Tue, Jun. 2, 7:31 AM
- Amgen (NASDAQ:AMGN) and Roche (OTCQX:RHHBY) collaborate on a Phase 1b study to assess the former's talimogene laherparepvec (T-Vec) in combination with the latter's MPDL3280A (atezolizumab) in patients with triple-negative breast cancer and colorectal cancer with liver metastases. The partnership is another example of the rationale that combining immunotherapies with different mechanisms of action may be more effective in treating certain cancers.
- T-Vec is an investigational oncolytic immunotherapy that works in two ways. First, it is injected into tumors where it replicates inside tumor cells causing them to rupture and die in a process called lysis. The ruptured cells then release tumor-derived antigens, along with a white blood cell growth factor called GM-CSF (granulocyte-macrophage colony-stimulating factor) that can stimulate a system-wide immune response.
- Atezolizumab is an investigational monoclonal antibody that binds to PD-L1 (programmed death-ligand 1), a protein found on the surface of cancer cells that enable them to avoid detection by the immune system.. Binding to the protein enables T cells to recognize and kill cancer cells.
Fri, May 29, 4:17 PM
- OPKO Health (NYSE:OPK) submits a New Drug Application (NDA) to the FDA seeking approval for Rayaldee, an oral vitamin D prohormone, for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. If approved, it will be the first therapy approved for this disease.
- Rayaldee's proprietary modified-release formulation is designed to gradually raise serum vitamin D prohormone levels while avoiding upregulating CYP24A1, an enzyme which reduces vitamin D's parathyroid hormone-lowering efficacy. Gradually increasing the level of vitamin D prohormone, called 25-hydroxyvitamin D, prevents excessive elevation of serum calcium and related vascular and renal calcification.
- About 20M Americans live with stage 3 or 4 CKD, SHPT and vitamin D insufficiency.
- Related ticker: (NASDAQ:AMGN)
Fri, May 29, 9:32 AM
- Furthering their cooperative work in cancer that began in late 2014, Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) will start a Phase 1 trial to assess Amgen's talimogene laherparepvec (T-Vec) and Merck's Keytruda (pembrolizumab) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). In addition, a Phase 3 study evaluating the combination in regionally or distally metastatic melanoma is being initiated.
- T-Vec is an immunotherapy that is designed to selectively replicate in tumors and to initiate an immune response to tumors. Keytruda is PD-1-inhibiting monoclonal antibody. PD-1 (programmed cell death 1) is a protein found on the surface of cancer cells that enables them to avoid detection by the immune system. Binding to PD-1 enables T cells to recognize and kill cancer cells.
- This collaboration is one of many in the cancer space. The current consensus is that drug combinations with different mechanisms of action offer the most promising potential to fight cancers.
- Previously: Amgen and Merck team up in melanoma (Dec. 8, 2014)
- Previously: Ad Comm gives thumbs up to Amgen's T-Vec for melanoma (April 29)
Fri, May 29, 7:51 AM
- Pooled data from two Phase 3 trials show Amgen's (NASDAQ:AMGN) novel calcimimetic, AMG 416, for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis met the primary endpoint of a greater proportion of patients achieving greater than 30% reduction in parathyroid hormone (PTH) compared to placebo. The data were presented today at the 52nd ERA-EDTA Congress in London.
- AMG 416, administered intravenously at the end of dialysis, acts by binding to and activating the calcium-sensing receptor on the parathyroid gland which causes a decrease in PTH.
- Secondary SHPT is caused by deficiencies in calcium and/or vitamin D, both characteristic of chronic kidney failure. Symptoms include kidney stones, frequent headaches, osteoporosis, fatigue and depression. It affects ~2M dialysis patients worldwide.
- Studies author Professor John Cunningham says, "Secondary hyperparathyroidism is a complex and challenging condition that can be difficult to manage, as it may require patients to take demanding drug regimens multiple times a day. Providing patients with [CKD] on hemodialysis with a calcimimetic that can be administered intravenously on the same schedule as dialysis has the potential to fulfill an unmet need in this patient population."
- Amgen does not disclose its timelines for regulatory applications for AMG 416.
Tue, May 26, 4:56 AM
- AstraZeneca's (NYSE:AZN) goal of topping $45B in revenue by 2023 has been dealt a severe blow by a problem with an experimental psoriasis drug that the company had viewed as a potential billion-dollar plus seller.
- Amgen (NASDAQ:AMGN), its partner on the project, announced late on Friday it was ending a collaboration to develop brodalumab after suicidal thoughts were observed in patients taking the medicine.
- AZN -1.6%; AMGN -0.8% premarket
Fri, May 22, 4:51 PM
- Amgen (NASDAQ:AMGN) has terminated its pact with AstraZeneca (NYSE:AZN) for the co-development and commercialization of brodalumab, an inhibitor drug aimed at treating plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.
