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merck & co. inc. (MRK) Key Developments

Merck Announces Results from Two Post-Hoc Analyses of the TRA 2°P TIMI 50

Merck announced results from two post-hoc analyses of the TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) trial of ZONTIVITY® (vorapaxar). These data on additional endpoints in subgroups of patients with peripheral arterial disease (PAD) are being presented at the 2015 American College of Cardiology (ACC) Scientific Sessions in San Diego from March 14-16, 2015 along with other post-hoc subgroup analyses from the trial, with abstracts currently available online. ZONTIVITY is indicated for the reduction of thrombotic cardiovascular (CV) events in patients with a history of myocardial infarction (MI) or in patients with PAD. The May 2014 U.S. approval of ZONTIVITY was based on the pivotal TRA 2°P TIMI 50 study, in which ZONTIVITY was shown to reduce the rate of a combined endpoint of CV death, MI, stroke and urgent coronary revascularization (UCR) when added to aspirin and/or clopidogrel. The U.S. Prescribing Information for ZONTIVITY includes a boxed warning regarding bleeding risk, which states that ZONTIVITY is not for use in patients with a history of stroke, transient ischemic attack (TIA) or intracranial hemorrhage (ICH), or active pathological bleeding. Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding.

Eisai and Merck's Subsidiary Enter into Collaboration to Explore Novel Combination Regimens of Anti-PD-1 Therapy Multi-Targeting RTK Inhibitor and Microtubule Dynamics Inhibitor in Multiple Types of Cancer

Eisai Co., Ltd. and Merck, through a subsidiary, announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Merck’s anti-PD-1 therapy, pembrolizumab (marketed in the U.S. under the brand name KEYTRUDA), in combination with Eisai oncology compounds lenvatinib mesylate (a multi-targeting RTK inhibitor marketed in the U.S. under the brand name LENVIMA, 'lenvatinib') and eribulin mesylate (a microtubule dynamics inhibitor marketed in nearly 60 countries including Japan, the U.S., and Europe under the brand name HALAVEN, 'eribulin') in multiple clinical trials. The planned studies include a multicenter, open-label Phase 1b/2 study of lenvatinib plus pembrolizumab in select solid tumors and an open-label, single-arm, multicenter Phase 1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in metastatic triple-negative breast cancer. Eisai and Merck will establish a Joint Development Committee to oversee clinical development activities. The studies are expected to begin in the second half of 2015. Financial terms of the agreement were not disclosed.

Merck Declares Unchanged Quarterly Dividend

Merck Declares Unchanged Quarterly Dividend Merck & Company (MRK) has declared a quarterly dividend of $0.45 per share, unchanged from the previous quarter. The dividend is payable on April 8 to shareholders of record as of March 16.

The Medicines Patent Pool Signs Licensing Agreement with MSD for Paediatric Formulations of Raltegravir

The Medicines Patent Pool (MPP) announced a licence with MSD, known as Merck in the United States and Canada, for paediatric formulations of raltegravir, a key medicine approved for children living with HIV four weeks of age and older. With the new licence, generic manufacturers and other companies based anywhere in the world can develop, manufacture and sell low cost, paediatric versions of raltegravir in countries with the highest burden of disease, where 98% of children with HIV in the developing world live. The World Health Organization recommends raltegravir as a component of paediatric third-line treatment. Its recent extended approval for infants as young as a month suggests its potential in filling an important gap in paediatric care. The medicine's current availability as chewable tablets and granules for oral suspension could potentially ease implementation in paediatric programmes. The medicine is currently in clinical studies for potential use in newborns.

Merck Collaborates with University of Indonesia and Maharashtra University to Build Diabetes and Thyroid Dysfunction Healthcare Capacity in Asia

Merck introduced European Accredited Clinical Diabetes management for more than 5,000 medical and pharmacy students of both universities as part of Merck Capacity Advancement Program (CAP) in Asia. The 5 years program has been developed by EXCEMED - Excellence in Medical Education and is accredited by the European Accreditation Council of Continuous Medical Education (EACCME). The course will be taught by European and local Diabetes and Thyroid experts. Based on its long experience in diabetes management, which began in 1957 with the development of metformin, Merck seeks to raise awareness of diabetes by supporting the healthcare system to prevent, diagnose and manage the condition effectively. As part of the Merck Capacity Advancement Program, by end of 2015, more than 5,000 medical students in partnership with African universities such as University of Nairobi, Makerere University, Namibia University and University of Ghana, in addition to Asian universities such as Maharashtra university, India and University of Indonesia will benefit from European-accredited clinical diabetes and chronic diseases management training, which is seeking to equip them with skills to avert the diabetes epidemic. Merck is planning to target more than 15,000 students by the end of 2018 expanding to more Universities in the developing countries.


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