Settlements, Statements, FDA Submissions and Approvals - Analyst Notes on Valeant, Pfizer, Actavis, Allergan and Teva
Editor Note: For more information about this release, please scroll to bottom.
NEW YORK, June 20, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Valeant Pharmaceuticals Intl Inc (NYSE: VRX), Pfizer Inc. (NYSE: PFE), Actavis plc (NYSE: ACT), Allergan, Inc. (NYSE: AGN) and Teva Pharmaceutical Industries Ltd (NYSE: TEVA). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/3940-100free.
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Valeant Pharmaceuticals Intl Inc Analyst Notes
On June 16, 2014, Valeant Pharmaceuticals Intl Inc (Valeant) announced that its Restylane® Silk Injectable Gel with 0.3% Lidocaine has received marketing clearance from the U.S. Food and Drug Administration (FDA). According to the Company, Restylane® Silk Injectable Gel is indicated for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21. J. Michael Pearson, Chairman and CEO remarked, "We are pleased to have received marketing clearance from the FDA for Restylane® Silk so quickly after the approval of Jublia. Our R&D team is hitting on all cylinders and demonstrating that Valeant has a successful, output-focused R&D model that concentrates on areas of expertise where we are confident that our investments will pay off." The full analyst notes on Valeant are available to download free of charge at:
http://www.analystsreview.com/Jun-20-2014/VRX/report.pdf
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Pfizer Inc. Analyst Notes
On June 17, 2014, Pfizer Inc. (Pfizer) announced that a Biologics License Application (BLA) has been submitted to the U.S. Food and Drug Administration (FDA) for bivalent recombinant LP2086 (rLP2086), which is the Company's vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds. Commenting on the submission, Dr. Emilio Emini, Senior Vice President of Vaccine Research and Development for Pfizer said, "The BLA submission for bivalent rLP2086 marks an important step toward our goal of helping to protect adolescents and young adults against this difficult to diagnose and often deadly disease. There is an urgent public health need to help prevent meningococcal B disease through vaccination, and we will continue to work closely with the FDA in our efforts to advance our vaccine candidate." The full analyst notes on Pfizer are available to download free of charge at:
http://www.analystsreview.com/Jun-20-2014/PFE/report.pdf
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Actavis plc Analyst Notes
On June 17, 2014, Actavis plc (Actavis) and Forest Laboratories, Inc. announced that all proposals related to Actavis' planned acquisition of Forest Laboratories, Inc (Forest) were approved by shareholders of both companies at shareholder meetings held on the date of announcement. Actavis said that both companies'shareholder approvals satisfy certain conditions to the closing of the transaction, which is expected to occur mid-year, subject to certain regulatory approvals and other customary closing conditions. The full analyst notes on Actavis are available to download free of charge at:
http://www.analystsreview.com/Jun-20-2014/ACT/report.pdf
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Allergan, Inc. Analyst Notes
On June 16, 2014, Allergan, Inc. (Allergan) repeated its concerns in relation to Valeant Pharmaceuticals International, Inc.'s (Valeant) unsustainable business model, which depends on serial acquisitions and cost reductions, as compared to top-line revenue growth and operational excellence. Allergan also stated that a number of third parties have also expressed similar views. The Company added that as previously announced, its Board of Directors had determined that the re-revised unsolicited proposal dated May 30, 2014 by Pershing Square Capital Management, L.P. and Valeant substantially undervalues the Company, creating significant risks and uncertainties for the stockholders of Allergan, and is not in the best interests of the Company and its stockholders. The full analyst notes on Allergan are available to download free of charge at:
http://www.analystsreview.com/Jun-20-2014/AGN/report.pdf
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Teva Pharmaceutical Industries Ltd Analyst Notes
On June 17, 2014, Teva Pharmaceutical Industries Ltd (Teva) announced that it has reached settlements with Actavis, Lupin and Apotex regarding U.S. Patent 7,132,570 (the 570 patent) for its wakefulness product, NUVIGIL® (armodafinil) tablets. The Company informed that these settlements dismiss a pending appeal with the United States Court of Appeals for the Federal Circuit of a trial court decision that found the '570 patent to be valid and infringed. The Company stated that under the settlement, it has granted licenses to allow these parties to market their generic products 180 days after Mylan, the first generic company to file an abbreviated new drug application for the 50 mg, 150 mg, and 250 mg dosages of NUVIGIL®. The settlements also permit Actavis to launch generic 100 mg and 200 mg dosages in June 2016, and the others may launch these dosages 180 days after Actavis. The full analyst notes on Teva are available to download free of charge at:
http://www.analystsreview.com/Jun-20-2014/TEVA/report.pdf
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