Merck & Co Inc. (MRK) - NYSE
  • Mon, Apr. 18, 8:53 AM
    • The FDA designates Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) a Breakthrough Therapy for the treatment classical Hodgkin lymphoma (cHL), the fourth BTD tag for the therapeutic.
    • Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the (supplemental) New Drug Application.
    • KEYTRUDA was previously granted BTD status for advanced melanoma, advanced non-small cell lung cancer and advanced colorectal cancer.
    | Mon, Apr. 18, 8:53 AM
  • Sat, Apr. 16, 1:56 PM
    • Results from two Phase 3 trials, C-EDGE IBLD and C-EDGE CO-STAR, show Merck's (NYSE:MRK) Zepatier (elbasvir/grazoprevir) achieved cure rates as high as 96% after 12 weeks of treatment in certain patients with chronic hepatitis C virus (HCV) infection. The data were presented at The International Liver Congress 2016 in Barcelona, Spain.
    • C-EDGE IBLD, a randomized, double-blind, placebo-controlled study evaluating Zepatier in patients with HCV genotypes 1,4 or 6 with inherited blood disorders, including hemophilia A/B, von Willebrand disease, beta thalassemia and sickle cell anemia, showed a cure rate (SVR12) of 93% (n=100/107), although six patients relapsed (five had detectable NS5A resistance-associated polymorphisms at baseline) after the 12-week treatment period.
    • C-EDGE CO-STAR, a randomized, double-blind, placebo-controlled trial assessing Zepatier in patients with HCV genotypes 1,4 or 6 who are on opioid agonist therapy (methadone, buprenorphine), showed a cure rate of 94% (n=175/186) in the immediate treatment group and 96% (n=82/85) in the deferred treatment group (12 weeks of placebo followed by 12 weeks of Zepatier). Six probable re-infections occurred.
    • Zepatier, approved by the FDA in January, is a fixed-dose combination of an NS5A inhibitor (elbasvir) and an NS3/4A protease inhibitor (grazoprevir) indicated, with or without ribavirin, for the treatment of adult patients with chronic HCV-1 or HCV-4 infection with or without cirrhosis.
    | Sat, Apr. 16, 1:56 PM | 13 Comments
  • Thu, Apr. 14, 7:10 AM
    • Results from an open-label 255-subject Phase 3 clinical trial, C-EDGE Head-to-Head, evaluating Merck's (NYSE:MRK) ZEPATIER (elbasvir and grazoprevir) 50mg/100mg tablets compared to a regimen of Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir) plus peginterferon and ribavirin (pegIFN/RBV) in treatment-naive and pegIFN/RBV treatment-experienced HCV-1 or -4 patients, with or without cirrhosis, showed superiority of ZEPATIER. The data will be presented today at The International Liver Congress 2016 in Barcelona, Spain.
    • The overall cure rate (SVR12) for the ZEPATIER cohort was 99% (n=128/129) versus 90% (n=114/126) for sofosbuvir + pegIFN/RBV. For genotype G1a, the cure rates were both 100%. For genotype 1b and genotype 4, the cure rates were 99%/90% and 100%/60%, respectively. In cirrhotic patients, the cure rates were 100% and 76%, respectively. Finally, in patients who failed to respond to pegIFN/RBV therapy, the cure rates were 100% and 50%, respectively.
    • The safety profile also favored ZEPATIER. Tier 1 adverse events were 1% (n=1/129) compared to 28% (n=35/126) for sofosbuvir + pegIFN/RBV. The incidences of Tier 2 adverse events were 52% (n=67/129) and 93% (n=117/126), respectively. This was predictable considering the serious side effects associated with pegIFN/RBV therapy.
    • ZEPATIER, approved by the FDA in January, is a fixed-dose combination of an NS5A inhibitor (elbasvir) and an NS3/4A protease inhibitor (grazoprevir) indicated, with or without ribavirin, for the treatment of adult patients with chronic HCV-1 or HCV-4 infection with or without cirrhosis.
    • Related tickers: (NYSE:ABBV)(NYSE:BMY)
    | Thu, Apr. 14, 7:10 AM | 50 Comments
  • Wed, Apr. 13, 7:16 AM
    • The FDA accepts for review Merck's (NYSE:MRK) supplemental New Drug Application (sNDA) seeking approval of KEYTRUDA (pembrolizumab) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-based chemo. For this indication, KEYTRUDA will be used as a single agent at a dose of 200 mg administered intravenously every three weeks.
