Biotech investors are patient people. They are also diligent in their research; looking closely into a company’s compounds and the market potential that surrounds them. Keryx Biopharmaceuticals, Inc. is a company that has been the focus of several articles recently due to the dip in share price which is offering an opportunity for value pricing of a company that is pushing forward with late-stage research on its novel compounds.
Regarding therapies for end-stage renal disease (ESRD), a more than billion-dollar market controlled by Genzyme (NASDAQ:GENZ) with Renagel and Renvela, there still remains a void that can be filled by a therapy that overcomes many of the issues with current phosphate-binders. Calcium-based phosphate binders increase the risk of metastatic calcification in many patients. The most commonly prescribed phosphate binders in the United States are non-calcium-based non-absorbed phosphate binders, including sevelamer products. However, sevelamer hydrochloride has been shown to increase the risk of metabolic acidosis, which can result in coma or death. A drug which can increase iron levels and lower the risk of metabolic acidosis and still perform effectively is the quest of several companies today.
Keryx is developing Zerenex™, an iron-based phosphate binder for the treatment of elevated serum phosphorus levels (hyperphosphatemia) in patients with ESRD. Research on Zerenex™ has provided positive data in the Phase III short-term efficacy study, while a 58-week, long-term safety study (approx. 300 patients) was initiated on in September of 2010 with Keryx expecting to complete patient enrollment during mid-2011 and report results mid-2012. Initial results from the short-term efficacy study met both primary and secondary endpoints by showing a highly statistically significant dose response in the change in serum phosphorus from baseline to Day 28 in the intention to treat group of patients as well as final data indicating the potential ability of Zerenex to manage metabolic acidosis. Data from these early Phase III studies reinforces earlier studies which show that Zerenex™ may have a leg up on the competition and, if brought to market, take a bite out of Genzyme’s 66% control of the market.
Keryx also possesses perifosine to treat advanced colorectal cancer and multiple myeloma. Perifosine is a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. Perifosine is in Phase III clinical trials as a therapy for both of these diseases under a Special Protocol Assessment from the FDA.
Anyone involved with investing in biotechnology companies realizes that there are some “ups and downs” involved with quiet times. Early trials can produce more press releases and announcements on the conclusions of certain aspects of the development, but later-stage developments often do not see frequent press due to the sheer magnitude of the studies. For many, it provides an opportunity to snatch shares while the price is depressed, but only as a result of the typical cycle of a developmental biotech, not the quality of the company or the drugs it possesses.
More information on Keryx and its pipeline of drugs can be found on the Company’s website at www.keryx.com