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Date : 08/20/2010 @ 6:01PM
Source : Edgar (US Regulatory)
Stock : (KERX)
http://ih.advfn.com/...nmona&article=44090251&symbol=N%5EKERX
Common Stock 8/20/2010 S 10000 D $3.84 (1) 358041 (2) D
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Wertpapier: Keryx Biopharmaceutical |
Angehängte Grafik:
chart_year_keryxbiopharmaceuticalsinc.png (verkleinert auf 93%)
chart_year_keryxbiopharmaceuticalsinc.png (verkleinert auf 93%)
theflyonthewall.com:§ Keryx Biopharmaceuticals initiated with a Buy at Stifel Nicolaus
Target $6.
wenn ne zulassung kommt sogar noch mehr
das volumen zieht an...deutliche zeichen nach den präsentationen
By Mike Havrilla on 09/19/2010 – 5:14 am PDTLeave a Comment
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Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is an emerging, small-cap biopharma company that has a pair of lead compounds in late-stage, Phase 3 development for the treatment of cancer (perifosine) and renal disease (Zerenex) under Special Protocol Assessment (SPA) agreements with the FDA. I initially wrote about KERX in January 2010, and the Company has performed well (with stock price doubling from approx. $2.50 to $5.00 per share) thanks to delivering on its strategic objectives of advancing its lead compounds into three pivotal Phase 3 studies – with Phase 3 results expected for Zerenex in about three months (December timeframe).
KERX is well capitalized with no debt / convertibles and approximately $32 million in cash / equivalents as of 6/30/10. In addition, the Company has about 59 million shares of common stock outstanding with a fully diluted share count of 70 million and average daily trading volume that has grown over the past year to over 1 million shares per day. The expected cash burn rate for KERX during 2H10 is approximately $10 million, which will be offset b y the same amount in expected milestone payments over the next six months that include option / warrant exercises and a milestone payment from its Zerenex partner in Japan (JT Torii) upon initiation of a pivotal Phase 3 study.
KERX has retained all key commercial rights for its two lead compounds and has the resources to complete Phase 3 development for both of its lead compounds, which provides more leverage in partnership discussions. Below is an outline of the two lead compounds and three ongoing pivotal Phase 3 studies for KERX…
Zerenex (ferric citrate) (an iron-based phosphate binder to treat elevated phosphorus blood levels in dialysis patients) – has out-licensed rights to JT Torii in China, Taiwan, Korea, and Japan.
Initiated short-term efficacy study 5/6/10 with top-line results expected in DEC 2010, long-term safety plus efficacy study (58-week study in approx. 300 patients) expected to begin in SEP or OCT 2010 with data anticipated during 1H12, Japan Partner (JT Torii) Phase 3 pivotal study expected to begin by year-end 2010 (a mid-single digit million dollar milestone payment is due to KERX once started). An additional $15 million milestone is possible upon regulatory approval in Japan, with approximately $55 million in remaining milestone payments based on the achievement of sales targets upon commercialization.
Perifosine (KRX-0401) (PI3K/Akt pathway inhibitor anti-cancer agent) – has in-licensed the North American rights to this compound from Aeterna Zentaris (NASDAQ:AEZS) as part of milestone-based plus royalty agreement – Pivotal Phase 3 Clinical Trials under SPA
Refractory metastatic colorectal cancer (mCRC) study initiated 4/8/10, patient enrollment (430 patients) expected to conclude in 12-14 months, study completion and top-line results projected during 2H11, announced Fast Track designation by FDA for mCRC on 4/5/10
Relapsed or relapsed / refractory multiple myeloma (MM) patient study began Dec. 2009, patient recruitment (400 patients) expected to conclude in 16-18 months, study completion and top-line results projected during 1H12, FDA Orphan Drug / Fast Track status
Zerenex works by forming iron-phosphate complexes in the gut that are not absorbed since patients with end-stage renal disease (ESRD) are prone to electrolyte disorders such as elevated phosphorus due to the absence of normal kidney function. Zerenex represents a niche market opportunity within well understood / established class of drugs (phosphate binders) that has a key differentiation of being iron-based compared to existing treatments such as PhosLo, Fosrenol, and Renagel/Renvela. In addition, Zerenex has the potential to offer an improved safety profile / patient acceptance with reduced GI / bloating side effects and approximately 50% less dosing burden (i.e. taking less pills less often) compared to existing phosphate binders.
Secondary endpoints that will be evaluated in the upcoming long-term study for Zerenex include the potential to increase iron levels and decrease the need for blood cell stimulators EPO agents such as Epogen and Aranesp), which could result in a first-line phosphate binder indication and pharmaco-economic advantages by reducing the need for IV iron / EPO products in dialysis patients. The global market for phosphate binders is over $1 billion and is dominated by Genzyme (NASDAQ: GENZ), which markets both Renagel and Renvela that control a market share of approximated one-half of all prescriptions and over two-thirds of global sales (over $700 million for these two drugs).
