conference call, please call (855) 296-9612 (toll-free) or (920) 663-6277 (toll-free number) and reference number 2977157. A webcast of the call may also be made. be consulted by visiting the Investors website page of the company’s website www.ardelyx.com and will be available on the website for 30 days after the call.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SEVERE DEHYDRATION IN PEDIATRIC PATIENTS

IBSRELA is contraindicated in patients less than 6 years of age; in non-clinical studies in juvenile juvenile rats, administration of tenapanor caused presumptive death due to dehydration. Avoid the use of IBSRLA in patients aged 6 to less than 12 years. The safety and efficacy of IBSRLA have not been established in patients less than 18 years of age.

CONTRAINDICATIONS

  • IBSRELA is contraindicated in patients under 6 years of age due to the risk of severe dehydration.

  • IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS

Risk of severe dehydration in pediatric patients

  • IBSRELA is contraindicated in patients less than 6 years of age. The safety and efficacy of IBSRLA in patients less than 18 years of age have not been established. In young juvenile rats (less than one week old; approximate human age equivalent of less than 2 years), decreased body weight and deaths occurred, presumably due to dehydration, after oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent to 2 years to less than 12 years).

  • Avoid the use of IBSRLA in patients aged 6 to less than 12 years. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRLA in patients aged 6 to less than 12 years.

Diarrhea

Diarrhea was the most common side effect in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of patients treated with IBSRELA. In the event of severe diarrhea, suspend the dosage and rehydrate the patient.

MOST COMMON SIDE EFFECTS

The most common adverse reactions in patients treated with IBSRELA (incidence ≥2% and greater than placebo) were: diarrhea (16% vs. 4% placebo), abdominal distension (3% vs.

INDICATION

IBSRELA (tenapanor) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Please see full Prescribing information, including the boxed warning, for additional information on the risks.

About irritable bowel syndrome with constipation (IBS-C)

Irritable Bowel Syndrome with Constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered stools, believed to affect 11 million people in the United States. IBS-C is associated with significantly impaired quality of life, reduced productivity, and substantial economic burden.

About IBSRLA for IBS-C

IBSRELA (tenapanor) is a locally acting inhibitor of the sodium / hydrogen exchanger 3 (NHE3), an anti-carrier expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. By inhibiting NHE3 on the apical surface of enterocytes, tenapanor reduces sodium absorption from the small intestine and colon, resulting in an increase in luminal water concentration, which speeds up intestinal transit time and results in a softer stool consistency. IBSRELA has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and decreasing intestinal permeability in animal models. In a rat colonic hypersensitivity model, tenapanor reduced visceral hyperalgesia and normalized sensory neuronal excitability of the colon.

About Ardelyx, Inc.

Ardelyx is focused on the discovery, development and commercialization of innovative, first-class drugs to address significant unmet medical needs. Ardelyx has received approval for IBSRLA (tenapanor) and its launch is expected in the second quarter of 2022. Ardelyx is developing tenapanor, a new product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has led has three Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of hyperkalaemia or hyperkalaemia, a problem in some patients with kidney and / or heart disease, and has a program of early stage metabolic acidosis, a serious electrolyte disorder in patients with CRF. Ardelyx has entered into agreements with Kyowa Kirin in Japan, Fosun Pharma at China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

Forward-looking statements

To the extent that the statements in this press release are not descriptions of historical fact relating to Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made in accordance with the safe harbor of the Private Securities Reform Act. from 1995 including Ardelyx plans to launch IBSRLA in the second quarter of 2022; Ardelyx’s expectations regarding peak annual net sales for IBSRELA; Ardelyx’s expectations regarding the percentage of the market that Ardelyx hopes to conquer with IBSRELA; Ardelyx’s expectations regarding its ability to generate sufficient revenue to break even and potentially achieve profitability with sales of IBSRLA, and Ardelyx’s plans to continue seeking approval of tenapanor for phosphorus control serum in patients with chronic renal failure on dialysis. Such forward-looking statements involve substantial risks and uncertainties which could cause Ardelyx’s future results, performance or achievements to differ materially from those expressed or implied by forward-looking statements. These risks and uncertainties include, among others, uncertainties associated with the marketing of drugs and the regulatory approval process. Ardelyx assumes no obligation to update or revise any forward-looking statements. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Ardelyx’s business in general, please refer to Ardelyx’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2021, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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