KERX - Sector: Healthcare --- Industry: Drug Manufacturers - Major

[setravis]

Drug Manufacturing Industry on an Explosive Journey...

Press Release Source: Rothman Research On Wednesday April 21, 2010, 8:43 am EDT
JOHANNESBURG, SOUTH AFRICA--(Marketwire - 04/21/10) - http://www.rothmanresearch.com/ - Needless to say that the drug manufacturing industry is a multi-billion dollar industry that is set to experience ongoing growth mid- to long-term. With this anticipated industry growth and increased competition in the drug market, the number of mergers and acquisitions would be on the rise as major players will strive to become more aggressive in their attempt to boost their market presence by increasing their product-line through new acquisitions. This trend is not new within the industry, but it is certainly on an uptrend. Abbott Laboratories (NYSE:ABT - News), one of the major players within the pharma industry, has been one busy bee in the M & A front with its strings of broad-based acquisitions. Many experts believe that this sudden interest in M & A was triggered by the fact that Humira, one of the company's star medications, will lose U.S. patent protection in the next 7 years.

*Complimentary downloadable research on Abbott Laboratories is accessible upon registration at http://www.rothmanresearch.com/article/abt/23455/Apr-21-2010.html

The major drug manufacturer, in an effort to broaden its product-line, went on a rampage by acquiring numerous small- to-midsize companies, thus helping the company to steer away from its over-dependence on its performing products. Abbott will be releasing its first quarter results today pre-market and analysts believe that the company will deliver positive figures supported by sales of Humira and the company's cost cutting efforts. "There will be a lot of attention on Humira sales performance for this quarter, however, there are also growing concerns about Abbott's U.S. pharmaceutical business which has already recorded a sales decline of more than 8.5% in its last reported quarterly readings. Another key factor that the street and industry professionals will be focused on in the mid-term is the impact of the new healthcare law on companies like Abbott," commented Mathew collier of http://www.rothmanresearch.com/.

* http://www.rothmanresearch.com/ is a source for investors seeking free information on the major drug manufacturers industry; investors are encouraged to sign up for free at http://www.rothmanresearch.com/index.php?id=6&name=Register.

Another driving force for the industry's growth potential is the increasing R & D investments in markets where demand is extremely high like cancer. Companies like Keryx Biopharmaceuticals Inc. (NASDAQ:KERX - News) is already making great strides in this field of research. The company was recently given a Fast Track designation from the FDA for development of Perifosine in advanced colorectal cancer, which is the third most widespread form of cancer identified in the U.S. Competition in the colorectal cancer market space is huge, but demand remains high.

*Direct & free downloadable report on Keryx Biopharmaceuticals Inc. is available by signing up now at http://www.rothmanresearch.com/article/kerx/23456/Apr-21-2010.html

Keryx is expected to release its earnings reading on May 10th and there is already a lot a buzz that the company's share price could be heading for a double by next year.

Companies looking for additional media or advertising services can call Blue Chip IR at 1-917-267-8836.

About Rothman Research
Rothman Research brings independent company and sector research together, utilizing top financial advisors and investment tactics to provide you with a clear picture of investment opportunities.

Contact:
For More Information Contact:Mathew [email protected]

[setravis]

The top five performing stocks of the past 52 weeks overall ...

Make no mistake ...
I'm not showing you these two tables to try to talk you out of investing in large-cap stocks. In fact, I selected these five large caps because I think they're all potentially great investments. The first three are official Motley Fool recommendations, and I personally own shares of the last two.

But as you can clearly see, the size of a company puts major limits on its growth potential. And the larger the company, the more analysts are following its every move –and the less likely the market is to misjudge its value.

In other words, if you want to score really big ...
You've got to dedicate a portion of your time to finding stocks that -- just like the small-caps listed above – are small, obscure, and ignored. Don't forget that because relatively few analysts are covering these stocks, there is a much greater chance that the market is undervaluing them.

There's one more point worth pondering here. Whereas a company like American Express would have to pack on another $55 billion in value for its shares to merely double, any of these five-small cap stocks' shares would soar at least 500% if they gained just half that amount.

[setravis]

keeps on trucking..
updated chart look

Below the 1 year chart...

[setravis]

KERX Keryx Biopharmaceuticals Announces Highly Statistically Sign... 

