Merck & Co Inc. (MRK) - NYSE
  • 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
  • Tue, Mar. 8, 9:37 AM
    • Sanofi Pasteur (SNY +0.2%) and Merck (MRK -0.3%) will terminate their 50/50 joint venture, established in 1994, developing and commercializing vaccines in Europe. Once the JV is dissolved, expected by year-end, the companies will integrate their respective vaccine businesses into their own operations.
    • In a joint statement, the companies explain their rationale: "After carefully considering our individual strategic priorities, alongside the economic and regulatory environments for vaccine operations in the [EU], we have mutually agreed that it is in our best interests to manage our vaccine product portfolios independently. We believe that focusing our efforts on opportunities unique to our respective companies will better position us to drive growth, execute in a more efficient manner and optimize vaccine coverage."
    | Tue, Mar. 8, 9:37 AM
  • Tue, Mar. 8, 9:13 AM
    • Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
    • The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
    • Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
    • BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
    • Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
    • Update: Shares up 26% in early trading.
    | Tue, Mar. 8, 9:13 AM | 8 Comments
  • Mon, Mar. 7, 10:38 AM
    • The FDA accepts for review Merck's (MRK +0.3%) supplemental New Drug Application (sNDA) seeking clearance for an expanded label for cancer med KEYTRUDA (pembrolizumab), specifically, the inclusion of data from the KEYNOTE-010 study which showed a survival benefit in non-small cell lung cancer patients with PD-L1 expression on 1% or more of cancer cells.
    • KEYTRUDA's original NSCLC indication was approved based tumor response rate and durability of response in patients with PD-LI expression on 50% or more of cancer cells.
    • Per the accelerated approval process, KEYNOTE-010 is the confirmatory trial for receiving full approval.
    • Previously: Top-line data show treatment effect of Merck's KEYTRUDA in advanced lung cancer (Oct. 26, 2015)
    | Mon, Mar. 7, 10:38 AM | 3 Comments
  • Wed, Feb. 24, 1:40 PM
    • ViiV Healthcare, the HIV-focused joint venture between GlaxoSmithKline (GSK -1.1%), Pfizer (PFE -0.5%) and Shionogi Limited (OTC:SGIOF)(OTCPK:SGIOY), announces the results from a 41-week Phase 2a study, ECLAIR, assessing the safety, tolerability, dosing and satisfaction with long-acting, injectable cabotegravir as monotherapy for the prevention of HIV infection in adult males not at high risk of acquiring HIV. The data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
    • ECLAIR randomized 127 HIV-negative subjects 5:1 to cabotegravir or placebo beginning with a safety assessment on oral cabotegravir 30 mg or placebo tablet for four weeks followed by an intramuscular injection of 800 mg cabotegravir or placebo (sterile saline) every 12 weeks for three cycles.
    • The proportions of participants who completed three injections for cabotegravir and placebo were 93% (n=87/94) and 95% (n=20/21), respectively. The incidences of Grade 2 (moderate) to Grade 4 (life-threatening or disabling) adverse events during the injection phase were 80% (n=75/94) and 48% (n=10/21), respectively. The most common Grade 2-4 AE was injection site pain (59% and 5%, respectively). The incidences of all grades of adverse events during the injection phase were 98% (n=92/94) and 90% (n=19/21), respectively.
    • Following repeat injections, 74% (n=67/91) favored long-acting cabotegravir over the oral version.
    • ViiV intends to advance cabotegravir to Phase 3 development later this year.
    | Wed, Feb. 24, 1:40 PM | 14 Comments
  • Wed, Feb. 24, 7:11 AM
    • Waltham, MA-based Syndax Pharmaceuticals (Pending:SNDX) is set for its IPO of 4.4M shares of common stock at $14 - 16.
    • The clinical stage biopharmaceutical firm is developing a small molecule drug called entinostat as a combination therapy for the treatment of a range of cancers. Entinostat inhibits a class of enzymes called histone deacetylases (HDACs), which plays a key role in controlling cell survival, proliferation, angiogenesis and immunity. The company is initially focusing on tumors that show sensitivity to immunotherapy, including lung cancer, melanoma, ovarian cancer and triple negative breast cancer (TNBC).
    • Entinostat is currently being evaluated with Merck's (NYSE:MRK) Keytruda (pembrolizumab) in a Phase 1b/2 study in non-small cell lung cancer and melanoma. Another Phase 1b/2 trial should commence in H1 assessing entinostat with Roche's (OTCQX:RHHBY) atezolizumab (MPDL3280A) in TNBC. A third Phase 1b/2 study should commence in H2 evaluating entinostat with Pfizer's (NYSE:PFE) avelumab in ovarian cancer.
