Keryx Biopharmaceuticals (NASDAQ:KERX) announced that the European Commission has approved Fexeric® (ferric citrate coordination complex) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD), including both dialysis and pre-dialysis patients. The European Commission considered ferric citrate coordination complex a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe.
“We are pleased that this medicine was approved for broad use, in both the pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with chronic kidney disease,” said John Neylan, M.D., chief medical officer of Keryx. “Importantly, the EU product information contains data that is reflective of Fexeric’s full clinical profile, including all of the primary and secondary endpoint data from the Phase 3 study. With Fexeric’s broad label, nephrologists have a new, well tolerated and effective phosphate binder to control hyperphosphatemia as the patient progresses through the late stages of CKD and into dialysis.”
“The differentiated profile of ferric citrate will be a new treatment option for our patients on dialysis and pre-dialysis,” said Gilbert Deray, MD, Professor of Nephrology at Université Paris 6 Pierre et Marie Curie in Paris and Nephrologist and Head of the Department of Nephrology at Pitié-Salpêtrière University Hospital. “I look forward to using this medicine to control phosphorus levels when it becomes available in the E.U.”
The European Commission’s decision is based on evidence from approximately 1900 patients, including two key clinical trials: a Phase 2, non-dialysis study and a 58-week, Phase 3 registration trial. In the Phase 3 trial, ferric citrate effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL (p<0.0001), the primary endpoint. These data were published in 2014 in the Journal of the American Society of Nephrology.
“EC approval is another validation by a global regulatory agency of the medicine’s profile, and is another milestone in our efforts to expand the reach of ferric citrate to treat patients with renal disease,” said Greg Madison, chief executive officer. “We continue to work with potential partners regarding commercialization in the EU, and expect to finalize our commercial strategy by the end of 2015.”
The most commonly reported adverse reactions in dialysis-dependent CKD patients during treatment were discolored feces (18%) and diarrhea (13%). All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhea, gastritis, gastritis erosive, and hematemesis). The most commonly reported adverse reactions in CKD non-dialysis patients during treatment were discolored feces (27%) constipation (13%) and diarrhea (11%).
Ferric citrate coordination complex was approved under the brand name Auryxia™ by the U.S. Food and Drug Administration in September 2014, and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Keryx is conducting a Phase 3 study to potentially expand the label in the U.S. to treat iron deficiency anemia in pre-dialysis patients with chronic kidney disease. (Original Source)
Shares of Keryx Biopharmaceuticals closed yesterday at $3.92. KERX has a 1-year high of $17.97 and a 1-year low of $3.77. The stock’s 50-day moving average is $5.52 and its 200-day moving average is $9.43.
On the ratings front, KERX has been the subject of a number of recent research reports. In a report issued on September 4, Brean Murray Carret analyst Jonathan Aschoff reiterated a Buy rating on KERX, with a price target of $22, which represents a potential upside of 461.2% from where the stock is currently trading. Separately, on August 10, FBR’s Christopher James initiated coverage with a Hold rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Christopher James have a total average return of 5.2% and -23.0% respectively. Aschoff has a success rate of 45.8% and is ranked #593 out of 3766 analysts, while James has a success rate of 25.0% and is ranked #3651.
Overall, 3 research analysts have assigned a Hold rating and 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $18.00 which is 359.2% above where the stock closed yesterday.
Keryx Biopharmaceuticals Inc is a biopharmaceutical company focused on therapies for patients with renal disease. Its first product is the AuryxiaTM (ferric citrate), an oral, absorbable iron-based compound.