Nov. 4, 2014, 11:01 AM
- In a Phase 3 clinical trial assessing Amgen's (AMGN -1.1%) trebananib in combination with paclitaxel as a treatment for women with platinum-resistant ovarian cancer, the combo failed to demonstrate a statistically significant improvement in overall survival (OS) compared to placebo in combination with paclitaxel. Median OS, which was a secondary endpoint, in the test group was 19.3 months compared to 18.3 months in the control group.
- As previously announced, trebananib did show a statistically significant improvement in progression-free survival (PFS), the primary endpoint. Median PFS in the test arm was 7.2 months compared to 5.4 months in the control arm (p<0.001).
- EVP of R&D Sean Harper, M.D., says, "While the overall survival results of the TRINOVA-1 study are disappointing, this study is the first of three Phase 3 trials designed to evaluate the safety and efficacy of trebananib in patients with ovarian cancer. We continue to explore the potential of trebananib's novel anti-tumor mechanism of action in other cancer settings."
- Previously: A Phase 3 trial of the angiopoietin inhibitor trebananib plus paclitaxel in ovarian cancer...
Oct. 28, 2014, 9:34 AM
Oct. 28, 2014, 9:24 AM
- In outlining its strategy today, Amgen (NASDAQ:AMGN) notes it will increase its biosimilar porfolio by 33%:
- "In addition to the biosimilar adilimumab, trastuzumab, bevacizumab, infliximab, rituximab and cetuximab programs, Amgen has initiated three additional biosimilar programs." No details on what they are.
- AMGN says biosimilars are "a good strategic fit" and "represent a compelling growth opportunity with the potential to deliver more than $3B in annual revenues."
- Infliximab and rituximab have advanced to the "clinical ready" phase.
- Amgen's first biosimilar is expected to launch in 2017, followed by four others through 2019.
- Previously: Amgen cash flow ops up 52%, guidance raised
Oct. 27, 2014, 4:21 PM
- Amgen (AMGN -0.6%) Q3 results ($M): Total Revenues: 5,031 (+6.0%); Product Revenues: 4,848 (+4.3%); COGS: 1,068 (+35.5%); R&D Expense: 1,018 (+2.9%); SG&A Expense: 1,213 (-2.9%); Net Income: 1,244 (-9.1%); EPS: 1.61 (-10.1%); CF Ops: 2,741 (+51.7%); Quick Assets: 28,075 (+24.5%).
- Gross Profit: 3,963 (+0.1%); COGS: 21.2% (+27.9%); Gross Margin: 78.8% (-5.6%); Operating Profit: 1,732 (+0.6%); Operating Earnings Yield: 34.4% (-5.1%); Net Earnings Yield: 24.7% (-14.2%).
- Product Sales: Neulasta/Neupogen: 1,493 (-6.7%); Neulasta: 1,193 (+5.1%); Enbrel: 1,120 (+3.0%); Xgeva/Prolia: 573 (+30.5%); Epogen: 518 (+5.5%); Aranesp: 474 (+5.6%); Xgeva: 318 (+21.8%); Sensipar/Mimpara: 273 (+5.4%); Prolia: 255 (+43.3%).
- 2014 Guidance: Total revenue: $19.8B - 20.0B from $19.5B - 19.7B; non-GAAP EPS: $8.45 - 8.55 from $8.20 - 8.40; capex: $800M (unch); effective tax rate: 16 - 17% from 15 - 16%.
Oct. 27, 2014, 4:05 PM
Oct. 26, 2014, 5:35 PM
Oct. 23, 2014, 5:38 PM
Oct. 22, 2014, 12:49 PM
- Hedge fund manager Dan Loeb's bullish thesis on Amgen (AMGN -1.4%) relies on a break-up of the company into two separate organizations, one that would sell its legacy drugs and one that would focus on developing its pipeline. The idea was originally proposed by Sanford Bernstein's Geoffrey Porges in June.
- Mr. Loeb believes that the split would increase the company's value ~80% or to ~$249 per share. He says that the market has penalized Amgen for three reasons: lack of R&D productivity, flat operating margins and the suspension of its share repurchase program. He also states that the market appears to be ignoring the disruptive potential of some of the firm's new products, like evolocumab for the treatment of dyslipidemia.
- Amgen CEO Bob Bradway appears open-minded to the idea. The company has a business review meeting scheduled for October 28.
Oct. 21, 2014, 1:55 PM
Oct. 21, 2014, 9:08 AM
- Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
- Nintedanib (trade name Ofev) is a small molecule tyrosine kinase inhibitor that was recently approved by the FDA for idiopathic pulmonary fibrosis.
- CRC-related tickers: (NASDAQ:GILD) (NYSE:LLY) (NASDAQ:MGNX) (OTCPK:BAYRY) (OTCPK:BAYZF) (NASDAQ:AMGN) (OTC:MKGAF) (NYSE:BMY) (NASDAQ:ONXX) (NASDAQ:IMMU) (NASDAQ:ONCY) (NASDAQ:ARQL) (NYSE:SNY) (OTCQB:SNYNF) (NASDAQ:REGN)
Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 17, 2014, 4:22 PM
Oct. 17, 2014, 9:30 AM
- Amgen (NASDAQ:AMGN) files suit in the U.S. District Court of Delaware against Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN) alleging infringement on three of its patents covering monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen seeks an injunction to prevent the manufacture, use and sale of Sanofi and Regeneron's PCSK9 inhibitor alirocumab.
- Amgen recently submitted its BLA to the FDA for its PCSK9 inhibitor evolocumab.
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 10, 2014, 11:29 AM
- Atara Biotherapeutics (Pending:ATRA) is set for its IPO of 5M shares at $14 - 16.
- The clinical-stage firm develops therapeutics for serious unmet medical needs. Its initial focus is on muscle wasting conditions and oncology.
- Its lead product candidate is PINTA 745, currently in Phase 2 development for protein-energy wasting, a condition affecting many end-stage renal disease patients. Its second product candidate is STM 434 for ovarian cancer. A Phase 1 trial is set to begin shortly.
- The company was created by Amgen (AMGN +1.1%) and VC firm Kleiner Perkins in 2012.
- ETFs: IBB, BIB, BIS (IPO -2%)
Oct. 8, 2014, 9:47 AM
- In a 347-patient Phase 3 clinical trial, Amgen's (AMGN +0.4%) biosimilar candidate ABP 501 compared to Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.
- The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment, which was within the prespecified equivalence margin for ABP 501 compared to Humira.
- The study is the first of two Phase 3 trials that will be the basis for global regulatory submissions for ABP 501.
- Amgen has six biosimilar product candidates in development. It expects to launch the portfolio beginning in 2017.
- Related ticker: (ABBV -0.2%)
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