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Amgen Inc. (AMGN)

  • 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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  • Aug. 27, 2013, 7:36 AM
    • The FDA has given Bayer and Onyx Pharmaceuticals (ONXX) priority review for their application to use their Nexavar (sorafenib) drug against a difficult-to-treat type of thyroid cancer.
    • The designation means that the FDA will endeavor to complete the review within six months rather than nine.
    • Nexavar is already authorized for use against liver and kidney tumors, and it is being trialled for breast cancer. (PR)
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  • Aug. 26, 2013, 2:05 PM
    • More from the sell-side on Amgen (AMGN +7.8%) post-Onyx acquisition, this time from Deutsche's Robyn Karnauskas who raises the price target on AMGN to $138 from $115.
    • The deal will be 3% accretive in 2015, Karnauskas says.
    • FY14, 15, and 16 EPS estimates are revised to $8.43, $9.09, and $9.51 respectively ($8.53, $8.87, $8.84 previous).
    • Also: Sell-side weighs in on AMGN/ ONXX
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  • Aug. 26, 2013, 8:21 AM
    • Sell-side notes on Amgen's (AMGN) deal for Onyx (ONXX) begin to roll in.
    • "We view the proposed acquisition as a strategic positive for AMGN," Goldman's Terence Flynn says, adding that the deal will "leverage AMGN's existing oncology infrastructure, boost [its] top and bottom line growth, and further diversify the company's revenue base."
    • Goldman sees EPS accretion of -2%, 10%, and 17% in FY14,15, and 16 respectively.
    • Jefferies sees the deal as accretive to the tune of 3%, 8%, 9%, and 6% in FY15, 16, 17, and 18 respectively.
    • Piper upgrades AMGN to Overweight from Neutral and hikes its price target to $140 from $120.
    • AMGN +4.9% premarket
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  • Aug. 26, 2013, 3:23 AM
    • Amgen (AMGN) is paying $10.4B, or $9.7B excluding Onyx's (ONXX) cash, making it the fifth-largest biotechnology deal in history. The $125-a-share offer represents a 4.2% increase from Amgen's $120 bid in June. Onyx closed at $116.96 on Friday.
    • By buying Onyx, Amgen is gaining full rights to Kyprolis, a potential blockbuster treatment for multiple myeloma, revenue from liver and kidney cancer drug Nexavar, royalties on Bayer's colon cancer medicine Stivarga, and prospective future payments on a breast cancer drug that Pfizer is developing.
    • The deal comes as safety fears have hit sales of Amgen's flagship anemia drugs, Aranesp and Epogen, and ahead of a patent cliff starting in 2015 in which four of the company's five top-selling products are due to lose patent protection. (PR)
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  • Aug. 25, 2013, 5:52 PM
    • It's official: Amgen (AMGN) will acquire Onyx (ONXX) for $125/ share, putting to rest weeks of speculation about what the terms of the deal would turn out to be after a dispute over Kyprolis data reportedly put the two companies at odds over price.
    • More on the deal here.
  • Aug. 24, 2013, 3:54 PM
    • The paper adds a deal could be "announced as soon as Monday," but cautions "talks are ongoing and could still fall apart."
    • The reported price would represent a 7% premium to Onyx's (ONXX) Friday close of $116.96.
    • Amgen (AMGN) reportedly revised its bid from a prior $130/share after failing to obtain trial data related to Onyx's Kyprolis blood-cancer drug. The company is still paying a steep 10.5x 2014E sales.
    • More on Amgen/Onyx
    • Update: The WSJ also reports a $125/share deal is close. Its sources think a deal "is likely to be announced Monday, if not sooner."
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Company Description
Amgen Inc is a biotechnology company that discovers, develops, manufactures and delivers human therapeutics. It operates in one business segment being human therapeutics.
Sector: Healthcare
Industry: Biotechnology
Country: United States