- Amgen says the decision was "based on events of suicidal ideation and behavior in the brodalumab program," which it felt would lead brodalumab to require "restrictive labeling." The company insists it doesn't expect the decision to have "any meaningful impact" on its ability to hit strategic/financial commitments.
- Going forward, AstraZeneca will have sole discretion over "future decisions on the clinical development and submission of marketing applications for brodalumab," save for Japan and certain other Asian markets where partner Kyowa Hakko Kirin has rights.
- Amgen and AstraZeneca originally partnered in 2012. In November, positive Phase 3 trial results were reported for brodalumab in the treatment of moderate-to-severe plaque psoriasis.
Fri, May 22, 9:05 AM
- Amgen's (NASDAQ:AMGN) new cholesterol drug, Repatha (evolocumab), has been recommended for approval in Europe, putting the U.S. drugmaker ahead of a race with rival Sanofi's (NYSE:SNY) Praluent.
- Neither has won approval in the all-important U.S. market yet.
- Repatha belongs to a new class of cholesterol-lowering drugs known as PCSK9 inhibitors that have the potential to drastically reduce the risk of heart attacks when used in addition to standard treatment.
- AMGN +0.5% premarket
Thu, May 21, 9:30 AM
- Alongside Goldman's list of 50 stocks appearing most as top holdings at hedge funds is its list of the 50 top shorts.
- New additions this quarter: Baxter Intl (NYSE:BAX), UPS, Marriott (NASDAQ:MAR), NextEra (NYSE:NEE), Ford (NYSE:F), National Oilwell Varco (NYSE:NOV), McDonald's (NYSE:MCD), M&T Bank (NYSE:MTB), CenturyLink (NYSE:CTL), Amgen (NASDAQ:AMGN), Pioneer Natural (NYSE:PXD), Duke Energy (NYSE:DUK), Seagate (NASDAQ:STX), AbbVie (NYSE:ABBV), Cisco (NASDAQ:CSCO).
- The full list (in order of $ value of short interest): AT&T (NYSE:T), Disney (NYSE:DIS), IBM, Verizon (NYSE:VZ), Intel (NASDAQ:INTC), Kinder Morgan (NYSE:KMI), Exxon (NYSE:XOM), Pfizer (NYSE:PFE), J&J (NYSE:JNJ), Deere (NYSE:DE), Caterpillar (NYSE:CAT), Exelon (NYSE:EXC), GE, Boeing (NYSE:BA), Halliburton (NYSE:HAL), Fox (NASDAQ:FOXA), Comcast (NASDAQ:CMCSA), UTX, Regeneron (NASDAQ:REGN), Merck (NYSE:MRK), salesforce.com (NYSE:CRM), AbbVie (ABBV), Conoco (NYSE:COP), Wal-Mart (NYSE:WMT), Eli Lilly (NYSE:LLY), Celgene (NASDAQ:CELG), Schlumberger (NYSE:SLB), AutoZone (NYSE:AZO), Wells Fargo (NYSE:WFC), Emerson (NYSE:EMR), McDonald's (MCD), Reynolds (NYSE:RAI), Target (NYSE:TGT), Accenture (NYSE:ACN), Coca-Cola (NYSE:KO).
Wed, May 20, 11:47 AM
- Final results from the TIVO-1 extension study, known as Study 902, assessing Aveo Oncology's (AVEO +19.4%) lead product candidate, tivozanib, as second-line treatment in patients with advanced renal cell carcinoma (RCC) that progressed after treatment with sorafenib (branded as Nexavar and co-promoted by Onyx Pharmaceuticals (AMGN +0.3%) and Bayer (OTCPK:BAYRY -0.3%)) show a median progression-free survival of 11.0 months and median overall survival of 21.6 months (statistical significance not disclosed). The data, along with results from the Phase 3 TIVO-1 trial, will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago on the afternoon of June 1.
- The company has had a bit of a rough time time finding a niche for tivozanib. In January 2014, it axed a Phase 2 trial in breast cancer due to poor enrollment. Its collaboration with Astellas Pharma in colon cancer ended a month later after a mid-stage trial failed. Both followed the FDA's rejection of its New Drug Application (NDA) for kidney cancer due to inconsistent study results.
- The company is undeterred, though. It sought FDA guidance about a new 314-subject Phase 3 trial assessing tivozanib as third-line treatment in advanced RCC. The regulator responded that the data "may support" the indication. As always, it will be review issue.
Fri, May 15, 7:52 AM
- A Phase 2 clinical trial evaluating Amgen's (NASDAQ:AMGN) fully monoclonal antibody, AMG 334, for the prevention of migraine met its primary efficacy endpoint of reducing monthly mean migraine days versus placebo at a dose of 70 mg. The data were presented at the 17th Congress of the International Headache Society in Valencia, Spain.
