Amgen (AMGN) reported third quarter earnings per share of $1.47, well above the Zacks Consensus Estimate of $1.26 and 21% above the year-ago earnings of $1.21. Cost cuts and a lower tax rate helped boost the top-line despite a 2% decline in total revenues, which came in at $3,812 million. Total product sales decreased 1% to $3,736 million. While sales in the U.S. were relatively unchanged at $2,918 million, international sales declined 4% to $818 million mainly due to the unfavorable impact of foreign exchange (Fx) fluctuation, which affected sales by approximately $76 million. Aranesp sales declined 19% to $685 million (U.S. - $333 million, down 27%; ex-U.S. - $352 million, down 9%), mainly due to a decline in demand reflecting the negative impact, primarily in the supportive cancer care setting, of additional product label changes which occurred in August 2008. Aranesp continued to lose share ...

Yesterday, Amgen (AMGN) said that Aranesp failed in a large, randomized, double-blind, placebo-controlled, phase III study that was conducted in patients with chronic kidney disease (not requiring dialysis), anemia and type II diabetes.

The study, referred to as the Trial to Reduce Cardiovascular Endpoints with Aranesp Therapy (TREAT), had two primary endpoints. The first evaluated time to all-cause mortality or cardiovascular morbidity including heart attack, congestive heart failure, hospitalization for angina, or stroke. The second primary endpoint evaluated time to all-cause mortality or chronic dialysis.

Aranesp could not show statistically significant improvement in either. While a higher number of strokes were observed in the Aranesp-treated group compared to the placebo arm, we note that drug’s label already carries a warning regarding the stroke events.

Full efficacy and safety analyses are yet to take place. Amgen will present full results at an upcoming medical meeting later this year.

Aranesp

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In a latest development, the U.S. Medicare agency will seek an advisory panel’s recommendation regarding the use of anemia drugs developed by Amgen (AMGN) as well as Johnson & Johnson (JNJ), in patients with chronic kidney diseases. The advisory committee is likely to review the use of erythropoiesis-stimulating agents (ESAs) for anemia in patients with chronic kidney disease at a meeting to be held on March 24, 2010.   While, Johnson & Johnson has one ESA, Procrit, Amgen has two ESAs in its product portfolio, Aranesp and Epogen. Further review of these drugs became necessary as recent studies conducted over the past few years have shown that high doses could lead to heart complications or death in some cases. Accordingly, the FDA ordered strong warnings to be added to the labels.

During the second quarter, Amgen’s ESA franchise contributed 36% to total revenues. Aranesp sales declined 16% to $693

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Amgen (AMGN) reported financial results for the second quarter 2009 on Jul 27, 2009. Revenues totaled $3,713 million, down 1% from the second quarter in 2008, but far ahead of our expectations by approximately $150 million. The revenue upside was driven by strong sales of key products: Aranesp at $693 million, nearly $50 million above expectations, and Enbrel at $899 million, nearly $70 million above expectations. Other products - including Epogen at $638 million, Neupogen at $327 million, and Neulasta at $831 million - were in-line with expectations.

Sales of the company's two ESA (Erythropoiesis-Stimulating Agent) products, Aranesp and Epogen, declined by 8% from the second quarter 2009, reflecting the negative impact, primarily in the supportive cancer care setting, of additional product label changes that occurred in August 2008. However, market share stabilization and modest pricing strength lead to the upside to our forecasts. Sales of Enbrel increased 7%

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HST Global, Inc. is a development-stage biotechnology company committed to acquiring, developing and commercializing innovative products to enhance cancer care. The company determines to acquire proprietary rights to these products, fund their R&D, and bring the products to market. Since HST’s inception, they have focused their efforts and resources primarily on Salicinium, a clinical stage drug candidate, as well as raising capital and recruiting personnel.

The company’s focus is on in-licensing and further advancing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer. Although the cost of licensing drug candidates that have already completed initial clinical testing is significantly greater than those that clinical testing has not been completed, HST believes there is significantly less risk associated with the investment and continued development of clinical stage drugs since they are able to obtain an initial indication

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