Keryx Biopharmaceuticals Announces Live Webcast of Upcoming Analyst Day (KERX)

Keryx Biopharmaceuticals (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City.

The Company has announced that its upcoming Analyst Day will be webcast live on Thursday, June 21, 2012 at 4:30 pm ET. Scheduled speakers include the following:

• Julia Lewis, M.D. will provide her perspective on the Zerenex (ferric citrate) Phase 3 clinical program and the potential Zerenex product profile.-- Professor of Medicine, Division of Nephrology, Vanderbilt University School of Medicine
• Geoffrey Block, M.D. will discuss the potential for Zerenex in pre-dialysis.-- Director of Research, Denver Nephrology and Associate Clinical Professor in Medicine, University of Colorado Health Sciences Center
• David Goldfarb, M.D. will discuss the potential importance of citrate.-- Chief, Nephrology Division, NY Campus of NY Harbor Health Care Veterans Affairs System and Professor of Medicine & Physiology, NYU School of Medicine.

To access the live audio webcast, please visit the Company's Investor Relations section of their website ( http://investors.keryx.com ). An archived version of the webcast will become available following the conclusion of the live presentation.

Keryx a Buy @ The Motley Fool (KERX)

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. 

At The Motley Fool, contributor Jordo Bivona writes that "There is no shame in wanting to find cheap investments that pay off in the long run. The trouble is it can be tough to tell what is worth your money and what is cheap simply because it is worthless." In some cases, like Keryx, "the prices are low, but the stocks are worth a great deal. For these stocks, now is the time to buy and hang on until something major happens and the prices soar."

About Keryx, he writes,

"Keryx (NASDAQ: KERX) is currently selling for around $1.50 and has been floundering, primarily because its flagship drug perifosine failed its latest round of clinical trials. The drug was intended to offer a new treatment option for those suffering from colorectal cancer. When it did not live up to expectations, Keryx plummeted more than 60% and continues to fall.

...The company still has approximately $30 million in cash to fund operations, and a quarterly burn rate of around $4 million to $6 million, depending on research demands. For the company to succeed with Zerenex, it needs successful trials in its fourth quarter and a new drug application from the FDA. Recently, the stock saw a 22% gain on news of a successful clinical trial for Zerenex that was completed in Japan. Thus, this stock may be down, but it is definitely not out."

Read more at beta.fool.com. 

Hope Springs Eternal In Biotech @ Seeking Alpha (KERX)

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City. 

At Seeking Alpha, contributor Michael J. Ray writes that while it is true that hope is not the best strategy when it comes to investing, "there is one sector that does embrace hope as an investing component and that sector is speculative biotech." He argues that it is patients' hope for a cure that "highlight[s] unmet medical need, which in turn brings investors and researchers to the scene."

He points to Keryx's Perifosine as an example in which "the hope[s] of both investors and patients were dashed, and the stock price quickly declined." But he goes on to say that,

"Both KERX and BPAX are not completely out the game though. Each has other products in the pipeline, but their most touted opportunities came up empty. But this article is about hope, and hope is said to spring eternal."

He goes on to discuss 3 companies "keeping hope alive" for both patients and investors alike: Osiris Therapeutics (OSIR), Advanced Cell Technology Inc. (ACTC.OB), and Galena Biopharma, Inc. (GALE).

Read the full article at SeekingAlpha.com. 

Keryx Biopharmaceuticals Announces Upcoming Poster Presentation of Zerenex™ (ferric citrate) at the 49th ERA-EDTA Congress (KERX)

Keryx Biopharmaceuticals (KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City. 

The Company announced that one of its abstracts has been accepted for poster presentation at the upcoming 49th ERA-EDTA (European Renal Association European Dialysis and Transplant Association) Congress, taking place May 24-27, 2012, in Paris, France. The abstract is entitled "A Meta-Analysis of Ferric Citrate for Hyperphosphatemia: The Effects of an Oral Iron-Containing Phosphate Binder on Serum Ferritin and Saturated Transferrin in Hemodialysis Patients (Abstract # SAP534);" it highlights the dose related increases in iron storage parameters as observed in prior clinical trials of Zerenex" (ferric citrate). 

The poster will be presented on Saturday, May 26, 2012, from 9:30am to 10:45am local time.

The above referenced abstract is available for viewing on-line at http://www.m-events.com/customer/2012/era-edta/data/12575.pdf. Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

Read more at Seeking Alpha. 

