Key Developments: Merck & Co Inc (MRK)
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18 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Merck & Co Inc Announces FDA Acceptance of Biologics License Application for Investigational Grass Pollen Allergy Immunotherapy Tablet
Merck & Co Inc announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT. The BLA for Merck`s grass pollen AIT is supported by Phase III trials that evaluated the safety and efficacy of the investigational product, including a long-term, multi-season trial. Merck's grass pollen (Phleum pratense) AIT is an investigational sublingual dissolvable tablet designed to help treat the underlying cause of allergic rhinitis by generating an immune response to help protect against targeted allergens. Merck has partnered with ALK-Abello to develop its grass pollen (Phleum pratense) AIT in North America. Full Article
Merck & Co Inc And Luminex Corporation Enter Agreement To Develop Companion Diagnostic To Support Investigational BACE Inhibitor Clinical Development Program For Alzheimer’s Disease
Merck & Co Inc and Luminex Corporation announced that it has signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck's clinical development program for MK-8931, a oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck's lead investigational candidate for Alzheimer's disease (AD). Financial terms were not disclosed. Luminex will be responsible for development, regulatory submission and commercialization of the candidate companion diagnostic device, which will employ Luminex`s xMAP Technology to measure concentrations of two candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid (CSF) samples from patients with mild cognitive impairment (MCI). The candidate device will be evaluated as a means to identify subjects with MCI who have a higher risk of developing AD to support patient selection for Merck`s therapeutic BACE inhibitor clinical program. Full Article
Alk Abello A/S's Partner Merck & Co Inc Submits BLA for Marketing Authorization of Ragweed AIT
Alk Abello A/S announced that its partner Merck & Co Inc has submitted a Biologics License Application (BLA) to the US (United States) Food and Drug Administration (FDA) for a marketing authorization for ragweed allergy immunotherapy tablet (AIT). ALK’s partnership with Merck covers the development, registration and commercialization of a portfolio of AITs in North America. The application to the FDA is based on results from a clinical development program. Data from the clinical trials have demonstrated that treatment with ragweed AIT reduces patients’ allergy symptoms and their concomitant use of symptom-relieving medication and that the treatment is well tolerated. The submission of the BLA entitles ALK to a milestone payment of USD 5 million from Merck. Full Article
Merck & Co Inc Announces Second-Quarter 2013 Dividend
Merck & Co Inc announced that the Board of Directors has declared a quarterly dividend of $0.43 per share on the Company`s common stock for the second quarter of 2013. Payment will be made on Apr. 5, 2013, to stockholders of record at the close of business on Mar. 15, 2013. Full Article
Merck & Co Inc To Pay $688 Million To Settle Enhance Lawsuits-Reuters
Reuters reported that Merck & Co Inc on February 14, 2013 said it has agreed to pay $688 million to settle two U.S. investor lawsuits over disclosures of the results of a clinical trial involving the anti-cholesterol drug Vytorin. The lawsuits alleged that Merck and Schering-Plough Corp knew far in advance that the trial was a failure, but withheld that information from investors. The trial, known as Enhance, had sought to demonstrate that Vytorin, a combination drug marketed by the two companies, was more effective than a competing drug in combating plaque build-up on artery walls. Investors claimed they lost money in both companies' securities after results of the clinical trial were published. In a statement, Merck said it will pay $215 million to settle a lawsuit brought against Merck defendants, and $473 million to settle a lawsuit against Schering-Plough defendants. Full Article
Merck & Co Inc Issues Q1 2013 EPS Guidance Below Analysts' Estimates
Merck & Co Inc announced that for first quarter of 2013, it expects non-GAAP EPS to be between $0.76 and $0.78, and the GAAP EPS range to be $0.37 to $0.42. According to I/B/E/S Estimates, analysts are expecting the Company to report EPS of $0.85 for first quarter of 2013. Full Article
Merck & Co Inc Hit With $285,000 Verdict In Fosamax Trial-Reuters
Reuters reported that A federal jury has ordered Merck & Co Inc to pay $285,000 in a lawsuit over the risks of its osteoporosis drug Fosamax. Merck said in a statement that it disagreed with the verdict and noted that the jury returned a mixed verdict. Full Article
Merck & Co Inc Issues FY 2013 Guidance In Line With Analysts' Estimates
Merck & Co Inc announced that it expects fiscal 2013 non-GAAP EPS to be between $3.60 and $3.70, and fiscal 2013 GAAP EPS range to be $2.03 to $2.26. The 2013 non-GAAP range excludes acquisition-related costs and costs related to restructuring programs. The Company expects fiscal 2013 revenues to be near fiscal 2012 levels on a constant currency basis. At current exchange rates, sales would be affected unfavorably by approximately 1% to 2% for fiscal 2013. The Company reported revenue of $47.267 billion in fiscal 2012. According to I/B/E/S Estimates, analysts are expecting the Company to report EPS of $3.68 and revenue of $45.611 billion for fiscal 2013. Full Article
Alk Abello A/S's Partner Merck & Co Inc Submits BLA for Marketing Authorization of Grass AIT to FDA
Alk Abello A/S announced that its partner Merck & Co Inc has submitted a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for a marketing authorization for grass allergy immunotherapy tablet (AIT) – a disease-modifying AIT against grass pollen allergy. The product is marketed as GRAZAX in Europe. The partnership with Merck covers the development, registration and commercialization of a portfolio of AITs in North America. The application to the FDA is based on results from a clinical development program. Data from the clinical trials have demonstrated that treatment with grass AIT reduces patients’ allergy symptoms and their need for symptom-relieving medication and provides a sustained long-term effect after completion of treatment. Full Article
Merck & Co Inc Begins Overseas Recall Of HDL Cholesterol Drug-Reuters
Reuters reported that Merck & Co Inc is recalling Tredaptive, its medicine to raise good HDL cholesterol levels, in overseas markets where it is sold, after it failed to prevent heart problems in a large study and raised safety concerns. The medicine is not approved in the United States but the U.S. drugmaker sells it in about 40 countries. Merck said it would recall stocks of Tredaptive now held by wholesalers, but that pharmacies can continue to dispense their remaining supplies. Even so, the company said it plans to discourage doctors from prescribing the pill based on negative findings from the trial which were announced last month. The study followed more than 25,000 patients in Europe and China for almost four years. The company said it will encourage doctors to consider alternative treatments to control cholesterol, but advised patients not to discontinue Tredaptive without first speaking with their physicians. Full Article
Exclusive: EU to fine Lundbeck, others for blocking generic drugs
BRUSSELS - A European regulator will fine Denmark's Lundbeck and eight other makers of generic drugs for limiting the supply of cheaper medicines, two people with knowledge of the matter said, its first sanction against "pay-for-delay" deals.
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