Merck & Co Inc.(MRK)- NYSE
  • Wed, Sep. 28, 7:29 AM
    • The first patient has been enrolled in a pivotal Phase 3 clinical trial,VICTORIA, assessing Bayer's (OTCPK:BAYRY) vericiguat for the treatment of patients with chronic heart failure with reduced ejection fraction (HFrEF). The study is being led by collaboration partner Merck (NYSE:MRK).
    • VICTORIA will involve ~4,900 subjects and take three years to complete. It will assess the safety and efficacy of up to 10 mg of vericiguat once daily compared to placebo (on a background of standard-of-care treatment) in reducing the risk of cardiovascular (CV) death or hospitalization due to heart failure(HF) in HFrEF patients following HF hospitalization or an intravenous diuretic without hospitalization. The primary endpoint is the time to first occurrence of the composite endpoint of CV mortality or HF hospitalization.
    • Vericiguat, discovered at Bayer, is a soluble guanylate cyclase (sGC) stimulator. Guanylate cyclase is a key enzyme in the nitric oxide (NO) signaling pathway which promotes vasodilation while inhibiting smooth muscle proliferation, leukocyte recruitment, platelet aggregation and modulating inflammation. The agents are being developed to treat hypertension and chronic obstructive pulmonary disease in addition to heart failure.
    • Vericiguat is being co-developed by the two companies under their October 2014 strategic collaboration. Funding for development and commercialization are being shared equally. Merck has commercial rights in the Americas and Bayer elsewhere.
    • About 20% of people worldwide will develop HF in their lifetime.
    | Wed, Sep. 28, 7:29 AM
  • Mon, Sep. 26, 1:10 PM
    • The first patient has been enrolled in recent IPO Gemphire Therapeutics' (GEMP -0.4%) Phase 2b clinical trial, COBALT-1, assessing sole product candidate gemcabene for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).
    • The trial is assessing three doses (300 mg, 600 mg, 900 mg) of gemcabene in subjects on stable lipid-lowering therapy, including statins, ezetimibe [Merck's (NYSE:MRK) ZETIA] and Amgen's (AMGN -0.9%) Repatha (evolocumab). The primary efficacy endpoint is the change in LDL-C from baseline at 28, 56 and 84 days. According to ClinicalTrials.gov, the estimated study completion date is February 2017.
    • Gemcabene is a once-daily orally available medication for patients unable to achieve normal levels of LDL-C or triglycerides with currently available therapies. It has a dual mechanism of action that blocks the production of hepatic triglyceride and cholesterol synthesis and enhances the clearance of VLDL (very low density lipoprotein). Specifically, it inhibits a liver protein called apolipoprotein C-III and may inhibit a liver enzyme called acetyl-CoA carboxylase. Gemphire licensed it from Pfizer in April 2011.
    | Mon, Sep. 26, 1:10 PM
  • Wed, Sep. 21, 9:53 AM
    • Cerecor (CERC) hits its enrollment target in a Phase 2 clinical trial, Clin301-203, evaluating CERC-301 for the adjunctive treatment of major depressive disorder (MDD), a Fast Track-designated indication by the FDA. Top-line data should be available in November.
    • The double-blind, placebo-controlled study has enrolled 115 subjects with MDD who experienced a severe depressive episode despite stable ongoing treatment with either a serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor. Participants have been randomized to receive intermittent 12 mg or 20 mg oral doses of CERC-301 or placebo seven days apart followed by a 14-day observation period. The primary endpoint is the change from baseline in depression as measured by a scale called Bech-6. Secondary endpoints also assess the change in depression from baseline as determined by a range of scales.
    • CERC-301, licensed from Merck (MRK +0.4%), is an N-methyl-D-aspartate receptor (NMDA) antagonist, a class of drugs that induce dissociative anesthesia (e.g., ketamine).
    | Wed, Sep. 21, 9:53 AM | 2 Comments
  • Tue, Sep. 20, 4:59 PM
    • Clovis (NASDAQ:CLVS) has always been considered an acquisition target with a “long list” of potential suitors including Eli Lilly (NYSE:LLY), Merck & Co. (NYSE:MRK) , and Roche, Janney tells Bloomberg in an interview.
    • CEO Patrick Mahaffy has sold other companies including Pharmion, NeXstar Pharmaceuticals.
    • Clovis closed +12.7% and is up another 7.7% AH. Earlier today the stock jumped when Gilead (NASDAQ:GILD) said it is looking for cancer deals.
