Rockwell Medical

Last updated
Rockwell Medical Inc.
Company type Public
Nasdaq:  RMTI
Russell 2000 Index component
Industry Pharmaceutical industry
Founded1996;28 years ago (1996)
Headquarters Wixom, Michigan
Key people
Stuart Paul (president and CEO)
Ajay Gupta (CSO
Raymond D. Pratt (CMO)
RevenueIncrease2.svg $63 million (2018)
Decrease2.svg -$32 million (2018)
Total assets Decrease2.svg $52 million (2018)
Total equity Decrease2.svg $27 million (2018)
Number of employees
269 (2018)
Website rockwellmed.com
Footnotes /references
[1]

Rockwell Medical Inc. is a publicly traded pharmaceutical company based in Wixom, Michigan and founded in 1996 that focuses on development and commercialization of treatments against diseases such as end-stage renal disease (ESRD) and chronic kidney disease (CKD).

Contents

The company's primary customers are dialysis providers. [1]

Products

Triferic

Triferic was approved by the Food and Drug Administration (FDA) in January 2015. Triferic is the only FDA-approved therapy indicated to replace iron and maintain hemoglobin in adult hemodialysis patients with chronic kidney disease. Triferic replaces the iron lost during hemodialysis treatments. Triferic delivers iron directly to transferrin which transports it to the bone marrow to make hemoglobin. Rockwell is actively marketing and commercializing Triferic in the U.S. hemodialysis market. [2] [3] [4] In February 2014, the Company completed its long-term safety study for Triferic. [5]

Rockwell Medical began commercializing Triferic (dialysate) and Triferic AVNU (intravenous) in the United States in the second half of 2019 and in early 2021, respectively. Triferic was launched into a very competitive marketplace with well-entrenched products and a lack of consensus regarding unmet medical needs for dialysis patients with anemia. Due to its limited market adoption, unfavorable reimbursement, and absence of interest from other companies to license or acquire Triferic despite Rockwell's significant effort to partner the program, Rockwell Medical discontinued its New Drug Applications (“NDAs”) for Triferic and Triferic AVNU in the United States in the fourth quarter of 2022. [6]

Calcitriol

Calcitriol (active vitamin D) generic is FDA approved for treating secondary hyperparathyroidism or hypocalcemia in hemodialysis patients. [7]

Hemodialysis Concentrates

Rockwell is a manufacturer of hemodialysis concentrates/dialysates for dialysis providers and distributors in the U.S. and globally. Hemodialysis concentrates remove toxins and replace critical nutrients in the dialysis patient's bloodstream during hemodialysis. Rockwell has three U.S. manufacturing and distribution facilities. [7]

Iron (III) pyrophosphate

One of the main treatments that the company develops is iron (III) pyrophosphate, for iron supplementation, a key element in the formation of new red blood cells. It was licensed in 2011 for the delivery of iron supplementation for patients who suffer from anemic dialysis since the process accounts for treatment in around 90% of anemia patients.

International Partnerships

While Rockwell has discontinued commercialization of Triferic in the United States, the company has established international partnerships with companies seeking to develop and commercialize Triferic outside the United States and is working closely with these international partners to develop and commercialize Triferic in their respective regions.

South Korea for example; Triferic and Triferic AVNU have been approved in South Korea, and our partner, Jeil Pharmaceutical, launched Triferic in South Korea during the third quarter of 2022.

Also, in April 2023, Drogsan submitted a Marketing Authorization application and GMP application for Triferic AVNU to the Turkish Medicines and Medical Devices Agency ("TMMDA"), for which Drogsan received priority status and high priority status, respectively. Taking into consideration that Drogsan was granted an accelerated review for Triferic AVNU with the Turkish regulatory authority, Rockwell anticipates approval for Triferic AVNU in Turkey in 2024. Drogsan is responsible for all regulatory approval and commercialization activities. [6]

Related Research Articles

<span class="mw-page-title-main">Kidney dialysis</span> Removal of nitrogenous waste and toxins from the body in place of or to augment the kidney

Kidney dialysis is the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally. This is referred to as renal replacement therapy. The first successful dialysis was performed in 1943.

<span class="mw-page-title-main">Uremia</span> Type of kidney disease, urea in the blood

Uremia is the term for high levels of urea in the blood. Urea is one of the primary components of urine. It can be defined as an excess in the blood of amino acid and protein metabolism end products, such as urea and creatinine, which would be normally excreted in the urine. Uremic syndrome can be defined as the terminal clinical manifestation of kidney failure. It is the signs, symptoms and results from laboratory tests which result from inadequate excretory, regulatory, and endocrine function of the kidneys. Both uremia and uremic syndrome have been used interchangeably to denote a very high plasma urea concentration that is the result of renal failure. The former denotation will be used for the rest of the article.

