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Sep. 1, 2015, 5:48 AM
- Valeant Pharmaceuticals (NYSE:VRX) is buying rights to AstraZeneca's (NYSE:AZN) late-stage experimental psoriasis drug brodalumab after it was dropped by Amgen (NASDAQ:AMGN) over concerns about the medicine's "suicidal" side effects.
- Valeant will make an upfront payment of $100M to AstraZeneca, with another $170M in prelaunch milestones and up to $175M following launch.
Aug. 31, 2015, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Aug. 27, 2015, 5:56 PM
- The FDA approves Amgen's (NASDAQ:AMGN) Repatha drug for patients with hereditary forms of high cholesterol and those at high risk of cardiovascular disease.
- The scope of the approval was similar to the recent approval given to Regeneron's (NASDAQ:REGN) Praluent, which was approved for patients with cardiovascular disease and those with heterozygous familial hypercholesterolemia.
- Each of the drugs are expected to generate more than $2B/year in sales by 2020.
Aug. 25, 2015, 9:51 AM
- Amgen (AMGN +2.3%) says it submitted a new drug application to the FDA for its intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.
- AMGN says the treatment, if approved, would be the first of its kind that can be administered intravenously at the end of the dialysis session.
- Secondary hyperparathyroidism affects many of the ~2M people throughout the world who receive dialysis, including 450K in the U.S., the company says.
Aug. 18, 2015, 3:53 PM
- Ending an investigation by 48 states and the District of Columbia into its promotional practices related to Aranesp (darbepoetin alfa) and Enbrel (apremilast), Amgen (AMGN -1.2%) agrees to pay $71M to settle the matter. The case pertained to the company's promotion of Aranesp for anemia caused by cancer, its dosing schedule and the promotion of Enbrel for mild plaque psoriasis.
- Aranesp is approved for the treatment of anemia caused by chronic kidney disease and chemotherapy. Per the package insert, it should be dosed every one to three weeks depending on the indication and every four weeks for patients with chronic kidney disease not on dialysis. Prosecutors said the company tried to convince doctors and patients to administer the drug in larger doses once per month in response to the encroachment of a competitor, but there is insufficient evidence that it works when administered this way.
- Enbrel is approved for the treatment of moderate-to-severe plaque psoriasis as well as certain other inflammatory conditions.
- A few years ago, Amgen paid $762M to settle a federal suit pertaining to off-label marketing in addition to pleading guilty to one criminal charge.
Aug. 12, 2015, 12:11 PM
- RBC Capital's Michael Yee maintains his Outperform rating on Amgen (AMGN -1.2%) with a price target of $190 (14% upside). His rationale is based on the potential for a delay in the U.S. launch of the Neulasta (pegfilgrastim) biosimilar from Toronto, Canada-based Apotex, still under FDA review.
- He feels that there is a chance that the product will not be approved (unlikely) or Amgen's litigation will tie matters up until at least mid-2016 (likely). Amgen sued Apotex accusing it of infringing on two patents ('138 and '784). The case is scheduled to be heard in July 2016.
- Amgen is also accusing Apotex of violating the Biosimilar Price Competition and Innovation Act (BPCIA) by failing to provide 180-day effective notice of commercial marketing. Apotex has not provided the notice because its offering has not been cleared yet (FDA filing was December 2014). Amgen successfully employed this delaying tactic in its suit against Novartis' (NVS -0.9%) Sandoz unit over its Neupogen (filgrastim) biosimilar Zarxio, approved by the FDA in March but unable to be launched until September.
- Mr. Yee believes that the legal maneuverings will give Amgen sufficient time to convert many Neulasta customers to its on-body formulation even if it does not prevail in its case against Apotex.
Aug. 11, 2015, 10:15 AM
- In a letter published in the Journal of the American Medical Association (AMA), CVS Health (CVS -0.5%) urges heart specialists to revamp guidelines for treating patients with high cholesterol to provide clarity on how best to choose the best and most cost effective therapy now that expensive new drugs called PCSK9 inhibitors are now on (or will soon be on) the market.
- PCSK9 inhibitors, led by recently-approved Praluent (alirocumab) (SNY -0.4%)(REGN -0.8%) and soon-to-be-approved Repatha (evolocumab), are, at least initially, more than 20 times more expensive than statins. Pharmacy benefit managers, like CVS, aim to control costs by extracting significant discounts from manufacturers and controlling patient access to the pricier drugs.
- CVS wants the guidelines to include specific LDL targets, which older guidelines did before new ones issued in 2013 did away with them. The emphasis now is on a patient's risk of developing heart disease as the main determinant for more intensive treatment. Unsurprisingly, the American College of Cardiology and the AMA have shown scant enthusiasm for revisiting the issue.
- CVS Chief Medical Officer Dr. Troyen Brennan says that if the guidelines are not changed, then CVS will use its own targets, which will vary depending on each patent's medical history. "We expect patients to first use statins. If they can't use statins or can't make (NYSE:LDL) targets, then they would use PCSK9 inhibitors."
- The PDUFA date for Amgen's (AMGN -1%) Repatha is August 27.
