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merck & co. inc. (6MK) Snapshot

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merck & co. inc. (6MK) Details

Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products worldwide. The company’s Pharmaceutical segment offers human health pharmaceutical products, such as therapeutic and preventive agents for the treatment of human disorders in the areas of cardiovascular, diabetes and obesity, respiratory, women's health and endocrine, inflammatory and infectious diseases, oncology, ophthalmology, immunology, infectious diseases, and others. This segment also provides vaccines, including preventive pediatric, adolescent, and adult vaccines. Its Animal Health segment discovers, develops, manufactures, and markets animal health products comprising vaccines, antibiotics, and anti-inflammatory drugs for respiratory diseases, as well as products for the treatment of fertility disorders. The company’s Consumer Care segment develops, manufactures, and sells over-the-counter products consisting of non-drowsy antihistamines; decongestant-free cold/flu medicine for people with high blood pressure; nasal decongestant sprays; and products for occasional constipation, frequent heartburn, and overactive bladder in women; foot care products, including topical antifungal, and foot and sneaker odor/wetness products; and sun care products, such as sun care lotions, sprays, and dry oils. The company serves drug wholesalers and retailers, hospitals, government agencies, physicians, physician distributors, veterinarians, animal producers, food chain and mass merchandiser outlets, club stores, and specialty channels, as well as managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions. It has collaborations with AstraZeneca LP, Pfizer Inc., Samsung Bioepis Co., Ltd., Sanofi Pasteur S.A., and Sysmex Inostics GmbH. The company was founded in 1891 and is headquartered in Whitehouse Station, New Jersey.

77,300 Employees
Last Reported Date: 02/27/14
Founded in 1891

merck & co. inc. (6MK) Top Compensated Officers

Chairman and Chief Executive Officer
Total Annual Compensation: $1.5M
Executive Vice President and President of Mer...
Total Annual Compensation: $1.2M
Executive Vice President and President of Glo...
Total Annual Compensation: $957.3K
Compensation as of Fiscal Year 2013.

merck & co. inc. (6MK) Key Developments

Merck Announces First Presentation of Data on the Investigational Use of KEYTRUDA(R) (Pembrolizumab) in Patients with Advanced Gastric Cancer At ESMO 2014

Merck announced the first presentation of data on the investigational use of KEYTRUDA(R) (pembrolizumab) -- the company's anti-PD-1 therapy -- in PD-L1 positive, advanced gastric cancer. The early findings presented showed an overall response rate (confirmed and unconfirmed) of 31% with KEYTRUDA as monotherapy, as measured by investigator assessed, RECIST v1.1 (n= 12/39: 95% CI, 17-47). Similar overall response rates were observed in Asian patients (a population with a high incidence of gastric cancer) and non-Asian patients. At the time of analysis, response durations ranged from 8+ to 20+ weeks with 11 of 12 responders continuing on therapy. These data, from a cohort of the ongoing Phase 1b KEYNOTE-012 study, were presented as part of a late-breaking oral session, by Dr. Kei Muro, Aichi Cancer Center Hospital, Nagoya, Japan, at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain (ABSTRACT #LBA15). Data investigating the use of KEYTRUDA monotherapy in five tumor types will be presented at ESMO 2014. KEYTRUDA is indicated in the United States 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Data from a cohort of the ongoing Phase 1b KEYNOTE-012 study evaluated KEYTRUDA monotherapy at 10 mg/kg every two weeks in patients with advanced gastric cancer whose tumors were determined to be positive for PD-L1 expression (n=39). As measured by Merck's proprietary immunohistochemistry (IHC) clinical trial assay, tumors were classified as PD-L1 positive based on greater than or equal to 1% of tumor cells demonstrating expression of the PD-L1 marker, or any positive staining with the same reagent in tumor stroma. Enrollment was designed to include an equal number of Asian and non-Asian patients. The majority of patients had received two or more prior lines of therapy. Using a prototype assay for PD-L1 assessment, there was evidence of a preliminary relationship between PD-L1 expression and ORR (P = 0.071). In the study, tumor shrinkage was demonstrated in 41% of evaluable patients who had measurable disease with one post baseline scan, per RECIST v1.1 criteria. Adverse events were consistent with previously reported safety data for KEYTRUDA. The most common investigator-assessed, treatment-related adverse events (occurring in greater than 5%) included hypothyroidism (12.8%) and fatigue (12.8%). Grade 3-5 investigator-assessed, treatment-related adverse events occurred in a total of three patients, with one patient each in peripheral sensory neuropathy (Grade 3), hypoxia (Grade 5) and pneumonitis (Grade 4). No infusion-related reactions were observed and no patients discontinued KEYTRUDA due to a treatment-related adverse reaction. One treatment-related death due to hypoxia, as assessed by the investigator, was reported.

