Acquisition Updates, Drug Approval, Drug Development Discontinuation, and Contract Update - Research Reports on AbbVie, Gilead, Pfizer, Lilly and Aetna
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NEW YORK, October 20, 2014 /PRNewswire/ --
Today, Analysts Review released its research reports regarding AbbVie Inc. (NYSE: ABBV), Gilead Sciences Inc. (NASDAQ: GILD), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY) and Aetna Inc. (NYSE: AET). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/7291-100free.
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AbbVie Inc. Research Reports
On October 16, 2014, Bloomberg reported that AbbVie Inc. (AbbVie) may reassess its planned $51.5 billion acquisition of Dublin-based drugmaker Shire Plc (Shire) as the new rules announced by the Treasury make it more difficult for the companies to execute so-called corporate tax inversion deals. According to the report, AbbVie has said that its Board will meet by October 20, 2014 to reconsider its recommendation that shareholders approve the deal. Also, as per the report, Shire has said that it would waive the three-day notice period required before the AbbVie's Board can reconsider the deal to reduce the uncertainty for shareholders, employees and other stakeholders. Shares of AbbVie gained 0.92% to close at $54.63 on October 15, 2014. The full research reports on AbbVie are available to download free of charge at:
http://www.analystsreview.com/Oct-20-2014/ABBV/report.pdf
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Gilead Sciences Inc. Research Reports
On October 10, 2014, Gilead Sciences Inc. (Gilead) announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni®, the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead informed that its Harvoni received a Priority Review and Breakthrough Therapy designation from the FDA, supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. According to the Company, the primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy. Moreover, in case of certain treatment-naïve patients, the treatment duration could be shortened to just eight weeks, the Company said. "Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks," said John C. Martin, PhD, Chairman and CEO, Gilead. The full research reports on Gilead are available to download free of charge at:
http://www.analystsreview.com/Oct-20-2014/GILD/report.pdf
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Pfizer Inc. Research Reports
On October 13, 2014, Pfizer Inc. (Pfizer) announced that its New Drug Application (NDA) seeking approval for palbociclib as a first-line therapy in combination with Letrozole for ER+, HER2- Advanced Breast Cancer has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. The FDA's priority review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing. "If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the U.S. who are living with metastatic breast cancer," said Garry Nicholson, President, Pfizer Oncology. The full research reports on Pfizer are available to download free of charge at:
http://www.analystsreview.com/Oct-20-2014/PFE/report.pdf
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Eli Lilly and Company Research Reports
On October 2, 2014, Eli Lilly and Company (Lilly) announced that it will discontinue development of tabalumab, being evaluated for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus), due to insufficient efficacy in two pivotal Phase 3 trials. The decision was not based on safety concerns, according to the Company. "Although we were pleased that tabalumab met the criteria for statistically significant improvement in the SRI-5 endpoint in one of our trials, we are nonetheless disappointed that the overall results did not meaningfully improve the condition of the patients in these studies," said J. Anthony Ware, M.D., Senior Vice President, Product Development, Lilly Bio-Medicines. Lilly expects the move to result in a Q3 2014 charge to research and development expense of up to $75 million (pretax), or approximately $0.04 - $0.05 per share (after-tax). The full research reports on Lilly are available to download free of charge at:
http://www.analystsreview.com/Oct-20-2014/LLY/report.pdf
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Aetna Inc. Research Reports
On October 15, 2014, Aetna Inc.'s (Aetna) subsidiary Aetna Medicaid announced that Delaware Physicians Care (DPCI) will not renew its contract to participate in the State of Delaware's Medicaid and other assistance programs. As a result, the award-winning Medicaid plan will close its operations, effective December 31, 2014. Aetna Medicaid's President and CEO Pamela Sedmak said that the move has come after several months of extended negotiations with the State, which have failed to result in a rate agreement that would cover the costs of operating the plan. "Without payment rates that support our ability to continue to provide high-quality service to members, we cannot keep this great health plan open," said Sedmak. The full research reports on Aetna are available to download free of charge at:
http://www.analystsreview.com/Oct-20-2014/AET/report.pdf
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