Sep. 2, 2014, 9:01 AM
- Amgen (NASDAQ:AMGN) submits a Marketing Authorization Application to Europe's EMA for evolocumab for the treatment of high cholesterol. Evolocumab is inhibits proprotein convertase subtilis/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.
- The company submitted its BLA to the FDA last week.
Sep. 2, 2014, 8:46 AM
- Amgen (NASDAQ:AMGN) submits a Marketing Authorization Application to the European Medicines Agency (EMA) for talimogene laherparepvec (TL) for the treatment of adult patients with melanoma that is regionally or distantly metastatic. TL is an investigational oncolytic immunotherapy administered as an intralesional injection. It is designed to initiate a systemic anti-tumor immune response. If approved, it will be the first therapy of its kind to achieve regulatory clearance.
- Once injected into a tumor, TL replicates causing the cells to rupture and die (lysis). Ruptured cells release tumor-derived antigens along with granulocyte-macrophage colony-stimulating factor (GM-CSF). This can stimulate a system-wide immune response where leukocytes attack cancer cells that have spread throughout the body.
Aug. 28, 2014, 10:09 AM
- In a Phase 3 clinical trial conducted in Japan (Yukawa-2 study), Amgen's (AMGN +0.9%) PCSK9 inhibitor evolocumab, in combination with statin therapy, met its two co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction in LDL-C at weeks 10 and 12. The percent reduction in LDL-C was clinically meaningful, statistically significant and consistent with results seen in the Phase 2 Yukawa trial comparing evolocumab to placebo.
- Evolocumab is a mAb that inhibits proprotein convertase subtilis/kexin type 9, a protein that reduces the liver's ability to remover LDL-C from the blood.
- The study results will be presented at a future medical conference and for publication.
- The company also announced that it submitted a BLA to the FDA for evolocumab for the treatment of high cholesterol.
Aug. 27, 2014, 9:41 AM
- The FDA grants priority review for Amgen's (AMGN) NDA for ivabradine for the treatment of chronic heart failure. Ivabradine is an oral inhibitor of the "funny" current in the sinoatrial node, the body's cardiac pacemaker. It slows the heart rate without the negative effects on myocardial contractility or ventricular repolarization.
- The agency designated ivabradine Fast Track in April 2014.
Aug. 21, 2014, 11:19 AM
- Eli Lilly (LLY +0.5%) Bio-Medicines chief David Ricks says that "complete resolution of psoriasis is possible for significantly more people" after the company's therapy candidate, ixekizumab, achieves all primary and secondary endpoints in a 3,866-patient Phase 3 clinical trial comparing it to placebo and Amgen's (AMGN -0.1%) Enbrel (etanercept).
- Patients receiving both dosing regimens of ixekizumab (80 mg every two or four weeks) had significantly greater levels of skin clearance than the control group or the etanercept cohort. Between 78% and 90% of the test group achieved at least a 75% reduction in PASI score at 12 weeks. Also, 31% to 41% achieved PASI 100 (clear skin) at week 12 compared to 5% - 7% in the etanercept group.
- Lilly plans to submit its marketing application to regulators in 1H 2015.
Aug. 18, 2014, 5:51 PM
- Amgen's (NASDAQ:AMGN) AMG 416 drug met its primary and secondary endpoints during a Phase 3 trial covering "the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis." (PR)
- The findings follow positive Phase 3 results for AMG 416 announced in July. Amgen says it looks forward to "sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
Aug. 13, 2014, 5:54 PM
- Amgen's (AMGN) Kyprolis (carfilzomib) failed to achieve its primary endpoint of improving overall survival (OS) in a 315-patient Phase 3 clinical trial (FOCUS) evaluating the safety and efficacy of the product in patients with relapsed and advanced refractory multiple myeloma compared to an active control regimen of low-dose dexamethasone (or equivalent corticosteroids) plus optional cyclophosphamide.
- Despite the setback, Amgen subsidiary Onyx Pharmaceuticals (ONXX) President Pablo J. Cagnoni says, "While it is unfortunate that the FOCUS study did not meet its primary endpoint, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world."
