Onyx Pharmaceuticals (ONXX) reported third quarter earnings of 28 cents per share, well above the Zacks Consensus Estimate of 22 cents as well as 21 cents reported in the year-ago period. The company, along with Bayer AG (BAYRY.PK), developed Nexavar (sorafenib) tablets, an anticancer therapy currently approved and marketed for the treatment of liver cancer and advanced kidney cancer in the US, European Union, Japan and some other countries. Onyx’s earnings come in the form of royalty and collaboration income on Nexavar sales.  For the quarter, Onyx reported revenues of $69.1 million compared to $50.8 million for the same period in 2008 primarily due to an increase in Nexavar sales and royalty revenue and a decline in the drug’s commercial expenses. While revenues increased 36%, a 43.6% rise in operating expenses brought down Onyx’s operating margin by 450 basis points to 14.5%. R&D and SG&A expenses increased ...

This morning, Celgene Corp. (CELG) reported third quarter earnings of 56 cents per share, beating the Zacks Consensus Estimate by 7 cents. The company had reported earnings of 40 cents in the year-ago period. Total revenues came in at $695.1 million for the quarter, an increase of 17.3% over the same period in 2008. The increase in total revenues was driven by global market share gains and increased duration of the therapy of multiple myeloma drug Revlimid and the worldwide growth of myelodysplastic syndrome (MDS) drug Vidaza. Revlimid net sales came in at $449.6 million, an increase of 31% over the third quarter of 2008. Net sales of Thalomid, also approved for multiple myeloma, were $110 million. Vidaza net sales came in at $103.1 million, an increase of 62% over the third quarter of 2008. Research and development spend increased to $193.4 million from $160.9 ...

Recently, Onyx Pharmaceuticals (ONXX) announced that it will purchase privately held cancer drugmaker Proteolix for an upfront cash payment of $276 million. This transaction gives Onyx access to Proteolix's lead compound, carfilzomib, a mid-stage multiple myeloma drug. Apart from the upfront cash payment, Onyx, which currently sells the liver and kidney cancer drug Nexavar along with Bayer AG, is also liable to pay $40 million in 2010 if carfilzomib achieves a development milestone and up to $535 million depending on the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe.  That is inclusive of a payment of $170 million if the Food and Drug Administration (FDA) decides to conduct a fast review of the drug. The all-cash transaction is expected to close in the fourth quarter of this year. As a reminder, carfilzomib is currently undergoing a phase II b trial (n=250) in ...

Last week, Keryx Biopharmaceuticals, Inc. (KERX) announced that its renal cancer drug KRX-0401 (perifosine) met both primary and secondary endpoints in a mid-stage trial. KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) in the US, Canada and Mexico. The data was presented at the eighth International Kidney Cancer Symposium in Chicago. The candidate demonstrated efficacy, safety and tolerability in metastatic renal cell carcinoma (RCC) patients whose disease progressed after failing treatment with both a VEGF (vascular endothelial growth factor) receptor inhibitor and an mTOR (mammalian target of rapamycin) inhibitor. Even though the drug was well-tolerated, the most common adverse events were gastrointestinal discomfort and fatigue. RCC is the most common of all kidney tumors, accounting for 85% of the cases. The advanced form of the disease is resistant to standard therapies such as radiation and chemotherapy. The initial treatment in most cases ...

Last week, Keryx Biopharmaceuticals, Inc. (KERX) announced that its renal cancer drug KRX-0401 (perifosine) met both primary and secondary endpoints in a mid-stage trial. KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) in the US, Canada and Mexico. The data was presented at the eighth International Kidney Cancer Symposium in Chicago. The candidate demonstrated efficacy, safety and tolerability in metastatic renal cell carcinoma (RCC) patients whose disease progressed after failing treatment with both a VEGF (vascular endothelial growth factor) receptor inhibitor and an mTOR (mammalian target of rapamycin) inhibitor. Even though the drug was well-tolerated, the most common adverse events were gastrointestinal discomfort and fatigue. RCC is the most common of all kidney tumors, accounting for 85% of the cases. The advanced form of the disease is resistant to standard therapies such as radiation and chemotherapy. The initial treatment in most cases ...