The Case For Keryx Biopharmaceuticals' Analyst Upgrade May Be Justified @ Seeking Alpha (KERX)

Keryx Biopharmaceuticals (NASDAQ:KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.

At Seeking Alpha, contributor VFC's Stock House argues that investors would be unwise to dismiss Keryx as a company because of the failure of Perifosine, especially given the strong potential of Zerenex. 

He writes,

"Since the Perifisone failure essentially made Keryx a 'one trick wonder' for the time being, the concerns expressed by numerous investors and media outlets regarding Zerenex have mostly been based on the solid entrenchment of Renagel in the market, and the fact that generic competition is just right around the corner. These concerns have been widespread enough to cause the mass exodus of investors and traders that led to last month's share price drop, but they ignore some unique qualities of Zerenex treatment that have not been widely discussed -- and which could offer insight into the product's true market potential."

He points out that while Renagel is "the recognized leader in its field," it also comes with some unpleasant side effects that Zerenex, so far, does not share. Another advantage is that Zerenex is a phosphate binder that is iron based; this may "enable patients to retain iron more efficiently than the competition currently on the market. This could play be key, as many patients on dialysis in end stage renal disease are anemic and are stuck on IV treatment - along with everything else - in order to maintain iron levels."

He continues,

"It's possible that Zerenex could alleviate the need for the IV and end up being considered one-stop shopping: A package deal that could provide enough of a pricing and logistical boost to make it the preferable treatment of choice. The same cannot be said, at least for the time being, for the competition, generic or not.

Given those advantages, it may be concluded that Zerenex is positioned to not only heavily compete with the competition currently on the market, but it might also have enough behind it to potentially become the market leader."

Read more at SeekingAlpha.com. 

6 Low Debt Pharmaceutical Stocks Rated Buy Or Better @ Seeking Alpha (KERX, VTUS)

At Seeking Alpha, contributor ZetaKap wrote an article asking, "Interested in pharmaceutical companies? In search of companies that can manage their debt well? Do you prefer companies that can manage their long term debt? Are you after stocks that analysts are calling 'buy' or 'strong buy'? If so, you'll probably like this list."

Two of the six companies listed were Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) and Ventrus Biosciences (NASDAQ: VTUS).

About Keryx, ZetaKap wrote,

"Keryx Biopharmaceuticals Inc. has a Debt/Equity Ratio of 0.00 and Long Term Debt/Equity Ratio of 0.00 and Analysts' Rating of 1.80. The short interest was 13.77% as of 05/12/2012. Keryx Biopharmaceuticals, Inc., a biopharmaceutical company, together with its subsidiaries, focuses on the acquisition, development, and commercialization ofpharmaceutical products for the treatment cancer and renal disease. The company's products under development include KRX-0401 (perifosine), an oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, as well as affects other pathways associated with programmed cell death, cell growth, cell differentiation, and cell survival. Its KRX-0401 is in Phase III clinical development stage for the treatment of refractory advanced colorectal cancer and multiple myeloma, as well as in Phase I and Phase II clinical development stages for the treatment of other tumor types."

About Ventrus Biosciences, ZetaKap writes,

"Ventrus Biosciences Inc. has a Debt/Equity Ratio of 0.00 and Long Term Debt/Equity Ratio of 0.00 and Analysts' Rating of 1.40. The short interest was 3.14% as of 05/12/2012. Ventrus Biosciences, Inc., a development stage specialty pharmaceutical company, focuses on the development and commercialization of late-stage prescription drugs for gastrointestinal disorders, primarily hemorrhoidal disease, anal fissures, and fecal incontinence. It is developing three late-stage product candidates, including Iferanserin ointment (VEN 309) for the topical treatment of symptomatic internal hemorrhoids; Diltiazem cream (VEN 307), a topical treatment for the relief of pain associated with anal fissures; and Phenylephrine gel (VEN 308) for the treatment of fecal incontinence associated with ileal pouch anal anastomosis, an FDA orphan indication. The company was formerly known as South Island Biosciences, Inc."

Read the full article at SeekingAlpha.com.  

Keryx ($KERX) Biopharmaceuticals announces positive top-line results from phase 3 study of ferric citrate (Zerenex) in Japan

Keryx Biopharmaceuticals (NASDAQ: KERX) announced today that its Japanese partners, Japan Tobacco (2914.JP) and Torii Pharmaceutical (4551.JP) have announced positive top-line results from a Phase 3 study of ferric citrate (Zerenex) in Japan for the treatment of hyperphosphatemia in end-stage renal disease patients on hemodialysis. This study is part of an ongoing Phase 3 program for ferric citrate in Japan for the treatment of hyperphosphatemia.