    • The sNDA has Priority Review status with a PDUFA date of August 9.
    • KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells. It is currently approved for the treatment of melanoma and a certain type of lung cancer.
    • Read now Merck Is Improving Its Standing In A Growing Immunotherapy Subsector
    | Wed, Apr. 13, 7:16 AM | 1 Comment
  • Fri, Apr. 8, 11:05 AM
    • MacroGenics (MGNX +3.1%) initiated with Buy rating and $35 price target by BTIG Research.
    • Viking Therapeutics (VKTX -39.4%) initiated with Buy rating and $6 price target by H.C. Wainwright.
    • Pfizer (PFE -0.3%) initiated with an Overweight rating and $38 price target by JP Morgan.
    • Medivation (MDVN -0.1%) initiated with Buy rating and $56 price target by SunTrust Robinson Humphrey.
    • Eyegate Pharmaceuticals (EYEG +6.5%) initiated with Buy rating and $10 price target by Noble Financial.
    • Eiger Biopharmaceuticals (EIGR +0.5%) initiated with Buy rating and $35 price target by Jefferies.
    • Vertex Pharmaceuticals (VRTX +0.3%) initiated with Market Perform rating and a $90 price target by BMO Capital.
    • SocGen has been busy with initiations on six large cap pharmas: Buy: Merck (MRK +0.1%); Hold: Johnson & Johnson (JNJ -0.4%), Eli Lilly (LLY -0.3%) and Pfizer; Sell: Bristol-Myers Squibb (BMY -0.4%) and AbbVie (ABBV -0.9%).
    • Tokai Pharmaceuticals (TKAI -6.7%) initiated with Buy rating and $16 price target by Bank of America. Initiated with Buy rating by Janney Capital.
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    • Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
    • TherapeuticsMD (TXMD) initiated with Buy rating and $10 price target by Goldman Sachs.
    • Protalix (PLX -4.2%) initiated with Buy rating and $3.50 price target by Rodman & Renshaw.
    • Raptor Pharmaceuticals (RPTP -0.4%) upgraded to Outperform from Market Perform by JMP Securities.
    • Ironwood Pharmaceuticals (IRWD -0.6%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $16 from $12.
    • Intercept Pharmaceuticals (ICPT -6%) upgraded to Outperform from Market Perform by Wells Fargo.
    • Edwards Lifesciences (EW -0.1%) upgraded to Buy from Neutral with $115 price target by BTIG Research.
    • Express Scripts (ESRX +0.7%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $80 from $76.
    • BIND Therapeutics (BIND -7%) downgraded to Market Perform from Outperform by Cowen & Company.
    • Allergan (AGN -0.5%) downgraded to Neutral from Buy by Mizuho Securities. Downgraded to Neutral from Positive by Susquehanna. Price target lowered to $275 from $345.
    • Bruker (BRKR +0.2%) downgraded to Market Perform from Outperform by Leerink Swann. Price target is $27.
    | Fri, Apr. 8, 11:05 AM | 9 Comments
  • Thu, Apr. 7, 7:04 AM
    • The European Commission approves Boehringer Ingelheim's Giotrif (afatinib) for the treatment of advanced squamous cell carcinoma of the lung (SqCC) whose disease has progressed on or after platinum-based chemo. SqCC, the largest sub-type of non-small cell lung cancer (20-30% of cases), is associated with a poor prognosis. Median overall survival (OS) is only about one year.
    • The data supporting the marketing application was generated in the LUX-Lung 8 trial which showed patients treated with Giotrif experienced a 19% improvement in OS, a 19% reduction is the risk of cancer progression and an 11% improvement in disease control rate.
    • The most frequent serious adverse events were grade 3 diarrhea (10%) and grade 3 stomatitis (mouth sores)(4%).
    • Giotrif was previously cleared for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC).
    • NSCLC-related tickers: (NYSE:BMY)(NYSE:AZN)(NYSE:PFE)(NYSE:MRK)(OTCQX:RHHBY)
    | Thu, Apr. 7, 7:04 AM
  • Sun, Apr. 3, 10:36 AM
    • In a late-breaking clinical trial session at the American College of Cardiology’s 65th Annual Scientific Session, Amgen's (NASDAQ:AMGN) Repatha trial showed that in patients with reproducible statin intolerance due to muscle-related side effects, Repatha vs. ezetimibe (NYSE:MRK) resulted in significantly greater reduction in low-density lipoprotein cholesterol (LDL-C) after 24 weeks.
