Amgen, Inc. Issues FY 2010 Guidance In Line With Analysts' Estimates
January 25, 2010 |
| Amgen, Inc. announced that for fiscal 2010, it expects revenue to be in the range of $15.1-$15.5 billion and earnings per share (EPS) to be in the range of $5.05-$5.25, excluding stock option expense, certain expenses related to prior acquisitions and the non-cash interest expense resulting from a change in accounting for our convertible debt. According to Reuters Estimates, analysts were expecting the Company to report revenue of $15.4 billion and EPS of $5.12 for the same period. |
Amgen, Inc. Announces Agreement With MedGenesis Therapeutix Inc
January 12, 2010 |
| Amgen, Inc. announced that MedGenesis Therapeutix Inc, a biopharmaceutical company developing and commercializing treatments for patients with serious central nervous system (CNS) diseases, announced that it has successfully entered into an agreement with Amgen Inc., granting MedGenesis, worldwide license for glial cell line-derived neurotrophic factor (GDNF) protein in CNS and non-CNS indications. As part of the license agreement, Amgen holds a small equity stake in MedGenesis. |
Amgen, Inc. Sees FY 2009 Revenue Slightly Above Midpoint Of Prior Guidance; Sees FY 2009 EPS At Lower End Of Prior Guidance-Conference Call
January 12, 2010 |
| Amgen, Inc. announced that for fiscal 2009, it sees revenue slightly above the midpoint of its guidance of $14.4 billion to $14.8 billion and sees earnings per share (EPS) to be at the low end of its guidance of $4.90 to $5.05. According to Reuters Estimates, analysts were expecting the Company to report revenues of $14.7 billion and EPS of $5.00 for the same period. |
Amgen, Inc. Shares Dip On Anemia Drug Concerns-AP
January 7, 2010 |
| The Associated Press reported that shares of Amgen, Inc. fell sharply as the Food and Drug Administration's plans to re-examine the safety of anemia drugs, which could put more pressure on sales of anemia treatments Aranesp and Epogen. |
U.S. FDA Says To Take New Look At Amgen, Inc.'s Anemia Drugs-Reuters
January 7, 2010 |
| Reuters reported that U.S. regulators plan to ask outside experts to re-evaluate the use of Amgen, Inc. anemia drugs when given to patients with chronic kidney disease. Food and Drug Administration officials anticipates convening a public advisory committee meeting in 2010 to reevaluate the use of drugs known as erythropoiesis-stimulating agents (ESAs) in people with chronic kidney disease. ESAs include Amgen's Aranesp. |
Amgen, Inc. Resolves EPO Patent Dispute With Roche Holding Ltd.
December 22, 2009 |
| Amgen, Inc. announced that the United States (U.S.) District Court in Boston has entered final judgment and a permanent injunction against Roche Holding Ltd. prohibiting Roche from infringing Amgen's patents on recombinant erythropoietin (EPO), thus bringing the five-year patent infringement dispute to an end. Today's judgment was accompanied by Roche's admission that the five Amgen EPO patents involved in the lawsuit are valid, enforceable and infringed by Roche's pegylated-erythropoietin (peg-EPO) product, MIRCERA and by Amgen allowing Roche to begin selling MIRCERA in the U.S. in mid-2014 under terms of a limited license agreement. The settlement terms do not include any financial payments between the parties. |
Amgen, Inc. Receives CHMP Positive Opinion For Prolia(Denosumab) In The European Union
December 18, 2009 |
| Amgen, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. If approved by the European Commission, Amgen would receive marketing authorization for Prolia in all European Union (EU) Member States. The CHMP positive opinion is based on data from six Phase 3 trials. Two Phase 3 pivotal studies with fracture endpoints in the osteoporosis and prostate cancer settings demonstrated that Prolia administered as a subcutaneous injection twice yearly (60mg) reduces the incidence of fractures. All six studies showed Prolia's ability to increase bone mineral density at all skeletal sites measured. |
Array BioPharma, Inc. And Amgen, Inc. Partner In Type 2 Diabetes
December 14, 2009 |
