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 Inc (AMGN) announced that the US Food and Drug Administration (FDA) delayed the approval of its osteoporosis drug denosumab, with a proposed trade name of Prolia.  In response to the Biologic License Applications (BLA) filed by Amgen in Feb 2009 for Prolia, the Complete Response Letter (CRL) issued by the FDA requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. The FDA has asked the company to develop a strategy to evaluate the risks of Prolia. However, the agency did not ask for further clinical trials, which would have resulted in a longer delay.  Management believes that it can satisfy the queries of the FDA. The company intends to market Prolia for the treatment and prevention of postmenopausal osteoporosis (PMO) and bone loss in patients undergoing hormone ablation for either prostate or breast cancer.  Based on ...

Yesterday, the U.S. Food and Drug Administration's (FDA) advisory panel ruled in favor of Amgen’s (AMGN) osteoporosis drug denosumab (proposed trade name: Prolia), but with certain exceptions.

While the advisory panel unanimously gave its stamp of approval to the injectable drug for prevention of bone fractures in women with postmenopausal osteoporosis, it stated that the drug should only be used by patients facing the highest risk of fractures. The ruling was based on safety and efficacy data from 30 studies of the drug involving more than 12,000 patients.

However, the panel did not approve use of the drug in the prevention and treatment of bone loss in women with breast cancer undergoing hormone ablation. It demanded additional data to ensure that denosumab would not hasten tumor growth in such patients, but supported use of the drug for prostate cancer as it appeared safer for men.

The committee also

...

FDA Panel to Review Denosumab The U.S. Food and Drug Administration’s (FDA) Advisory Committee for Reproductive Health Drugs will be reviewing Amgen’s (AMGN) key pipeline candidate, denosumab (proposed trade name: Prolia) on August 13, 2009. Amgen is seeking approval for denosumab for the treatment and prevention of postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The committee will review and discuss the safety, efficacy, and overall risk/benefit profile of denosumab. While the company has presented encouraging phase III results on denosumab demonstrating the candidate’s superiority over Novartis’ (NVS) Zometa in the treatment of bone metastases in patients with advanced breast cancer, we think there could be a delay in approval of the candidate based on the FDA’s concerns regarding the safety profile of the drug. The FDA is concerned that patients using denosumab are ...

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%

...

Today Amgen Inc. (AMGN) announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for its potential next blockbuster drug, denosumab. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six phase-III trials involving more than 11,000 patients.Denosumab is a fully human monoclonal antibody target receptor activator of nuclear factor kappa B ligand (RANK-L). The clinical data on denosumab, or D-Mab as management calls it, is impressive. In July 2008, Amgen release top-line data from the pivotal trial testing denosumab in 7,800 women with postmenopausal osteoporosis over a 3-year period. Data from the trial showed taking denosumab subcutaneous injections once every six months resulted in statistically ...