NEW YORK, May 8, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for patients suffering from renal disease (the "Company"), today announced its financial results for the first quarter ended March 31, 2014. In the first quarter, Keryx raised approximately $107.6 million, net of underwriting discounts and offering expenses, through an underwritten public offering of common stock, ending the quarter with $155.1 million of cash, cash equivalents, short-term investments and interest receivable, and no debt. "Over the past few months we have made significant strides in expanding our leadership team and building our commercial organization to support the launch of Zerenex™, pending potential approval," said Ron Bentsur, Chief Executive Officer of Keryx. "This work, along with the progress made on regulatory filings and clinical development, bring us closer to potentially providing Zerenex to patients in the U.S. and Europe." Business Highlights
- Keryx has made significant progress preparing for the potential launch of Zerenex™ (ferric citrate coordination complex) in the U.S. With key strategic staff in place, the Company has opened an office in Boston, which will serve as the home base for its expanding commercial infrastructure. Among a host of activities, the Company is developing a brand plan, conducting market research, and determining sales force sizing and territory alignment to support the launch of Zerenex late in the third quarter, pending FDA approval.
- Important data related to Zerenex were presented in several posters and a late-breaking oral presentation at the National Kidney Foundation's Spring Clinical Meeting in Las Vegas in late April. The data included several analyses of the potential pharmacoeconomic benefits of Zerenex use in dialysis-dependent chronic kidney disease (CKD), if approved by the FDA, as well as efficacy and safety data from a phase 2 trial of Zerenex in non-dialysis dependent CKD patients.
- Outside of the U.S., progress was made on two important fronts:
- The European Medicines Agency (EMA) validated the Company's marketing authorization application (MAA), which seeks the approval of Zerenex as a treatment for hyperphosphatemia in patients with CKD, including both dialysis and non-dialysis dependent CKD. The review is ongoing and, if reviewed on a standard timeline, the Company would anticipate a determination by the EMA in mid-2015.
- The Company's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical (JT/Torii), received manufacturing and marketing approval of ferric citrate in Japan for the improvement of hyperphosphatemia in patients with CKD, including both dialysis and non-dialysis dependent CKD. The Japanese launch is planned for May 12, 2014, where it will be marketed as Riona ®. Keryx will receive royalties on net sales of Riona in Japan.
- During the quarter, Keryx also made progress on the further clinical development of Zerenex. The Company has substantially finalized the trial design for a phase 3 study to evaluate Zerenex for the treatment of iron deficiency anemia in non-dialysis dependent CKD patients. Keryx plans to initiate the phase 3 trial in the third quarter of 2014.