Aug. 13, 2014, 5:38 PM
- After observing cellulose and/or polyester particles in a small number of pre-filled syringes of Aranesp (darbepoetin alfa) during a routine quality check, Amgen (AMGN) initiates a voluntary recall of nine lots of the product.
- Evaluations by the company found a very low potential to impact patients who may have received an affected product. However, the FDA determined that the health implications depend on a number of variables. Patients injected with a solution containing particulate foreign matter could experience chronic and acute inflammatory and/or allergic responses that could be life-threatening.
- None of the recalled lots were distributed in the U.S. The lots were shipped to various countries in Europe and the Middle East.
Aug. 4, 2014, 9:45 AM
- In an interim analysis of results from Amgen's (AMGN +1.6%) Phase 3 clinical trial to expand the label of Kyprolis (carfilzomib), the study achieved its primary endpoint of progression-free survival (PFS). The trial, called ASPIRE, evaluated the safety and efficacy of Kyprolis combined with Celgene's (CELG +1.8%) Revlimid (lenalidomide) and dexamethasone compared to Revlimid and dexamethosone alone to treat patients with relapsed multiple myeloma. The median PFS of the Kyprolis cohort was 26.3 months versus the non-Kyprolis cohort's 17.6 months. The results were statistically significant.
- Possibly dampening the mood is the secondary endpoint of overall survival (OS). While the data is not yet mature, the trend favored Kyprolis, but the results did not achieve statistical significance.
- The company intends to commence its regulatory submissions throughout the world in 1H 2015.
Jul. 30, 2014, 1:52 AM
- Following its announcement of a 23% increase in Q2 earnings yesterday, Amgen (NASDAQ:AMGN) stated its intention to cut its workforce by 12%-15% and close two laboratories in Washington state and two manufacturing plants in Colorado.
- The layoffs will begin later this year and continue through 2015, eliminating 2,400 to 2,900 positions that will span the range of job types.
- Through the restructuring, Amgen is hoping to gain additional savings to put toward developing new drugs.
- AMGN +3.6% AH
Jul. 29, 2014, 5:11 PM
- Amgen (AMGN +0.5%) Q2 results: Total Revenues: $4,949M (+5.5%), Product Revenues: $4,949M (7.7%); Gross Profit: $3,868M (-0.9%); R&D Expense: $1,018M (+5.3%); SG&A Expense: $1,136M (-9.6%); Operating Income: $1,714M (+2.0%); Net Income: $1,547M (+23.0%); EPS: $2.01 (+21.8%); CF Ops: $2,227M (+39.2%); COGS: 21.8% (+30.5%); Gross Margin: 78.2% (-6.1%); Operating Earnings Yield: 34.6% (-3.4%); Net Earnings Yield: 31.3% (+16.5%).
- Product sales: Neulasta/Neupogen: $1,429M (-1.0%), Neulasta: $1,133M (+1.2%), Enbrel: $1,243M (+7.4%), Sensipar/Mimpara: $298M (+15.1%); Vectibix: $132M (+41.9%), Neupogen: $296M (-8.6%).
- 2014 Guidance: Revenues: $19.5B - 19.7B from $19.2B - 19.6B; EPS: $8.20 - 8.40 from $7.90 - 8.20; CAPEX: $800M (unch); tax rate: 15 - 16% (unch).
Jul. 29, 2014, 4:19 PM
Jul. 28, 2014, 5:35 PM
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Jul. 25, 2014, 4:03 PM
Jul. 25, 2014, 11:48 AM
- Bayer HealthCare Pharmaceuticals (OTCPK:BAYRY -2.4%) (OTCPK:BAYZF -1.7%) and development partner Onyx Pharmaceuticals (AMGN -0.3%) report that the 537-patient Phase 3 clinical trial evaluating the safety and efficacy of Nexavar (sorafenib) plus capecitabine for the treatment of advanced breast cancer failed to achieve its primary endpoint of improving progression-free survival (PFS). Nexavar is currently approved in over 100 countries for other cancers.
- The companies are evaluating Nexavar in a variety of different cancers. Bayer has exclusive marketing rights to the product ex. U.S. and Japan. They co-promote it in America and share profits globally.
Jul. 24, 2014, 2:15 PM| 3 Comments
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