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.
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 14, 2014, 12:00 PM
Oct. 22, 2014, 9:44 AM
- Biogen Idec (BIIB -10.6%) is under selling pressure after this morning's earnings call. Some observers perceive that Tecfidera sales came in a bit light despite its 98% yoy growth. The company also disclosed the death of one patient who had taken the drug for four years. The death was apparently due to pneumonia and not due to the drug.
Oct. 22, 2014, 9:19 AM
Oct. 22, 2014, 7:55 AM
- Biogen Idec (NASDAQ:BIIB) Q3 results ($M): Total Revenues: 2,511.4 (+37.4%); Net Product Revenues: 2,117.4 (+45.7%); Joint Business: 290.7 (-4.1%); Royalty: 67.1 (+24.0%); Corporate Partner: 36.3 (+114.9%); COGS: 302.6 (+28.9%); R&D Expense: 417.2 (+1.7%); SG&A Expense: 570.4 (+40.6%); Net Income: 856.9 (+75.7%); EPS: 3.62 (+76.6%); Quick Assets: 1,861.3 (+178.4%).
- Gross Profit: 2,208.8 (+38.6%); COGS: 12.1% (-6.2%); Gross Margin: 87.9% (+0.9%); Operating Profit: 1,221.2 (+57.1%); Operating Earnings Yield: 48.6% (+14.3%); Net Earnings Yield: 34.1% (+27.9%).
- Product Sales: Tecfidera: 787.1 (+98.0%); Avonex: 741.8 (+1.1%); Tysabri: 501.2 (+25.0%); Alprolix: 25.3; Eloctate: 21.6; Fampyra: 20.4 (+22.1%).
- 2014 Guidance: Revenue growth: 38 - 41% (unch); R&D Expense: 20 - 21% of sales (unch); SG&A Expense: 22 - 23% of sales (unch); CAPEX: ~$300M (unch); GAAP EPS: $12.00 - 12.10 from $11.26 - 11.46; non-GAAP EPS: $13.45 - 13.55 from $12.90 - 13.10.
- Shares off 3% premarket on light volume.
Oct. 22, 2014, 7:06 AM
Oct. 21, 2014, 5:30 PM
Oct. 20, 2014, 10:57 AM
- Cytokinetics (CYTK +5.5%) reports that its lead drug candidate, tirasemtiv, demonstrated clinically meaningful improvements in Slow Vital Capacity (SVC) versus placebo in ALS patients in a Phase 2b study. SVC is a measure of skeletal muscle strength for breathing and is an important predictor of ALS disease progression and survival.
- The company has begun discussions with the FDA on a Phase 3 trial which would begin in 2015.
- ALS-related tickers: (CUR -6.9%)(BCLI -2.6%)(MNOV -13.7%)(BIIB +1%)
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