Thu, May 28, 4:47 PM
- Merck (NYSE:MRK) submits a New Drug Application (NDA) to the FDA seeking approval for its single-tablet combination therapy of grazoprevir/elbasvir (100 mg/50 mg) for the treatment of adult patients with chronic hepatitis C genotypes 1,4 or 6 infection.
- The FDA has designated the combo a Breakthrough Therapy (BTD) for the treatment of patients with HCV-1 with end-stage renal disease and for patients with chronic HCV-4 infection. BTD status allows for more intensive guidance from the FDA, the involvement of more senior managers and a rolling review of the NDA.
- It plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency by the end of the year.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV)
Thu, May 28, 10:22 AM
- As expected, the European Commission approves privately-held Boehringer Ingelheim's single-pill Synjardy (empagliflozin/metformin hydrochloride) for glycemic control in adult type 2 diabetics. The product was developed under its alliance with Eli Lilly (LLY +0.3%).
- Diabetes-related tickers: (SNY -0.5%)(JNJ +0.1%)(OTCQB:ISLT)(OTCQB:BTHE)(VTAE -2.4%)(MRK +0.4%)(NVO -1.5%)(ABT +0.2%)(VKTX +1.4%)(HPTX)(OTCPK:TKPYY +0.3%)(ALR -0.4%)(MNKD -0.8%)(TNDM -1.6%)
- Previously: European Ad Comm recommends approval of combo pill for type 2 diabetes (March 30)
Thu, May 28, 9:52 AM
- Merck (MRK +0.3%) and NanoString Technologies (NSTG +1.4%) establish a clinical research collaboration to develop an assay that will optimize immune-related gene expression signatures and evaluate the potential to predict patient benefit from Keytruda (pembrolizumab), Merck's anti-PD-1 therapy for melanoma.
- The gene expression signatures will be optimized using NanoString's nCounter Analysis System.
- Merck Research Laboratories' Dr. Eric Rubin says, "Our commitment to advancing the science of immuno-oncology includes pursuing cutting edge RNA and DNA approaches to identify a range of biomarkers, such as immune-related gene expression signatures, that in addition to PD-L1 expression, may help to identify patients who may be more likely to experience improved benefit with Keytruda."
Wed, May 27, 7:30 AM
- A Phase 3 study, GIFT-1, evaluating AbbVie's (NYSE:ABBV) investigational, all-oral, interferon-free, ribavirin-free, two direct-acting (2-DAA) antiviral combination of ombitasvir/paritaprevir/ritonavir for the treatment patients with HCV-1b infection met its primary endpoint demonstrating a high cure rate.
- In a subgroup of treatment-naive, non-cirrhotic adult HCV-1b Japanese patients who were eligible for interferon therapy and had a high viral load, the cure rate was 95% (n=106/112) determined by sustained virologic response 12 weeks after the completion of therapy (SVR12). The cure rate in HCV-1b patients with compensated cirrhosis was 91% (n=38/42).
- In an intent-to-treat analysis, the cure rate was 98% (n=104/106) in HCV-1b patients without cirrhosis. This population included every patient that was randomized to placebo during the test period and then received at least one dose of 2-DAA combo in the open label stage.
- The data were presented at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.
- AbbVie's regulatory application for the 2-DAA candidate is currently under priority review by the Japanese Ministry of Health, Labour and Welfare.
- As many as 2M Japanese are infected with HCV. Up to 70% are infected with genotype 1. About 95% of the HCV-1s are sub-type 1b.
- Previously: AbbVie's 2-DAA HCV-1 candidate gets priority peview in Japan (April 16)
- Related tickers: (NASDAQ:GILD) (NYSE:MRK) (NASDAQ:ENTA)
Tue, May 26, 1:43 PM
Tue, May 26, 7:40 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Janssen's (NYSE:JNJ) Simponi (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA) who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
- Nr-axial SpA is a painful and potentially progressive condition that principally affects the spine and pelvic joints. It is characterized by chronic lower back pain and stiffness.
