Feb. 4, 2014, 8:28 AM
- Ten major pharmaceuticals companies are getting together with the National Institutes of Health and other organizations in a five-year partnership that will look to understand the science behind Alzheimer's, Type 2 diabetes, rheumatoid arthritis and lupus.
- In an unusual move, the normally secretive participants will share scientists, tissue, blood samples and data, with the aim being to identify targets for new drugs.
- The firms involved include Bristol-Myers Squibb (BMY), Johnson & Johnson (JNJ), GlaxoSmithKline (GSK), Takeda (TKPHF) and Sanofi (SNY).
- Those that haven't joined include Amgen (AMGN), Roche (RHHBY) and AstraZeneca (AZN).
Feb. 3, 2014, 8:39 AM
- Pfizer's (PFE +1.4%) Palbociclib drug for treating breast cancer demonstrated statistically significant improvement in patients' progression-free survival rates in a Phase II trial.
- Palbociclib was tested in post-menopausal women in combination with the hormonal therapy Letrozole; the control group received just the latter drug.
- Analysts reckon that Pfizer might now seek accelerated approval for Palbociclib, whose importance has increased following the recent failure of Dacomitinib in two late-stage lung-cancer trials.
- Adam Feuerstein notes that Amgen (AMGN) owns a piece of Palbociclib via the acquisition of Onyx. (PR)
Jan. 30, 2014, 4:50 PM
- The Phase 3 Rutherford-2 trial evaluating evolocumab meets its primary endpoints: The percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, were consistent with the results observed for the same doses in the Phase 2 RUTHERFORD trial for evolocumab compared to placebo 1.
- "Data from the RUTHERFORD-2 study suggest that evolocumab, when used as an add-on therapy to existing lipid-lowering medications, may offer a new treatment option for patients with heterozygous familial hypercholesterolemia," says EVP of R&D Sean Harper.
- Press release
- AMGN +0.1% AH
Jan. 29, 2014, 2:29 PM
- Calling Amgen's (AMGN -1%) FY14 guidance "underwhelming," Jefferies' Eun Yang nevertheless boosts the price target on the Buy-rated stock to $138 from $133. She notes the company's revenue and EPS growth (3-5%, and 4-8% Y/Y, respectively) is above that of big pharmaceutical firms, yet Amgen trades at a 15 multiple vs. 16x for big pharma. "We see incremental potential upside from multiple Ph3 data readouts in 2014, if positive."
- The team ups its Q1 EPS forecast to $1.86 from $1.71, but lowers FY14 to $8.21 from $8.35, and 2015 to $9.26 from $9.33.
- Previous earnings coverage
Jan. 28, 2014, 4:46 PM
- Amgen (AMGN) reported its Q4 earnings rose 30% Y/Y on broad sales growth, but FY 2014 forecasts of $7.90-$8.20 EPS and $19.2B-$19.6B in revenues are at the low end of analyst estimates.
- Sales rose across the board for AMGN's product lines, with double-digit quarterly increases for all but a handful of its drugs; AMGN also says it was helped by lower tax rates.
- Among AMGN's largest franchises, global sales of Neulasta/Neupogen rose 10% Y/Y and sales of arthritis drug Enbrel gained 3%.
- Separately, AMGN announces positive top-line results from the Phase 3 LAPLACE-2 trial evaluating evolocumab in combination with statin therapy in patients with high cholesterol.
- Shares -0.8% AH.
Jan. 28, 2014, 4:06 PM
Jan. 28, 2014, 12:10 AM
Jan. 27, 2014, 5:35 PM
Jan. 23, 2014, 9:40 AM
- Amgen's (AMGN -1.8%) Evolocumab treatment met its main goal of cutting "bad" or LDL cholesterol in the GAUSS-2 Phase III trial of patients with who cannot tolerate statins.
- "The positive GAUSS-2 results suggest that Evolocumab may offer a new lipid-lowering treatment to meet an important medical need for high-risk patients who cannot tolerate effective doses of statins," Amgen says.
Jan. 22, 2014, 6:45 PM
- Better late than never, Cowen analysts seem to say as they recommend their top biotech names even after four straight years of sector outperformance against the S&P 500.
- Amgen (AMGN) is one of the big-cap biotechs Cowen thinks will handily beat this year’s earnings estimates.
- Biogen (BIIB) remains the top name in class, and the firm thinks the stock is not overvalued at 20x 2015 earnings; Cowen also believes BIIB can beat this year’s earnings expectations.
