Fri, Jan. 30, 12:31 PM
- Opko Health (OPK +3.5%) submits an Investigational New Drug Application (IND) to the FDA for clearance to commence a Phase 2a study evaluating its long-acting Orphan Drug-designated coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VII or Factor IX.
- Currently, Factor VIIa therapy is administered intravenously which requires multiple infusions, due to its short half-life, to treat a bleeding episode.
- The longer duration of action of Opko's Factor VIIa-CTP is based on the naturally occurring peptide, C-terminal peptide, of the beta chain of human chorionic gonadotropin (hCG).
- Opko acquired the rights to the product when it bought Prolor Biotech.
- Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
- Related tickers: (BAX +0.4%)(SGMO +0.6%)(ALNY +0.5%)(BIIB +11.4%)(OTCPK:BAYRY -1.4%)
Fri, Jan. 30, 9:12 AM| 3 Comments
Thu, Jan. 29, 4:32 PM
Thu, Jan. 29, 4:30 PM
- Biogen Idec (NASDAQ:BIIB) Q4 results ($M): Total Revenues: 2.640.7 (+34.3%); Net Product Sales: 2,287.0 (+42.3%); Joint Business: 304.5 (+13.0%); Royalty: 31.4 (-48.2%); Corporate Partner: 17.8 (-38.0%).
- Key Product Sales: Avonex: 736.0 (-2.1%); Tysabri: 483.9 (+13.4%); Tecfidera: 916.0 (+81.1%); Fampyra: 18.5 (+6.9%); Fumaderm: 14.4 (+2.1%); Plegridy: 41.1; Alprolix: 40.3; Eloctate: 36.8.
- COGS: 297.3 (+15.0%); R&D Expense: 500.1 (+18.5%); SG&A Expense: 573.6 (+9.7%); Net Income: 883.5 (+93.2%); EPS: 3.74 (+94.8%); Quick Assets: 1,845.4 (+50.9%).
- Gross Profit: 2,343.4 (+37.3%); COGS: 11.3% (-14.4%); Gross Margin: 88.7% (+2.2%); Non-GAAP Operating Earnings: 1,269.7 (+66.6%); Operating Earnings Yield: 48.1% (+24.0%); Net Earnings Yield: 33.5% (+43.8%).
- Net income growth the past four quarters: 12.5%, 47.4%, 75.7%, 93.2%.
- 2015 Guidance: Revenue growth: 14 - 16%; Non-GAAP EPS: $16.60 - 17.00; EPS: $15.45 - 15.85.
Wed, Jan. 28, 5:35 PM
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Mon, Jan. 26, 5:57 PM
Wed, Jan. 14, 12:20 PM
- Isis Pharmaceuticals (ISIS -1.1%) earns a $7M milestone payment from Biogen Idec (BIIB -0.6%) related to the advancement of the ongoing open-label extension study of ISIS-SMNrx in children with spinal muscular atrophy.
- Patients in this stage have completed the dosing in previous trials. They are receiving a 12 mg dose of ISIS-SMNrx every six months for the duration of the study.
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Sun, Jan. 11, 10:14 PM
- In the context of accelerating the growth of its pain portfolio, Biogen (NASDAQ:BIIB) acquires Cambridge-based Convergence Pharmaceuticals, a clinical-stage biotech whose technology platform is based on ion channel electrophysiology and ion channel medicinal chemistry. Biogen is particularly interested in CNV1014802, a small molecule state-dependent sodium channel blocker, currently being developed for the treatment of neuropathies like lumbosacral radiculopathy (sciatica) and trigeminal neuralgia.
- Under the terms of the acquisition agreement, Biogen will pay Convergence shareholders an upfront payment of $200M and up to $475M in milestones. The transaction is expected to close this quarter.
Thu, Jan. 8, 11:10 AM
- A Phase 2 trial assessing Biogen Idec's (BIIB -1.9%) monoclonal antibody anti-LINGO-1 for the treatment of acute optic neuritis (AON) achieved its primary endpoint of recovery of optic nerve latency compared to placebo but showed no effect on the secondary endpoints of change in thickness of the retinal layers, visual function and low contrast letter acuity.
- The trial was designed to study the ability of ant-LINGO-1 to enable repair of an optic nerve lesion via axonal remyelination following the onset of a first episode of AON. The condition is considered a good clinical model to assess the hypothesized mechanisms of action of anti-LINGO-1, remyelination and neuroprotection.
- The study measured the effects of remyelination by measuring the latency of nerve conduction between the retina and the brain's visual cortex using full field evoked potential (FF-VEP) at Week 24. Anti-LINGO-1 demonstrated a 34% improvement compared to placebo. The results were statistically significant (p=0.0504) by a nose.
Dec. 23, 2014, 4:21 PM
Dec. 2, 2014, 12:26 PM
- Traders jumping into Biogen (BIIB +5.8%) this morning after the company's announcement of preliminary results for BIIB037 will have to wait a while to see if Phase 3 results demonstrate efficacy in Alzheimer's disease. Top-line data will not be available until 2018 - 2019 according to Ben Levishon.
- Bulls are already prognosticating that BIIB037 is a $5B - 10B opportunity and may add as much as $21 to the company's share price. Bears are skeptical in light of the consistent failures of plaque inhibitors to prove long-term improvements in cognition.
- Previously: Biogen up on Alzheimer's results
Dec. 2, 2014, 11:32 AM
- Biogen (BIIB +5.3%) jumps on double normal volume in response to its disclosure of interim data at an investors conference from an early-stage study of BIIB037 that demonstrated encouraging results. BIIB037 is designed to clear amyloid plaques from the brain. The study results indicated that it reduced amyloid levels in the brain in both a dose- and time-dependent way. It also demonstrated a positive effect on cognition after 54 weeks.
- The company says it will move aggressively into later-stage trials.
- Alzheimer's disease has been a tough nut to crack for drug makers. Pfizer, J&J and Eli Lilly have all experienced clinical trial failures, for example. Biogen did not issue a press release on its results because it was primarily a safety study.
Dec. 2, 2014, 9:12 AM
Nov. 25, 2014, 12:02 PM
- A woman with multiple sclerosis who had taken Biogen Idec's (BIIB -0.6%) Tecfidera (dimethyl fumarate) for four years developed progressive multifocal leukoencephalopathy (PML) and later died. She was not taking any other drugs that affect the immune system or thought to be associated with PML, although she had a low lymphocyte count prior to the emergence of the disease.
- PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. It is harmless in healthy people but can cause PML in those with weakened immune systems.
- Information describing the case is being added to Tecfidera's label as a matter of full disclosure. There appears to be no evidence that Tecfidera contributed to the PML infection.
Nov. 25, 2014, 8:32 AM
- Isis Pharmaceuticals (NASDAQ:ISIS) initiates a Phase 3 study to evaluate the safety and efficacy of its antisense drug ISIS-SMNrx in ~120 non-ambulatory children with spinal muscular atrophy (SMA), a severe and rare genetic neuromuscular disease characterized by muscle atrophy and weakness.
- This is the second Phase 3 trial the company has initiated for ISIS-SMNrx. The first involved infants with SMA.
- Isis earned a $27M milestone payment from development partner Biogen Idec (NASDAQ:BIIB) upon the dosing of the first patient in the second study.
BIIB vs. ETF Alternatives
Biogen Idec Inc, is a biotechnology company that discovers, develops, manufactures and markets therapies for the treatment of multiple sclerosis (MS) and other autoimmune disorders, neurodegenerative diseases and hemophilia.
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