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merck & co. inc. (MRK) Key Developments

Merck Announces Increased Quarterly Dividend, Payable on Jan. 8, 2015

Merck announced that the Board of Directors has increased the company's quarterly dividend to $0.45 per outstanding share of the company's common stock, up $0.01 from $0.44 per outstanding share paid last quarter. Payment will be made on Jan. 8, 2015, to stockholders of record at the close of business on Dec. 15, 2014.

Merck and BioProtection Systems Sign Ebola Vaccine Licensing Deal

Merck & Co. has entered a partnership with a small company to research and manufacture a potential Ebola vaccine now in initial patient testing. The exclusive deal involves a vaccine candidate called rVSV-EBOV that's under early development by BioProtection Systems. Under the new deal, Merck gets exclusive rights to the vaccine and any follow-up products.

Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin

Merck announced that the company has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The new drug application for omarigliptin is based on a comprehensive clinical development program in Japan. The results from the first Phase 3 study of omarigliptin, conducted in Japan, were presented recently at the 50(th) European Association for the Study of Diabetes (EASD) Annual Meeting.

Merck & Co. Inc. Announces Positive Data from Phase II Melanoma Analysis

Merck & Co. Inc. has announced that a pre-specified analysis of investigational data from a pivotal Phase II study, or KEYNOTE-002, showed KEYTRUDA, its anti-PD-1 therapy, substantially improved the primary endpoint of progression-free survival, or PFS, compared to chemotherapy in patients with ipilimumab-refractory advanced melanoma. At six months, the PFS rates for KEYTRUDA were 34% at the 2 mg/kg dose (95% CI, 27-41) (n=180) and 38% at the 10 mg/kg dose (95% CI, 31-45) (n=181), compared to 16% for chemotherapy (95% CI, 10-22) (n=179). The median duration of follow-up at the interim analysis was 10 months. KEYTRUDA is indicated in the US at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. For the pre-specified analysis of PFS, no significant differences were observed between KEYTRUDA doses (HR 0.91, range 0.71-1.16) (P<0.44). An assessment of PFS by investigator review was shown to be consistent with the central review findings. In addition, the PFS effect in favor of KEYTRUDA was consistent across all pre-specified sub-groups. The objective of the pre-specified analysis was to evaluate the superiority of either dose of KEYTRUDA over chemotherapy for PFS (conducted after greater than or equal to A 270 PFS events at a 0.25% significance level) (one-sided) (estimated HR, 0.66). The study was designed with co-primary endpoints of PFS and overall survival. Overall response rates (confirmed) for KEYTRUDA were five to six times higher compared to chemotherapy. For KEYTRUDA, ORR was 21% at 2 mg/kg dose (95% CI, 15-28) and 25% at 10 mg/kg dose (95% CI, 19-32), compared to 4% for chemotherapy (95% CI, 2-9) (P<0.0001 for both comparisons). At the time of pre-specified analysis, the median duration of response for KEYTRUDA was not reached, and confirmed responses were ongoing in 92% of patients receiving 2 mg/kg dose (range 6+ to 50+) and 87% receiving 10 mg/kg dose (range 5+ to 48+), respectively. The median duration of response was 37 weeks for chemotherapy arm and 63% of responses were ongoing (range 7+ to 41). There was no significant difference in ORR or duration of response between the doses of KEYTRUDA (P=0.21). In a pre-specified exploratory analysis for HRQoL, patients treated with KEYTRUDA reported a significantly smaller decrement in health status/quality of life score compared to those treated with chemotherapy (based on European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire or EORTC QLQ-C30). The mean change from baseline at week 12 (difference in least squares) for KEYTRUDA compared to chemotherapy was 6.52 (P=0.011) at 2 mg/kg dose and 6.57 (p=0.009) at 10 mg/kg dose, respectively. The incidence of adverse events was consistent with previously reported data for KEYTRUDA. Despite longer median treatment duration, the incidence of treatment-related, grade 3-5 adverse events was lower with KEYTRUDA at 2 mg/kg dose (11%) and at 10 mg/kg dose (14%) compared to chemotherapy (26%). Serious treatment-related adverse events were observed for KEYTRUDA at 2 mg/kg dose (8%) and 10 mg/kg dose (11%), and for chemotherapy (10%). Immune-related grade 3 adverse events observed for KEYTRUDA across doses included hepatitis (n=3), colitis (n=2), pneumonitis (n=3), hypophysitis (n=1) and iritis or uveitis (n=1). No grade 4/5 immune-related adverse events were reported. 3% of patients receiving KEYTRUDA at 2 mg/kg dose and 7% at the 10 mg/kg dose, as well as 6% receiving chemotherapy discontinued treatment due to investigator assessed, treatment-related adverse events. One treatment-related death was reported for KEYTRUDA and none in the chemotherapy arm. KEYNOTE-002 is a global, randomized pivotal Phase II study (n=540) evaluating KEYTRUDA at doses of 2 mg/kg every three weeks (n=180) and 10mg/kg every three weeks (n=181) compared to investigator's choice chemotherapy (n=179) (paclitaxel plus carboplatin, paclitaxel, carboplatin, dacarbazine, or temozolomide) in patients with ipilimumab-refractory advanced melanoma. In the study, 83% of patients had the most advanced stage of disease (M1c) and 73% of patients had received at least two prior systemic therapies including ipilimumab. The co-primary endpoints were PFS and OS; secondary endpoints were ORR, duration of response and safety; and HRQoL as a pre-specified exploratory endpoint. Tumor response was assessed at week 12, then every 6 weeks through week 48, followed by every 12 weeks thereafter by independent, central, blinded radiographic review per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors). Patients on chemotherapy with progressive disease as assessed by blinded central review were able to cross over to KEYTRUDA arms after three months.