| Array BioPharma, Inc. and Amgen, Inc. announced that they entered into an agreement granting Amgen exclusive worldwide rights to Array BioPharma, Inc.'s small-molecule glucokinase activator program, including ARRY-403, currently being tested in a Phase 1 clinical trial in patients with Type 2 diabetes. Under the terms of the agreement, Array BioPharma, Inc. will receive an upfront payment of $60 million and additional contingent payments for certain clinical and commercial milestones. Array is responsible for completing the Phase 1 trial for ARRY-403. Amgen is responsible for future clinical development and commercialization for ARRY-403 and any resulting back-up compounds, with Array BioPharma, Inc. having an option to co-promote in the United States. Array BioPharma, Inc. will receive double digit royalties on sales of ARRY-403. In addition, Amgen will fund an agreed upon number of full time Array BioPharma, Inc. employees as part of a two-year research collaboration intended to identify and advance second-generation glucokinase activators. |
Amgen, Inc. Board Authorizes $5 Billion Increase In Stock Repurchase Program
December 7, 2009 |
| Amgen, Inc. announced that its Board of Directors have authorized repurchases of up to an additional $5 billion in Amgen common stock. Amgen currently has approximately $1.2 billion remaining under its previous stock repurchase authorization. |
Amgen, Inc. Presents Data From First Nplate Study In Children With Chronic ITP
December 7, 2009 |
| Amgen, Inc. announced results from its first Phase 1/2 study evaluating the safety and efficacy of Nplate (romiplostim) in children with chronic immune thrombocytopenic purpura (ITP). Results from Phase 1/2 Study in Children (Abstract #680) ITP in children most commonly presents as an acute illness; however, 20%-30% of these cases will persist as chronic ITP (duration over six months). Results of the study showed that treatment with Nplate appeared to be generally well-tolerated compared to placebo in children (aged 12 months to less than 18 years old) with chronic ITP (treatment related adverse events = 18% vs. 20%, respectively). Safety results of the study showed that adverse event rates were similar between those patients treated with Nplate or placebo with most adverse events being mild to moderate in severity. Efficacy results showed that Nplate was effective in treating thrombocytopenia compared to placebo, with 88% of the 17 patients receiving Nplate achieving both efficacy endpoints during treatment (number of patients achieving a platelet count of over 50,000 platelets per microliter for two consecutive weeks during the treatment period and/or achieving an increase in the platelet count of 20,000 platelets per microliter above baseline for two consecutive weeks). Other observations included a decrease in rescue medication use, and numerically lower duration-adjusted bleeding adverse event rates with Nplate treatment as compared with placebo. |
Amgen, Inc. Announces Nplate Data From MDS Studies
December 6, 2009 |
| Amgen, Inc. announced the results from three studies on the safety and efficacy of Nplate (romiplostim) in adult patients with myelodysplastic syndromes (MDS). The results of the studies were presented at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (ASH Abstracts #1769, #1770 and #2765). The ongoing, open-label extension study was designed to evaluate the safety and efficacy of Nplate in lower risk MDS patients. The primary endpoints of the interim study for presentation at ASH evaluated adverse event rates with long-term use of Nplate and incidence of antibody development to Nplate and/or thrombopoietin (TPO). Secondary endpoints evaluated the incidence of bleeding events and platelet response during the study period. Results for the secondary endpoint showed that 64% of patients (n=18) reported one or more bleeding events and 21% of patients (n=6) reported one or more clinically significant bleeding events. In the study, 29% of patients (n=8) received platelet transfusions. Frequency of bleeding events and platelet transfusions decreased over time. Bleeding events were evaluated on Common Terminology Criteria for Adverse Events (CTCAE) grades one to four, and clinically significant bleeding events were evaluated on CTCAE grades three and over, serious adverse events or any bleeding adverse event requiring intervention. |
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