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Merck & Co Inc. (MRK)

  • 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
  • Nov. 24, 2014, 9:59 AM
    • Merck (MRK -0.5%) submits a new drug application to the Japanese Pharmaceuticals and Medicinal Devices Agency for omarigliptin for the treatment of type 2 diabetes. Japan is the first country with a regulatory filing for the drug candidate.
    • Omarigliptin is a once-weekly DPP-4 inhibitor. Merck's Januvia (sitagliptin), approved by the FDA in 2006, was the first agent in the class to achieve regulatory clearance.
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  • Nov. 24, 2014, 9:48 AM
    • Merck (MRK -0.7%) enters into an exclusive worldwide license agreement with NewLink Genetics (NLNK +0.5%) to develop and commercialize the latter's investigational rVSV-EBOV (Ebola) vaccine candidate.
    • Phase 1 trials are currently underway at Walter Reed Army Institute of Research and the NIAID at the NIH. If successful, the NIH will commence a large, randomized Phase 3 study to evaluate the safety and efficacy of rVSV-EBOV and another investigational Ebola vaccine candidate co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK -0.3%).
    • The rVSV-EBOV vaccine was created by scientists at the Public Health Agency of Canada's National Microbiology Laboratory.
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  • Nov. 24, 2014, 8:40 AM
    • Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
    • The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
    • A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
    • TTPH is up 18% premarket on light volume.
    • Previously: Tetraphase completes eravacycline Phase 3 enrollment
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  • Nov. 21, 2014, 8:48 AM
  • Nov. 17, 2014, 3:59 PM
    • In a Phase 2 clinical trial, Merck's (MRK +0.7%) anti-PD-1 therapy, Keytruda (pembrolizumab), improved progression-free survival (PFS) versus chemotherapy in patients with ipilimumab-refractory advanced melanoma. At six months, PFS for the 2 mg/kg and 10 mg/kg doses was 34% and 38%, respectively, compared to 16% for chemo (p<0.0001).
    • Study results, including secondary endpoints, were presented today by Dr. Antoni Ribas, professor, Hematology/Oncology and Surgery, UCLA at the Society of Melanoma Research 2014 Congress in Zurich, Switzerland.
    • The study's co-primary endpoints are PFS and overall survival (OS). Investigators will evaluate OS in 2015.
    • Keytruda is approved in the U.S. at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
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  • Nov. 17, 2014, 1:02 PM
    • In a Phase 3 trial, patients receiving Merck's (MRK +0.9%) Vytorin (ezetimibe/simvastatin) experienced fewer major cardiovascular events than those receiving simvastatin alone. In the study, called Improve-It, at seven years, 32.7% of patients taking Vytorin experienced a primary endpoint event compared to 34.7% of patients taking simvastatin alone (p=0.016) (hazard ratio: 0.936).
    • Based on the LDL-cholesterol range in the study's treatment arms, the 6.4% relative risk reduction observed in the Vytorin arm was consistent with the treatment effect that had been projected based on prior studies of statins.
    • The company intends to submit the data to the FDA to support a new indication for the reduction on major cardiovascular events for Vytorin and Zetia (ezetimibe).
  • Nov. 13, 2014, 11:56 AM
    • The FDA's Anesthetic and Analgesic Drug Products Advisory Committee meets on November 24, 25 to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also review the efficacy of ESI and the overall risk benefit profile of injecting steroids in the epidural space to treat pain. Regulatory options will also be discussed which could include changes to product labeling.
    • Briefing doc
    • Related tickers: (MRK +0.7%)(PFE +0.2%)(BMY -1.3%)(NVS +2%)
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  • Nov. 13, 2014, 9:01 AM
    • Researchers from the Broad Institute and Massachusetts General Hospital identify rare mutations that inactivate a gene the body uses to take cholesterol in food and move it into the bloodstream. The mutations, found in 1 in 650 people, lead to lower cholesterol levels and a reduction in heart disease risk of as much as 50%.
