Replies to post #18459 on Biotech Values

[DewDiligence]

Praveen re KERX:

Thank you for your detailed post on the new data. I’ll defer replying on the details until I’ve listened to today’s CC, which apparently was the source of many of your statements.

My general assessment remains that these results were tepid and not really positive in the true sense of the word. (The market evidently agrees.)

The word positive in press releases describing clinical data has such a wide connotation that it’s an unfortunate usage. KERX’s results may be good enough for the clinical program to continue as planned, but were these results sincerely as strong as the company hoped for? I have my doubts.

More later (after the CC). Regards, Dew

[DewDiligence]

Praveen et al re KERX data:

I finally listened to the CC from last week and I’m no more impressed than I was before listening. In fact, I’m somewhat less impressed now.

One reason is that I’m suspicious of companies who change their story ex post facto about what kinds of results are good results.

Perhaps the main question about the most recent data is the lack of a standard dose response: the 400mg cohort had substantially worse results than the 200mg cohort. On the recent CC, Weiss called this a “bell shaped dose-response curve” and said that this bell-shaped curve was expected given KRX-101’s MoA, which includes both an agonist and an antagonist.

I found Weiss’ assertion surprising, so I went back and checked what KERX was saying about this subject before the recent data came out. Here’s an excerpt from KERX’s PR on 6/29/05 (#msg-6895846):

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A randomized, double- blind, placebo-controlled, Phase 2 study of the use of sulodexide for treatment of diabetic nephropathy was conducted in 223 patients in Europe, and was published in the June 2002 issue of the Journal of the American Society of Nephrology. The results of this [earlier] Phase 2 study showed a dose-dependent reduction in proteinuria or urinary albumin excretion rates.
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No mention about any “bell shaped” curve in the post-mortem of this earlier phase-2 study.

[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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