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Sep. 27, 2015, 8:59 AM
- The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
- The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
- Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
- ETFs: IWM, TZA, TNA, UWM, VB, VBK, URTY, SCHA, TWM, IWO, RWM, SRTY, VTWO, RCG, JKJ, VTWG, TWOK, FYX, JKK, EWRS, ZSML, FYC, SMLL, RYRSX
Sep. 25, 2015, 3:07 PM
- A sharply lower healthcare sector (XLV -3%) has dragged the S&P 500 (SPY -0.2%) into the red and the Nasdaq (NASDAQ:QQQ) down a full 1%. The Dow (DIA +0.4%) remains higher, courtesy of a post-earnings 9% moonshot in Nike.
- Biotechs (IBB -5.7%) and Pharmaceuticals (XPH -5.9%) are hardest hit, continuing to feel the pressure from Hillary Clinton's assault on drug-pricing. Gilead (GILD -2.5%), Biogen (BIIB -3.5%), Celgene (CELG -5.4%), Amgen (AMGN -3.6%), Allergan (AGN -4%), Mylan (MYL -5.6%).
- ETFs: IBB, IYH, XLV, XBI, VHT, PJP, BBH, FBT, HQH, CURE, XPH, HQL, PBE, FXH, RXL, IHE, FHLC, SBIO, PPH, RYH, BBC, THQ, BBP, RXD, LABU, LABD, UBIO, ZBIO
Sep. 25, 2015, 8:58 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib), in combination with lenalidomide and dexamethasone, for the second line treatment of multiple myeloma (MM) and BLINCYTO (blintumomab) as a conditional marketing authorization for the treatment of adults with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
- A final decision by the European Commission usually takes ~60 days.
- The FDA cleared BLINCYTO in December 2014 and Kyprolis for the second line treatment of MM in July. Kyprolis was originally approved in July 2012 for the third-line treatment of MM.
- Previously: The FDA approves Kyprolis to treat patients with multiple myeloma who have received at least two... (July 20, 2012)
Sep. 23, 2015, 9:32 AM
- A Phase 3 clinical trial comparing Amgen's (NASDAQ:AMGN) biosimilar candidate ABP 215 to Roche's (OTCQX:RHHBY) Avastin (bevacizumab) successfully achieved its primary endpoint of demonstrating clinical equivalence to Avastin in lung cancer patients.
- The 642-subject, randomized, double-blind, active-controlled study assessed the objective response rates of ABP 215 and bevacizumab in patients with advanced non-squamous non-small cell lung cancer receiving first-line chemotherapy with carboplatin and paclitaxel. The duration of treatment included a screening period of up to four weeks followed by up to six treatment cycles (IV infusion of 15 mg/kg every three weeks) and an end-of-treatment visit 21 days after the last dose of either ABP 215 or bevacizumab.
- ABP 215 is one of four oncology biosimilars being developed under a collaboration with Allergan (NYSE:AGN). Amgen has a total of nine biosimilars in development.
Sep. 16, 2015, 9:50 AM
- Amgen (NASDAQ:AMGN) acquires Naarden, The Netherlands-based Dezima Pharma for $300M in cash and up to $1.25B in development- and sales-related milestones.
- Privately-held Dezima, founded in 2012, develops treatments for dyslipidemia. Its lead program is DEZ-001, a cholesteryl ester transfer protein that has shown efficacy in lowering LDL-C levels (bad cholesterol). According to the company, it is a potential rival to PCSK9 inhibitors because of its comparable effect on lowering LDL-C and its beneficial effect on cholesterol efflux, which is the capacity of the plasma to remove toxic cholesterol from the plaque in the coronary arteries.
- In a recent Phase 2b study, called TULIP, 5 mg of DEZ-001 (formerly TA-8995), lowered LDL-C by 45% and increased HDL-C by 161%. 10 mg of DEZ-001, in combination with statin therapy, reduced LDL-C by an additional 48%. Almost all patients on the combo regimen achieved the LDL-C target of <1.8 mmol/L, a more stringent metric than the historical target of 2.6 mmol/L. DEZ-001 also significantly boosted cholesterol efflux while being safe and well-tolerated.
