Nov. 9, 2014, 5:37 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its ALLY Phase 3 clinical trial investigating a 12-week ribavirin-free regimen of daclatasvir in combination with Sovaldi (sofosbuvir) in HCV genotype 3 patients, a population that has emerged as one of the most difficult to treat. The SVR12 in treatment-naive patients was 90% and 86% in treatment-experienced patients. SVR12, sustained viral response 12 weeks after the completion of therapy, is considered cured.
- The results compare favorably with SVR12 in 89% of patients with HCV-1,2 and 3 in an open-label randomized study of a 24-week regimen of the two drugs.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Nov. 9, 2014, 5:06 PM
- At this week's Annual Meeting for the Study of Liver Diseases in Boston, Achillion Pharmaceuticals (NASDAQ:ACHN) gave poster presentations on two of its HCV product candidates.
- In a Phase 2 pilot study evaluating eight-week treatment of its NS5A inhibitor, ACH-3102, in combination with Sovaldi (sofosbuvir) in treatment-naive HCV genotype 1 patients, the interferon-free, ribavirin-free regimen demonstrated 100% SVR12 in 12 patients. SVR12 or sustained viral response 12 weeks after the completion of therapy, is considered cured. Sovaldi's SVR12 (in combination with peg-interferon alfa and ribavirin) is 90% for HCV-1. Harvoni's (sofosbuvir + ledipasvir) is 94 - 99%.
- The company presented three posters on preclinical results for its uridine analog prodrug, ACH-3422. The data showed improved potency against HCV-3 compared to sofosbuvir. The combination of ACH-3422 with ACH-3102 or sovaprevir (Achillion's Phase 2 NS3/4A inhibitor) displayed additive synergistic activity in vitro. Also, ACH-3422, in combination with other direct-acting antiviral agents, demonstrated the ability to block the appearance of resistant colonies in vitro.
- According to recent research, the global prevalence of HCV genotypes is: type 1: 46%; type 2: 13%; type 3: 22% and type 4: 13%.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:ENTA) (NYSE:MRK) (NASDAQ:LGND) (NASDAQ:CNAT)
Nov. 5, 2014, 11:10 AM
- Advaxis (ADXS +1%) files an Investigational New Drug application with the FDA for clearance to initiate a Phase 1/2 clinical trial to assess ADXS31-142 for the treatment of metastatic castration-resistant prostate cancer as a monotherapy and in combination with Merck's (MRK +1.1%) Keytruda (pembrolizumab).
- The Phase 1 stage is designed to identify a recommended dose of ADXS31-142 and the Phase 2 stage will evaluate the safety of efficacy of ADXS31-142 alone and in combination with Merck's PD-1 inhibitor.
- The FDA has 30 days to respond with questions or suggested protocol revisions.
Oct. 27, 2014, 9:52 AM
- The FDA designates Merck's (MRK -1%) Keytruda (pembrolizumab) a Breakthrough Therapy for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. This is the second BTD tag for Keytruda.
- A product candidate labelled a Breakthrough Therapy is eligible for all the benefits of Fast Track plus more intensive FDA guidance on its development, the involvement of more senior agency managers and rolling/priority review.
Oct. 27, 2014, 7:36 AM
- Merck (NYSE:MRK) Q3 results ($M): Total Revenues: 10,557 (-4.3%); Pharmaceutical: 9,134 (-3.6%); Animal Health: 885 (+10.6%); Other: 137 (-56.4%); COGS: 4,223 (+2.9%); R&D Expense: 1,659 (-0.1%); SG&A Expense: 2,975 (+6.1%); Net Income: 842 (-26.8%); EPS: 0.31 (-18.4%).
- Gross Profit: 6,334 (-8.6%); COGS: 40.0% (+7.5%); Gross Margin: 60.0% (-4.5%); Operating Profit: 1,700 (-31.0%); Operating Earnings Yield: 16.1% (-27.9%); Net Earnings Yield: 8.0% (-23.5%).
