Amgen Inc.

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  • Wed, Jan. 27, 3:30 PM
    • As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
    • Only Biogen and Abbott have bucked the trend.
    • Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
    • ETFs: BIB, BIS, CNCR
    | Wed, Jan. 27, 3:30 PM | 60 Comments
  • Wed, Jan. 20, 1:47 PM
    • It appears that biotech investors have had enough of the sidelines. Many tickers are showing bullish reversals.
    • Representative tickers: (RLYP +15.3%)(CELG +2.6%)(AMGN +0.2%)(BIIB -1.6%)(ALXN -0.6%)(VRTX +0.2%)(IBB +0.8%)(XBI +2.1%)
    | Wed, Jan. 20, 1:47 PM | 20 Comments
  • Wed, Jan. 20, 11:36 AM
    • To point out the obvious, the biotech sector has been unable to fight off the widespread selling. The iShares Nasdaq Biotech Index Fund (IBB -1.8%) is down again, albeit on modestly higher volume. It's down over 21% since late December.
    • Representative tickers: (GILD -1.7%)(CELG +0.7%)(BIIB -2.7%)(AMGN -0.6%)(ALXN -2.8%)
    | Wed, Jan. 20, 11:36 AM | 17 Comments
  • Thu, Jan. 14, 5:59 PM
    • Amgen's (AMGN +5.3%) efforts to make a biosimilar version of the top-selling prescription medicine get a setback as the U.S. patent office ruled against its petition regarding Humira, AbbVie's drug (ABBV +6.6%).
    • Amgen asked the patent office to review two formulation patents on Humira -- a rheumatoid arthritis drug with annual sales near $14B -- with the argument that they shouldn't have been granted.
    • The company had filed in November seeking approval to sell a cheaper biosimilar to Humira. It expects the first of its biosimilars in development to hit the market between 2017 and 2019.
    • Meanwhile, AbbVie says that based on its patents it doesn't expect biosimilar competition until 2022.
    • The patent office said Amgen "has not shown a reasonable likelihood of prevailing on any of its challenges."
    • After hours: AMGN is flat; ABBV is up 0.8%.
    | Thu, Jan. 14, 5:59 PM | 1 Comment
  • Mon, Jan. 4, 10:36 AM
    • Unilife (UNIS +66.3%) enters into an exclusivity agreement with Amgen (AMGN -2.8%) in effect through the end of the month during which they will negotiable a license deal for Unilife's wearable injector devices. In consideration of the exclusive period, Amgen has paid the company a non-refundable deposit of $15M.
    • The license agreement provides for a perpetual, global non-exclusive license to Unilife's technology, know-how and IP for the development, manufacture and sale of wearable injector devices for use with certain large volume Amgen products. Amgen will also receive a perpetual worldwide exclusive license to Unilife's 1mL wearable injector for use with certain small volume drug products. It will pay Unilife an undisclosed price per device.
    • Other items under negotiation are: a non-exclusive license to Unilife's other devices, an interest-bearing note to be satisfied through discounted pricing and/or credits against future amounts owed, the purchase by Amgen of up to 19.9% of Unilife's common stock, a preferred right of access to certain new delivery platforms and a manufacturing rights agreement.
    | Mon, Jan. 4, 10:36 AM | 7 Comments
  • Dec. 14, 2015, 5:41 PM
    | Dec. 14, 2015, 5:41 PM | 7 Comments
  • Dec. 3, 2015, 7:41 AM
    • Thinly traded micro cap Foamix Pharmaceuticals (NASDAQ:FOMX) announces positive top-line results from a 24-subject Phase 2 clinical trial assessing FDX104 for the prevention of moderate-to-severe skin rashes in patients receiving epidermal growth factor receptor antibody inhibitors (EGFRI) [Eli Lilly's (NYSE:LLY) Erbitux (cetuximab) or Amgen's (NASDAQ:AMGN) Vectibix (panitumumab)] for the treatment of cancers such as colon and head and neck. The acne-like (acneiform) rash is the most common side effect from EGFRI drugs and, if severe enough, treatment should be withheld, reduced or discontinued.
    • Each randomized patient in the study acted as their own control by treating one side of the face with FDX104 and the other with a foam vehicle (placebo) in a blinded manner.
    • Results showed the side treated with FDX104 was better overall than the placebo-treated side. The mean maximal rash severity favored FDX104, 1.33 versus 1.71. 37.5% of patients (n=9/24) developed a Grade 3 rash (severe) on the placebo side compared to 16.7% (n=4/24) on the FDX104 side. The difference in the prevention of severe rash was statistically valid (p<0.05) in favor of FDX104 as measured by the Wilcoxon Signed-Rank test. Other exploratory analyses also trended positively.