    • Clovis's PDUFA date  for ovarian cancer drug rucaparib is Feb. 23, 2017.
    | Tue, Sep. 20, 4:59 PM | 19 Comments
  • Tue, Sep. 20, 7:05 AM
    • BioLineRx (NASDAQ:BLRX) initiates a Phase 2a study, COMBAT, assessing lead product candidate BL-8040 and Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) for the treatment of metastatic pancreatic adenocarcinoma. The 30-subject open-label, single-arm trial will evaluate the clinical response, safety and tolerability of the combination. The study is being performed under the companies' January immunotherapy collaboration. According to ClinicalTrials.gov, the estimated study completion date is December 2018.
    • BL-8040 is a synthetic peptide that binds to a protein found on the surface of cancer cells called CXCR4, a chemokine receptor that that plays a key role in tumor growth and survival. CXCR4 is overexpressed in more than 70% of human cancers and is associated with a poor prognosis.
    | Tue, Sep. 20, 7:05 AM | 1 Comment
  • Mon, Sep. 19, 5:26 AM
    • Sanofi (NYSE:SNY) has filed a lawsuit against Merck's (NYSE:MRK) international unit for alleged patent infringements, following the company's filing for new drugs applications with FDA.
    • Sanofi claims that Merck Sharp & Dohme Corp. violated as many as 10 of its patents, including ones for its blockbuster diabetes treatment Lantus and its insulin delivery device soloSTAR.
    | Mon, Sep. 19, 5:26 AM
  • Thu, Sep. 15, 11:30 AM
    • Teva Pharmaceutical Industries (TEVA +0.1%) commences the U.S. commercial launch of its generic version of Merck's (MRK +1.5%) antibiotic CUBICIN (daptomycin for injection) 500 mg. It is indicated for the treatment of complicated skin and skin structure infections caused by certain Gram-positive bacteria and bloodstream infections caused by Staphylococcus aureus.
    • The U.S. market is ~$1.2B/year according to IMS.
    | Thu, Sep. 15, 11:30 AM
  • Thu, Sep. 15, 10:28 AM
    • GlaxoSmithKline (GSK +0.1%) announces that full results from its Phase 3 clinical trial, ZOE-70, assessing its shingles vaccine candidate Shingrix have been published in the New England Journal of Medicine (NEJM). Headline results were initially reported in October 2015.
    • The study demonstrated that the two-dose regimen of Shingrix had 90% efficacy versus placebo in participants over 70 years old. Vaccine efficacy was maintained across the age groups in the trial: 90% in ages 70 - 79 and 89% in ages 80 and above.
    • The results were in line with the results from ZOE-50 (people over 50 years old) published last year.
    • By comparison, the efficacy of Merck's (MRK +0.3%) ZOSTAVAX is 64% in people aged 60 -69, but only 18% in those aged 80+.
    • Shingrix is a non-live, adjuvanted subunit (HZ/su) vaccine that combines gE, a protein found on the herpes zoster virus, with the adjuvant ASO1B which boosts the immune response to gE.
    • Shingles is characterized by a painful, itchy rash caused by the reactivation of latent chicken pox virus, varicella zoster. The risk of developing shingles increases with age and altered immune system status.
    • Glaxo intends to start the global regulatory application process later this year.
    • Previously: Glaxo shingles vaccine 97% effective in Phase 3 study (April 28, 2015)
    | Thu, Sep. 15, 10:28 AM | 1 Comment
  • Thu, Sep. 15, 9:42 AM
    • Merck (MRK +0.3%) and development partner Pfizer (PFE -1%) announce positive results from a Phase 3 clinical trial, VERTIS SITA2, evaluating ertugliflozin in patients with type 2 diabetes on a background of sitagliptin and stable metformin. The data were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes in Munich, Germany.
    • The double-blind, placebo-controlled trial randomized 463 subjects 1:1:1 to receive either 5 mg or 15 mg of ertugliflozin or placebo. The study met its primary endpoint of a statistically valid reduction in HbA1c at Week 26 compared to placebo. Secondary endpoints met included the proportion of patients achieving HbA1c levels less than 7.0%, placebo-adjusted mean reduction in body weight, placebo-adjusted mean reductions in fasting plasma glucose and placebo-adjusted mean reductions in systolic blood pressure.
    • The incidences of adverse events were similar between the two doses of ertugliflozin and placebo, although there was a higher incidence of genital mycotic (yeast) infections in the ertugliflozin cohorts (4.9%, 3.7% and 0%, respectively).
    • Successful results from two earlier Phase 3s, VERTIS Mono and VERTIS Factorial, were reported in June.