<span class="mw-page-title-main">Hemodialysis</span> Medical procedure for purifying blood

Hemodialysis, also spelled haemodialysis, or simply dialysis, is a process of filtering the blood of a person whose kidneys are not working normally. This type of dialysis achieves the extracorporeal removal of waste products such as creatinine and urea and free water from the blood when the kidneys are in a state of kidney failure. Hemodialysis is one of three renal replacement therapies. An alternative method for extracorporeal separation of blood components such as plasma or cells is apheresis.

<span class="mw-page-title-main">Chronic kidney disease</span> Medical condition

Chronic kidney disease (CKD) is a type of long-term kidney disease, in which either there is a gradual loss of kidney function occurs over a period of months to years, or abnormal kidney structure. Initially generally no symptoms are seen, but later symptoms may include leg swelling, feeling tired, vomiting, loss of appetite, and confusion. Complications can relate to hormonal dysfunction of the kidneys and include high blood pressure, bone disease, and anemia. Additionally CKD patients have markedly increased cardiovascular complications with increased risks of death and hospitalization.

<span class="mw-page-title-main">Home hemodialysis</span>

Home hemodialysis (HHD) is the provision of hemodialysis to purify the blood of a person whose kidneys are not working normally, in their own home. One advantage to doing dialysis at home is that it can be done more frequently and slowly, which reduces the "washed out" feeling and other symptoms caused by rapid ultrafiltration, and it can often be done at night, while the person is sleeping.

Artificial kidney is often a synonym for hemodialysis, but may also refer to the other renal replacement therapies that are in use and/or in development. This article deals mainly with bio-artificial kidneys featuring cells that are grown from renal cell lines/renal tissue.

<span class="mw-page-title-main">Hemofiltration</span> Medical procedure

Hemofiltration, also haemofiltration, is a renal replacement therapy which is used in the intensive care setting. It is usually used to treat acute kidney injury (AKI), but may be of benefit in multiple organ dysfunction syndrome or sepsis. During hemofiltration, a patient's blood is passed through a set of tubing via a machine to a semipermeable membrane where waste products and water are removed by convection. Replacement fluid is added and the blood is returned to the patient.


Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. Authorized by the European Medicines Agency in August 2007, it stimulates erythropoiesis and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy.

<span class="mw-page-title-main">Robert Provenzano</span> American physician

Robert Provenzano is an American nephrologist. He is also an Associate Clinical Professor of Medicine at Wayne State University School of Medicine.

Continuous erythropoietin receptor activator (CERA) is the generic term for drugs in a new class of third-generation erythropoiesis-stimulating agents (ESAs). In the media, these agents are commonly referred to as 'EPO', short for erythropoietin. CERAs have an extended half-life and a mechanism of action that promotes increased stimulation of erythropoietin receptors compared with other ESAs.

Dialysis Clinic, Inc. is a nonprofit medical corporation founded in 1971 and chartered as a 501(c)(3) tax-exempt organization under IRS regulations.

Aluminium toxicity in people on dialysis is a problem for people on haemodialysis. Aluminium is often found in unfiltered water used to prepare dialysate. The dialysis process does not efficiently remove excess aluminium from the body, so it may build up over time. Aluminium is a potentially toxic metal, and aluminium poisoning may lead to mainly three disorders: aluminium-induced bone disease, microcytic anemia and neurological dysfunction (encephalopathy). Such conditions are more prominently observed in people with chronic kidney failure and especially in people on haemodialysis.

Peginesatide, developed by Affymax and Takeda, is an erythropoietic agent, a functional analog of erythropoietin.

AMAG Pharmaceuticals, Inc. is an American pharmaceutical company developing products that treat iron deficiency anemia (IDA) in adult patients. The company was a publicly traded company listed on NASDAQ under the symbol "AMAG" until November 2020 when it was acquired by Covis Pharma.

Sucroferric oxyhydroxide, sold under the brand name Velphoro, is a non-calcium, iron-based phosphate binder used for the control of serum phosphorus levels in adults with chronic kidney disease (CKD) on haemodialysis (HD) or peritoneal dialysis (PD). It is used in form of chewable tablets.