    • The mean LDL-C reduction from baseline at weeks 22 and 24 was 54.5% for Repatha vs. 16.7% for ezetimibe.
    • Muscle-related side effects were reported in 20.7% of Repatha patients and 28.8% of ezetimibe patients.
    • Now read Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond »
    | Sun, Apr. 3, 10:36 AM | 7 Comments
  • Wed, Mar. 30, 10:33 AM
    • Biogen (BIIB +0.7%) appoints Michael Vounatsos as EVP and Chief Commercial Officer effective April 18. He joins the firm from a 20-year career at Merck (MRK), where he most recently served as President, Primary Care Business Line and Merck Customer Centricity.
    | Wed, Mar. 30, 10:33 AM | 4 Comments
  • Tue, Mar. 29, 9:05 AM
    • The FDA approves Lannett Company's (NYSE:LCI) Abbreviated New Drug Applications (ANDAs) for potassium chloride extended-release capsules, the therapeutic equivalent of the reference listed drug made by Actavis, and temozolomide capsules, the therapeutic equivalent to Merck's (NYSE:MRK) Temodar capsules.
    • According to IMS, the U.S. wholesale market for potassium chloride extended-release capsules is ~$89M and ~$206M for Temodar.
    • Temodar is a chemotherapy agent used in brain cancer. Potassium chloride is used to treat low levels of potassium (hypokalemia) in the blood.
    • The company intends to launch temozolomide within the next few months. The launch of potassium chloride is under review.
    | Tue, Mar. 29, 9:05 AM | 5 Comments
  • Thu, Mar. 24, 10:16 PM
    • A jury has ordered Gilead Sciences (NASDAQ:GILD) to pay $200M to Merck (NYSE:MRK) for patent infringement in a case over hepatitis C drugs -- that vs. Merck's demand for more than $2B in damages.
    • Jurors had sided with Merck in ruling its patents related to sofosbuvir that were infringed by Gilead were valid. But they rejected a call for a 10% royalty on some $20.7B in revenue that Gilead's drugs (Sovaldi and Harvoni) earned between 2013 and 2015.
    • The jury settled on a 4% royalty for $5B in sales, after subtracting a Gilead investment of $15B from the revenues.
    • Gilead says it will appeal the amount if a judge upholds it: “Since Merck made no contribution and assumed none of the risk in the discovery and development of sofosbuvir, we do not believe Merck is entitled to any amount of damages,” says Gilead's Michele Rest.
    • Previously: Ionis Pharma to receive 20% of Gilead patent infringement damages; shares up 11% premarket (Mar. 23 2016)
    • Previously: Merck +0.9%, Gilead -2.1% as jury rules Merck's patents valid (Mar. 22 2016)
    | Thu, Mar. 24, 10:16 PM | 92 Comments
  • Wed, Mar. 23, 8:23 AM
    • Ionis Pharmaceuticals (NASDAQ:IONS) is up 11% premarket on increased volume in response to yesterday's jury verdict in California that Gilead Sciences' (NASDAQ:GILD) HCV meds Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) infringe on two patents invented by Merck (NYSE:MRK) and Ionis. The next phase of the trial will determine the amount of the damages.
    • Ionis will receive 20% of the amount awarded to Merck that exceed its litigation costs and 20% of all future payments.
    • Previously: Merck +0.9%, Gilead -2.1% as jury rules Merck's patents valid (March 22)
    | Wed, Mar. 23, 8:23 AM | 32 Comments
  • Wed, Mar. 23, 3:09 AM
    • The U.S. Supreme Court today will consider appeals by Christian groups demanding full exemption on religious grounds from a requirement under the Affordable Care Act to provide health insurance covering contraceptives.
    • Arguments on seven related cases will focus on whether nonprofit entities can object to a compromise measure offered by the Obama administration, which allowed groups to comply with the law without actually paying for the required coverage, under the 1993 Religious Freedom Restoration Act.
    • Related tickers: PFE, MRK, JNJ, TEVA, CHD, OTCPK:BAYRY
    | Wed, Mar. 23, 3:09 AM | 22 Comments
  • Tue, Mar. 22, 5:37 PM
    • Merck (NYSE:MRK) is up 0.9% after a quick 3.7% spike after hours, and Gilead Sciences (NASDAQ:GILD) down 2.1%, as a jury has decided that Merck's 2002 patents related to sofosbuvir are valid, lending credence to Merck's argument that Gilead is infringing via its Pharmasset unit, acquired in 2011.