• The Phase 3 study, conducted in Japan, evaluated the efficacy and safety of ferric citrate against an active control, sevelamer hydrochloride, over 12 weeks in hemodialysis patients with hyperphosphatemia.
• In the top-line results, which evaluated the change of serum phosphorus from baseline, the primary endpoint of efficacy met non-inferiority to sevelamer hydrochloride. Furthermore, there were no clinically significant findings on safety and tolerability of ferric citrate within the treatment period.
• JT/Torii stated that it is aiming to submit the marketing application for ferric citrate in Japan in the fiscal year ending March 31, 2013.
• Zerenex is also in a Phase 3 clinical program in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis, which is being conducted pursuant to a Special Protocol Assessment agreement with the FDA.

Rodman and Renshaw update on $KERX

Perifosine Strikes Out – Zerenex at Bat – A Potential Home Run Opportunity

Rodman and Renshaw update on KERX (PDF)
 
Summary: X-PECT Trial Fails to Meet Primary Endpoint – Removing All Perifosine Revenues from Model Today, Keryx announced that the Phase 3 X-PECT trial for the treatment of metastatic colorectal cancer failed to meet its primary endpoint of overall survival (OS). During the conference call, management elaborated that the median OS observed in the control arm of capecitabine + placebo was significantly higher than any other historical control treatment investigated in other randomized trials for the similar patient population. Additionally, further analysis revealed no benefit of perifosine + capecitabine treatment in the KRAS wild type or mutant population, or any other subgroup of patients. No further details regarding the difference in the survival between the treatment and the control arm, or the toxicities related to the treatment were provided. The management further indicated that given the failure of the X-PECT trial, the recruitment in the Phase 3 multiple myeloma trial may be affected, and the company is contemplating whether to continue the Phase 3 trial of perifosine with Velcade and dexamethasone in relapsed / refractory multiple myeloma patients. In our opinion, the company will likely shut down all clinical programs involving perifosine in an effort to conserve cash.
 
Phase 3 Zerenex Trial for Hyperphosphatemia to Report in 4Q12 During the call, the management also reminded investors about the ongoing Phase 3 trial evaluating Zerenex for the treatment of hyperphosphatemia in end-stage renal disease (ESRD) patients. Keryx is conducting a 58-week long-term, multicenter, randomized, open-label, safety and efficacy Phase 3 trial evaluating Zerenex, a phosphate binder, in 440 patients with ESRD on dialysis. During the call today, management reiterated that the data from the Phase 3 trial is expected to be available in 4Q12, with potential filing of the NDA and MAA in 1H13. In our opinion, the long-term study of Zerenex has a higher than average likelihood to succeed given that the short-term Phase 3 trial of Zerenex in ESRD patients met its primary endpoint of demonstrating a dose response in the change of serum phosphorous from baseline to day 28 (p-value < 0.0001). Of additional significance, Zerenex may reveal additional benefits in combating anemia if the Phase 3 data demonstrate a reduced need for intravenous and/or EPO blood cell stimulating drugs such as Procrit, Epogen and Aranesp.
 
Zerenex Market Potential We would like to remind investors that the US market for phosphate binders in the dialysis setting is approximately $700 MM and worldwide the market is approximately $1.2 BN. The 25% year-over-year growth in the phosphate binding market over the past 5 years has been driven by an increased incidence of dialysis with a growing diabetic population, as well price increases from market leader Genzyme for Renagel and Renvela. We believe that Zerenex has the potential to address the deficiencies among marketed phosphate binders, and capture 14% of the hyperphosphatemia market, corresponding to peak US revenues of approximately $250 MM by 2018, if successful.
 
Quick Take We are reiterating our Market Outperform / Speculative Risk rating but lowering our target price of $8 to $3 based on a discounted 2015 revenues and earnings multiples analysis. In our opinion, the failure of perifosine is a temporary setback, and provides an opportunity to a value-oriented investor to invest in the potential of the Zerenex franchise. The potential cost-savings benefit, combined with previous efficacy data, makes Zerenex an attractive treatment option in the approximately $700 MM U.S. market for agents that lower phosphate in ESRD patients on dialysis. We believe that Keryx represents a significantly undervalued and underappreciated company and is potentially suitable for the risk-oriented investor.