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 $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 14, 2014, 12:00 PM| 41 Comments
Oct. 22, 2014, 9:44 AM
- Biogen Idec (BIIB -10.6%) is under selling pressure after this morning's earnings call. Some observers perceive that Tecfidera sales came in a bit light despite its 98% yoy growth. The company also disclosed the death of one patient who had taken the drug for four years. The death was apparently due to pneumonia and not due to the drug.
Oct. 22, 2014, 9:19 AM| 1 Comment
Oct. 22, 2014, 7:55 AM
- Biogen Idec (NASDAQ:BIIB) Q3 results ($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%)
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Oct. 14, 2014, 3:31 PM
- Global growth, foreign-exchange, oil, and small caps are the subject of every client inquiry, says David Kostin. His team's recommendation: Buy "American exceptionalism."
- In Kostin's view, U.S. economy and corporate fundamentals are still strong, with economic growth expected by Goldman economists to be 3.2% next year, the fastest expansion since 2005. Europe is expected to grow just 1%.
- What his team likes are those stocks of companies which have a high proportion of domestic sales, plus sectors like Consumer Staples (XLP -0.1%) and Discretionary (XLY +0.7%) which stand to benefit from lower oil prices (plunging again today).
- As for small caps (IWM +0.9%), Kostin is wary, noting downward earnings revisions have boosted small cap P/E ratios even as prices have declined.
- The list of S&P 500 names capturing two or more of Kostin's themes: GT, GM, PCLN, AMZN, CMCSA, LOW, DG, TSN, ADM, CVS, AVP, WAG, PXD, HAL, JPM, BAC, SCHW, PNC, MS, C, GNW, LNC, MET, THC, AET, UNH, ESRX, HUM, WLP, BIIB, GILD, DAL, CMI, FLR, CRM, JBL, MA, FB, MU, FSLR, VMC, MON, T.
Oct. 7, 2014, 8:33 AM
- Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
- Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
- Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
- The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
- MS-related tickers: (NASDAQ:BIIB) (NYSE:ABBV) (NYSEMKT:SYN) (NASDAQ:CNCE) (NYSE:SNY) (NASDAQ:XNPT) (NASDAQ:INO) (NASDAQ:OPXA) (NYSE:TEVA) (NASDAQ:ALKS) (NASDAQ:RCPT) (NASDAQ:AVNR) (NASDAQ:GCVRZ) (NYSE:NVS) (NASDAQ:QCOR)
Sep. 26, 2014, 10:06 AM
Sep. 12, 2014, 9:00 AM
- In a 1,800-patient Phase 3 clinical trial comparing Zinbryta (daclizumab) to Avonex (interferon beta-1a) in patients with relapsing-remitting multiple sclerosis (RRMS), Zinbryta demonstrated a statistically significant improvement in reducing disease activity by virtue of a 45% reduction in annualized relapse rate (p=0.0001).
- Select secondary endpoints: the Zinbryta group demonstrated superiority in reducing the number of new or newly enlarging T2-hyperintense lesions at week 96 (54% reduction compared to Avonex), 73% were relapse-free at week 96 vs. 59% for Avonex and the risk of meaningful worsening in the physical impact of MS was reduced 24% compared to the Avonex cohort.
- Development partners Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV) plan to submit regulatory applications for Zinbryta in 1H 2015.
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