- Simponi, currently cleared for the treatment of moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and moderate-to-severe ulcerative colitis, is a human monoclonal antibody that binds to tumor necrosis factor (TNF)-alpha, a protein that is overproduced in chronic inflammatory diseases. Merck (NYSE:MRK) has the marketing rights in the EU.
Fri, May 22, 8:57 AM
- The European Medicines Agency has recommended approval for Merck's (NYSE:MRK) immune system-boosting cancer drug Keytruda (pembrolizumab), following a similar green light last month for Bristol-Myers Squibb's (NYSE:BMY) rival product Opdivo.
- Both Keytruda and Opdivo are already approved in the U.S.
- Previously: Merck files for new indication for Keytruda (Apr. 20 2015)
- Previously: Merck presents new data showing effectiveness of Keytruda (Apr. 20 2015)
Thu, May 21, 9:30 AM
- Alongside Goldman's list of 50 stocks appearing most as top holdings at hedge funds is its list of the 50 top shorts.
- New additions this quarter: Baxter Intl (NYSE:BAX), UPS, Marriott (NASDAQ:MAR), NextEra (NYSE:NEE), Ford (NYSE:F), National Oilwell Varco (NYSE:NOV), McDonald's (NYSE:MCD), M&T Bank (NYSE:MTB), CenturyLink (NYSE:CTL), Amgen (NASDAQ:AMGN), Pioneer Natural (NYSE:PXD), Duke Energy (NYSE:DUK), Seagate (NASDAQ:STX), AbbVie (NYSE:ABBV), Cisco (NASDAQ:CSCO).
- The full list (in order of $ value of short interest): AT&T (NYSE:T), Disney (NYSE:DIS), IBM, Verizon (NYSE:VZ), Intel (NASDAQ:INTC), Kinder Morgan (NYSE:KMI), Exxon (NYSE:XOM), Pfizer (NYSE:PFE), J&J (NYSE:JNJ), Deere (NYSE:DE), Caterpillar (NYSE:CAT), Exelon (NYSE:EXC), GE, Boeing (NYSE:BA), Halliburton (NYSE:HAL), Fox (NASDAQ:FOXA), Comcast (NASDAQ:CMCSA), UTX, Regeneron (NASDAQ:REGN), Merck (NYSE:MRK), salesforce.com (NYSE:CRM), AbbVie (ABBV), Conoco (NYSE:COP), Wal-Mart (NYSE:WMT), Eli Lilly (NYSE:LLY), Celgene (NASDAQ:CELG), Schlumberger (NYSE:SLB), AutoZone (NYSE:AZO), Wells Fargo (NYSE:WFC), Emerson (NYSE:EMR), McDonald's (MCD), Reynolds (NYSE:RAI), Target (NYSE:TGT), Accenture (NYSE:ACN), Coca-Cola (NYSE:KO).
Fri, May 15, 7:16 AM
- India's Supreme Court blocks Mumbai-based Glenmark Pharmaceuticals Ltd. from selling generic versions of Merck's (NYSE:MRK) diabetes drugs Januvia and Janumet, although Glenmark will be able to sell its existing inventory.
- Merck sued Glenmark in 2013 for infringing on a patent covering sitagliptin, the active ingredient in its two drugs.
Tue, May 12, 10:14 AM
- One consequence of the wind down of the Ebola outbreak in West Africa is that there is little chance that the vaccine trials going on there will show efficacy, according to the World Health Organization. Since the number of cases has dropped substantially, Liberia was declared Ebola-free on Saturday, Guinea reported seven cases last week while Sierra Leone reported only two, there may not be enough data to prove that people are actually protected.
- The FDA's Materials, Vaccines and Related Biological Products Advisory Committee is meeting today to discuss alternative approval paths for Ebola vaccines, considering situations like West Africa. One option for approval is the "animal rule" which grants licensure based on the results from animal studies that show the vaccine is reasonably likely to produce clinical benefit in humans.
- Previously: Ad Comm approaches for alternative development and licensure paths for Ebola vaccine candidates (May 8)
- Related tickers: (MRK -1.2%)(JNJ -0.5%)(GSK -1.2%)(NLNK -22.2%)(EBS -2.8%)
Fri, May 8, 11:33 AM
- The FDA's Materials, Vaccines and Related Biological Products Advisory Committee meets Tuesday, May 12 to discuss the benefits and risks of various development and approval paths for Ebola vaccines.
