NDA Updates, Signed Agreements, Awarded Patents, and Clinical Study Results - Research Report on Merck, Bristol-Myers Squibb, Amarin, GlaxoSmithKline, and Sanofi
NEW YORK, September 17, 2013 /PRNewswire/ --
Editor Note: For more information about this release, please scroll to bottom.
Today, Analysts' Corner announced new research reports highlighting Merck & Co., Inc. (NYSE: MRK), Bristol-Myers Squibb Company (NYSE: BMY), Amarin Corporation plc (NASDAQ: AMRN), GlaxoSmithKline plc (NYSE: GSK), and Sanofi SA (NYSE: SNY). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Merck & Co., Inc. Research Report
On September 9, 2013, Merck & Co., Inc. (Merck) announced that it has entered into a multi-year agreement with Israel's Maccabi Healthcare Services (Maccabi) to leverage real-world data from Maccabi's unique longitudinal database to inform novel, patient-centered health approaches. The
Company informed that under the terms of the agreement, the duos will apply technical and information research capabilities to draw insights from Maccabi's data to support personalized health care delivery strategies across several therapeutic areas, including prevalent and costly chronic diseases. Varda Shalev, M.D., Director of Primary Care Division at Maccabi, said, "We believe that combining Merck research expertise with our fully integrated, electronic, de-identified patient data can unlock major insights for achieving better outcomes in healthcare, including chronic diseases where education, medication and adherence are so important. Our goal is that our data will enable research projects that advance healthcare, from product development to patient wellness programs." The Full Research Report on Merck & Co., Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/430d_MRK]
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Bristol-Myers Squibb Company Research Report
On September 12, 2013, Bristol-Myers Squibb Company (Bristol-Myers) announced the results from its Phase 3 trial of Yervoy (Ipilimumab) in previously-treated castration-resistant prostate cancer. According to the Company, in its Phase 3 randomized, double-blind clinical trial, the Company compared Yervoy 10 mg/kg to placebo following radiation in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who have received prior treatment with docetaxel. The Company informed that the study's primary endpoint of overall survival (OS) didn't reach statistical significance; however, it noted anti-tumor activity across some efficacy endpoints. Bristol-Myers further informed that it will present the data at the 2013 European Cancer Congress on September 28, 2013. The Full Research Report on Bristol-Myers Squibb Company - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/81a9_BMY]
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Amarin Corporation plc Research Report
On September 9, 2013, Amarin Corporation plc (Amarin) announced that it presently has 30 patents issued or allowed by the US Patent and Trademark Office (USPTO), in relation to its flagship product, Vascepa (icosapent ethyl) capsules. The Company informed that it has recently received Notices of Allowance for US Patent Application Serial Number 13/777,398, 13/768,897, and 13/768,869, each titled Stable Pharmaceutical Composition and Methods of Using Same. "With 30 patents issued and allowed and over 30 additional applications pending in the United States, Amarin now has one of the most extensive, and expanding, patent portfolios covering a product in the industry," said Joseph Zakrzewski, Chairman and CEO of Amarin. "The continued issuance of a variety of patents covering Vascepa is emblematic of the success achieved at Amarin toward its goal of protecting the commercial potential of Vascepa to beyond 2030 through patent protection. In addition, Amarin's Vascepa is also protected by trade secrets and existing manufacturing barriers to entry, along with anticipated three- or five-year regulatory exclusivity in the United States." The Full Research Report on Amarin Corporation plc - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/7cf9_AMRN]
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GlaxoSmithKline plc Research Report
On September 10, 2013, GlaxoSmithKline plc (GlaxoSmithKline), together with Theravance, Inc. (Theravance), announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) has recommended approval of umeclidinium/vilanterol for the treatment of chronic obstructive pulmonary disease (COPD), in the US. According to the Company, a majority of the FDA Advisory Committee is of the opinion that the efficacy and safety provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with COPD. The Company informed that the proposed proprietary name for UMEC/VI will be ANORO ELLIPTA. Patrick Vallance, President of Pharmaceuticals R&D at GlaxoSmithKline, said, "Today's recommendation is good news and a reflection of our commitment to giving an alternative treatment option for patients living with COPD - a disease that affects millions of Americans. If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US, marking another significant milestone for GSK's portfolio of medicines to treat respiratory disease. We will continue to work with the FDA as they complete their review." The Full Research Report on GlaxoSmithKline plc - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/2a35_GSK]
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Sanofi SA Research Report
On September 12, 2013, Sanofi SA (Sanofi) announced its decision to withdraw the lixisenatide New Drug Application (NDA) in the US, which included early interim results from the ongoing ELIXA cardiovascular (CV) outcomes study. The Company informed that it plans to resubmit the NDA for lixisenatide in 2015, upon completion of the ELIXA CV study. According to Sanofi, the decision follows a discussion with the US Food and Drug Administration (FDA) regarding its proposed process for the review of interim data. The Company also believes that potential public disclosure of early interim data could potentially compromise the integrity of the ongoing ELIXA study. The Full Research Report on Sanofi SA - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.analystscorner.com/r/full_research_report/29ea_SNY]
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