    • One of the mutations is the same one targeted by Merck's (NYSE:MRK) Zetia (ezetimibe). The drug works by blocking the absorption of cholesterol in the stomach. Whether the drug can prevent heart attacks and death over and above the use of statins is unclear. A definitive study on the issue, called Improve-It, will be presented at next week's American Heart Association meeting in Chicago. It compares the combination (Merck's Vytorin) of Zetia and the generic cholesterol-lowering drug simvastatin to simvastatin alone.
    • There is a high degree of interest in the study results since the failure to prove that Vytorin (and, therefore, Zetia) contributes to a decrease in heart disease and death over and above simvastatin could have a devastating impact on Merck's $4B franchise. FDA guidelines issued last year recommend only those drugs shown to reduce heart attack, stroke and death should be prescribed.
  • Nov. 11, 2014, 4:52 PM
    • A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
    • Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
    • Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
    • Amgen plans to present the complete results at a future medical conference.
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  • Nov. 11, 2014, 11:03 AM
    • At The Liver Meeting in Boston, Gilead Sciences (GILD +1.1%) presented results from several Phase 2 and Phase 3 trials evaluating Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of chronic HCV infection in patients with limited or no treatment options, including decompensated cirrhosis, HCV recurrence following liver transplantation and patients refractory to other direct-acting antivirals.
    • In a pooled analysis of Phase 2 and Phase 3 open-label studies involving more than 500 HCV-1 patients with compensated cirrhosis who received Harvoni alone or with ribavirin (RBV) for 12 or 24 weeks, 96% achieved SVR12.
    • In a Phase 2 open-label study evaluating patients with decompensated cirrhosis and those with HCV recurrence after a liver transplant, 87% of those receiving Harvoni + RBV for 12 weeks achieved SVR12 compared to 89% of the treatment arm receiving a 24-week regimen (subgroup analysis of 108 HCV genotype 1 and 4 patients).
    • In another subgroup analysis from the same Phase 2 trial, response rates for patients who developed HCV (genotypes 1 and 4) recurrence following liver transplantation who were treated with Harvoni + RBV were analyzed. SVR12 rates for non-cirrhotic patients were 96% and 98%, respectively, for the 12- and 24-week regimens. For patients with compensated cirrhosis, the SVR12 rate was 96% for both regimens. For patients with decompensated cirrhosis, the SVR12 rate was 81% for both regimens.
    • In two studies of HCV patients who failed prior therapy, those receiving Harvoni + RBV for 12 weeks achieved SVR12 rates of 96% and 98%. Those receiving Harvoni alone for 24 weeks (Study GS-US-337-0121) achieved an SVR12 rate of 97%.
    • HCV-related tickers: (BMY -0.1%)(MRK +1.4%)(ABBV +0.3%)(JNJ +0.2%)(ACHN -0.6%)(RGLS -2.7%)(CNAT -1.1%)(ENTA -0.4%)
  • Nov. 11, 2014, 10:07 AM
    • At The Liver Meeting in Boston, AbbVie (ABBV -0.1%) presented results from studies in HCV patients co-infected with HIV and liver transplant recipients who received its all-oral, interferon-free investigational treatment combining three antivirals (ombitasvir/ABT-450/ritonavir and dasabuvir)
    • SVR12 rates for patients co-infected with HCV/HIV that received the company's investigational treatment plus ribavirin were 93.5% for the 12-week regimen and 90.6% for the 24-week regimen.
    • In non-cirrhotic liver transplant recipients with recurrent HCV-1 new to treatment, SVR12 and SVR24 rates were each 97.1%.
    • HCV-related tickers: (GILD +0.5%)(MRK +1%)(JNJ -0.1%)(BMY -0.2%)(ENTA +0.2%)(RGLS +0.2%)(CNAT -0.5%)(ACHN -1.7%)
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  • Nov. 11, 2014, 9:37 AM
    • At The Liver Meeting in Boston, Merck (NYSE:MRK) presented data from a Phase 2 clinical trial evaluating the combination of the company's investigational NS3/4A inhibitor, grazoprevir, and its investigational NS5A inhibitor, elbasvir, with and without ribavirin, in treatment-naive and treatment-experienced HCV-1 patients. The length of treatment was either eight,12 or 18 weeks.