Aug. 10, 2015, 12:25 PM
- CVS Health (CVS +0.8%), the number two pharmacy benefit manager (PBM), says it will wait until a second PCSK9 inhibitor is approved before adding either one to its list of covered drugs and negotiating price discounts, clearly an effective strategy if its hopes to win significant price reductions, which is likely if one firm secures exclusive coverage.
- Last month, the FDA cleared Praluent (alirocumab), co-developed by Sanofi (SNY +1.6%) and Regeneron Pharmaceuticals (REGN +0.9%). The PDUFA date for a second PCSK9 inhibitor, Amgen's (AMGN -0.8%) Repatha (evolocumab), is August 27.
- PCSK9 inhibitors are the "next big thing" in lowering bad cholesterol. They ain't cheap, though. Generic statins cost ~$50 per month while Praluent costs ~$1,200 before discounts.
Aug. 6, 2015, 9:41 AM
- Dr. Reddy's Laboratories (RDY +0.8%) enters into a strategic collaboration with Amgen (AMGN -1.5%) to market and distribute Kyprolis (carfilzomib), BLINCYTO (blinatumomab) and Repatha (evolocumab) in India.
- Under the terms of the agreement, Dr. Reddy's will be responsible for all regulatory and commercial activities for the three products. Specific financial terms are not disclosed.
Aug. 5, 2015, 7:35 AM
- Nano cap Biocept (NASDAQ:BIOC) launches its proprietary quantitative Target Selector assay targeting KRAS mutations, a predictive biomarker in cancer. The assay is performed on a blood sample (liquid biopsy) instead of a tissue biopsy which allows physicians to more easily monitor cancer patients for response to treatment and progression of disease.
- ~40% of colorectal cancer patients are KRAS mutation positive. KRAS is also present in high frequency in other solid tumor cancers including lung and pancreatic cancers. Patients with the mutation are much more resistant to anti-EGFR monoclonal antibodies such as Amgen's (NASDAQ:AMGN) Vectibix (panitumumab) and Lilly's (NYSE:LLY) Erbitux (cetuximab).
- Investors should keep an eye on the uptake of this test. If robust, then it validates its value proposition of a more convenient, cheaper and much less invasive method of monitoring cancer patients. To date, investors appear to lack confidence in the company's prospects. Shares are down 76% since its IPO at $10 in February 2014.
- Shares are up 10% premarket on light volume.
Jul. 30, 2015, 4:21 PM
- Amgen (NASDAQ:AMGN) Q2 results ($M): Total Revenues: 5,370 (+3.7%); Product Sales: 5,225 (+5.6%).
- Key Product Sales: Enbrel: 1,348 (+8.4%); Neulasta: 1,158 (+2.2%); Epogen: 491 (-4.1%); Aranesp: 479 (-7.4%); Sensipar/Mimpara: 344 (+15.4%); Prolia: 340 (+28.8%); Xgeva: 331 (+10.7%); Neupogen: 256 (-13.5%); Vectibix: 160 (+21.2%); Kyprolis: 119 (+52.6%).
- Net Income: 1,653 (+6.9%); EPS: 2.15 (+7.0%); CF Ops: 2,814 (+26.4%).
- 2015 Guidance: Total Revenues: $21.1B - 21.4B from $20.9B - 21.3B; EPS: $8.06 - 8.35 from $7.48 - 7.87; Non-GAAP EPS: $9.55 - 9.80 from $9.05 - 9.40.
- Shares are up 2% after hours on increased volume.
Jul. 30, 2015, 4:03 PM
- Amgen (NASDAQ:AMGN): Q2 EPS of $2.57 beats by $0.14.
- Revenue of $5.37B (+3.7% Y/Y) beats by $50M.
- Shares +1.72%.
Jul. 29, 2015, 5:35 PM
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Jul. 29, 2015, 12:44 PM
- Amgen (AMGN -1.4%) will report Q2 results tomorrow after the close. Consensus view is EPS of $2.43 (+2.5%) on revenues of $5.3B (+2.3%).
Jul. 28, 2015, 5:47 PM
- Amgen (NASDAQ:AMGN) declares $0.79/share quarterly dividend, in line with previous.
- Forward yield 1.83%
- Payable Sept. 8; for shareholders of record Aug. 17; ex-div Aug. 13.
Jul. 28, 2015, 12:57 PM
- Privately-held Boehringer Ingelheim (BI) enters into an exclusive license and collaboration agreement with Seoul, Korea-based Hanmi Pharmaceutical to develop and commercialize HM61713, a third generation epidermal growth factor receptor (EGFR)-targeted therapy for the treatment of EGFR mutation-positive lung cancer.
- Under the terms of the agreement, Hanmi will receive an upfront payment of $50M, milestones up to $680M and tiered double-digit royalties on net sales. BI will have exclusive global commercialization rights to HM61713 except South Korea, China and Hong Kong.
- HM61713 is an orally active, irreversible EGFR mutation-selective tyrosine kinase inhibitor (TKI). It is currently in Phase 2 development for the treatment of patients with non-small cell lung cancer with T790M mutations who have developed resistance to other EGFR-targeting agents. A Phase 3 study will commence next year.
- EGFR-related tickers: (AZN +0.3%)(OTCQX:RHHBY +1.3%)(OTCPK:ALPMY) (OTCPK:ALPMF) (BMY +0.1%)(LLY +1.4%)(GSK -0.1%)(AMGN +4.3%)
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