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Amgen Inc. (AMGN)

  • Oct. 13, 2013, 2:59 AM
    • California Governor Jerry Brown has vetoed a bill that would have limited the use of biosimilar pharmaceuticals in the state.
    • Brown explained that the legislation was premature, as the FDA hasn't yet set the rules governing such drugs.
    • Biosimilars are the copycat versions of biotech drugs - also known as biologics - which are complex proteins developed in living cells. Biosimilars are not called generics, as it's difficult to prove that they're exactly the same as the biologic original.
    • The campaign to limit the use of biosimilars has been led by Amgen (AMGN) and Genentech (RHHBY.OB); so far, 10 states have blocked such efforts this year, including Illinois and Texas.
    • Companies developing biosimilars include Hospira (HSP), Novartis (NVS), Momenta Pharmaceuticals (MNTA), Baxter (BAX) and Teva (TEVA).
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  • Oct. 11, 2013, 10:25 AM
    • Cytokinetics (CYTK +7.6%) rallies after Needham's Chad Messer reminds investors that despite a misread by the media, last month's ATOMIC-AHF readout was actually in line with expectations.
    • "Significant increases in systolic injection and reduction in worsening of heart failure while actually lowering heart rate, distinguish omecamtiv from older inotropic agents [and] are more than positive enough for Amgen (AMGN) to proceed with a Phase 3 study next year, triggering a milestone payment to CYTK shareholders," Messer notes, downplaying the overall dypsnea response miss.
    • Price target raised to $25 from $20.
    • While today's vote of confidence is good for morale, the rationale here was discussed at length in early September after the presentation at the ESC Congress.
  • Oct. 9, 2013, 12:44 PM
    • Biotech stocks suffer a third straight day of heavy losses after recording their worst selloff in two years yesterday, but Bernstein’s Geoffrey Porges says it's not time to panic.
    • Stocks with major uncertain events looming, such as MDVN, or with significant revenue upside already built into valuation, such as PCYC, were among the most severely affected, Porges says, but "nothing changed in the environment to suggest that those events were any more or less likely to have positive outcomes yesterday, or to suggest that revenue potential was any more or less likely to be achieved than was previously expected."
    • Still, investors shouldn’t buy the sector willy-nilly; Porges recommends Celgene (CELG) and Gilead (GILD) among large caps, and notes that less-pricey stocks such as Amgen (AMGN) should hold up better, as should midcaps with earnings and products, such as Alexion (ALXN).
  • Oct. 4, 2013, 10:02 AM
    • Amgen (AMGN +1.2%) is set to present new data on romosozumab and Prolia at ASBMR.
    • The company says the Prolia data demonstrate the long-term safety and efficacy of the osteoporosis drug. (PR)
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  • Oct. 3, 2013, 9:51 AM
    • Novartis' (NVS +0.1%) IL-17A inhibitor secukinumab cleared skin faster and for longer than Enbrel (AMGN -0.9%) in a Phase 3 plaque psoriasis study.
    • FIXTURE met all primary and secondary endpoints.
    • Here's NVS' head of pharmaceuticals with the no-frills take: "These exciting data suggest that with secukinumab, we have the potential to help more patients achieve clear skin, which is the ultimate treatment goal."
    • Expect regulatory submissions later this year in both the U.S. and Europe. (PR)
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  • Oct. 2, 2013, 1:39 PM
    • Leerink is out reiterating a Market Perform rating and a $128 price target on Amgen (AMGN -1%) on the heels of new AMG386 TRINOVA-1 data.
    • New data included interim OS results "which showed a relatively modest positive trend with half of the events," analyst Howard Liang notes, adding that the regulatory fate of the angiopoietin inhibitor will likely rest on final survival data due H2 2014.
    • Back in June, investors got top-line PFS data which showed a Hazard Ratio of 0.66. More on this here.
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  • Sep. 30, 2013, 8:44 AM
    • Amgen (AMGN) is out with additional results from the Phase 3 talimogene laherparepvec trial (results reported at ASCO earlier this year) in patients with unresected stage IIIB, IIIC or IV melanoma.
    • Essentially the new results are just the investigator assessments (versus the independent assessment).
    • DRR for talimogene laherparepvec was 19% versus 1% for granulocyte-macrophage colony-stimulating factor.
    • Objective response rate was 31% versus 6% for GM-CSF. (PR)
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  • Sep. 28, 2013, 10:20 PM
    • Amgen's (AMGN) Vectibix meets its primary endpoint of non-inferiority (overall survival) to Erbitux (BMY, LLY, MKGAF.PK) in a Phase 3 trial in patients with wild-type KRAS metastatic colorectal cancer that has not responded to chemotherapy.
    • Median OS for Vectibix was 10.4 months compared to 10 months for Erbitux.
    • Median PFS for Vectibix was 4.1 months versus 4.4 months for Erbitux. (PR)
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  • Sep. 13, 2013, 9:47 AM
    • Rockwell Medical (RMTI +12.4%) trades higher in early action.