    • Gilead's Sovaldi and Harvoni were ruled last month to infringe on Merck patents, and the next step was to decide the validity of the Merck patents.
    • The case now proceeds to damages owed. Sovaldi and Harvoni brought $19.2B in global sales last year.
    • Merck has demanded more than $2B in damages and 10% of Gilead's sales of the products going forward.
    • Previously: Merck after a big slice of Gilead's sofosbuvir pie (Mar. 08 2016)
    | Tue, Mar. 22, 5:37 PM | 123 Comments
  • Tue, Mar. 22, 9:38 AM
    • Privately held Canadian drug firm Apotex launches its generic version of Merck's (MRK -0.2%) allergy med Nasonex nasal spray (mometasone furoate monohydrate) in the U.S.
    • According to IMS, branded Nasonex generated ~$956M in U.S. sales in the 12-month period ending January 2016.
    | Tue, Mar. 22, 9:38 AM | 2 Comments
  • Thu, Mar. 17, 5:21 PM
    • Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is down 16% after hours on robust volume in response to its announcement of results in a Phase 2 pilot study assessing Orphan Drug-tagged MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH), an inherited disorder characterized by abnormally high levels of bad LDL cholesterol (LDL-C) leading to premature cardiovascular disease.
    • The 12-week, open-label, dose escalation trial enrolled 13 HoFH patients. All were receiving ezetimibe [Merck's (NYSE:MRK) Zetia] and were on maximum statin therapy. None were being treated with lomitapide [Aegion's (NASDAQ:AEGN) Juxtapid], mipomersen [Sanofi's (NYSE:SNY) Kynamro] or a PSCK9 inhibitor. The average baseline LDL-C level was 368 mg/dL (optimal level: less than 100 mg/dL). Subjects received 50 mg of MBX-8025 once daily for four weeks.
    • Two per-protocol analyses were performed on 12 subjects (one was excluded due to missed apheresis visits). A responder analysis showed three patients experienced a reduction in LDL-C greater than 30%, five patients at least 20% and seven patients at least 15%. The average maximum decrease was 19%. A second analysis, averaging values across all doses and dosing periods, showed an overall average decrease in LDL-C of 10%, with eight subjects showing a mean decrease of 16% and three greater than 20%. Four patients showed a mean increase in LDL-C of 4%.
    • Mean PCSK9 was elevated at baseline and increased significantly during treatment by an average of 43%, which was unexpected, and creates the need to assess the combination of MBX-8025 and a PCSK9 inhibitor [Amgen's (AMGN +0.1%) Repatha (evolocumab) or Regeneron (NASDAQ:REGN) and Sanofi's Praluent (alirocumab)] in a pilot study.
    • MBX-8025 is an agonist of peroxisome proliferator-activated receptor delta, a nuclear receptor that regulates genes involved in lipid transport, storage and metabolism in liver and muscle.
    • Previously: CymaBay product candidate an Orphan Drug for severe hypertriglyceridemia (April 22, 2015)
    | Thu, Mar. 17, 5:21 PM
  • Tue, Mar. 8, 1:14 PM
    • Gilead Sciences (GILD +0.4%) and Merck (MRK +0.2%) are in the midst of a courtroom spat over sofosbuvir patents. Merck claims Gilead is infringing on its intellectual property and owes it 10% of the $31.7B it has made to date on the hepatitis C med. Unsurprisingly, Gilead disagrees with Merck's assertion saying sofosbuvir was invented by Pharmasset, which it acquired in 2011 for $11B.
    • Last month, a judge ruled that Gilead's Sovaldi and Harvoni do, indeed, infringe on Merck's patents. Now a jury will decide if they remain valid and how much Gilead owes to the Kenilworth, NJ-based drug firm.
    • The dispute centers on a patent published in 2002 by Merck, who alleges that Pharmasset used it to develop sofosbuvir. Gilead says Pharmasset's development work on sofosbuvir began in 2001, a year before Merck secured patent rights.
    • The rhubarb began in 2013 when Gilead sued Merck over what it called a "threat" by Merck to sue Gilead over two of its patents registered in 2002 in an attempt to extract a "prohibitive" royalty on sofosbuvir.
    • In a worse case scenario, Gilead would hardly miss a step if it had to disgorge $3B considering its cash horde of over $26B. Nevertheless, it won't do so without a fight. If it loses the current case, expect an appeal.
    | Tue, Mar. 8, 1:14 PM | 89 Comments
Company Description
Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products worldwide. It is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets vaccines and... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: United States