- The committee will discuss three: 1) traditional approval based on clinical endpoint efficacy data, 2) accelerated approval and 3) approval under the "animal rule."
- Traditional approval is unlikely to be recommended due to the inability and unethical aspect of comparing the vaccine candidates to placebo and the difficulty of recruiting a sufficient number of subjects due to the significant decline in Ebola infection rates.
- Under accelerated approval, a surrogate endpoint that is reasonably likely to predict clinical benefit (e.g., immune response) may serve as the basis for licensure. In this scenario, post-approval studies would be required to verify and describe the vaccine's clinical benefit.
- The "animal rule" may apply if traditional studies are unfeasible or unethical and accelerated approval cannot be used. In this scenario, approval would based on the results from animal studies that show the vaccine is reasonably likely to produce clinical benefit in humans, provided that safety in humans has been established. Post-approval studies would be required here as well.
- Briefing information
- Related tickers: (MRK +1.5%)(JNJ +1.8%)(GSK +3.2%)(NLNK +3.1%)(EBS -1.6%)
Thu, May 7, 11:13 AM
- Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
- Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
- The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
- Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
- Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
- Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
Wed, Apr. 29, 10:39 AM
- Phase 3 trials assessing Merck's (MRK +0.2%) combination antibiotic Zerbaxa (ceftolozane/tazobactam) for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) demonstrated effectiveness.
- In a 1,083-subject study in cUTI, patients were randomized to receive either intravenous (IV) Zerbaxa or high-dose IV levofloxacin for seven days. The study met its primary endpoint of statistical non-inferiority (no worse than) to levofloxacin.
- In a 993-subject study in cIAI, patients were randomized to receive either IV Zerbaxa plus metronidazole or IV meropenem for four to ten days. Treatment with Zerbaxa + metronidazole was shown to be effective but it is unclear whether the trial met its primary endpoint of statistical non-inferiority as measured by the clinical cure rate 24 - 32 days after the initiation of therapy.
- The FDA cleared Zerbaxa, developed by Cubist Pharmaceuticals, in December for the treatment of cUTI and cIAI infections. Merck acquired Cubist the same month. The marketing application in Europe is currently under review with a decision by the European Commission expected in H2.
Tue, Apr. 28, 12:53 PM
- In this morning's earnings call, Merck (MRK +5.2%) reported that the FDA has again declined to approve Bridion (sugammadex) as a reversal agent for muscle relaxants used in surgery, citing the need to see more data on potential allergic reactions to the product. The decision was no surprise. The company expected to receive a Complete Response Letter (CRL), its second regarding sugammadex, by April 22. It originally submitted the New Drug Application (NDA) in 2008.
- The product is sold in over 60 countries so the risk of allergic reactions appears to be manageable.
Tue, Apr. 28, 9:12 AM
Tue, Apr. 28, 7:52 AM
- Merck (NYSE:MRK) Q1 results ($M): Total Revenues: 9,425 (-8.2%); Pharmaceutical: 8.266 (-2.2%); Animal Health: 829 (+2.0%); Consumer Care: 2 (-99.6%); Other: 328 (-27.8%); Net Income: 953 (-44.9%); GAAP EPS: 0.33 (-42.1%).
- Key Product Sales: Januvia/Janumet: 1,393 (+4.4%); Zetia/Vytorin: 887 (-8.7%); Remicade: 501 (-17.1%); Isentress: 385 (-1.3%); Gardasil: 359 (-6.3%); Nasomex: 289 (-7.4%); Proquad, MMRII & Varivax: 348 (+24.3%); Singulair: 245 (-9.6%).
- 2015 Guidance: Revenues: $38.3B - 39.8B (unch); GAAP EPS: $1.58 - 1.85 from $1.62 - 1.91; Non-GAAP EPS: $3.35 - 3.48 from $3.32 - 3.47.
- Shares are up 5% premarket on light volume.
MRK vs. ETF Alternatives
Other News & PR