    • Craig-Hallum has initiated the shares at Buy with a $16 price target (slightly less optimistic than the $25 objective Summer Street slapped on the shares post-CRUISE-2).
    • The firm thinks SFP is set to become the standard of care.
    • Apparently mentioned in the note is RMTI's potential to reduce erythropoiesis stimulating agent usage. This may end up threatening Amgen's (AMGN) Epogen and Aranesp, although, as SA contributor Paulo Santos notes, the potential hit to Aranesp might be a larger concern because Epogen is "losing patent protection now, so it's going to be pressured anyway."
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  • Sep. 3, 2013, 9:51 AM
    • Shares of Cytokinetics (CYTK -20.8%) are getting punished today after omecamtiv mecarbil — developed with Amgen (AMGN +1.4%) — missed its primary endpoint in a Phase 2 acute heart failure trial.
    • Investors shouldn't necessarily be surprised, theStreet's Adam Feuerstein writes, noting that both companies "had been warning investors not to expect a statistically significant improvement in overall dypsnea response because the lowest dose of omecamtiv mecarbil tested was thought to be sub-therapeutic."
    • Leerink agrees. "These results are in line with our expectations since the study was underpowered to hit its primary endpoint," analyst Joseph Schwartz says.
    • Both Leerink and Feuerstein point out that the highest dose of omecamtiv mecarbil performed better.
    • While investors await data from COSMIC, it's worth noting the following comment from CYTK CEO Robert Blum: "We're impressed and pleased with the study results because the drug behaved consistent with what we've seen in previous studies."
  • Sep. 3, 2013, 7:07 AM
    • An intravenous version of Amgen's (AMGN) and Cytokinetics' (CYTK -17.3%) Omecamtiv Mecarbil treatment missed its target of improving shortness of breath in heart-failure patients in a Phase II trial.
    • However, Amgen plans to continue testing an oral version in a separate Phase II study. The companies will use the combined results to determine whether to take Omecamtiv Mecarbil into Phase III testing. (PR)
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  • Sep. 1, 2013, 2:41 PM
    • Amgen (AMGN) says patients treated with the investigational PCSK9 inhibitor AMG 145 exhibited reductions in bad cholesterol of up to 59%.
    • The efficacy analysis data showed mean LDL-C reductions of between 40-59% from baseline to week 12.
    • PCSK9 targets LDL receptors and impairs the liver's ability to remove bad cholesterol from the blood.
    • AMGN is currently conducting a large Phase 3 trial. (PR)
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  • Aug. 30, 2013, 7:20 AM
    • The European Commission has approved Onyx's (ONXX) and Bayer's (BAYZF.PK) Stivarga (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer.
    • The EC's authorization adds to approval from the FDA. (PR)
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  • Aug. 28, 2013, 6:50 PM
    • Fitch follows Moody's lead, lowering its outlook on Amgen (AMGN) to negative from stable on the back of its recent deal to buy Onyx Pharmaceuticals (ONXX) for around $10.4B in cash.
    • Fitch says AMGN's leverage is going to increase significantly because of the acquisition, by at least $8B.
    • To pay for the deal, AMGN is taking out $8.1B of five-year loans and paying an average interest rate 104 basis points above the three-month London Interbank Offered Rate - despite the fact that it's sitting on $22B in cash.
    • Why? Because of a quirk in the U.S. tax system in which companies' foreign earnings are taxable in the U.S., but only once they are repatriated to the parent.
    • Companies sitting on large amounts of cash can cut their tax bills by keeping income offshore in lower-tax countries. As a result, American companies - like Amgen - are holding a lot of cash offshore, but cash poor at home - which in AMGN's case leads to higher leverage and lower credit ratings.
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  • Aug. 28, 2013, 2:20 PM
    • Roth Capital Partners doesn't want investors to forget that Kyprolis — the multiple myeloma drug at the center of Amgen's (AMGN) deal for Onyx (ONXX) — is a moneymaker for Ligand Pharmaceuticals (LGND +1.1%) which receives tiered royalties tied to the use of Captisol technology in the drug.
    • LGND gets 3% above $750M in Kyprolis sales, Roth notes, adding that "based on current Wall Street estimates ... the 3.0% level will be reached in the next 24 months at the minimum."
    • Kyprolis' potential will now be backed by AMGN's "juggernaut sales and marketing efforts," Roth says.
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  • Aug. 27, 2013, 4:19 PM
    • Amgen (AMGN) says it will present new data on Omecamtiv Mecarbil at the upcoming ESC Congress 2013, organized by the European Society of Cardiology, in Amsterdam.
    • Omecamtiv Mecarbil is a small molecule cardiac myosin activator that is being studied for the treatment of heart failure in collaboration with Cytokinetics.
    • The company also plans to present data on AMG 145, an investigational human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol from the blood.
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Company Description
Amgen Inc. is a biotechnology medicines company. It discovers, develops, manufactures and delivers innovative human therapeutics.
Sector: Healthcare
Industry: Biotechnology
Country: United States