Yesterday, Keryx Biopharmaceuticals Inc. (KERX) announced positive long-term results from an open-label extension trial of its kidney drug, Zerenex. This oral, iron-based compound treats elevated serum phosphorous levels (hyperphosphatemia) in patients with end-stage renal disease (ESRD) on dialysis.

Results revealed that serum phosphorous was well-controlled under the drug’s effect. The mid-stage trial involved 29 patients in Taiwan who were followed for a year. Prior studies of the drug did not exceed 28 days.

The study also indicated that Zerenex could maintain phosphorus content at a normal level when used over an extended period of time. Additionally, signs of potential iron overload in the blood were not displayed. Zerenex is expected to enter a late-stage study at the end of the year.

As per data from the US Renal Data System, America has nearly 485,000 ESRD patients. This is projected to rise to about 785,000 by 2020. The majority

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Recently, Incyte Corporation (INCY) presented impressive data from a mid-stage trial for its pipeline candidate INCB18424 for psoriasis treatment. The phase IIb trial, carried out on 200 patients over a period of three months, compared three once-daily doses of the drug compared to the placebo. It was observed that patients treated with INCB18424 had a statistically significant improvement over the placebo in reducing total lesion score (erythema + scaling + thickness), which was also the primary endpoint of the trial. In addition, the trial met its secondary endpoint which was the Physician Global Assessment score and the Psoriasis Area and Severity Index score. Apart from psoriasis, Incyte is conducting trials of INCB18424 for several other indications which include myelofibrosis, polycythemia vera/essential thrombocythemia, rheumatoid arthritis, refractory prostate cancer and multiple myeloma. Incyte has other potential candidates targeting treatment for diabetes, breast cancer and HIV. However, the ...

Amgen (AMGN) maintained a strong presence at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany where the company presented data on lead pipeline candidate, denosumab. The company presented solid data on denosumab from a phase III study that was conducted in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma. Top-line results from this study were presented in August 2009. Overall results were good, with denosumab not causing any imbalance in overall survival (OS) or disease progression. Results showed that the median time to first on-study skeletal-related event (SRE) was 20.6 months for patients receiving denosumab and 16.3 months for patients receiving Novartis’ (NVS) Zometa. These results are statistically significant for non-inferiority. Denosumab also delayed the median time to first on-study SRE or hypercalcemia of malignancy (HCM) compared to Zometa. ...

Keryx Biopharmaceuticals, Inc., a developer of medically important pharmaceutical products for the treatment of life-threatening diseases, recently announced that the company has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for KRX-0401 (perifosine) for the treatment of multiple myeloma.

Multiple myeloma is a cancer of the plasma cells. Although incurable, this disease, which represents 1 percent of all cancer diagnoses and 2 percent of all cancer deaths, is treatable. According to the American Cancer Society, there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States in 2009. Patients with multiple myeloma typically relapse and become refractory to prior treatments, causing them to eventually die from their disease. Keryx Biopharmaceuticals is committed to developing new therapies to improve patients’ quality of life and extend survival rates.

Ron Bentsur, chief executive officer of Keryx Biopharmaceuticals, stated, “The

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PWRM, Power 3 Medical Products Inc, PWRM.OB

AMGN, Amgen Inc.

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Power3 Medical Products, Inc. Headlines Session at International Molecular Diagnostic Meeting in China

- Power3 Medical Products, Inc. a Leader in Neurodegenerative Disease and Cancer Diagnostic Biomarkers Announces its Chief Scientific Officer is Chair and Keynote Speaker of Session at the BTI Life Sciences 2nd Annual Congress and Expo of Molecular Diagnostics in Beijing, China in November 2009 -

Power3 Medical Products, Inc. (OTC BB: PWRM), is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development

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