Key Developments: Merck & Co., Inc. (MRK)
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Latest Key Developments
Merck & Co., Inc. Receives European Approval For ELONVA (corifollitropin alfa injection)
Merck & Co., Inc. announced the European Commission (EC) approval of ELONVA (corifollitropin alfa injection). ELONVA is indicated for controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. With the EC approval, Merck receives marketing authorization for ELONVA with unified labeling valid in all European Union Member States.
U.S. District Court Rules Against Merck & Co., Inc. In TEMODAR Patent Lawsuit
Merck & Co., Inc. announced that U.S. District Court for the District of Delaware ruled against the company in a patent infringement suit against Teva Pharmaceuticals USA Inc. Teva is seeking FDA approval to sell a generic version of the 5, 20, 100, 140, 180 and 250 mg capsules of TEMODAR, a chemotherapeutic agent approved for the treatment of adult patients with newly diagnosed glioblastoma multiforme and for refractory anaplastic astrocytoma, two forms of brain cancer.
Envoy Therapeutics, Inc. Enters Diabetes and Obesity Collaboration with Merck & Co., Inc.
Envoy Therapeutics, Inc. announced that it has entered into a multi-year research collaboration agreement with an affiliate of Merck & Co., Inc. to discover diabetes and obesity drug targets. Under the agreement, Envoy will use its bacTRAP technology to identify proteins expressed specifically in certain cell types. Merck will then work to identify and develop compounds that modulate protein targets with therapeutic potential for the treatment of metabolic disorders. Merck will pay Envoy an upfront fee and research funding. In addition, Envoy is eligible to receive payments upon achievement of certain milestones associated with development of drug candidates and royalties on any products derived from the collaboration.
Merck & Co., Inc. HIV Drug From Schering Merger Fails Trials-Reuters
Reuters reported that Merck & Co., Inc. said its experimental HIV treatment vicriviroc proved ineffective in two late-stage studies involving patients who had previously been treated with other HIV medicines. Wall Street had expected Merck to seek approval this year for the drug. But Merck said it now has no plans to seek marketing approval for the product at this time. In two Phase III studies in this patient population, vicriviroc did not meet the primary efficacy endpoint, the two-paragraph notice said. It said the failed trials enrolled a high percentage of patients who continued to take three or more other active HIV drugs, along with vicriviroc. A previous mid-stage trial of the drug among treatment-experienced patients suggested it was able to suppress the virus, and was generally well tolerated, during two years of therapy. Merck said it will continue mid-stage studies of the drug among a different group of patients, those not previously treated for HIV.
Merck & Co., Inc. Submits Gardasil Data For Women 27 To 45-Reuters
Reuters reported that Merck & Co., Inc. has provided U.S. regulators with new information needed for approval to market its Gardasil cervical cancer vaccine to women between the ages of 27 to 45.
Arena Pharmaceuticals Announces Merck & Co., Inc. Discontinues Development of Investigational Niacin Receptor Agonist Program for Atherosclerosis
Arena Pharmaceuticals announced Merck & Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed Arena that the company will not continue the collaboration. Merck made the decision to discontinue development of MK-1903 following evaluation of the results of a completed Phase 2a clinical trial. The randomized, double-blind, placebo-controlled trial evaluated the safety, tolerability and potential efficacy in patients with dyslipidemia. According to Merck, elevation of HDL cholesterol relative to placebo did not meet the trial's pre-specified primary objective for efficacy; no safety signals were implicated as drivers of the decision to discontinue development.
Labopharm Inc. Completes Distribution And Supply Agreement With Merck & Co., Inc.'s MSD For Tradorec XL
Labopharm Inc. announced that its wholly owned subsidiary, Labopharm Europe Limited, has completed a distribution and supply agreement with Merck Sharp & Dohme Limited (MSD), a United Kingdom (U.K.) subsidiary of Merck & Co., Inc., under which MSD will distribute and market Tradorec XL (once-daily tramadol based on Labopharm's proprietary Contramid technology). Under the terms of the agreement, MSD has the exclusive right to market and sell Tradorec XL in England, Northern Ireland, Scotland, Wales, the Channel Islands and the Isle of Man. Labopharm will supply MSD with finished, packaged product at a fixed transfer price inclusive of gross margin. Labopharm will also receive an up-front payment of 650,000 British pounds.
US Patent Office Backs Merck & Co., Inc. In Challenge To Singulair Patent-DJ
Dow Jones reported that the U.S. Patent and Trademark Office has sided with Merck & Co., Inc. in a dispute over its patent for the blockbuster asthma drug Singulair. The PTO ruled that it would end its re-examination of the Singulair patent, which is due to expire in 2012. It launched the re-examination in May at the request of Article One Partners LLC, an online patent-research service that said it uncovered new information raising questions about the validity of the Singulair patent, which was issued in the 1990s. In the latest ruling, the PTO said it withdrew that finding after a doctor provided reasons why the patented procedure was not obvious.
Merck & Co., Inc. To Acquire Avecia Biologics
Merck & Co., Inc. and Avecia Investments Limited announced that they have entered into a definitive agreement by which Merck will acquire the biologics business of the Avecia group through a Merck affiliate (Merck Sharp & Dohme (Holdings) Limited or MSD). Avecia Biologics is a contract manufacturing organization with specific expertise in microbial-derived biologics. Financial details of the transaction were not disclosed. Under the terms of the agreement, Merck will acquire Avecia Biologics Limited and all its assets, including all the company's process development and scale-up, manufacturing, quality and business support operations located in Billingham, UK. In addition to honoring all Avecia Biologics contractual commitments, Merck plans to engage in discussions with individual customers relating to their specific ongoing and future biological process development and manufacturing needs after the transaction is closed. The Oligomedicines Business of the Avecia group based in the United States does not form part of this transaction.
ARIAD Pharmaceuticals, Inc. Announces Updated Data From Clinical Trial Of Its Investigational mTOR Inhibitor, Ridaforolimus, In Combination With Trastuzumab
ARIAD Pharmaceuticals, Inc. announced the presentation of updated clinical data from its Phase 2 study evaluating oral ridaforolimus in combination with trastuzumab (Herceptin) in patients with resistant, metastatic breast cancer. As assessed by the study investigators, the clinical trial met its primary endpoint of objective response rate. ARIAD is developing ridaforolimus, an investigational mTOR inhibitor, in collaboration with its partner, Merck & Co, Inc. The Phase 2 clinical trial in patients with HER2 positive breast cancer was designed to evaluate whether the addition of ridaforolimus to trastuzumab in the treatment of patients with metastatic breast cancer who have become resistant to trastuzumab would result in objective evidence of tumor shrinkage. The objective response rate was defined by RECIST criteria (complete or partial responses) as assessed by the study investigators. Clinical and pathological data were also evaluated in confirming disease status. Clinical-benefit response (CBR) (objective responses and durable stable disease) was assessed as a secondary endpoint. 34 patients were enrolled in the trial, and all had documented disease progression on trastuzumab, either alone or in combination with chemotherapy, prior to entry. Study treatment consisted of oral ridaforolimus (40 mg/day, qdx5) and trastuzumab at standard doses and intervals. None of the patients received chemotherapy during the trial.
Drug shows promise against river blindness: study
CHICAGO (Reuters) - Closantel, an older drug used to treat a parasitic liver disease in animals, may prove effective at combating river blindness in humans, a major cause of infection-related blindness, U.S. researchers said on Monday.
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