The Future Is Bright: Keryx Biopharmaceuticals Receives Patent Protection
One of the best performing biotech stocks in 2013 was Keryx Biopharmaceuticals (NASDAQ:KERX). Keryx Biopharmaceuticals is a development-stage biopharmaceutical company focused on the acquisition, development, and commercialization of medically important pharmaceutical products to address underserved needs.
The year 2013 has been phenomenal for the company as shares of Keryx have soared by more than 350 percent during the past 52 weeks. The company’s value has grown because of the increased expectations regarding the potential of Keryx’s flagship product, KRX-0502 (Zerenex). It is an investigational, ferric citrate, oral compound that binds to phosphate. Keryx believes the compound may have the potential to treat hyperphosphatemia (elevated phosphate levels). This is a common symptom of patients who are on dialysis for chronic kidney disease (or, CKD).
The excitement for Keryx began on January 28, 2013, when the company announced that Zerenex met the primary and secondary endpoints in its Phase 3 trial. In the trial, Zerenex demonstrated a highly statistical significant decrease in serum phosphorus levels compared to the placebo over a four-week EAP (Efficacy Assessment Period). Zerenex also demonstrated statistically significant decreases at 12 weeks, 24 weeks, 36 weeks, 48 weeks, and a year compared to the baseline of 7.4 mg/dl. After the positive data, Keryx management announced its intention to file an NDA (New Drug Application) with the FDA and an MAA (Marketing Authorization Application) with the European Medicines Agency during the second quarter of 2013.