As I wrote in January, KERX remains a focused, well-funded small-cap bio-pharma play that has three ongoing Phase 3 studies under SPA for its two lead compounds with results pending in about three months (December) for Zerenex in the short-term efficacy study and initiation of the long-term study in the near-term. Perifosine remains a major catalyst in 2011 with Phase 3 data from the colon cancer study expected in about one year (2H11) , and KERX has adequate funding to fully develop both of its lead compounds with additional potential for partnership / licensing opportunities for the North American rights to perifosine and ex-Asia rights to Zerenex.
From a trading / investing standpoint, I am currently tracking KERX on my watch list and will be looking to buy on any pullbacks (as stock price has risen sharply recently) ahead of the Phase 3 results for Zerenex in December, which have an excellent chance of meeting all endpoints based on positive results achieved to date in Phase 2 trials and the straightforward mechanism of binding phosphate to lower blood levels in patients with kidney disease
Posted by penny_saver on Sep 20, 2010 | No comment
Keryx Biopharmaceuticals (NASDAQ: KERX) is a New York City-based biopharmaceutical company, focusing on the acquisition, development and commercialization of pharmaceutical products for treating life-threatening diseases such as cancer. The company is currently developing KRX-0401 (perifosine), which is an oral cancer treatment.
KRX-0401 has shown safety and clinical efficacy in several tumor types. KRX-0401 is in phase III clinical development for refractory advanced colorectal cancer and multiple myeloma and in phase I and phase II development for a number of other tumor types.
Keryx is also engaged in the development of Zerenex™, which is an oral iron-based compound with the capacity to attach to phosphate and form non-absorbable complexes. Following a Special Protocol Assessment (SPA) agreement with the FDA, the company is conducting a phase III clinical program of Zerenex in the treatment for hyperphosphatemia in patients with end-stage renal disease.
Keryx announced its second-quarter financial results in August. The company ended the second quarter with cash, cash equivalents, interest receivable and investment securities of $31.7 million.
Keryx registered a net loss of $5.2 million, or $0.09 per diluted share in the second quarter of 2010, compared with net income of $14.1 million, or $0.29 per diluted share reported for the same period in 2009. For the six-month period ended June 30, 2010, the company registered a net loss of $9.2 million, or $0.16 per diluted share, compared with a net income of $14.6 million, or $0.30 per diluted share reported for the same period in 2009.
Ron Bentsur, CEO of Keryx, said at the time of the announcement of second-quarter financial results last month that the company is continuing to make significant progress with each of its phase III programs and has sufficient capital to conduct and complete them. Bentsur said that the company is poised for continued success with the goal of bringing perifosine and Zerenex to the patients who would benefit from them.
Read more: http://www.beaconequity.com/...future-ahead-2010-09-20/#ixzz105Ub8i00
The initiation of this study marks the final component of the Keryx’s Phase 3 registration program for Zerenex, which is being conducted in accordance with a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
Under the SPA agreement, the Zerenex Phase 3 registration program consists of a short-term efficacy study, which started in May and is expected to be completed in the fourth quarter of 2010, and the 58-week long-term safety and efficacy study started Sept. 29.
The long-term study is a multicenter, randomized, open-label, safety and efficacy clinical trial with a planned enrollment of approximately 300 ESRD patients on hemodialysis or peritoneal dialysis. The 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 an active control.
The 52-week safety assessment period will be followed by a 4-week efficacy assessment in which only patients randomized to treatment with Zerenex during the safety assessment period will be randomized in a 1:1 ratio to either continue treatment with Zerenex or switch to placebo for a 4-week efficacy assessment period. Approximately 45 sites in the U.S. and select ex-U.S. sites will participate in the study. Patient enrollment is expected to take approximately 6 to 9 months.
Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, and member of the Executive Committee of the Collaborative Study Group, is the Study Chair of the Zerenex Phase 3 registration program. Dr. Samuel S. Blumenthal, Professor of Medicine at Medical College of Wisconsin, is the study's Co-Principal Investigator.
"We are excited to be leading this long-term safety and efficacy study of Zerenex and are looking forward to the pending completion of the short-term study,” Lewis said. “While there are treatment options available to patients with hyperphosphatemia, there are safety and compliance concerns associated with the currently marketed therapies. The Phase 3 registration program is designed to confirm prior clinical data which suggests that Zerenex is potentially an attractive, differentiated treatment option for ESRD patients with hyperphosphatemia."
Keryx has a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex from Panion & BF Biotech, Inc. In addition, Keryx has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.