- Nektar Therapeutics (NKTR) is a top name to buy due to its impressive clinical pipeline and list of big pharma partners; despite having eight late-stage candidates, NKTR’s market cap is just $1.3B.
- Also named: ACOR, BMRN, CELG, CMRX, DVAX, IMGN, PTLA, VVUS.
Jan. 22, 2014, 2:51 PM
- Good things could be ahead for Amgen (AMGN +3.8%), RBC analyst Michael Yee writes, believing the company has been laying the groundwork for growth through pipeline renewal, the effects of which should become evident in mid-2014.
- In the near term, the firm says shares could be range-bound as investors await the ASPIRE interim analysis in mid-2014; removal of this overhang should allow AMGN to embark on a ‘new product story” supported by Phase III PCSK-9 data and eventual approval; Phase III readout for AMG-416 (hyperparathyroidism) and Brodalumab (psorasis) and Phase II proof-of-concept data in migraine prevention (AMG-334); and Phase III anti-sclerostin data in 2015.
- AMGN has climbed 48% during the past 12 months, a fine showing but lagging Biogen’s 116% rise, Gilead Sciences' 111% gain, and even the SPDR S&P Biotech ETF’s 67% advance.
Jan. 16, 2014, 8:39 AM
- Illumina (ILMN) +4.8% premarket after reaching an agreement with Amgen (AMGN) to develop an oncology companion diagnostic test.
- The companies will develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab) in the treatment of metastatic colorectal cancer approved in the U.S. and EU.
- The test will be developed for use with ILMN's MiSeqDx instrument, which has received premarket clearance from the FDA and CE-marked for the European Union.
Jan. 15, 2014, 10:05 AM
- Amgen (AMGN) is partnering with Massachusetts General Hospital and the Broad Institute to develop treatments for inflammatory bowel disease (IBD), a chronic disorder that affects millions worldwide.
- "IBD treatment options are limited," says Amgen VP of R&D Sean Harper. "We believe this collaboration...will help identify improved treatment options for these patients." (PR)
Jan. 13, 2014, 2:03 PM
- Cytokinetics (CYTK -7.9%) is lower on the day after giving an update on the development of omecamtiv mecarbil.
- CYTK says that it and partner Amgen (AMGN) have "agreed to amend the protocol to evaluate a dose titration strategy in the expansion phase of COSMIC-HF [and up] the size of the expansion phase ... with the objective to provide greater statistical power for the planned evaluation of several pharmacodynamic parameters during oral dosing." (PR)
- Here's The Street's Adam Feuerstein, commenting: "Sounds like data release will be pushed back."
Jan. 8, 2014, 10:46 AM
- Nomura's Ian Somaiya (formerly at Piper) is out with a number of healthcare initiations.
- Gilead (GILD +1.7%) is the firm's top biotech pick for 2014 as the company is "set to dominate the HCV market." GILD started at Buy. Price target is $118.
- Neurocrine Biosciences (NBIX -3.2%) started at Buy. Somaiya sees peak sales of $700M for NBI-98854. Price target is $23.
- Celgene (CELG +1.2%) started at Buy. "Revlimid for multiple myeloma, is less than a third of the way to realizing its peak sales potential," Somaiya says. Price target is $236.
- Biogen (BIIB +4.1%) initiated at Buy. Tecfidera, is "a blockbuster ... treatment for MS, with estimated peak sales of $9B," Somaiya notes. Price target is $368.
- Alexion (ALXN +1.5%) initiated at Buy. Price target $150.
- Pharmacyclics (PCYC +1.9%) will "transform the treatment paradigm and disease course of CLL and mantle cell lymphoma MCL." Shares started at Buy. Price target is $137.
- Other initiations: Incyte (INCY +5.9%) started at Buy. Synageva BioPharma (GEVA +3.7%) started at Buy. BioMarin (BMRN +1.2%), Amgen (AMGN), and Infinity Pharmaceuticals (INFI +2.8%) started at Neutral.
Jan. 2, 2014, 7:23 AM
- Amgen (AMGN +0.4%) says its Romosozumab drug for treating osteoporosis in postmenopausal women, which the company is developing with Belgium's UCB, significantly increased bone mineral density when compared with other treatments in a Phase II trial.
- The improvements occurred in the the lumbar spine, hip and neck bones. (PR)
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