    • The companies intend to file New Drug Applications with the FDA for ertugliflozin and two fixed-dose combinations [ertugliflozin + JANUVIA (sitagliptin) and ertugliflozin + metformin] by year end. Regulatory applications outside the U.S. will be made in 2017.
    • Ertugliflozin inhibits sodium-glucose co-transporter 2 (SGLT2), a protein that facilitates glucose reabsorption in the kidney. Inhibiting SGLT2 increases the excretion of glucose which lowers blood glucose levels. Merck and Pfizer are co-developing and co-commercializing the product under their April 2013 collaboration agreement.
    | Thu, Sep. 15, 9:42 AM | 7 Comments
  • Wed, Sep. 7, 11:29 AM
    • Aralez Pharmaceuticals (ARLZ +3.5%) acquires the rights to Merck's (MRK -0.2%) antiplatelet drug ZONTIVITY (vorapaxar) in the U.S. and Canada. Under the terms of the asset purchase agreement, Merck will receive an upfront cash payment of $25M plus sales-based milestones and royalties. Merck will continue to distribute the product for up to 12 months on Aralez's behalf while the product rights, packaging, labeling and other items are transferred to Aralez's Ireland-based subsidiary Aralez Pharmaceuticals Trading DAC.
    • ZONTIVITY is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (heart attack) or with peripheral artery disease. Vorapaxar is a protease-activated receptor-1 (PAR-1) antagonist. Inhibiting PAR-1 interferes with thrombin-induced platelet aggregation.
    | Wed, Sep. 7, 11:29 AM | 15 Comments
  • Wed, Sep. 7, 7:44 AM
    • The FDA accepts for review Merck's (NYSE:MRK) supplemental Biologics License Application (sBLA) seeking approval of the use of KEYTRUDA (pembrolizumab) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, a Breakthrough Therapy designation. The agency's action date (PDUFA) is December 24.
    • The data supporting the application was generated in the Phase 3 KEYNOTE-024 study which showed KEYTRUDA monotherapy demonstrated superior progression-free survival and overall survival compared to standard chemo.
    • Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
    • The company has filed a marketing application in Europe for the same indication.
    • KEYTRUDA is Merck's fastest growing drug. It generated over $1.1B in sales over the past four quarters.
    | Wed, Sep. 7, 7:44 AM
  • Tue, Sep. 6, 11:03 AM
    • August monthly performance was: +1.89%
    • AUM of $13.5B
    • 52-week performance vs. the S&P 500 is: -13%
    • No dividends were paid in August
    • Top 10 Holdings as of 6/30/2016: JPMorgan Chase & Co (JPM): 3.02927%, US Treasury Note 1.125%, Citigroup Inc (C): 2.72752%, Bank of America Corporation (BAC): 1.75979%, General Electric Co (GE): 1.64495%, Apache Corp (APA): 1.43672%, Merck & Co Inc (MRK): 1.40565%, Royal Dutch Shell PLC Class A (OTCPK:RYDAF): 1.39841%, Morgan Stanley (MS): 1.39796%, US Treasury Note 0.625%
    | Tue, Sep. 6, 11:03 AM
  • Fri, Sep. 2, 1:19 PM
    • In a factsheet just published on Presidential candidate Hillary Clinton's website, she outlines her plan to reign in rogue drug companies who aggressively increase the prices of their medicines.
    • Her plan features three methods for containing runaway drug costs: make alternatives available and increase competition; enable emergency importation of safe treatments and fine drug firms for unjustified price increases.
    • Her first action, as President, will be to create a dedicated group of representatives from Federal agencies that oversee health and safety and fair competition that will be charged with protecting consumers from "outlier" price increases. The group will establish criteria for determining if a price increase is justified for a long-available treatment and investigate and consider enforcement in certain situations.
    • In cases where the level of competition is light, her plan will enable the emergency purchases of alternative versions and make them available to patients in need while encouraging competition from additional suppliers.
    • She also calls for legislation to safely and securely import drugs from foreign nations whose regulatory regimes are as robust as the FDA, with the proviso of a "careful review" by the agency (more temporary than permanent).
    • In cases where miscreant drug firms are fined, the funds will be used to support new programs to make lower-cost alternatives available and speed up approvals in order to beef up competition (specifics are not provided).
    • In her broader plan to lower prescription drug costs for all Americans, she proposes a cap on out-of-pocket costs, additional funding to support the clearing of the FDA's backlog of generic drug applications, prohibit "pay for delay" deals (long overdue), a moratorium on direct-to-consumer advertising and allowing Medicare to negotiate drug and biologic prices.