CSL Vifor is a global specialty pharmaceuticals company in the treatment areas of iron deficiency, dialysis, nephrology & rare disease. It is headquartered in Switzerland and consists of CSL Vifor, Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Sanifit Therapeutics.

<span class="mw-page-title-main">Vadadustat</span> Chemical compound

Vadadustat, sold under the brand name Vafseo, is a medication used for the treatment of symptomatic anemia associated with chronic kidney disease. Vadadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor.

<span class="mw-page-title-main">Roxadustat</span> Anti-anemia medication

Roxadustat, sold under the brand name Evrenzo, is an anti-anemia medication. Roxadustat is a HIF prolyl-hydroxylase inhibitor that increases endogenous production of erythropoietin and stimulates production of hemoglobin and red blood cells. It was investigated in clinical trials for the treatment of anemia caused by chronic kidney disease (CKD). It is taken by mouth. The drug was developed by FibroGen, in partnership with AstraZeneca.

<span class="mw-page-title-main">Daprodustat</span> Chemical compound

Daprodustat, sold under the brand name Duvroq among others, is a medication that is used for the treatment of anemia due to chronic kidney disease. It is a hypoxia-inducible factor prolyl hydroxylase inhibitor. It is taken by mouth.

<span class="mw-page-title-main">Desidustat</span> Chemical compound

Desidustat is a drug for the treatment of anemia of chronic kidney disease. This drug with the brand name Oxemia is discovered and developed by Zydus Life Sciences. Desidustat reduces the requirement of recombinant erythropoietin requirement in anemia, and decreases EPO-resistance, by reducing IL-6, IL-1β, and anti-EPO antibodies. The subject expert committee of CDSCO has recommended the grant of permission for manufacturing and marketing of Desidustat 25 mg and 50 mg tablets in India,based on some conditions related to package insert, phase 4 protocols, prescription details, and GCP. Clinical trials on desidustat have been done in India and Australia. In a Phase 2, randomized, double-blind, 6-week, placebo-controlled, dose-ranging, safety and efficacy study, a mean hemoglobin increase of 1.57, 2.22, and 2.92 g/dL in desidustat 100, 150, and 200 mg arms, respectively, was observed. The Phase 3 clinical trials were conducted in chronic kidney disease patients which were not on dialysis as well as on dialysis. Desidustat is developed for the treatment of anemia as an oral tablet, where currently injections of erythropoietin and its analogues are drugs of choice. Desidustat is a HIF prolyl-hydroxylase inhibitor. In preclinical studies, effects of desidustat was assessed in normal and nephrectomized rats, and in chemotherapy-induced anemia. Desidustat demonstrated hematinic potential by combined effects on endogenous erythropoietin release and efficient iron utilization. Desidustat can also be useful in treatment of anemia of inflammation since it causes efficient erythropoiesis and hepcidin downregulation. In January 2020, Zydus entered into licensing agreement with China Medical System (CMS) Holdings for development and commercialization of desidustat in Greater China. Under the license agreement, CMS will pay Zydus an initial upfront payment, regulatory milestones, sales milestones and royalties on net sales of the product. CMS will be responsible for development, registration and commercialization of desidustat in Greater China. National Medical Products Administration of China (NMPA) accepted the new drug application for desidustat on 23rd April 2024. It has been observed that desidustat protects against acute and chronic kidney injury by reducing inflammatory cytokines like IL-6 and oxidative stress. A clinical trial to evaluate the efficacy and safety of desidustat tablet for the management of COVID-19 patients is ongoing in Mexico, wherein desidustat has shown to prevent acute respiratory distress syndrome (ARDS) by inhibiting IL-6. Zydus has also received approval from the US FDA to initiate clinical trials of desidustat in chemotherapy Induced anemia (CIA). Zydus Lifesciences and Sun Pharmaceuticals have entered an agreement in October 2023 to co-market Desidustat. Sun Pharma will sell the drug as Rytstat, while Zydus will continue to sell it as Oxemia.

References

  1. 1 2 "Rockwell Medical Inc. 2018 Form 10-K Annual Report". U.S. Securities and Exchange Commission.
  2. "Triferic Pharmacokinetics Characterized". Renal and Urology News. 2017-04-20.
  3. "FDA Drug information" (PDF). FDA.
  4. "NASDAQ SEC Filing". SEC.
  5. "Rockwell Medical Completes Long-Term Safety Study for Triferic(TM)".
  6. 1 2 Medical, Rockwell. "Pipeline". Rockwell Medical. Retrieved 2024-02-22.
  7. 1 2 "NASDAQ | SEC Filing". secfilings.nasdaq.com.