NEW YORK, Nov. 30, 2010 /PRNewswire via COMTEX/ -- Keryx Biopharmaceuticals, Inc. (KERX, Trade ) today announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex(TM) (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis. In this study, conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA), Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant dose response. In addition, key secondary endpoints were also met with high statistical significance.

STUDY DESIGN

This Phase 3 study was a multicenter, randomized, open-label trial with a two-week washout period, following which patients were randomized 1:1:1 to receive a fixed dose of Zerenex of either 1 gram, 6 grams or 8 grams per day for a treatment period of 28 days. Zerenex was administered using a 1 gram oral caplet formulation, hence, the fixed-dose arms of 1 gram, 6 grams and 8 grams per day represent 1, 6 and 8 pills per day, respectively.

One hundred fifty-one dialysis patients were enrolled into the study. The Intent-to-Treat (ITT) group included 146 patients, representing all patients who took at least one dose of Zerenex and provided a Baseline (at the end of washout) and at least one post-Baseline efficacy assessment. Efficacy assessments were taken weekly starting at Baseline and subsequently at days 7, 14, 21 and 28.

EFFICACY DATA ANALYSES

The primary endpoint of the study was to determine whether there is a dose response in the change in serum phosphorus from Baseline to Day 28 in the ITT group, using a regression analysis to evaluate this objective.

The study met the primary endpoint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).

Additional efficacy results are as follows:


Mean Serum Phosphorus (mg/dL)                        1g/Day 6g/Day     8g/Day
ITT (n=146)                                          (n=50) (n=51)     (n=45)
---------------------------------------------------- ------ ---------- ----------
Baseline (End of Washout)                            7.3    7.6        7.5
---------------------------------------------------- ------ ---------- ----------
Day 28 (End of Treatment)                            7.4    5.7        5.3
---------------------------------------------------- ------ ---------- ----------
Change from Baseline at Day 28                       0.1    -1.9       -2.2
P-Value                                                     !!!!0.0001 !!!!0.0001
---------------------------------------------------- ------ ---------- ----------
% Change from Baseline at Day 28                     0.5%   -25.0%     -28.8%
---------------------------------------------------- ------ ---------- ----------
Change from Baseline at Day 28 vs. 1g/Day Dose Group        -2.0       -2.3
P-Value                                                     !!!!0.0001 !!!!0.0001
----------------------------------------------------        ---------- ----------



In addition, a statistically significant dose response increase in serum bicarbonate was observed in the study, indicating the potential ability of Zerenex to manage metabolic acidosis, as seen in prior clinical studies with Zerenex. Metabolic acidosis is a condition that occurs in many dialysis patients when the kidneys do not remove sufficient acid from the body, leading to low blood pH. The consequences of metabolic acidosis can be severe, including coma and death. The inability to manage metabolic acidosis is believed to be a drawback for some of the currently marketed phosphate binders.

Importantly, and as anticipated, no clinically meaningful change in serum calcium was observed in the study. Additionally, a statistically significant dose response reduction in calcium-phosphorus product was also observed in the study. Elevated levels of serum calcium (hypercalcemia) and high levels of calcium-phosphorus product, both of which are believed to be drawbacks from the use of some of the currently marketed phosphate binders, increase the risk of soft tissue calcification and may contribute to the substantial morbidity and mortality seen in patients with end-stage renal disease.

Certain iron parameters, including ferritin and TSAT, were measured in the study. Modest upward trends in ferritin and TSAT levels were observed in the 6 grams/day and 8 grams/day dose groups, which further support the Company's belief that Zerenex has the potential to reduce the need for intravenous (IV) iron supplements and/or erythropoiesis-stimulating agents (ESAs) in dialysis patients. IV iron and ESA use is being evaluated in the ongoing Phase 3 long-term study. If reductions in use are confirmed, the Company believes this additional benefit would significantly expand Zerenex's market potential.

Zerenex appeared to be safe and well-tolerated in the study, with only nine patients (6%) in the ITT group dropping out of the study, which further supports Zerenex's favorable safety profile seen in prior clinical trials.

The full efficacy and safety data from the study is expected to be presented at a future medical conference.

Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, member of the Executive Committee of the Collaborative Study Group and Study Chair of the Zerenex Phase 3 registration program, commented, "This is a very important day for all of us involved in the Zerenex program. Based on the results of this Phase 3 study, it appears that the Zerenex efficacy and safety profile is emerging in a way that could make it the phosphate binder of choice for dialysis patients." Dr. Lewis continued, "We are very excited to have taken this step forward towards bringing Zerenex to the patients who are in need of additional alternatives to the existing phosphate binders."

Ron Bentsur, Chief Executive Officer of Keryx, stated, "The successful completion of this Phase 3 study is perhaps the most important milestone in Keryx's history. We are excited to be announcing these robust results which demonstrate Zerenex's potential benefits over the currently marketed phosphate binders, including advantages in pill burden, safety and compliance. We believe that the data presented today and the overall profile of Zerenex position the drug candidate to potentially become market leader in this $1.5 billion, rapidly growing market." Mr. Bentsur continued, "We sincerely thank the study investigators and coordinators, and we are particularly grateful to the Collaborative Study Group, whose expertise, guidance and dedication have been extraordinary."

CONFERENCE CALL INFORMATION

Keryx will host a conference call today, November 30, 2010, at 8:30 a.m. EST, to discuss the top-line results from this study. In order to participate in the conference call, please call 1-877-869-3847 (U.S.), 1-201-689-8261 (outside the U.S.), call-in ID: KERYX. The rebroadcast of the conference call will be available for replay at http://www.keryx.com , for a period of 15 days after the call.

Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. The Phase 3 program in Japan is pending commencement.

About the Zerenex Phase 3 Program

In accordance with the Company's SPA agreement with the FDA, in addition to the short-term Phase 3 study reported on today, the Company is also conducting a long-term (58-week) Phase 3 safety and efficacy study for which enrollment is ongoing. The long-term study is a multicenter, randomized, open-label, safety and efficacy clinical trial with a planned enrollment of approximately 300 patients on hemodialysis or peritoneal dialysis. The long-term study will consist of a 2-week washout period followed by a 52-week safety assessment in which patients will be randomized 2:1 to receive either Zerenex or another phosphate binder. The 52-week safety assessment will be followed by a 4-week efficacy assessment in which only patients randomized to treatment with Zerenex during the safety assessment will be randomized to continue treatment with either Zerenex or placebo for a 4-week period. Keryx expects to complete the Zerenex Phase 3 long-term study and file a New Drug Application for Zerenex for the treatment of hyperphosphatemia by mid-2012.

About Hyperphosphatemia

According to data from the U.S. Renal Data System, in the United States, there are approximately 485,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise 60% to approximately 785,000 patients by 2020. The majority of ESRD patients, close to 400,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism (and its related cardiovascular complications), renal osteodystrophy and soft tissue mineralization. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. The need for alternative phosphate-binding agents has long been recognized, especially given the increasing prevalence of ESRD as well as shortcomings with current therapies. Zerenex has the potential to be an effective and safe treatment in lowering and/or maintaining normal serum phosphorus levels in patients with ESRD and hyperphosphatemia.

The market for phosphate binders is approximately $750 million in the U.S. and $1.5 billion worldwide annually.

About Special Protocol Assessments

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.

Final marketing approval depends on the efficacy and safety results, including the adverse event profile, and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf .

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) 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. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also 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 in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex(TM) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for Zerenex; top-line results are based on a preliminary analysis of then available data (both safety and efficacy) and there is the risk that that such findings and conclusions could change following a more comprehensive review of the data; the risk that the data (both safety and efficacy) from the long-term Phase 3 trial will not coincide with the data analyses from the short-term Phase 3 and Phase 2 clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com . The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.


KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: [email protected]



SOURCE Keryx Biopharmaceuticals, Inc.

[setravis]

Would like to see it top $5.75 this week.
News will be coming out by year end that could send this much much higher ($7?). 
KERX can easy sky rocket like DNDN.

Day's Range: 5.41 - 5.91
52wk Range: 2.22 - 6.67
Volume: 6,288,812
Avg Vol (3m): 1,175,640

Technicals
Last Price Quote is:
4.84%above 13-day EMA
9.17%above 50-day EMA
RS Rating: 90 

[setravis]

KERX  Phase 2 Data Presented at the 52nd Annual Meeting of... 

