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%)
Oct. 2, 2014, 8:15 AM
- The Lancet publishes data from two Phase 3 clinical trials showing treatment with Amgen's (NASDAQ:AMGN) evolocumab resulted in a statistically significant lowering of low-density lipoprotein cholesterol (LDL-C) compared to placebo in patients with different types of familial hypercholesterolemia (FH). FH is an inherited condition caused by a gene mutation that results in high levels of LDL-C.
- In the 329-heterozygous FH patient Rutherford-2 study, adding subcutaneous evolocumab (140 mg) every two weeks to a stable dose of statin and other lipid-lowering therapies reduced mean LDL-C by 59 - 66% from baseline versus placebo at week 12. Also at week 12, 68% of the evolocumab cohort treated every two weeks achieved an LDL-C level of 70 mg/dL (63% of the evolocumab cohort treated once per month) compared to 2% for placebo.
- In the 49-homozygous FH patient (not on apheresis) Tesla study, adding 420 mg of evolocumab once per month to a stable dose of statin and other lipid-lowering therapies reduced LDL-C 31% from baseline compared to placebo. In patients with at least one defective LDL receptor mutation, evolocumab reduced LDL-C 41% versus placebo.
- Amgen submitted marketing applications for evolocumab in Europe and the U.S. about a month ago.
Sep. 22, 2014, 9:48 AM
- Amgen (AMGN -0.7%) submits a Biologics License Application to the FDA for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab, for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia.
- Blinatumomab is an orphan drug- and breakthrough therapy-designated immunotherapy that engages two different targets simultaneously.
- BiTE antibody constructs help place the T cells within reach of the targeted cell with the intent of allowing T cells to inject toxins and trigger cancer cell apoptosis.
Sep. 12, 2014, 12:30 PM
- When the FDA finally opens the door for biosimiars in the U.S. it could save as much as $250B per year by 2024 according to Express Scripts (ESRX -1.3%). There are 14 biotech meds being targeted by pharmaceutical firms who want to sell cheaper versions. Novartis (NVS -0.7%) submitted the first filing with the FDA in July for its version of Amgen's (AMGN -0.9%) Neupogen (filgrastim). Regulatory clearance could happen as early as March 2015.
- Drug companies have sought at least 76 meetings with the FDA to discuss the requirements to bring 14 different biosimilar drugs to market. Nothing will happen quickly, though. Work remains on how to name generics that are a little different from the branded versions due to different cell lines used to create them and how to design clinical studies the prove they can be safely swapped with the originals.
- The U.S. is far behind Europe. The EC began approving biosimilars in 2006. A generic version of Neupogen was cleared in 2008.
- A second biosimilar approved by the FDA may be Celltrion's version of J&J's (JNJ -0.2%) arthritis drug Remicade (infliximab). It filed its application last month.
- ETFs: DRGS
Sep. 2, 2014, 9:01 AM
- Amgen (NASDAQ:AMGN) submits a Marketing Authorization Application to Europe's EMA for evolocumab for the treatment of high cholesterol. Evolocumab is inhibits proprotein convertase subtilis/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.
- The company submitted its BLA to the FDA last week.
Sep. 2, 2014, 8:46 AM
- Amgen (NASDAQ:AMGN) submits a Marketing Authorization Application to the European Medicines Agency (EMA) for talimogene laherparepvec (TL) for the treatment of adult patients with melanoma that is regionally or distantly metastatic. TL is an investigational oncolytic immunotherapy administered as an intralesional injection. It is designed to initiate a systemic anti-tumor immune response. If approved, it will be the first therapy of its kind to achieve regulatory clearance.
- Once injected into a tumor, TL replicates causing the cells to rupture and die (lysis). Ruptured cells release tumor-derived antigens along with granulocyte-macrophage colony-stimulating factor (GM-CSF). This can stimulate a system-wide immune response where leukocytes attack cancer cells that have spread throughout the body.
Aug. 28, 2014, 10:09 AM
- In a Phase 3 clinical trial conducted in Japan (Yukawa-2 study), Amgen's (AMGN +0.9%) PCSK9 inhibitor evolocumab, in combination with statin therapy, met its two co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction in LDL-C at weeks 10 and 12. The percent reduction in LDL-C was clinically meaningful, statistically significant and consistent with results seen in the Phase 2 Yukawa trial comparing evolocumab to placebo.
- Evolocumab is a mAb that inhibits proprotein convertase subtilis/kexin type 9, a protein that reduces the liver's ability to remover LDL-C from the blood.
- The study results will be presented at a future medical conference and for publication.
- The company also announced that it submitted a BLA to the FDA for evolocumab for the treatment of high cholesterol.
Aug. 27, 2014, 9:41 AM
- The FDA grants priority review for Amgen's (AMGN) NDA for ivabradine for the treatment of chronic heart failure. Ivabradine is an oral inhibitor of the "funny" current in the sinoatrial node, the body's cardiac pacemaker. It slows the heart rate without the negative effects on myocardial contractility or ventricular repolarization.
- The agency designated ivabradine Fast Track in April 2014.
Aug. 21, 2014, 11:19 AM
- Eli Lilly (LLY +0.5%) Bio-Medicines chief David Ricks says that "complete resolution of psoriasis is possible for significantly more people" after the company's therapy candidate, ixekizumab, achieves all primary and secondary endpoints in a 3,866-patient Phase 3 clinical trial comparing it to placebo and Amgen's (AMGN -0.1%) Enbrel (etanercept).
- Patients receiving both dosing regimens of ixekizumab (80 mg every two or four weeks) had significantly greater levels of skin clearance than the control group or the etanercept cohort. Between 78% and 90% of the test group achieved at least a 75% reduction in PASI score at 12 weeks. Also, 31% to 41% achieved PASI 100 (clear skin) at week 12 compared to 5% - 7% in the etanercept group.
- Lilly plans to submit its marketing application to regulators in 1H 2015.
Aug. 18, 2014, 5:51 PM
- Amgen's (NASDAQ:AMGN) AMG 416 drug met its primary and secondary endpoints during a Phase 3 trial covering "the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis." (PR)
- The findings follow positive Phase 3 results for AMG 416 announced in July. Amgen says it looks forward to "sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
Aug. 13, 2014, 5:54 PM
- Amgen's (AMGN) Kyprolis (carfilzomib) failed to achieve its primary endpoint of improving overall survival (OS) in a 315-patient Phase 3 clinical trial (FOCUS) evaluating the safety and efficacy of the product in patients with relapsed and advanced refractory multiple myeloma compared to an active control regimen of low-dose dexamethasone (or equivalent corticosteroids) plus optional cyclophosphamide.
- Despite the setback, Amgen subsidiary Onyx Pharmaceuticals (ONXX) President Pablo J. Cagnoni says, "While it is unfortunate that the FOCUS study did not meet its primary endpoint, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world."
Aug. 13, 2014, 5:38 PM
- After observing cellulose and/or polyester particles in a small number of pre-filled syringes of Aranesp (darbepoetin alfa) during a routine quality check, Amgen (AMGN) initiates a voluntary recall of nine lots of the product.
- Evaluations by the company found a very low potential to impact patients who may have received an affected product. However, the FDA determined that the health implications depend on a number of variables. Patients injected with a solution containing particulate foreign matter could experience chronic and acute inflammatory and/or allergic responses that could be life-threatening.
- None of the recalled lots were distributed in the U.S. The lots were shipped to various countries in Europe and the Middle East.
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