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.
Tue, Apr. 28, 7:02 AM
Mon, Apr. 27, 7:35 PM
- Results from a 14,724-patient CV risk study, TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin), showed Merck's (NYSE:MRK) Januvia (sitagliptin) was no worse than (non-inferior) placebo in cardiovascular (CV) risk as measured by the composite CV endpoint. The composite CV endpoint was defined as the composite of time to the first of any of the following confirmed events: CV-related death, nonfatal myocardial infarction, nonfatal stroke or unstable angina requiring hospitalization. The mean followup period was ~three years.
- Also, there was no increase in hospitalization for heart failure in the sitagliptin cohort versus placebo.
- The complete results will be presented on June 8 at the 75th Scientific Sessions of the American Diabetes Association.
- Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Mon, Apr. 27, 5:40 PM
Mon, Apr. 27, 5:30 PM
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Mon, Apr. 27, 4:34 PM
Mon, Apr. 27, 3:30 PM
- Two Phase 3 clinical trials evaluating Tetraphase Pharmaceuticals' (TTPH -5.1%) lead product candidate, eravacycline, show positive results for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
- The first study, IGNITE-1, compared eravacycline to Merck's (MRK -1.1%) Invanz (ertapenem) for the treatment of cIAI. It achieved the primary endpoint of statistical non-inferiority (no worse than) of clinical response at the test-of-cure (TOC) visit. In the microbiological intent-to-treat (micro-ITT) population (n=446) 86.8% of patients receiving eravacycline achieved a clinical cure compared to 87.6% of patients receiving ertapenem (FDA criteria). In the clinically evaluable population (n=477) 92.9% of patients receiving eravacycline achieved a clinical cure versus 94.5% of patients receiving ertapenem (EMA criteria). These results were first reported in December.
- In the lead-in portion of the second study, IGNITE-2, both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg followed by 200 mg or 250 mg) compared favorably with levofloxacin, a broad spectrum antibiotic, for the treatment of cUTI. The primary endpoint, per the FDA's criteria, was the responder rate (defined as both clinical cure and successful microbiological outcome) in the micro-ITT population. The responder rates for 200 mg (n=24), 250 mg (n=28) and levofloxacin (n=23) were 75.0%, 64.3% and 56.4%, respectively. In the microbiologically evaluable population, the primary endpoint was the microbiological response per the EMA's criteria. The respective responses for levofloxacin isolates (n=24) were: 83.3%, 72.7% and 42.9%. Based on these data, the 200 mg dose will be used for the pivotal portion of the Phase 3 that is currently underway.
- The company expects to submit its regulatory applications by the end of the year.
- The data were presented at this week's 25th European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, Denmark.
- Previously: Tetraphase antibiotic non-inferior to ertapenem in Phase 3 study (Dec. 17, 2014)
Sat, Apr. 25, 7:05 PM
- Merck (NYSE:MRK) announces the presentation of results from two Phase 2 studies of its investigational HCV combination therapy, grazoprevir/elbasvir (G/E).
- The first trial, C-SALVAGE, assessed 12 weeks of G/E therapy plus ribavirin (RBV) in HCV-1 patients who previously failed treatment with peginterferon and RBV combined with a direct-acting antiviral (DAA) (boceprevir, simeprevir or telaprevir). 34 patients (43%) of the 79 who received at least one dose of G/E were cirrhotic. The overall cure rate (sustained virologic response 12 weeks after treatment or SVR12) was 96% (n=76/79). The cure rate in patients with compensated cirrhosis was 94% (n=32/34). Three patients relapsed after the completion of therapy. All three had resistance-associated variants at baseline.