- The randomized 483-subject study compared monthly subcutaneous doses of AMG 334 (7 mg, 21 mg or 70 mg) to placebo in a 3:2:2:2 ratio. The mean baseline was 8.7 migraine days per month. Patients in the 70 mg dose arm showed a statistically significant reduction of 3.4 migraine days per month (p=0.021). The results in the 7 mg and 21 mg arms did not reach statistical significance.
- Patients receiving the 70 mg dose also demonstrated statistically significant increases in the 50% responder rate compared to placebo (47% vs. 30%), reductions in monthly headache days (-3.54 vs. -2.39) and monthly migraine-specific medication use days (-1.64 vs. -0.69).
- AMG 334 inhibits the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that cause incapacitating pain. Two additional Phase 2 trials are in process (NCT02174861 and NCT02066415).
- Monoclonal antibodies for the prevention of migraines are the "next big thing" in the space. Alder BioPharmaceuticals (NASDAQ:ALDR) and Eli Lilly (NYSE:LLY) also have monoclonals in development. Regulatory clearance remains at least 3-4 years away, though.
Mon, May 11, 8:29 AM
- The European Medicines Agency gives Can-Fite BioPharma (NYSEMKT:CANF) the go-ahead to commence a Phase 2 trial assessing CF102 in patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. The randomized, double-blind study, also being conducted in the U.S. and Israel, will enroll 78 HCC patients with Child-Pugh Class B cirrhosis who failed treatment with Nexavar (sorafenib), the only FDA-approved drug for HCC. Nexavar was co-developed by Bayer (OTCPK:BAYRY) and Onyx Pharmaceuticals (NASDAQ:AMGN).
- CF102 is a small molecule drug that binds to the A3 adenosine receptor which is highly expressed in tumor cells. It has demonstrated a robust anti-tumor effect (apoptosis of liver cells) via its deregulation of the Wnt signaling pathway.
- The FDA designated CF102 an Orphan Drug for the treatment of HCC in 2012. It is approved for compassionate use in Israel.
- Shares are up 13% premarket on increased volume.
Wed, Apr. 29, 7:34 PM
- Members of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee voted 22 - 1 in favor of approval for Amgen's (NASDAQ:AMGN) talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma.
- Previously: Ad Comm review approaches for Amgen's cancer immunotherapy (April 27)
Wed, Apr. 29, 10:05 AM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on June 10 to discuss Amgen's (AMGN +0.2%) Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol. The FDA's PDUFA date is August 27.
- Evolocumab is an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) from the blood. It, along with Regeneron's (REGN +0.8%) Praluent (alirocumab), are the front-runners to dominate the post-statin cholesterol-lowering market. Praluent's PDUFA date is July 24. Both drugs should be blockbusters.
- Previously: Evolocumab successful in two Phase 3 studies (Oct. 2, 2014)
- Previously: Regeneron's alirocumab shows durable effect in lowering "bad" cholesterol in high risk patients (March 16)
Mon, Apr. 27, 4:53 PM
- A joint meeting of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee is on tap for this Wednesday. The two groups will discuss and make recommendations regarding regulatory approval of Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) for talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma.
- Briefing doc
- Amgen's briefing doc
Fri, Apr. 24, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
Tue, Apr. 21, 4:26 PM
- Amgen (NASDAQ:AMGN) Q1 results ($M): Total Revenues: 5,033 (+11.3%); Product Revenues: 4,874 (+11.9%); U.S.: 3,771 (+14.7%); Intl: 1,103 (+3.4%).
- Net Income: 1,623 (+51.3%); GAAP EPS: 2.11 (50.7%); CF Ops: 1,329 (+16.4%); Quick Assets: 27,118 (+36.9%); Operating Earnings: 2,080 (+50.6%); Operating Earnings Yield: 41.3% (+35.3%); Net Earnings Yield: 32.2% (+35.9%).
- Product Sales Leaders: Neulasta/Neupogen: 1,380 (+0.1%); Neulasta: 1,134 (+4.0%); Enbrel: 1,116 (+13.0%); Xgeva/Prolia: 612 (+28.8%); Epogen: 534 (+15.6%); Aranesp: 480 (+4.3%); Xgeva: 340 (+21.9%); Sensipar/Mimpara: 334 (+23.7%); Prolia: 272 (+38.8%); Kyprolis: 108 (+58.8%).
- Neupogen: 246 (-14.9%).
- U.S. product sales growth has accelerated the past two quarters: 1.6%, 8.6%, 14.7% as has EPS growth: -10.1%, 26.3%, 50.7%.
- 2015 Guidance: Total Revenues: $20.9B - 21.3B from $20.8B - 21.3B; Non-GAAP EPS: $9.35 - 9.65 from $9.05 - 9.40; CAPEX: ~$800M (unch).
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