Keryx Biopharmaceuticals (KERX) Up On Test Results

September 23, 2009 · Filed Under fda 

Keryx Biopharmaceuticals (KERX) is up 33% to $3.14 on news that results of the Open Label Extension (OLE) trial of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The OLE trial, conducted in Taiwan, enrolled 29 of the 37 Taiwanese patients that had completed the randomized, multi-center, multi-national (United States and Taiwan) dose-ranging Phase 2 study. This OLE represents the first trial to examine the long-term safety and efficacy of Zerenex as a phosphate binder. The treatment period in all previous Zerenex Phase 2 clinical trials did not exceed 28 days.

The OLE trial provided for a daily dose, ranging from 2 to 6 g/day of Zerenex, for a period of up to one year following completion of the 28-day, dose-ranging Phase 2 study. The average duration of the patients’ participation in the OLE trial was 306 +/- 85 days.

The company now trades at a 52-week high up from a period low of $.09. It is hard to say such a huge run is justified.

At June 30, 2009, the Company had cash, cash equivalents, short-term investment securities and interest receivable of $13.4 million, as compared to $15.5 million at December 31, 2008. In addition, at June 30, 2009, the Company had $7.1 million of auction rate securities which are classified as long-term investments. Additionally, in July 2009, the Company received $2.75 million of cash from a settlement with the former licensor of Sulonex (sulodexide). The Company will receive an additional $750,000 on or before July 30, 2010 related to this settlement.

The net income for the second quarter ended June 30, 2009 was $14.1 million, or $0.29 per diluted share, compared to a net loss of $7.7 million, or $0.17 per share, for the second quarter in 2008. The change in net income (loss) was primarily attributable to the recognition of $18.0 million in license revenue relating to an amendment to the September 2007 sublicense agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. (JT/Torii), which eliminated the Company’s significant ongoing obligations included in the original agreement, a $1.8 million decrease in research and development expenses related to KRX-0401, and a $1.0 million decrease in research and development expenses related to the cessation of the development of Sulonex in March 2008.

Douglas A. McIntyre

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