Sep. 16, 2015, 9:08 AM
- Xencor (NASDAQ:XNCR) licenses its Xmab antibody engineering technology to Amgen (NASDAQ:AMGN) for inclusion in a series of preclinical bispecific antibodies in cancer immunotherapy and inflammation. The deal also includes a preclinical bispecific T cell engager (BiTE) program directed at CD38 and CD3 in multiple myeloma, which complements Amgen's own BiTE platform, led by Blincyto (blinatumomab) and AMG-330.
- Under the terms of the agreement, Xencor will receive an upfront payment of $45M, up to $1.7B in potential milestones and high single- to low double-digit royalties on commercial sales.
- Bispecific technologies engineer monoclonal antibodies to bind to two unique drug targets, a difficult process characterized by molecules with poor stability and short half-lives. Xencor's approach produces stable antibodies that can be made with standard production methods.
- XNCR is up 26% premarket on light volume.
Sep. 14, 2015, 8:25 AM
- NantWorks subsidiary NantPharma inks an exclusive global license deal with Amgen (NASDAQ:AMGN) for its cancer therapy candidate, AMG 337, with the exception of Japan, Russia and certain other Central Asian countries.
- AMG 337, currently in Phase 2 development, is a small molecule inhibitor of the cell surface enzyme called c-Met, which, when dysregulated, stimulates cancer cell scattering, invasion and protection from apoptosis.
- Financial terms are not disclosed.
Sep. 14, 2015, 6:56 AM
- Sanofi (NYSE:SNY) enters into a multi-target peptide discovery and optimization collaboration with Tokyo-based PeptiDream.
- Under the terms of the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System technology to generate certain peptides against multiple targets of interest selected by Sanofi. PeptiDream will receive an undisclosed upfront payment, research funding, preclinical and clinical milestones and royalties of commercial sales.
- PeptiDream also has collaborations with Amgen (NASDAQ:AMGN), AstraZeneca (NYSE:AZN), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS), Mitsubishi Tanabe (OTCPK:MTZPY), Daiichi Sankyo (OTCPK:DSNKY), Merck (NYSE:MRK) and Ipsen (OTCPK:IPSEY).
Sep. 11, 2015, 9:39 AM
- Amgen (AMGN -0.8%) files an application with the FDA seeking clearance for a single once-per-month 420 mg injection of its cholesterol fighter Repatha (evolocumab). Presently, Repatha is available in a single-use 140 mg/mL prefilled autoinjector which requires three subcutaneous injections for a dose of 420 mg. One injection, obviously, would be much more patient-friendly for those patients requiring/preferring a once-per-month regimen.
- The FDA cleared Repatha, a PCSK9 inhibitor, on August 27, for lowering LDL-C (bad cholesterol).
- Sanofi (SNY -0.2%) and Regeneron's (REGN -0.4%) Praluent (alirocumab), Reptha's competitor, requires a subcutaneous injection every two weeks via a pre-filled syringe/pen.
Sep. 11, 2015, 7:34 AM
- AstraZeneca (NYSE:AZN) purchases a biologics bulk manufacturing facility from Amgen (NASDAQ:AMGN) for an undisclosed sum. The site, located in Boulder, CO, will eventually double AZN's U.S. manufacturing capacity for biologics. It is expected to be licensed and operational by late 2017, after refurbishment and infrastructure improvements are made.
Sep. 3, 2015, 5:05 PM
- Undoubtedly prompted by Novartis' launch of Zarxio (filgrastim-sndz), the first biosimilar commercially available in the U.S., Coherus BioSciences (NASDAQ:CHRS) provides investors with an update on its three lead programs.
- CHS-1701 [biosimilar of Amgen's Neulasta (pegfilgrastim)]: top-line data from pharmacokinetic and pharmacodynamic study should be completed this month; immunogenicity study expected to be completed in Q4; 351(k) BLA submission expected in Q1 2016.
- CHS-1420 [biosimilar of AbbVie's Humira (adalimumab)]: Phase 3 underway in psoriasis; pharmacokinetic bioequivalence bridging study to be initiated by end of H1 2016; BLA expected to be filed in H2 2016.
- CHS-0214: [biosimilar to Amgen's Enbrel (etanercept)]: top-line data from Phase 3 psoriasis study expected next quarter; rheumatoid arthritis data in Q1 2016; MAA filing in the EU in 2016.
