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News Breaks
December 27, 2012
16:21 EDTAMGN, ABCAmgen gets court approval in previously announced $762M settlement with FDA
U.S. District Judge Sterling Johnson, Jr. accepted a guilty plea by Amgen (AMGN) for illegally introducing a misbranded drug into interstate commerce, and approved Amgen’s global settlement with the United States in which Amgen agreed to pay $762M to resolve criminal and civil liability arising from its sale and promotion of certain drugs. Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136M and criminal forfeiture in the amount of $14M. As part of the civil settlement, Amgen has agreed to pay $612M, of which $587.2M is to the United States and $24.8M to the states, to resolve claims that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs. In a separate civil settlement, International Nephrology Network, renamed Integrated Nephrology Network, a subsidiary of AmerisourceBergen Corporation (ABC), has also agreed to pay $15M to resolve civil liability arising from its role in the marketing of Aranesp. Reference Link
News For AMGN;ABC From The Last 14 Days
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January 28, 2015
09:15 EDTAMGNOn The Fly: Pre-market Movers
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07:07 EDTABCAmerisourceBergen sees FY15 adjusted EPS $4.45-$4.55, consensus $4.51
Sees FY15 revenue growth 10%-11%, consensus $128.9B. Adjusted operating income growth in the 9 percent to 11 percent range; Flat adjusted operating margin; Free cash flow generation in the range of $1.8 billion to $2.0 billion; Capital expenditures in the $250 million range; Regular share repurchases of approximately $200 million; and Special share repurchases of approximately $400 million. In addition, sees acquisition of MWI (MWIV) will contribute an incremental 8 cents of adjusted diluted earnings per share in the second half of fiscal 2015.
07:04 EDTABCAmerisourceBergen sees MWI Veterinary Supply deal closing in March quarter
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07:04 EDTABCAmerisourceBergen reports Q1 adjusted EPS $1.14, consensus 97c
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January 27, 2015
17:00 EDTAMGNAmgen Q4 Enbrel sales grew 19% quarter over quarter
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16:15 EDTAMGNAmgen submits applications in US and Europe for Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced the submission of a supplemental New Drug Application,sNDA to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for Kyprolis for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. In the U.S., the sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. In the European Union, Kyprolis received orphan drug designation and the MAA has been granted accelerated assessment. The sNDA and MAA are based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data. "Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals, Inc. "The U.S. and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma."
16:06 EDTAMGNAmgen trades higher after hours, levels to watch
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16:04 EDTAMGNAmgen backs FY15 EPS view $9.05-$9.40, consensus $9.29
Backs FY15 revenue view $20.8B-$21.3B, consensus $20.87B.
16:03 EDTAMGNAmgen reports Q4 EPS $2.16, consensus $2.05
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15:35 EDTABCNotable companies reporting before tomorrow's open
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15:35 EDTAMGNNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Apple (AAPL), consensus $2.60; AT&T (T), consensus 55c; Amgen (AMGN), consensus $2.05; Yahoo (YHOO), consensus 29c; ACE (ACE), consensus $2.29; Stryker (SYK), consensus $1.45; Western Digital (WDC), consensus $2.10; Electronic Arts (EA), consensus 92c; Juniper (JNPR), consensus 31c; Total System Services (TSS), consensus 53c; Freescale Semiconductor (FSL), consensus 33c; Amdocs (DOX), consensus 81c; VMware (VMW), consensus $1.07; International Game Technology (IGT), consensus 25c; United States Steel (X), consensus 87c; Cytec (CYT), consensus 61c.
12:57 EDTAMGNEarnings Preview: Amgen's Kyprolis, Prolia sales key for Q4 results
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January 26, 2015
07:33 EDTABCAmerisourceBergen commences tender offer to acquire MWI Veterinary Supply
AmerisourceBergen (ABC) announced that it has commenced a tender offer to purchase all outstanding shares of MWI Veterinary Supply (MWIV) for $190.00 per share, net to the seller in cash, without interest, less any applicable withholding taxes. The tender offer is being made pursuant to the merger agreement entered into by AmerisourceBergen and MWI and announced on January 12. Unless extended, the tender offer will expire at 11:59 p.m., New York City time, on February 23. The completion of the tender offer is subject to the tender of at least a majority of MWI’s outstanding shares of common stock and other customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
January 21, 2015
10:16 EDTAMGNLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 15, 2015
16:04 EDTAMGNAmgen announces new data from Phase 2 PEAK, Phase 3 PRIME studies
Amgen announced new data from the Phase 2 PEAK and Phase 3 PRIME studies that support the first-line use of Vectibix in combination with Folfox, an oxaliplatin-based chemotherapy regimen, in patients with wild-type RAS metastatic colorectal cancer. In an exploratory analysis from the PEAK study, treatment with Vectibix compared to Avastin resulted in a "significantly higher proportion" of patients with earlier tumor shrinkage at week eight, 64% vs. 45%, respectively, and among responding patients, a longer duration of response, 11.4 vs. 8.5 months, respectively, and greater depth of response . Overall response rates appeared to be similar between Vectibix and Avastin. This is consistent with observed overall survival and progression-free survival (PFS) rates, and with data previously reported, Amgen said. It added, "While the primary analysis from PEAK showed similar ORR between the Vectibix- and bevacizumab-based regimens, this exploratory analysis demonstrates that Vectibix produces early, sustained anti-tumor activity, which may in part explain the OS and PFS benefits seen with Vectibix versus bevacizumab in this trial."
07:59 EDTAMGNAmerican Society of Clinical Oncology to hold a symposium
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