    • SVR12 rates in treatment-naive non-cirrhotic patients were: 8-week regimen with RBV: 80%; 12-week regiment with and without RBV: 93% and 98%.
    • SVR12 rates in treatment-naive patients with cirrhosis were: 12-week regimen with and without RBV: 90% and 97%; 18-week regimen with and without RBV: 97% and 94%.
    • SVR12 rates for treatment-experienced patients with and without cirrhosis: 12-week regimen with and without RBV: 94% and 91%; 18-week regimen with and without RBV: 100% and 97%.
    • SVR12 rates for HCV-1 patients co-infected with HIV: 12-week regimen with and without RBV: 97% and 87%.
    • Results from a Phase 3 trial are expected in 1H 2015.
    • Previously: Merck triple therapy HCV candidate fails as a four-week regimen
    • HCV-related tickers: (GILD +0.4%)(JNJ -0.2%)(BMY -0.1%)(ABBV +0.3%)(ACHN +3%)(ENTA +0.4%)(CNAT)(LGND +0.5%)(RGLS)
  • Nov. 11, 2014, 7:44 AM
    • Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
    • The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
    • Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
    • Sanofi plans to proceed to Phase 3 development.
  • Nov. 10, 2014, 7:49 AM
    • At The Liver Meeting in Boston, Merck (NYSE:MRK) presented interim data on its triple-therapy regimen for HCV-1 infection. The investigational product combines the company's NS3/4A protease inhibitor, grazoprevir and its NS5A inhibitor, elbasvir, with Sovaldi (sofosbuvir).
    • SVR4/8 for the 8-week regimen in treatment-naive cirrhotic patients was 94.7% (18 of 19). SVR4/8 values for other treatment groups, however, appear low. For the six-week regimen in treatment-naive cirrhotic patients, SVR4/8 was only 80% (16 of 20) with four relapses. For treatment-naive non-cirrhotic patients, the six-week regimen SVR4/8 was 86.7% (26/30) with four relapses while the four-week regimen failed to come anywhere close to efficacy at 38.7% (12/31) with 19 relapses.
    • Of the 28 total relapses, 25 were genotype 1a and three were genotype 1b.
    • The company plans to initiate Phase 2 clinical trials to assess the safety and efficacy of two short-duration triple therapy regimens: MK-3682 in combination with grazoprevir/elbasvir and MK-3682 in combination with grazoprevir and MK-8408 in non-cirrhotic HCV patients. MK-3682 is an investigational oral prodrug HCV nucleotide analogue NS5B polymerase inhibitor. MK-8408 is an investigational early-stage NS5A inhibitor.
  • Nov. 9, 2014, 6:04 PM
    • At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its Phase 3 UNITY program investigating a 12-week all-oral TRIO regimen of daclatasvir (DCV) with asunaprevir and beclabuvir for the treatment of HCV-1 infection.
    • In the UNITY-1 trial, a 12-week regimen of DCV-TRIO without ribavirin was evaluated in treatment-naive and treatment-experienced non-cirrhotic HCV patients. SVR12 was 91% overall, 92% for the treatment-naive group and 89% for the treatment-experienced group.
    • In UNITY-2, a 12-week regimen of DCV-TRIO was evaluated in cirrhotic patients. SVR12 was 98% in the treatment-naive group and 93% in the treatment-experienced group with ribavirin and 93% and 87%, respectively, without ribavirin.
    • In October, the company announced it would not pursue FDA approval for the dual regimen of asunaprevir and daclatasvir for the treatment of HCV-1b infection.
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Company Description
Merck & Co Inc is a health care company that delivers health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products.