- Product Sales: Januvia/Janmet: 1,439 (+5.1%); Zetia/Vytorin: 1,028 (-2.8%); Remicade: 604 (-3.5%); Gardisil: 590 (-11.3%); Proquad, MMRII & Varivax: 421 (0.0%); Isentress: 412 (-3.5%); Nasomex: 261 (-12.1%); Singulair: 218 (-22.1%).
- 2014 Guidance: Adjusted revenues: $42.4B - 42.8B from $42.4B - 43.2B; R&D/SGA&A: <2013 expenses; EPS: $4.06 - 4.29 from $4.44 - 4.77; non-GAAP EPS: $3.46 - 3.50 from $3.43 - 3.53.
- Shares up 0.7% premarket on light volume.
Oct. 27, 2014, 7:05 AM
Oct. 26, 2014, 5:30 PM
Oct. 21, 2014, 6:14 PM
- Cubist Pharmaceuticals (CBST -1.4%) Q3 results: Total Revenues: $309.2M (+16.2%), U.S. Cubicin: $256.7M (+11.7%), U.S. Dificid: $17.4M; U.S. Entereg: $15.3M (+11.7%); U.S. Entereg: $15.3M (%); U.S. Sivextro: $2.4M; COGS: $95.0M (+55.6%); R&D Expense: $66.0M (-46.5%); SG&A Expense: $77.8M (+5.3%); Operating Income: $67.8M (+999%); Net Income : $22.8M (+167.3%); EPS of $0.29 (+158.0%); Quick Assets: $687.0M (+18.7%).
- No guidance given.
Oct. 21, 2014, 4:06 PM| Comment!
Oct. 21, 2014, 10:52 AM
- The FDA accepts Eli Lilly's NDA for empagliflozin plus immediate-release metformin hydrochloride for the treatment of adults with type 2 diabetes (T2D). The product is part of the Lilly/Boehringer Ingelheim Diabetes alliance portfolio.
- Empagliflozin is a sodium glucose co-transporter-2 inhibitor which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilize glucose.
- The FDA approved Jardiance (empagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with T2D in August 2014. Metformin has been in clinical use for many years.
- Diabetes-related tickers: (JNJ +0.4%)(OTCQB:ISLT)(OTCQB:BTHE +20%)(VTAE +2.5%)(NVO +0.5%)(MRK +0.9%)(NASDAQ:VKTX)(HPTX +0.4%)(ABT +1.2%)(OTCPK:TKPHF)(OTCPK:TKPYY -0.5%)(MDT +1.7%)(SNY -0.2%)(OTCQB:SNYNF -0.5%)(MNKD +2.4%)(ALR +1.4%)(TNDM +3%)
Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 20, 2014, 5:35 PM
Oct. 20, 2014, 11:55 AM
Oct. 20, 2014, 11:44 AM
- The FDA accepts Merck (MRK) and Sanofi's (SNY -0.7%) (OTCQB:SNYNF) BLA for the firms' investigational hexavalent vaccine, DTaP5-IPV-Hib-HepB, for review. If approved, it will be the first pediatric combination vaccine in the U.S. designed to protect children from six diseases: diptheria, tetanus, pertussis, polio, H. influenza type B and hepatitis B.
- The antigens for H. influenza and hep B are from Merck. Sanofi supplied the remaining antigens.
Oct. 20, 2014, 10:40 AM
- Laboratory Corporation of America (LH -0.2%) launches its HIV GenoSure Archive, the first laboratory test that helps clinicians optimize antiretroviral (ARV) drug regimens for virally suppressed HIV patients. The test was developed using the Next Generation Sequencing Platform (NGS).
- Previous lab testing to guide ARV drug selection required higher viral loads than many HIV patients have. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples and then analyzing the polymerase region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely used ARV drug classes.
- HIV-related tickers: (ABBV +1.2%)(GILD +1.6%)(BMY +0.1%)(PFE -0.2%)(GSK -0.3%)(ABT +0.2%)(JNJ +0.1%)(PGNX +3%)(MRK +0.1%)(OTCQX:RHHBY +0.6%)
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)
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