- Related tickers: (NYSE:NVS) (NASDAQ:AMGN) (NYSE:PFE) (NASDAQ:EPRS) (NYSEMKT:PFNX) (NYSE:ABBV)
Sep. 3, 2015, 4:41 AM
- Kicking off a new era in American medicine, Novartis (NYSE:NVS) has launched the first "biosimilar" copy of a biotechnology drug approved in the United States, following a green light from a U.S. appeals court.
- Biosimilars have been on the market in Europe since 2006, but the U.S. regulatory pathway for the drugs was only established by a healthcare reform in 2010.
- Novartis' Sandoz unit will now begin selling Zarxio, a knockoff version of Amgen's (NASDAQ:AMGN) Neupogen that was approved by the FDA in March.
Sep. 2, 2015, 4:21 PM
- Amgen (NASDAQ:AMGN) submits its Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval for etelcalcetide (AMG 416) for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on dialysis. If approved, it will be the first calcimimetic agent that can be administered intravenously.
- Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone by binding to the calcium-sensing receptor on the parathyroid gland. It is administered intravenously three times per week at end of each dialysis session.
- Amgen obtained the drug candidate in 2012 via its acquisition of KAI Pharmaceuticals.
- Secondary hyperparathyroidism affects ~2M dialysis patients worldwide.
- Previously: Amgen (AMGN) acquires privately-held KAI Pharmaceuticals for $315M in a deal that will give it... (April 10, 2012)
Sep. 2, 2015, 1:41 PM
- The U.S. Court of Appeals for the Federal Circuit declines to stop Novartis (NVS +0.3%) from launching its biosimilar Zarxio in the U.S. Neupogen (filgrastim) maker Amgen (AMGN +0.7%) sought to extend the injunction by asking the court to clarify federal regulations on when biosimilars may be brought to market. The current injunction expires today.
- Biosimilars have been commercially available in Europe since 2006. Zarxio was approved by the FDA in March.
- Previously: Amgen shot down in attempt to bar Neupogen biosimilar in U.S. (July 21)
- Previously: FDA clears first biosimilar (March 6)
Sep. 1, 2015, 5:28 PM
- Amgen (NASDAQ:AMGN) and Novartis (NYSE:NVS) enter into a collaboration agreement in neuroscience, specifically Alzheimer's disease (AD) and migraine.
- The agreement combines each firm's BACE (beta-site APP-cleaving enzyme-1) programs in AD into a global co-commercialization and co-development arrangement. Novartis' molecule, the Phase 1/2a-stage BACE inhibitor CNP520, will be the lead product candidate. Each company's preclinical BACE inhibitor programs will generate potential follow-ons. Amgen will make upfront and milestone payments and will be responsible for a majority of the R&D costs for an agreed-upon period. Thereafter, the partners will share costs and profits equally.
- BACE initiates the production of beta amyloid, the primary constituent of amyloid plaques which are believed to play a key role in the development of AD. Inhibiting BACE could potentially reduce the production of amyloid plaques.
- In the migraine space, Novartis will have global co-development rights and commercial rights, exclusive of the U.S., Canada and Japan, to Amgen's investigative molecules in its migraine portfolio, including AMG 334 and AMG 301. It will also have the option to commercialize an additional early-stage Amgen molecule in its territories. Novartis will fund the majority of global R&D expenses for an agreed-upon period and pay Amgen double-digit royalties on commercial sales.
- Specific financial terms of the deal are not disclosed.
Sep. 1, 2015, 4:42 PM
- Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF) announce positive results from a 436-subject Phase 3 clinical trial, called STRUCTURE, that compared their investigational monoclonal antibody, romosozumab, to teriparatide [Eli Lilly's (NYSE:LLY) Forteo] in postmenopausal women with osteoporosis at high risk of fracture. The study met its primary endpoint of a statistically significant difference in percent change of total hip bone mineral density through month 12 versus teriparatide.
- Romosozumab inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. The companies started Phase 3 development for the indication in April 2012.
- The analysis of the results is ongoing. The data will be presented at a future medical conference and for publication.
- Previously: Amgen osteoporosis drug increases bone density in Phase II trial (Jan. 2, 2014)
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