    • FDX104, a doxyocycline foam, appeared safe and well-tolerated with no drug-related systemic adverse events observed. Local reactions were noted in six patients with five resolved before the end of the study.
    • The company will host a conference call this morning at 8:30 am ET to discuss the results. Shares are up 9% premarket on light volume.
    | Dec. 3, 2015, 7:41 AM | 1 Comment
  • Oct. 28, 2015, 4:06 PM
    • Amgen (NASDAQ:AMGN): Q3 EPS of $2.72 beats by $0.34.
    • Revenue of $5.72B (+13.7% Y/Y) beats by $400M.
    • Shares +1.8%.
    | Oct. 28, 2015, 4:06 PM | 14 Comments
  • Oct. 27, 2015, 10:29 AM
    • Cytokinetics (CYTK +4.9%) and collaboration partner Amgen (AMGN) announce positive top-line data from a Phase 2 clinical trial assessing omecamtiv mecarbil in patients with chronic heart failure. Study participants treated with the drug candidate showed statistically significant improvements in several measures of cardiac function at 20 weeks following randomization.
    • The study, called COSMIC-HF, was designed to evaluate an oral formulation of omecamtiv mecarbil in chronic heart failure patients with reduced ejection fraction. It consisted of two parts: a dose escalation phase and a longer expansion phase. The latter enrolled 448 subjects who were dosed for 20 weeks and followed for a total of 24 weeks. They were randomized to receive either placebo or omecamtiv mecarbil 25 mg twice daily or 25 mg escalating to 50 mg twice daily. The primary endpoints were an assessment of the maximum and pre-dose plasma concentration of omecamtiv mecarbil. Secondary endpoints included measures of cardiac function including changes from baseline in systolic ejection time, stroke volume. left ventricular end-systolic diameter and heat rate at week 20.
    • Final results will be presented at a future medical conference and for publication.
    • Omecamtiv mecarbil activates a protein in cardiac muscle cells called myosin, which is directly responsible for converting chemical energy into the mechanical energy that results in cardiac contraction.
    | Oct. 27, 2015, 10:29 AM | 8 Comments
  • Oct. 21, 2015, 1:22 PM
    • As if anyone following biotechs needs reminding, sellers are overwhelming the space. The iShares Nasdaq Biotechnology ETF (IBB -2.8%) is down 6% since Monday.
    • Key tickers: (BIB -6.5%)(BIS +6.3%)(VRX -38.5%)(AGN -5.9%)(BIIB -0.1%)(AMGN -1.7%)(GILD -1%)(CELG -2%)
    | Oct. 21, 2015, 1:22 PM | 66 Comments
  • Oct. 13, 2015, 3:49 PM
    • Getting out in front of what should be more bashing of their business models at the Democratic debate tonight, the healthcare names (XLV -1.3%) have about doubled the decline in the S&P 500. Within healthcare, it's the biotechs (IBB -3.1%) and pharmaceuticals (XPH -3.2%) leading the way south.
    • Celgene (CELG -3.3%), Biogen (BIIB -3.6%), Amgen (AMGN -3.5%), Allergan (AGN -4.1%), Mylan (MYL -3.6%)
    • The biotech heavy Russell 2000 (IWM -1.4%) is feeling the pain as well.
    | Oct. 13, 2015, 3:49 PM | 27 Comments
  • Oct. 12, 2015, 8:38 AM
    • Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
    • The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
    • SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
    • Related tickers and status premarket: (NASDAQ:REGN+4%; (NASDAQ:AMGN+3%; (NASDAQ:ESPR+14%; (NYSE:SNY+1%.
    | Oct. 12, 2015, 8:38 AM | 7 Comments
  • Oct. 6, 2015, 6:44 PM
    • Leading pharmacy benefits manager Express Scripts (ESRX -1%) has settled an investor debate about which pricey cholesterol drug it will cover -- by saying it will cover both of them.
    • Praluent, from Regeneron (REGN -2.9%) and Sanofi (SNY -0.7%), and Repatha, from Amgen (AMGN -1.8%), will both be included on Express Scripts' formulary. Each of the PCSK9 inhibitors is at least $14,000/year, significantly higher than the cost of now-generic statins, though more effective.
    • The drugs are injectables that dramatically lower LDL (the "bad cholesterol").
    • Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
    • In after-hours action: ESRX flat; REGN +0.1%; SNY +0.8%; AMGN flat.
    | Oct. 6, 2015, 6:44 PM | 33 Comments
  • Sep. 30, 2015, 12:49 PM
    • Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
    • Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
    | Sep. 30, 2015, 12:49 PM | 26 Comments
  • Sep. 27, 2015, 8:59 AM
    • The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
    • The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
    • Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
    | Sep. 27, 2015, 8:59 AM | 127 Comments
  • Sep. 25, 2015, 3:07 PM
    | Sep. 25, 2015, 3:07 PM | 134 Comments
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