Biotech Values

[DewDiligence]

KERX Lead Drug Whiffs in Phase-3

[This is one case where the game of releasing bad news on Friday evening won’t work: expect the stock to get mercilessly hammered on Monday. Sulonex is a drug that KERX lifted from the scrap heap, and this should always be a red flag, IMO. I don’t recall any regulars on this board touting KERX, although Praveen (who rarely posts these days) used to speak highly of it.]

http://biz.yahoo.com/prnews/080307/nyf080.html

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Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint

Friday March 7, 8:00 pm ET

Company to host a conference call Monday, March 10, 2008 at 8:30am

NEW YORK, March 7 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) today announced top-line results from its SUN-MICRO Phase 3 clinical trial of Sulonex (sulodexide) for the treatment of diabetic nephropathy. The Company announced that this Phase 3 clinical trial failed to meet the primary objective of the study, which was to increase the proportion of patients that achieve therapeutic success at 6 months as compared to placebo over background therapy of maximal doses of ACE-inhibitors or ARBs. Therapeutic success was defined as (i) conversion from microalbuminuria to normoalbuminuria, as measured by albumin/creatinine ratio (ACR), with at least a 25% reduction in ACR relative to baseline ACR, or (ii) a 50% reduction in ACR relative to baseline ACR. In addition, in reviewing the mean changes in ACR over time, Sulonex and placebo appeared to be similar.

"We are all very disappointed with the outcome of this Study. While this represents the end of one chapter for Keryx, it is not the end of Keryx. Drug development is inherently risky and, accordingly, we have spent the last several years building what we believe to be a promising product portfolio in the event our lead drug failed. We plan to re-focus our primary efforts and resources on rapidly moving Zerenex forward for ESRD patients with hyperphosphotemia and Perifosine forward for cancer. Our goal is to have Perifosine in a pivotal program this year and be well into our Zerenex high-dose Phase 2 trial before the end of the year."

The Company will host a conference call on Monday, March 10, 2008 at 8:30am ET.

In order to participate in the conference call, please call 1-877-852-6578 (U.S.), 1-719-325-4794 (outside the U.S.), call-in ID: KERYX. The audio recording of the conference call will be available for replay at http://www.keryx.com, for a period of 15 days after the call.

ABOUT KERYX BIOPHARMACEUTICALS, INC.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, or ESRD. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401, which is currently in Phase 2 clinical development for multiple tumor types, is expected to move into a Phase 3 clinical program in 2008. The Company also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates.
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