    • 2015 Financials ($M): Operating Expenses: 21.1 (-1.0%); Net Loss: (24.1) (-21.7%); Cash Burn: (2.4) (+83.3%); Cash: 86.5; Pro Forma Cash: 146.3.
    | Wed, Feb. 24, 7:11 AM | 2 Comments
  • Tue, Feb. 23, 1:32 PM
    • Merck (NYSE:MRK) declares $0.46/share quarterly dividend, in line with previous.
    • Forward yield 3.63%
    • Payable April 7; for shareholders of record March 15; ex-div March 11.
    | Tue, Feb. 23, 1:32 PM | 1 Comment
  • Mon, Feb. 22, 1:53 PM
    • Results from a 159-subject Phase 3 clinical trial assessing Bristol-Myers Squibb's (BMY) all-oral HCV regimen, daclatasvir (Daklinza) combined with asunaprevir, in Asian patients positive for genotype 1b showed cure rates as high as 99%. The data were presented today at the Asian Pacific Association for the Study of the Liver Conference in Tokyo.
    • The trial was an open-label design that evaluated daclatasvir 60 mg once daily and asunaprevir 100 mg twice daily for 24 weeks. 80% of patients (n=127) were from mainland China, 11% (n=17) from Korea and 9% (n=14) from Taiwan.
    • Cure rates, defined as sustained virologic response at week 24 (SVR24), were 91% among all Chinese patients and 98% in those without NS5A resistance-associated variants (RAVs) at baseline. SVR24 rates were high among HCV-1b subgroups including those with cirrhosis (90%), Koreans (94%) and Taiwanese (87%). Japanese patients were not part of the study.
    • In all patients, the SVR24 rate was 99% (n=137/139) in those without NS5A RAVs, regardless of the presence (98%) or absence (99%) of cirrhosis, and 42% (n=8/19) in those with baseline NS5A RAVs.
    • The daclatasvir/asunaprevir regimen is currently cleared in Japan, Korea, Taiwan and certain countries in Latin America and Eastern Europe. More than 13M Chinese are HCV-positive so approval there is a priority for the company.
    • Related tickers: (GILD +2.2%)(ABBV +0.7%)(MRK +0.8%)(JNJ +0.5%)
    | Mon, Feb. 22, 1:53 PM | 48 Comments
  • Mon, Feb. 22, 9:54 AM
    • A Phase 3 clinical trial assessing a once-daily formulation (two 600 mg tablets taken at the same time) of Merck's (MRK +0.6%) HIV-1 drug ISENTRESS (raltegravir) met its primary endpoint of demonstrating non-inferiority (no worse than) to the twice-daily version (400 mg tablets), each in combination with Gilead Sciences' (GILD +1.7%) TRUVADA (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
    • Non-inferiority was measured by the proportion of patients achieving HIV-1 RNA of less than 40 copies/mL at Week 48. Tolerability and immunologic efficacy (change in CD4 cell counts from baseline to Week 48) were also comparable.
    • The company intends to present the data at an upcoming scientific conference. Regulatory applications will be filed as soon as feasible.
    | Mon, Feb. 22, 9:54 AM | 8 Comments
  • Wed, Feb. 17, 8:55 AM
    • Micro cap Regulus Therapeutics (NASDAQ:RGLS) is up 43% premarket on robust volume in response to its announcement of positive interim results from a Phase 2 clinical trial assessing RG-101, in combination with other antivirals, in patients with chronic hepatitis C virus (HCV) infection.
    • The study was designed to evaluate a four-week treatment regimen of 2 mg/kg of RG-101 at Day 1 and Day 29, in addition to four weeks of once/daily Harvoni (ledipasvir/sofosbuvir), Olysio (simeprevir) or Daklinza (daclatasvir). Seventy-nine HCV-1 and HCV-4 patients are enrolled, while 38 have been evaluated through eight weeks of follow up. Of these, 97% (n=37/38) had HCV RNA viral loads below the limit of quantification (SVR12). For those assessed through 12 weeks of follow up, 100% (n=14/14) remained below the level of detection.
    • The primary endpoint analysis (12 week follow up) for all 79 subjects should be available in late Q2.
    • RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
    | Wed, Feb. 17, 8:55 AM | 65 Comments
  • Tue, Feb. 16, 6:48 AM
    • As expected, Merck (NYSE:MRK) receives a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for cholesterol drugs ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin) seeking approval for the claim of reducing cardiovascular events in patients with coronary heart disease. The applications were based on the Phase 3 IMPROVE-IT study which showed a modest 6.4% risk reduction in patients treated with ezetimibe compared to simvastatin alone.