Merck & Co. Inc. and Sun Pharmaceutical Industries Ltd. Enter into Licensing Agreement for Tildrakizumab

Merck & Co. Inc. and Sun Pharmaceutical Industries Ltd. through their respective subsidiaries, announced an exclusive worldwide licensing agreement for Merck's investigational therapeutic antibody candidate, tildrakizumab, (MK-3222), which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of $80 million. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales. The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.

Merck Announces Data from Pivotal Phase 3 Fracture Outcomes Study for Odanacatib, an Investigational Oral, Once-Weekly Treatment for Osteoporosis

Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck's investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial (LOFT), odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The results from this trial were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Houston, Texas. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo. In the study, odanacatib significantly reduced osteoporotic fracture risk In LOFT, odanacatib significantly reduced the risk of three types of osteoporotic fractures compared to placebo in the primary efficacy analysis, and also reduced the risk of the secondary endpoint of clinical vertebral fractures. Specifically, compared to patients receiving placebo, patients who received odanacatib had a: 54% relative risk reduction of new and worsening morphometric (radiographically-assessed) vertebral fractures (p<0.001); 47% relative risk reduction of clinical hip fractures (p<0.001); 23% relative risk reduction of clinical non-vertebral fractures (p<0.001); and 72% relative risk reduction of clinical vertebral fractures (p<0.001). In addition, treatment with odanacatib led to progressive increases over five years in bone mineral density (BMD) at the lumbar spine and total hip. Compared to placebo, the change in BMD from baseline at five years with odanacatib for lumbar spine was 11.2% (p<0.001) and for total hip was 9.5% (p<0.001). Prior to the start of the study, certain adverse events of interest were identified for adjudication: morphea-like skin lesions, systemic sclerosis, serious respiratory infections, osteonecrosis of the jaw, atypical femoral shaft fractures, delayed fracture unions, atrial fibrillation and major adverse cardiovascular events (MACE). Adjudicated morphea-like skin lesions occurred more frequently on odanacatib: in 12 patients in the odanacatib group (0.1% incidence) and 3 patients in the placebo group (<0.1% incidence). These skin lesions resolved or improved after discontinuation of the study drug. Adjudicated atypical femoral shaft fractures were reported for 5 patients in the odanacatib group (incidence of 0.1%) and not reported in patients in the placebo group. No meaningful differences were observed in adjudicated events of systemic sclerosis, serious respiratory infections or delayed fractured unions between groups. There were no adjudicated cases of osteonecrosis of the jaw. Adjudicated atrial fibrillation was reported in 92 patients in the odanacatib group (incidence of 1.1%) and 80 patients in the placebo group (incidence of 1.0%). In the MACE analysis, events were reported for 215 patients in the odanacatib group and 194 patients in the placebo group (hazard ratio 1.12 (95% confidence interval (CI) 0.93, 1.36)). There were 271 deaths reported in the odanacatib group and 242 deaths in the placebo group (hazard ratio 1.13 (95% CI 0.95, 1.35)); this numeric difference does not appear to be related to a particular reported cause or causes of death. There was a numeric imbalance in adjudicated strokes with more events occurring in the odanacatib group. Based on the adjudication committee assessment, 109 patients in the odanacatib group experienced stroke (incidence 1.4%) and 86 patients (incidence 1.1%) in the placebo group (hazard ratio 1.28 (95% CI 0.97, 1.70)). Investigator-reported cerebrovascular events occurred in 305 patients in the odanacatib group (incidence 3.8%) and 290 patients taking placebo (incidence 3.6%) (hazard ratio 1.06 (95% CI 0.91, 1.25)). Merck continues to collect data from the blinded extension study and is planning additional analyses of data from the trial, including an independent re-adjudication of major adverse cardiovascular events, in support of regulatory submissions.


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