Keryx Biopharmaceuticals (KERX) Moves Toward 52-Week High
Keryx Biopharmaceuticals (NASDAQ: KERX – News) is up 12% on heavy volume to $3 after it announced that the U.S. Food and Drug Administration has granted Fast Track designation for KRX-0401 (perifosine), the Company’s novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, the Company announced that perifosine had received Orphan-Drug designation in the United States for the treatment of multiple myeloma.
Keryx Biopharmaceuticals (KERX) Up On Test Results
Keryx Biopharmaceuticals (KERX) is up 33% to $3.14 on news that results of the Open Label Extension (OLE) trial of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The OLE trial, conducted in Taiwan, enrolled 29 of the 37 Taiwanese patients that had completed the randomized, multi-center, multi-national (United States and Taiwan) dose-ranging Phase 2 study. This OLE represents the first trial to examine the long-term safety and efficacy of Zerenex as a phosphate binder. The treatment period in all previous Zerenex Phase 2 clinical trials did not exceed 28 days.
The OLE trial provided for a daily dose, ranging from 2 to 6 g/day of Zerenex, for a period of up to one year following completion of the 28-day, dose-ranging Phase 2 study. The average duration of the patients’ participation in the OLE trial was 306 +/- 85 days.
The company now trades at a 52-week high up from a period low of $.09. It is hard to say such a huge run is justified.
At June 30, 2009, the Company had cash, cash equivalents, short-term investment securities and interest receivable of $13.4 million, as compared to $15.5 million at December 31, 2008. In addition, at June 30, 2009, the Company had $7.1 million of auction rate securities which are classified as long-term investments. Additionally, in July 2009, the Company received $2.75 million of cash from a settlement with the former licensor of Sulonex (sulodexide). The Company will receive an additional $750,000 on or before July 30, 2010 related to this settlement.
The net income for the second quarter ended June 30, 2009 was $14.1 million, or $0.29 per diluted share, compared to a net loss of $7.7 million, or $0.17 per share, for the second quarter in 2008. The change in net income (loss) was primarily attributable to the recognition of $18.0 million in license revenue relating to an amendment to the September 2007 sublicense agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. (JT/Torii), which eliminated the Company’s significant ongoing obligations included in the original agreement, a $1.8 million decrease in research and development expenses related to KRX-0401, and a $1.0 million decrease in research and development expenses related to the cessation of the development of Sulonex in March 2008.
Douglas A. McIntyre
Keryx Biopharmaceuticals (KERX) Up 30%
Keryx Biopharmaceuticals (KERX) is trading up 30% to $2.11 a 52-week high against a low of $.09 for the period.
KERX announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.
Douglas A. McIntyre
A Rocket Ride For Keryx Biopharmaceuticals (KERX) Shares
Keryx Biopharmaceuticals (KERX) shares rode up 50% on volume that topped 10 million shares just after 10.30 EST. The company and Aeterna Zentaris will proceed with a late-stage study of the prospective multiple myeloma treatment Perifosine. Multiple myeloma is a type of blood cancer.
In March KERX was a $.09 stock which means that its extraordinary run could be overdone. For the first quarter, the company reported cash and cash equivalents of $15 million, and the company lost $451,000 on revenue of $3,327,000. The firm fired its CEO last April.
In its latest 10 Q, KERX wrote that “We have not yet commercialized any of our drug candidates and cannot be sure we will ever be able to do so. Even if we commercialize one or more of our drug candidates, we may not become profitable. Our ability to achieve profitability depends on a number of factors, including our ability to complete our development efforts, obtain regulatory approval for our drug candidates, successfully complete any post-approval regulatory obligations and successfully commercialize our drug candidates.”
The company now has a market cap over $80 million.
Douglas A. McIntyre
Keryx Biopharmaceuticals Inc. Announced Positive Results in Phase II for its Kidney Disease Drug – Zerenex. (KERX)
Shares of Keryx Biopharmaceuticals Inc. (Nasdaq: KERX) rose on June 8th after the company reported positive Phase 2 results for its kidney disease drug, Zerenex (ferric citrate), a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on tri-weekly hemodialysis.
Keryx Biopharmaceuticals Inc. ended the day up 0.27 (25.00%) with a closing trade price of 1.35.
The study was a multicenter, open-label clinical trial, which enrolled 55 patients. The primary objective of this study was to assess the tolerability and safety of Zerenex (ferric citrate) with doses ranging from approximately 1 gram per day to 12 grams per day. The FDA indicated that the results of the Phase 2 study were adequate to support entry into a Phase 3 program. Keryx is in the process of finalizing the Phase 3 program in consultation with the FDA.
Patients were treated with Zerenex (ferric citrate) for four weeks and were titrated weekly to achieve and maintain normal serum phosphorus level, between 3.5 to 5.5 mg/dL, the therapeutic goal.
Dr. Julia Lewis, Professor of Medicine at Vanderbilt University, the Principal Investigator in the study, commented, “This study, as well as earlier studies, suggest that Zerenex is an effective, tolerated phosphate binder that will potentially make a significant clinical addition to treating the important universally present problem of hyperphosphatemia in patients with end-stage renal disease.”
Sales of phosphate binders to treat hyperphosphatemia in ESRD patients in the U.S. were approximately $600 million in 2007, and have grown in excess of 20% per annum over the last five years.
Joshua Sherman
AEterna Zentaris Partner Keryx Reports Positive Phase 2 Data for Perifosine (KRX-0401) in the Treatment of Advanced Metastatic Colon Cancer (AEZS , KERX)
Keryx Biopharmaceuticals, Inc (Nasdaq: KERX) a partner of AEterna Zentaris (Nasdaq: AEZS) has announced positive results in its phase II trial of its advanced metastatic colon cancer drug, Perifosine.
Perifosine (KRX-0401) is the company’s Akt-inhibitor for cancer that is used in combination with capecitabine as a treatment for advanced colon cancer. This news was announced during the Colorectal session at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Orlando, Florida.
In this randomized, double-blind, placebo-controlled study conducted at 11 centers across the United States, patients with 2nd or 3rd line metastatic colon cancer were randomized to receive capecitabine (Xeloda®), an approved drug for metastatic colon cancer, plus either perifosine or placebo. Treatment was continued until progression. The study enrolled a total of 38 patients, of which 35 patients were evaluable for response (20 patients on the capecitabine + perifosine arm and 15 patients on the capecitabine + placebo arm). The three patients not evaluable for response were all in the capecitabine + placebo arm; 2 patients were not evaluable due to toxicity (days 14, 46) and 1 patient was not evaluable due to a new malignancy on day 6.
Perifosine combined with capecitabine was found to more than double the time to progression versus placebo with a statistically significant p-value of 0.0006. In addition, the perifosine treatment doubled the overall response rate and the clinical benefit rate.
Ron Bentsur, Chief Executive Officer of Keryx, commented, “Patients with advanced metastatic colon cancer, who fail standard first and second line treatment, are truly in need of additional therapies. We are excited about the data as the combination of perifosine and capecitabine, two oral agents, appears to demonstrate superior clinical benefit over capecitabine alone in this advanced patient population. We will now explore plans to move this program forward in patients with advanced colorectal cancer.”
According to the American Cancer Society, colorectal cancer is the third most common cancer diagnosed in the United States. It is estimated that 106,100 people will be diagnosed with colon cancer, 40,870 people will be diagnosed with rectal cancer, and approximately 50,000 deaths will be attributable to some form of colorectal cancer in 2009.
Joshua Sherman