    • Representative tickers: (NASDAQ:IBB)(NASDAQ:AMGN)(NASDAQ:BIIB)(NASDAQ:GILD)(NASDAQ:CELG)(NYSE:BMY)(NYSE:ABT)(NYSE:MRK)(NYSE:PFE)(NASDAQ:MYL)(NYSE:VRX)(NASDAQ:TEVA)(NASDAQ:PRGO)(NYSE:AGN)
    | Fri, Sep. 2, 1:19 PM | 454 Comments
  • Fri, Sep. 2, 7:23 AM
    • Despite demonstrating efficacy in reducing vertebral fractures in a Phase 3 study, Merck (NYSE:MRK) pulls the plug on osteoporosis candidate odanacatib due to an unacceptable safety profile, specifically an increased risk of stroke. It made the decision based on the findings from an independent analysis of the cardiovascular events.
    • The company originally planned to file an NDA in the U.S. in 2015 despite the safety issues. Analysts projected peak sales of $1B by 2020.
    • The data will be presented at the American Society for Bone Mineral Research  Annual Meeting in Atlanta, GA, September 16 - 19.
    • Odanacatib inhibits an enzyme involved in bone resorption called cathepsin K.
    • Previously: Merck osteoporosis drug candidate successful in Phase 3 trial (Sept. 15, 2014)
    • Previously: Merck surprises some with its plan to seek marketing approval for two drugs despite safety concerns (May 6, 2014)
    | Fri, Sep. 2, 7:23 AM | 3 Comments
  • Mon, Aug. 29, 8:13 AM
    • Amgen (NASDAQ:AMGN) says new clinical data presented at the European Society of Cardiology Congress in Rome reinforce Repatha's (evolocumab) efficacy in lowering low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups and in those with familial (inherited) hypercholesterolemia (FH).
    • Researchers categorized 2,532 patients from three 12-week Phase 3 studies into four CV risk groups (very high, high, moderate, low). The analysis showed that treatment with Repatha (140 mg every two weeks or 420 mg once per month) reduced LDL-C levels and other lipids from baseline to the mean of Weeks 10 and 12 across all risk groups compared to placebo or ezetimibe [Merck's (NYSE:MRK) Zetia]. In the very high-risk group, for example, treatment with Repatha lowered LDL-C 65.2% more that placebo and 40.7% more than Zetia. The overall rates of adverse events for Repatha, Zetia and placebo were 43.1%, 50.5% and 40;8%, respectively.
    • In another presentation of pooled long-term data from open-label extension studies (OSLER-1, OSLER-2) in patients with heterozygous FH showed treatment with Repatha plus standard-of-care (SOC) therapy for 48 weeks lowered LDL-C 53.6% from baseline compared to 2.1% for SOC alone. The adverse event rate in patients treated with Repatha was 80% compared to 67% for SOC.
    • Despite bullish expectations of quickly supplanting statins, PCSK9 inhibitors Repatha and Sanofi/Regeneron's Praluent (alirocumab) have struggled to penetrate the market. Last quarter, Repatha and Praluent sales were only $27M and $24M, respectively.
    | Mon, Aug. 29, 8:13 AM | 3 Comments
  • Wed, Aug. 24, 3:08 PM
    • She's at it again. Democratic nominee for President Hillary Clinton takes a dim view of Mylan's (MYL -5.4%) bullish pricing for its EpiPen (epinephrine injection), an auto-injector used to treat allergic reactions in an emergency. The company has raised the price five-fold since 2007.
    • In a statement, she says, "Over the last several years Mylan Pharmaceuticals has increased the price of EpiPens by more than 400%. They're now charging up to $600 for a two-EpiPen set that must be replaced every 12 - 18 months. This both increases out-of-pocket costs for families and first responders and contributes to higher premiums for all Americans and their employers. This is outrageous - and it's just the latest troubling example of a company taking advantage of its customers. I believe our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases. But it's wrong when drug companies put profits ahead of patients, raising pricing without justifying the value behind them. I am calling on Mylan to immediately reduce the price of EpiPens."
    • Her comments have stoked selling in the biotech/pharma sector, just like it did when Ms. Clinton had Valeant Pharmaceuticals (VRX -1.3%) in her sights a few months ago.
    • Previously: Mylan slumps on senator's inquiry into EpiPen price hikes (Aug. 23)
    • Representative tickers: (IBB -2.6%)(AMGN -1.8%)(VRX -1.3%)(BIIB -2.5%)(PFE -0.6%)(BMY -1.9%)(MRK -1.2%)(GILD -1%)(AGN -3%)
    | Wed, Aug. 24, 3:08 PM | 752 Comments