NEW YORK, Dec. 6, 2010 /PRNewswire via COMTEX/ -- Keryx Biopharmaceuticals, Inc. (KERX) today announced data presented for the first time at the 52nd Annual Meeting of the American Society of Hematology showing promising clinical activity, safety and tolerability of perifosine in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL). KRX-0401 (perifosine) is the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. Key highlights from the two Phase 2 poster presentations are as follows:

Abstract # 2861: "Clinical Activity and Safety of the Combined Therapy with the AKT Inhibitor Perifosine and the Multikinase Inhibitor Sorafenib In Heavily Pretreated Patients with Relapsed/Refractory Lymphomas: Preliminary Results of a Phase II Trial"

Study Background: In this Phase 2 study, 26 patients were enrolled with advanced lymphoma (6 NHL, 4 CLL, 1 Waldenstroms and 15 Hodgkin's lymphoma). 73% of patients were previously refractory to their prior therapy, with 85% of patients having had 4 or more prior therapies. Perifosine (50 mg BID) was started as a single agent for 28 days; After 28 days, patients achieving partial response (PR) or better were continued on single agent perifosine. Patients achieving less than a PR were given the combination of perifosine (50 mg BID) plus sorafenib (Nexavar(R)) at 400 mg BID.

Results: All of the 4 CLL patients in the study achieved a partial response on single-agent perifosine within one month of treatment and remained on perifosine single agent. Response durations for each of the 4 patients were 4, 8, 9+ and 12 months. The remaining 22 patients were administered the combination with sorafenib, where 5 of the 15 (33%) Hodgkin's lymphoma patients achieved a partial response with a median response duration of 9 months. An additional 6 patients receiving the combination (40%) achieved stable disease. The combination was well tolerated with no unexpected safety events.

The investigators concluded that perifosine in combination with sorafenib has significant anti-lymphoma activity in relapsed/refractory HL, and that perifosine as a single agent induced prolonged responses in high-risk, heavily pretreated CLL patients.

Abstract # 1842: "Pre-Clinical and Interim Results of a Phase II Trial of Perifosine In Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)"

Study Background: In this Phase 2 study, 12 patients with advanced CLL began treatment with single agent perifosine at 50 mg BID. Patients on study were heavily pre-treated having had a median of 4 prior lines of therapy with 75% of patients classified as Rai stage IV.

Results: 1 patient achieved a partial response (5 months on treatment) and 5 additional patients achieved stable disease (median duration of 4.25 months), for an overall 50% clinical benefit rate (PR + SD). Perifosine was well tolerated with minimal dose modifications.

Abstract #3064: "Final Phase I Results of Perifosine In Combination with Lenalidomide and Dexamethasone In Patients with Relapsed or Refractory Multiple Myeloma (MM)"

Additionally, the final dataset from the Phase 1 study of perifosine + lenalidomide (Revlimid(R)) + dexamethasone was also presented during the ASH meeting. The final data showed a 73% objective response rate (minimal response or better) with a 50% PR or better, a median Progression-Free Survival of 10.8 months, and a median duration for Overall Survival of 30.6 months. The myeloma investigators concluded that perifosine in combination with lenalidomide + dexamethasone was well tolerated even at the highest doses used, and demonstrated encouraging clinical activity and survival.

Ron Bentsur, CEO of Keryx, commented, "The data presented at the ASH meeting further demonstrate perifosine's potential beyond the ongoing Phase 3 registration trials in metastatic colorectal cancer and multiple myeloma. It is encouraging to see perifosine's activity as a single agent and in combination with sorafenib in heavily pre-treated, advanced CLL and HL patients, respectively. Moreover, the perifosine-Revlimid(R) (+ dexamethasone) combination data in multiple myeloma also presented at ASH indicate that the combination is well tolerated demonstrating promising clinical activity."

Perifosine is currently in Phase 3 clinical trials for refractory advanced colorectal cancer and multiple myeloma. Both of these Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA, and with Fast Track designations obtained for both indications. Perifosine is also in Phase 1 and 2 clinical development for several other tumor types.

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) 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. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also 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 in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401 (perifosine); the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com . The information found on our website and the ASH website is not incorporated by reference into this press release and is included for reference purposes only.


KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: [email protected]



SOURCE Keryx Biopharmaceuticals, Inc.

