Fri, Jul. 31, 8:47 AM
- An interim analysis of data from a Phase 3 ring vaccination trial in Guinea shows Merck's (NYSE:MRK) Ebola vaccine candidate, rVSV-ZEBOV, was 100% effective in protecting people from Ebola virus infection within six to 10 days of vaccination (p=0.0036). The preliminary conclusions will be published online today in The Lancet.
- Over 4,000 people have received the vaccine to date. Merck licensed rVSV-ZEBOV from NewLink Genetics (NASDAQ:NLNK) who licensed it from the Public Health Agency of Canada.
- The make the vaccine, a virus similar to the rabies virus called vesicular stomatitis virus is weakened by removing one of its genes which is then replaced with a single Ebola virus gene that, by itself, cannot cause disease.
- Two other trials assessing rVSV-ZEBOV are ongoing: a Phase 3 study, called STRIVE, in Sierra Leone and a Phase 2, called PREVAIL, in Liberia.
- MRK is up a fraction premarket. NLNK is up 9% on light volume.
Thu, Jul. 30, 1:37 PM
- Unsurprisingly, Express Scripts (ESRX -0.6%) takes a dim view of the proposed price of the cholesterol-lowering PCSK9 inhibitor Praluent (alirocumab). Last Friday, co-developers Sanofi (SNY +1.6%) and Regeneron Pharmaceuticals (REGN +0.4%) announced that the wholesale acquisition cost (WAC) of the once-every-two-week injection will be $40 per day or $14,600 per year. This is several orders of magnitude above the cost of statins, which average $2 - 3 per day.
- WAC is the average price that wholesalers and distributors pay for the drug. Patients will, of course, pay quite a bit more.
- Pharmacy benefit managers, still feeling the pinch from Gilead's (GILD +1.8%) HCV meds Sovaldi and Harvoni, will likely ratchet up their opposition as Praluent's U.S. launch commences.
- Related tickers: (AET +0.9%)(CTRX)(CNC +0.9%)(CI -0.7%)(HUM)(MRK +0.3%)(OCR +0.4%)(UNH -0.7%)(CVS -0.5%)
Thu, Jul. 30, 9:52 AM
- Tesaro (TSRO -3.8%) secures an exclusive license agreement with China-based Jiangsu Hengrui Medicine Co. for the development, registration, manufacture and commercialization of rolapitant in China. Specific financial terms are not disclosed.
- Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist under development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The company's NDA is currently under FDA review with a PDUFA date of September 5.
- CINV-related tickers: (GALE -1.8%)(HRTX -2.2%)(MRK -0.1%)(RDHL -0.1%) (OTC:ESALF) (OTCPK:ESALY) (OPK -1.3%)(INSY -2.3%)(GWPH -2.1%)
Tue, Jul. 28, 8:45 PM
- The FDA accepts for review the New Drug Application (NDA) from Merck (NYSE:MRK) for its once-daily single tablet combination of grazoprevir/elbasvir for the treatment of adult patients with chronic HCV genotypes 1, 4 or 6 infection. The agency will review the application under its Priority Review protocol. The PDUFA date is January 28, 2016.
- The FDA has designated grazoprevir/elbasvir a Breakthrough Therapy for the treatment of patients with HCV-1 with end stage renal disease and for the treatment of HCV-4. The designation provides for more intensive guidance from the agency, the involvement of more senior personnel and a rolling review of the NDA.
- Five days ago, the European Medicines Agency accepted the company's Marketing Authorization Application (MAA) under accelerated review for the treatment of HCV-1, 3, 4 or 6 infection.
- Related tickers: (NYSE:BMY) (NASDAQ:GILD) (NYSE:ABBV)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Tue, Jul. 28, 7:53 AM
- Merck (NYSE:MRK) Q2 results ($M): Total Revenues: 9,785 (-10.5%); Pharmaceutical: 8,564 (-5.8%); Animal Health: 840 (-3.7%); Other: 381 (-2.8%).
- Net Income: 688 (-66.2%); EPS: 0.24 (-64.7%).
- Key Product Sales: Januvia: 1,044 (-1.3%); Zetia: 635 (-11.4%); Janumet: 554 (+6.7%); Remicade: 455 (-25.0%); Gardisil: 427 (+4.4%); Isentress: 375 (-17.2%); Proquad, MMRII & Varivax: 358 (+9.8%); Vytorin: 320 (-23.3%); Cubicin: 293 (+999%); Nasomex: 215 (-16.7%); Singulair: 212 (-25.4%); Keytruda: 110.
- 2015 Guidance: EPS: $1.52 - 1.71 from $1.58 - 1.85; Non-GAAP EPS: $3.45 - 3.55 from $3.35 - 3.48.
