|KERYX BIOPHARMACEUTICALS INC filed this Form 424B5 on 07/27/2017|
The following is a summary of what we believe to be the most important aspects of our business and the offering of our securities under this prospectus. We urge you to read this entire prospectus, including the more detailed consolidated financial statements, notes to the consolidated financial statements and other information incorporated by reference from our other filings with the SEC or included in any applicable prospectus supplement. Investing in our securities involves risks. Therefore, carefully consider the risk factors set forth in any prospectus supplements and in our most recent annual and quarterly filings with the SEC, as well as other information in this prospectus and any prospectus supplements and the documents incorporated by reference herein or therein, before purchasing our securities. Each of the risk factors could adversely affect our business, operating results and financial condition, as well as adversely affect the value of an investment in our securities.
About Keryx Biopharmaceuticals, Inc.
We are a biopharmaceutical company focused on bringing innovative medicines to people with renal disease. Our product, Auryxia® (ferric citrate), also known as Riona® in Japan and Fexeric® in Europe, is an oral, absorbable iron-based medicine, that received marketing approval from the U.S. Food and Drug Administration, or FDA, in September 2014 for the control of serum phosphorus levels in patients with chronic kidney disease, or CKD, on dialysis. We believe that there currently are approximately 450,000 adults in the United States on dialysis of whom approximately 350,000 are on phosphate binders and eligible for treatment with Auryxia. When discussing ferric citrate in the United States in reference to our marketed product, we will refer to it as Auryxia, when discussing it in the United States in reference to our investigational medicine in Phase 3, we will refer to it as ferric citrate, when discussing it in Japan, we will refer to it as Riona, and when discussing it in Europe, we will refer to it as Fexeric.
We launched Auryxia in the United States in late December 2014. Auryxia is being marketed in the United States through our specialty salesforce and commercial infrastructure. Our sales organization is aligned to 95 territories calling on target nephrologists and their associated dialysis centers. In 2015, we reported net U.S. Auryxia product sales of $10.1 million.
On August 1, 2016, we announced that an interruption in the supply of Auryxia tablets was imminent due to a production-related issue in converting active pharmaceutical ingredient, or API, to finished drug product at our contract manufacturer. This issue resulted in variable production yields of finished drug product and, as a result, we exhausted our reserve of finished drug product. Inventories of Auryxia were not sufficient to ensure uninterrupted patient access to this medicine. The supply interruption did not affect the safety profile of currently available Auryxia and did not affect the supply of Riona manufactured and sold by our Japanese partner in Japan. We are working with this manufacturer to resolve the production-related issue. In addition, since approval of Auryxia in 2014, we had been working to bring a secondary manufacturer online to supply finished drug product. We recently filed for approval of an additional manufacturer, Patheon Manufacturing Services LLC, or Patheon, with the FDA and entered into a long-term arrangement with Patheon in October 2016 to supply finished Auryxia drug product. On November 9, 2016, the FDA approved our application and Patheon is now an approved drug product manufacturer of Auryxia. With FDA approval of this manufacturer, we have rebuilt supply of Auryxia and made Auryxia available to wholesalers again.
In March 2016, we announced positive top-line results from our pivotal Phase 3 study of ferric citrate for the treatment of iron deficiency anemia, or IDA, in adults with stage 3-5 non-dialysis dependent chronic kidney disease, or NDD-CKD. We believe there are approximately 650,000 adults in the United States with CKD currently being treated for IDA. The Phase 3 studys primary endpoint was the between group comparison of the proportion of patients achieving a 1 g/dL or greater increase in hemoglobin at any point during the 16-week randomized period of the study. Secondary endpoints in the Phase 3 study include the change from baseline to