Key Developments: Amgen Inc (AMGN.O)
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20 May 2013
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Latest Key Developments (Source: Significant Developments)
Amgen Inc And Zhejiang Beta Pharma Announce Planned Joint Venture In China
Amgen and Zhejiang Beta Pharma Co., Ltd. (Zhejiang Beta Pharma) announced that the companies have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. Together, Amgen and Zhejiang Beta Pharma aim to quickly and efficiently deliver Vectibix to patients in China. The joint venture will benefit from Zhejiang Beta Pharma's strong expertise in the development and commercialization of molecularly targeted therapies as well as Zhejiang Beta Pharma's industry-leading oncology sales network in China. Zhejiang Beta Pharma's China capabilities are complementary to Amgen's global expertise in the development and manufacturing of human therapeutics. Full Article
Amgen Inc Reaffirms FY 2013 Revenue Guidance; Raises FY 2013 EPS Guidance
Amgen Inc announced that for fiscal 2013, it expects revenue to remain unchanged at $17.8 billion to $18.2 billion and expects Adjusted EPS to be above the midpoint of the range of $7.05-$7.35. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $18.07 billion for fiscal 2013. Full Article
Amgen Inc Announces Top-Line Results Of Phase 3 Talimogene Laherparepvec Trial In Melanoma
Amgen Inc announced top-line results from the Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically difference was observed in DRR: 16% in the talimogene laherparepvec arm versus 2% in the GM-CSF arm. The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven. A pre-planned interim analysis conducted with the analysis of DRR has shown an OS trend in favor of talimogene laherparepvec as compared to GM-CSF. The OS data is expected to mature in late 2013 in line with previous guidance. The frequent adverse events observed in this trial were fatigue, chills and pyrexia. The common serious adverse events include disease progression, cellulitis and pyrexia. Among the various types of skin cancer, melanoma is the aggressive and also the serious. Although melanoma accounts for less than 5% of skin cancer cases, or 132,000 cases globally each year, melanoma accounts for 75% of all skin cancer deaths. Full Article
Amgen Inc Announces 2013 Second Quarter Dividend
Amgen Inc announced that Board of Directors declared a $0.47 per share dividend for the second quarter of 2013. The dividend will be paid on June 7, 2013, to all stockholders of record as of the close of business on May 16, 2013. Full Article
FDA Halts Trials Of Amgen Inc Drug In Children, Cites Death-Reuters
Reuters reported that The U.S. Food and Drug Administration said, it has stopped all pediatric clinical trials of Amgen Inc's Sensipar after the death of a 14-year-old patient taking part in a study of the drug. Sensipar, which is approved for adults, is used to lower dangerously high calcium levels in the blood. The agency said it was collecting information on the circumstances of the teenager's death. It said it does not know if the Amgen drug had any role in the death. Full Article
Amgen Inc Updates FY 2015 Guidance To A Range In Line With Analysts' Estimates-Conference Call
Amgen Inc updated guidance for fiscal 2015 with revenues of at least the upper end of $16 billion to $18 billion in adjusted EPS of at least $8 a share. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $18 billion and EPS of $8.49 for fiscal 2015. Full Article
Amgen Inc Announces Results From Phase 3 PAVES Study Evaluating Neulasta (pegfilgrastim) In Patients With Colorectal Cancer
Amgen Inc announced results from Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES), a Phase 3 trial which evaluated Neulasta (pegfilgrastim) in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer. FOLFOX and FOLFIRI are two of the most commonly used chemotherapy regimens for colorectal cancer. The study met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia. Febrile neutropenia is a low white blood cell count accompanied by a fever.1 In the study, the incidence of grade 3 or 4 febrile neutropenia in patients receiving Neulasta across the first four cycles of chemotherapy was 2.4% compared to 5.7% in the placebo group (OR=0.41, p=0.014). A similar incidence of grade 3 or higher adverse events was seen in both arms of the trial (28% placebo; 27% Neulasta). The trial was multicenter and multinational. All patients received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were randomized to one of two treatment arms that also received either placebo or 6 mg of Neulasta at least 24 hours after each cycle of chemotherapy. The primary endpoint was the incidence of grade 3 or 4 febrile neutropenia during the first four cycles. The study was not designed to define the febrile neutropenia rate of FOLFOX or FOLFIRI plus bevacizumab. Full Article
Amgen Inc Issues Guidance; Revenue Guidance Above Analysts' Estimates
Amgen Inc announced that for fiscal 2013, it expects total revenues to be in the range of $17.8 billion to $18.2 billion and adjusted earnings per share (EPS) to be in the range of $6.85-$7.15. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $17.7 billion and EPS of $6.99 for fiscal 2013. Full Article
Amgen Inc Announces Top-Line Results Of Phase 3 Aranesp (darbepoetin alfa) RED-HF Trial
Amgen Inc announced top-line results of the Phase 3 Aranesp (darbepoetin alfa) RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial. The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo. The study did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (Hazard Ratio 1.01, 95% CI 0.90, 1.13). Full Article
Amgen Inc Lowers FY 2012 EPS Guidance-Reuters
Reuters reported that Amgen Inc lowers fiscal 2012 earnings per share (EPS) by 10 cents and expects adjusted earnings of between $6.40 and $6.50 a share. According to I/B/E/S Estimates, analysts are expecting the Company to report EPS of $6.59 for fiscal 2012. Full Article
Drugs from Amgen, others assessed by FDA as radiation treatments
- Drugs from Amgen Inc, Teva Pharmaceutical Industries and Sanofi that boost white blood cells are being evaluated by U.S. regulators as treatments for radiation exposure caused by a nuclear attack or accident.
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