- The second trial, C-SWIFT, was a proof-of-concept study assessing G/E + Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) over shorter treatment durations in treatment-naive HCV-1 and HCV-3 patients with or without cirrhosis. The cure rates (SVR12) were: HCV-1 non-cirrhotic/4 weeks: 33% (n=10/30); HCV-1 non-cirrhotic/6 weeks: 87% (n=26/30); HCV-1 cirrhotic/6 weeks: 80% (n=16/20); HCV-1 cirrhotic/8 weeks: 94% (n=17/18); HCV-3 non-cirrhotic/8 weeks: 93% (n=14/15); HCV-3 cirrhotic/8 weeks: 100% (n=14/14); HCV-3 cirrhotic/12 weeks: 91% (n=10/11).
- The data were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
Sat, Apr. 25, 5:48 PM
- Preliminary data from a Phase 3 study, RUBY-1, evaluating AbbVie's (NYSE:ABBV) Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir), with or without ribavirin, for 12 or 24 weeks in treatment-naive, non-cirrhotic HCV-1 patients with severe renal impairment (stage 4 or 5), including those on hemodialysis, showed a 100% SVR4 rate (n=10/10) (sustained virologic response four weeks after treatment). Enrollment is 20 patients, but only half had reached week 4 post treatment at the data cutoff.
- The primary endpoint of the trial is the percentage of patients achieving SVR12. Cohort 1 consists of 20 patients without cirrhosis while cohort 2 has 20 patients with or without compensated cirrhosis.
- The data were presented at the 50th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY)
Fri, Apr. 24, 9:05 AM
- At the Liver Meeting in Europe, Merck (NYSE:MRK) presented data from its ongoing C-EDGE pivotal Phase 3 study evaluating its HCV combination of grazoprevir/elbasvir (100mg/50mg) in patients with genotypes 1, 4 or 6.
- Overall, treatment-naive patients treated with the combo for 12 weeks without ribavirin (RBV) showed a cure rate (sustained virologic response 12 weeks after therapy or SVR12) of 95% (n=299/316). Treatment-naive patients co-infected with HIV treated for 12 weeks, without RBV, also showed a cure rate of 95% (n=207/218).
- Treatment-experienced HCV patients treated with the combo, with and without RBV showed cure rates of 94% (n=98/104) and 92% (n=97/105), respectively. Treatment-experienced HCV patients treated for 16 weeks, with and without RBV, showed cure rates of 97% (n=103/106) and 92% (n=07/105), respectively.
- Cure rates in cirrhotic patients ranged from 89 - 100%; non-cirrhotic: 93 - 97%; genotype 1a: 90 - 95%; genotype 1b or other g-1: 96 - 100%; genotype 4: 60 - 100% and genotype 6: 75 - 100%.
- The results were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY)
Thu, Apr. 23, 11:55 AM
- An interim analysis of a Phase 2/3 trial, C-SURFER, evaluating Merck's (MRK -0.1%) investigational once-daily regimen of grazoprevir and elbasvir in patients with advanced kidney disease infected with the HCV-1 virus showed a 99% (n=115/116) cure rate (SVR12) after 12 weeks of treatment.
- The data will be presented at this week's 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Grazoprevir is an NS3/4A protease inhibitor and elbasvir is an NS5A complex inhibitor. Several weeks ago, the FDA designated the combo a Breakthrough Therapy for the treatment of HCV-1 in patients with end-stage renal disease on hemodialysis and patients with chronic HCV-4 infection.
- Breakthrough Therapy status provides for more intensive FDA guidance on development, the involvement of more senior managers and a rolling review of the New Drug Application (NDA).
- Previously: Merck HCV combo med tagged a Breakthrough Therapy for HCV-4 and HCV-1 dialysis patients (April 8)
- Related tickers: (GILD +0.4%)(ABBV -1.6%)
Wed, Apr. 22, 8:50 AM| 14 Comments
Mon, Apr. 20, 12:04 PM
- Merck (MRK +1.9%) submits its supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer whose disease has progressed on or after platinum-based chemo and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The submission was based on data from the KEYNOTE-001 study.
- Keytruda is currently cleared for the treatment of melanoma.
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