Tue, Jul. 28, 7:12 AM
Mon, Jul. 27, 5:30 PM
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Mon, Jul. 27, 1:11 PM
Mon, Jul. 27, 12:51 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Merck's (MRK -1.2%) ZERBAXA (ceftolozane/tazobactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), acute pyelonephritis (kidney infection) or complicated urinary tract infections (cUTI).
- ZERBAXA, intravenously administered, is a combination of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.
- A final decision by the European Commission usually takes ~60 days.
- ZERBAXA is cleared in the U.S. for the treatment of cUTI and cIAI (in combination with metrodinazole).
Fri, Jul. 24, 12:05 PM
- The FDA approves AbbVie's (ABBV -3%) Technivie (ombitasvir, paritaprevir, ritonavir), in combination with ribavirin, for the treatment of HCV genotype 4 infection in patients with poor liver function (cirrhosis) without scarring (fibrosis). Technivie is the first approved treatment for HCV-4 that does not require the use of interferon.
- About 3M Americans are chronically infected with HCV. Genotype 4 is the least common, representing ~1% of the total.
- Related tickers: (GILD -2.7%)(MRK -0.9%)
Thu, Jul. 23, 12:30 PM
- The European Medicines Agency (EMA) accepts for review Merck's (MRK -0.3%) Marketing Authorization Application (MAA) for its once-daily, single tablet formulation of grazoprevir 100mg/elbasvir 50 mg for the treatment of adult patients with hepatitis C genotype 1,3,4 or 6 infection. The EMA will review the application under its accelerated protocol.
- The company submitted a New Drug Application (NDA) to the FDA for HCV-1,4 or 6 in May of this year. In April, the agency designated grazoprevir/elbasvir a Breakthrough Therapy for HCV-1-infected patients with end stage renal disease and for HCV-4 infection.
- Related tickers: (GILD +0.1%)(ABBV -0.4%)
Wed, Jul. 22, 1:32 PM
Wed, Jul. 22, 10:28 AM
- As expected, the European Commission approves Merck's (MRK -0.6%) Keytruda (pembrolizumab) for the treatment of adult patients with advanced (unresectable or metastatic) melanoma.
- Pembrolizumab is PD-1-inhibiting monoclonal antibody. PD-1 (programmed cell death 1) is a protein found on the surface of T cells and pro-B cells that plays a key role in down-regulating the immune system. Binding to PD-1 enables the immune system to more effectively recognize and kill cancer cells.
- The FDA approved Keytruda for the treatment of melanoma in September 2014.
Tue, Jul. 7, 7:52 AM
- Allergan (NYSE:AGN) acquires the worldwide rights to Merck's (NYSE:MRK) investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor agonists which are under development for the treatment and prevention of migraine.
- Under the terms of the agreement, Allergan will pay Merck an upfront fee of $250M, half when the deal clears antitrust review and half in April 2016. Merck will be eligible for development and commercial milestones and tiered double-digit royalties. Allergan will be responsible for the full development costs of the CGRP programs as well as manufacturing and commercialization.
- Specifically, Allergan obtains the rights to two CGRP receptor agonists:
- MK-1602, for the acute treatment of migraine. A Phase 2 study was just completed. After discussing the results with the FDA, a Phase 3 trial should begin in 2016.
- MK-8031, for the prevention of migraine. A Phase 2 trial is expected to commence in 2016.
- In July 2011, Merck discontinued development of an earlier oral CGRP antagonist, Telcagepant (MK-0974), due to potential liver toxicity. MK-1602 and MK-8031 belong to a different chemical series than Telcagepant and have shown no evidence of liver toxicity.
- Migraines affect ~36M Americans.
Wed, Jul. 1, 11:30 AM
- Galectin Therapeutics (GALT -0.7%) announces the screening of the first five patients in its Phase 2 study, called NASH-CX, evaluating GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). The randomized, placebo-controlled study will enroll 156 patients who will receive either one of two doses of GR-MD-02 (2 mg/kg or 8 mg/kg) or placebo. Final data collection is expected in October 2017. The study completion date is February 2018.
- The primary endpoint is the reduction in hepatic portal vein pressure versus placebo as measured by the hepatic venous pressure gradient (HVPG).
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The FDA designated it for Fast Track review for the treatment of NASH in August 2013.
- NASH is one of the "next big things" for drug makers. It affects as many as 5% of Americans.
- Related tickers: (TBRA +1.7%)(ICPT -1%)(DRRX +0.4%)(MNOV +1.9%)(GLMD)(RGLS -6.3%)(AZN +1.2%)(OTCPK:GNFTF)(CNAT +4.3%)(VBLT +0.2%)(RPTP +2.7%)(LJPC +10.4%)(MRK +1.3%)(SHPG +1.4%)(OTCQB:ISLT)(GILD -0.4%)
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