    • A cardiovascular event is defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or need for revascularization).
    • In December, the FDA's advisory committee voted 10 - 5 against approval. A CRL means that the application is not approvable in its present form.
    • Previously: Ad Comm thumbs down on expanded label for Merck's Zetia (Dec. 15, 2015)
    | Tue, Feb. 16, 6:48 AM | 1 Comment
  • Thu, Feb. 11, 8:11 AM
    • The FDA approves Lannett Company's (NYSE:LCI) temozolomide capsules, its generic equivalent to Merck's (NYSE:MRK) chemo drug Temodar Capsules. According to IMS, annual U.S. sales of the branded product are ~$206M wholesale.
    | Thu, Feb. 11, 8:11 AM | 8 Comments
  • Thu, Feb. 11, 7:21 AM
    • Incyte (NASDAQ:INCY) terminates its Phase 3 clinical trial assessing Jakafi (ruxolitinib), in combination with chemo agent capecitabine, for the second-line treatment of advanced or metastatic pancreatic cancer after an interim analysis failed to show sufficient efficacy.
    • Based on these data and the interim analysis of the Phase 2 sub-study of Jakafi, in combination with Bayer's (OTCPK:BAYRY) STIVARGA (regorafenib), in patients with metastatic colorectal cancer and high C-reactive protein (CRP), the company will stop all Jakafi studies in solid tumors, including Phase 2 trials in breast and lung cancer. It will also discontinue its dose-finding study of INCB39110 ( a selective JAK1 inhibitor) as first-line treatment for pancreatic cancer.
    • Data from all the discontinued trials will be analyzed and shared with the scientific community over the next few months.
    • Ongoing studies of Jakafi and selective JAK1 inhibitors in hematology will continue as will those assessing selective JAK1 inhibition in solid tumors based on different hypotheses. These include a series of studies evaluating INCB39110 in combination with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) and Incyte's epacadostat and INCB50465. A Phase 1/2 trial will also be conducted assessing INCB39110 plus AstraZeneca's (NYSE:AZN) TAGRISSO (osimertinib).
    • Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
    • Shares are off 10% premarket on light volume.
    | Thu, Feb. 11, 7:21 AM
  • Thu, Feb. 4, 11:01 AM
    • ImmunoGen (IMGN +9.7%) establishes a clinical research collaboration with Merck (MRK -1.4%) to evaluate the combination of IMGN's mirvetuximab soravtansine and Keytruda (pembrolizumab) for the treatment of patients with folate receptor (FR) alpha-positive ovarian cancer. The combination therapy will be added to IMGN's Phase 1b/2 clinical trial called FORWARD II. The agreement, through a Merck subsidiary, includes an option to expand the collaboration to include a Phase 3 study if the results are positive.
    • Mirventuximab soravtansine is an antibody-drug conjugate (ADC) that contains a monoclonal antibody (mirventuximab) that binds to FRalpha-positive tumor cells thereby delivering its cytotoxic payload, soravtansine or DM4.
    • 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.
    | Thu, Feb. 4, 11:01 AM
  • Thu, Feb. 4, 9:50 AM
    • The FDA approves Merck's (MRK -1.9%) supplemental New Drug Application (sNDA) for single-dose EMEND (fosaprepitant dimeglumine) for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving moderately emetogenic chemotherapy. It is the first intravenous single-dose NK1 receptor antagonist approved in the U.S.
    • A one-to-three-day IV formulation was cleared in February 2008.
    | Thu, Feb. 4, 9:50 AM | 2 Comments
  • Wed, Feb. 3, 7:10 AM
    • Merck (NYSE:MRK) Q4 results ($M): Total Revenues: 10,215 (-2.5%); Pharmaceutical: 9,027 (-3.7%); Animal Health: 830 (-6.2%).
    • Net Income: 976 (-86.7%); EPS: 0.35 (-86.2%); Non-GAAP EPS: 0.93 (+6.9%).
    • Key Product Sales: Januvia: 921 (-14.9%); Zetia: 691 (+4.4%); Gardisil: 497 (+39.6%); Janumet: 526 (-7.7%); Remicade: 396 (-28.9%); Isentress: 374 (-10.5%); Keytruda: 214 (+328%); Cubicin: 322 (+999%); Vytorin: 308 (-16.8%).
    • 2016 Guidance: Revenues: $38.7B - 40.2B; EPS: $1.96 - 2.23; Non-GAAP EPS: $3.60 - 3.75.
    • Shares are off a fraction premarket.
    | Wed, Feb. 3, 7:10 AM | 1 Comment
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