[setravis]

Keryx Biopharmaceuticals Announces Commencement of Phase 3 Program of Ferric Citrate (Zerenex) in Japan by Partner, Japan Tobacco and Torii Pharmaceutical
Clinical Milestone Triggers Payment to Keryx

Press Release Source: Keryx Biopharmaceuticals, Inc. On Monday April 18, 2011, 8:30 am EDT
NEW YORK, April 18, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX - News), announced today that its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), JT's pharmaceutical business subsidiary, has commenced the Phase 3 clinical program of ferric citrate in Japan for the treatment of patients with hyperphosphatemia.  Under the license agreement with JT/Torii, within 30 days, Keryx will receive a non-refundable milestone payment of $5 million from JT/Torii for the achievement of this milestone.  Zerenex™ (ferric citrate), a ferric iron-based phosphate binder, is also in Phase 3 clinical development in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis.

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We congratulate our partner, JT/Torii, on the initiation of the Phase 3 program in Japan and are excited by their progress.  We believe that this serves to further validate the commercial potential for Zerenex worldwide." 

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc.

Sublicense Agreement with Japan Tobacco & Torii Pharmaceutical

In September 2007, Keryx sublicensed to JT and Torii the exclusive rights for the development and commercialization of its hyperphosphatemia drug, Zerenex (ferric citrate), in Japan. The licensing arrangement calls for JT and Torii to pay to Keryx up to $100 million in up-front license fees and payments upon the achievement of specified milestones, of which $28 million has been received by Keryx to date.  In addition, upon commercialization, JT and Torii will make royalty payments to Keryx on net sales of the drug in Japan. JT and Torii are responsible for all development and commercialization costs in Japan. 

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) 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. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with approved therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also 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 for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex™ (ferric citrate) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability, and our Japanese partner's ability, to successfully and cost-effectively complete clinical trials for Zerenex (ferric citrate); and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.

KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: [email protected]

[setravis]

InPlay...
8:32AM Keryx Biopharma announces commencement of Phase 3 program of Ferric Citrate in Japan by partner; Keryx will receive a non-refundable milestone payment of $5 mln from JT/Torii for the achievement of this milestone (KERX) 5.13 : Co announces that its Japanese partner, Japan Tobacco and Torii Pharmaceutical, JT's pharmaceutical business subsidiary, has commenced the Phase 3 clinical program of ferric citrate in Japan for the treatment of patients with hyperphosphatemia. Under the license agreement with JT/Torii, within 30 days, Keryx will receive a non-refundable milestone payment of $5 million from JT/Torii for the achievement of this milestone. Zerenex, a ferric iron-based phosphate binder, is also in Phase 3 clinical development in the United States for the treatment of hyperphosphatemia in patients with end-stage renal disease on dialysis.

Day's Range: 4.95 - 5.17
52wk Range: 3.03 - 6.67
Volume: 1,122,386
Avg Vol (3m): 1,184,010
Market Cap: 305.28M
P/E (ttm): N/A
EPS (ttm): -0.34
Div & Yield: N/A (N/A

Technicals
Close Above the 13-day EMA

Last Price Quote is:
-0.93%below 13-day EMA
7.71%above 50-day EMA
RS Rating: 84 

[setravis]

8 Promising Biotech Buyout Targets if Their Products Can Deliver...

Thefollowing are a few biotechs with promising products in their pipelines that have made the big boys sit up and take notice. Without further ado, the 8 promising biotechs priced for a buyout if their products can deliver:

Keryx Biopharmaceuticals Inc. (KERX): Trading at $5.38, Keryx develops pharmaceuticals for the treatment of life-threatening diseases such as diabetes and cancer. Keryx has three products in clinical trials for various cancers, but one that stands out - Perifosine. Perifosine is in Class 3 clinical trials, and is a potential first-class, oral anti-cancer agent for colorectal cancer and multiple myeloma. The drugs' two Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA, and have been given the "Fast Track" designation. The drug is in Phase 1 and 2 trials for other types of tumors as well. If Perifosine does gain regulatory approval, the drug could be a potential blockbuster for Keryx with its ability to prevent multiple forms of cancer. With a Market Cap of $289 million, Perifosine could make Keryx an ideal takeover candidate. Shares currently trade at $4.96

Technicals
Close Below the 13-day EMA

Last Price Quote is:
-1.32%below 13-day EMA
7.27%above 50-day EMA
RS Rating: 83 

[setravis]

A strong uptrend is in place...
and that the market remains positive longer term.
A triangle indicates the presence of a very strong trend that is
being driven by strong forces and insiders.