Key Developments: Merck & Co Inc (MRK)

MRK on New York Consolidated

9 Jul 2014
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Latest Key Developments (Source: Significant Developments)

SANTEN PHARMACEUTICAL CO LTD announces completes asset purchase agreement with respect to acquisition of ophthalmology assets from Merck
Wednesday, 2 Jul 2014 02:00am EDT 

SANTEN PHARMACEUTICAL CO LTD:Completed acquire certain ophthalmology assets from Merck & Co., Inc. on July 2.Santen's payment for the closed transaction totaled approximately $550 million (approximately 56 billion yen).Says details disclosed on May 13.  Full Article

Merck & Co Inc announces data from investigational phase 3 study on EMEND
Monday, 30 Jun 2014 08:00am EDT 

Merck & Co Inc:Results from global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.In this study in pediatric cancer patients undergoing very highly, highly, or moderately emetogenic (vomit-inducing) chemotherapy.Says use of EMEND regimen for CINV prevention was significantly more effective than control regimen in achieving Complete Response, defined as no vomiting or retching and no use of rescue medication for nausea and vomiting, in all phases of CINV (acute, delayed, and overall).Nausea and vomiting are common complications of cancer chemotherapy and can be particularly distressful and debilitating to pediatric cancer patients.Based on these data, Merck plans worldwide regulatory submissions for EMEND (aprepitant), beginning in the United States, for use in the prevention of CINV in pediatric and adolescent cancer patients (ages 6 months to 17 years).In the United States, Merck plans to submit a New Drug Application (NDA) for a new pediatric formulation (powder for suspension) and a supplemental NDA for use of the current formulation (capsules).Both filings are planned for the second half of 2014.  Full Article

Merck 's Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma
Monday, 30 Jun 2014 06:00am EDT 

Merck:Announced European Medicines Agency (EMA) has accepted for review Marketing Authorization Application (MAA) for pembrolizumab (MK-3475) co's investigational anti-PD-1 antibody, for treatment of advanced melanoma.If approved by European Commission (EC), pembrolizumab has potential to be first anti-PD-1 therapy in Europe.Additional regulatory filings in other countries outside of Europe are planned by end of 2014.  Full Article

Merck & Co Inc begins tender offer to acquire Idenix Pharmaceuticals Inc
Friday, 20 Jun 2014 07:30am EDT 

Merck & Co Inc:Commencing, through subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Idenix Pharmaceuticals, Inc.Upon successful closing of tender offer, stockholders of Idenix will receive $24.50 in cash for each share of Idenix common stock validly tendered and not validly withdrawn in offer, without interest and less any required withholding taxes.Following the purchase of shares in tender offer, Idenix will become a wholly-owned subsidiary of Merck.MacKenzie Partners, Inc. is acting as information agent for Merck.Credit Suisse is serving as financial advisor to Merck with this transaction and Hughes Hubbard & Reed LLP as its legal advisor.Merck will file with the U.S. Securities and Exchange Commission (SEC) a tender offer statement on Schedule TO, which provides the terms of the tender offer.  Full Article

Merck & Co Inc to acquire Idenix Pharmaceuticals Inc
Monday, 9 Jun 2014 07:30am EDT 

Merck & Co Inc and Idenix Pharmaceuticals Inc:Says the companies have entered into a definitive agreement under which Merck will acquire Idenix for $24.50 per share in cash.The transaction, which values the purchase of Idenix at about $3.85 billion, has been approved by the boards of directors of both companies.Upon the completion of the tender offer, Merck will acquire all remaining shares through a second-step merger.The companies expect the transaction to close in the third quarter of 2014.Credit Suisse acted as financial advisor to Merck in this transaction and Hughes Hubbard & Reed LLP as its legal advisor.Centerview Partners acted as financial advisor to Idenix and Sullivan & Cromwell as its legal advisor.  Full Article

Merck & Co Inc announces third-quarter 2014 dividend
Tuesday, 27 May 2014 12:21pm EDT 

Merck & Co Inc:Declares quarterly dividend of $0.44 per share of common stock for third quarter of 2014.Payment will be made on July 8, 2014, to stockholders of record at the close of business on June 16, 2014.  Full Article

Merck & Co Inc announces FDA approval of BRAVECTO
Tuesday, 20 May 2014 08:00am EDT 

Merck & Co Inc:U.S.FDA's approval of BRAVECTO chewable tablets for dogs (112.5 mg, 250 mg, 500 mg, 1000 mg, 1400 mg).BRAVECTO is first and only treatment that has been shown to quickly and effectively kill fleas and multiple tick species for 12 weeks in a single dose.BRAVECTO also is effective for eight weeks against Amblyomma americanum ticks.Active substance of BRAVECTO, fluralaner, new ectoparasiticide belonging to isoxazoline group, is systemically active against fleas and ticks.Product can be used as part of treatment strategy for control of Flea Allergy Dermatitis (FAD) as a direct result of eliminating flea infestations.  Full Article

Merck signs sale agreement with Santen for Merck's Ophthalmology Products in Japan and Key Markets in Europe and Asia Pacific
Tuesday, 13 May 2014 02:15am EDT 

Merck & Co Inc:Signs agreement for Santen Pharmaceutical Co., Ltd. (Santen) to purchase Merck's ophthalmology products.To divest ophthalmics business is part of ongoing strategy to sharpen commercial focus and improve operational effectiveness.Santen will make an upfront payment of about $600 mln and additional payments based on defined sales milestones as needed.Agreement is expected to close in most markets in a few months.  Full Article

Merck & Co Inc announces US FDA approved ZONTIVITY
Monday, 12 May 2014 07:30am EDT 

Merck & Co Inc:US FDA approved ZONTIVITY (vorapaxar) for reduction of thrombotic cardiovascular events in patients with history of heart attack or in patients with narrowing of leg arteries, called peripheral arterial disease.ZONTIVITY added to standard of care produced significant 17 pct relative risk reduction over three years of study for combined events of cardiovascular (CV) death, myocardial infarction (MI), stroke, and urgent coronary revascularization.For key secondary composite efficacy endpoint of CV death, MI and stroke alone, ZONTIVITY produced significant 20 pct relative risk reduction in these patients.These results were driven by an 18 pct relative risk reduction in MI and 33 pct relative risk reduction in first stroke.Prescribing information for ZONTIVITY includes boxed warning regarding bleeding risk.ZONTIVITY is not for use in patients with a history of stroke, TIA or intracranial hemorrhage, or active pathological bleeding.  Full Article

Merck & Co Inc and AiCuris announce publication in New England journal of medicine of Phase 2 clinical trial results of investigational antiviral agent Letermovir in bone marrow transplant patients
Thursday, 8 May 2014 09:00am EDT 

Merck & Co Inc:Publishes results from a Phase 2 clinical trial evaluating safety and efficacy of letermovir, an investigational, oral antiviral agent with AiCuris.For prevention of human cytomegalovirus (CMV) infection in patients receiving bone marrow transplant.Results published in latest issue of New England Journal of Medicine(NEJM) show that letermovir in CMV-seropositive allogeneic human blood precursor cell recipients (bone marrow transplant patients) met study's two primary efficacy endpoints.Merck plans to conduct a Phase 3 trial of letermovir, also known as AIC246 or MK-8228, starting in the first half of 2014.  Full Article

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