Merck Announces Results from Phase 2 Study of Investigational Chronic Hepatitis C Treatment Grazoprevir/Elbasvir in Genotype 1 Infected Treatment-Naïve and Difficult-to-Cure Patients

Merck announced the presentation of results from a multi-arm Phase 2 clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742, the company's investigational NS3/4A protease inhibitor and NS5A inhibitor, respectively) with or without ribavirin (RBV) in treatment-naïve and previously-treated (with peg-interferon/ribavirin [PR]) patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection - the C-WORTHy study. The final results were presented in oral sessions at the 65th American Association for the Study of Liver Diseases (AASLD) Annual Meeting and published as separate papers online in The Lancet. The rate of virologic failure was 5% (6/123) in treatment-naïve cirrhotic patients and 3% (4/130) in the null-responder population. Treatment was generally well-tolerated. The most common adverse events associated with the administration of grazoprevir/elbasvir in combination with or without RBV were: fatigue (26%), headache (23%) and asthenia (14%). There were no early discontinuations due to adverse events with grazoprevir/elbasvir and no clinically significant abnormalities observed in routinely evaluated biomarkers. Results for HCV Mono-Infected and HIV/HCV Co-Infected Patients: Treatment-naïve, non-cirrhotic mono-infected GT1 patients and non-cirrhotic HCV GT1 /HIV co-infected patients treated for 12 weeks with grazoprevir/elbasvir with or without RBV, demonstrated high rates of SVR12. Among this patient population treated for 12 weeks, the overall rate of virologic failure was 4% (7/188), including three breakthrough failures and four relapses, in both mono- and co-infected patients. In patients treated for eight weeks, the rate of virologic failure was 17% (5/30), with five relapses. The most common adverse events with or without RBV were fatigue (23%), headache (20%), nausea (15%) and diarrhea (10%). There were no early discontinuations due to adverse events with grazoprevir/elbasvir and no clinically significant abnormalities observed in routinely evaluated biomarkers. C-WORTHy is a randomized, dose response, parallel-group, multiple-site, double-blind clinical trial comparing diverse patient populations exposed to different durations of treatment of grazoprevir/elbasvir with or without RBV in patients with chronic HCV infection. In C-WORTHy Parts A and B, a total of 471 patients with chronic HCV GT1 infection with HCV RNA levels of >=10,000 IU/mL were enrolled and randomized across 16 arms.


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