Clinical Trial Data, NDA Submissions, and Board Changes - Analyst Notes on Alkermes, Cubist, Repligen, Flamel Technologies and Chimerix

NEW YORK, June 25, 2014 /PRNewswire/ --

Today, Analysts Review released its analysts' notes regarding Alkermes plc (NASDAQ: ALKS), Cubist Pharmaceuticals Inc. (NASDAQ: CBST), Repligen Corporation (NASDAQ: RGEN), Flamel Technologies SA (NASDAQ: FLML) and Chimerix, Inc. (NASDAQ: CMRX). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/4090-100free.

Alkermes plc Analyst Notes
On June 18, 2014, Alkermes plc (Alkermes) announced that it has presented the data from its Phase 3 clinical trial of aripiprazole lauroxil at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. According to the Company, in the study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. Additionally, the Company stated that it remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Q3 2014. Serge Stankovic, M.D., MSPH, Senior Vice President, Clinical Development and Medical Affairs of Alkermes, said, "With these compelling phase 3 data in hand, we are moving forward expeditiously to bring aripiprazole lauroxil to patients with schizophrenia and their families." The full analyst notes on Alkermes are available to download free of charge at:

http://www.analystsreview.com/Jun-25-2014/ALKS/report.pdf

Cubist Pharmaceuticals Inc. Analyst Notes
On June 19, 2014, Cubist Pharmaceuticals Inc. (Cubist) announced that the Company's New Drug Application (NDA) for its investigational antibiotic ceftolozane/tazobactam has been accepted by the U.S. Food and Drug Administration (FDA) with Priority Review. According to the Company, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 21, 2014. Additionally, the Company stated that it is seeking FDA approval of ceftolozane/tazobactam for treating complicated urinary tract infections and complicated intra-abdominal infections. Company Executive Vice President of Research and Development and Chief Scientific Officer, Steven Gilman, Ph. D., said, "We are pleased that the FDA accepted the NDA with Priority Review for ceftolozane/tazobactam. We look forward to working with the FDA on the review, and hope to bring this potential new treatment option to physicians and their patients to address resistant Gram-negative infections." The full analyst notes on Cubist are available to download free of charge at:

http://www.analystsreview.com/Jun-25-2014/CBST/report.pdf

Repligen Corporation Analyst Notes
On June 12, 2014, Repligen Corporation (Repligen) announced that the Company has elected Nicolas M. Barthelemy to the Company's Board of Directors. According to the Company, Mr. Barthelemy most recently served as the President, Global Commercial Operations at Life Technologies, a multinational life sciences company acquired by Thermo Fisher Scientific. Repligen President and CEO, Walter C. Herlihy, stated, "I am pleased to welcome Nicolas Barthelemy as a fitting addition to the Repligen Board. Mr. Barthelemy's input will have immediate value as we expand our commercial organization to market our growing portfolio of proprietary bioprocessing products that we sell to leading biopharmaceutical manufacturers worldwide." The full analyst notes on Repligen are available to download free of charge at:

http://www.analystsreview.com/Jun-25-2014/RGEN/report.pdf

Flamel Technologies SA Analyst Notes
On June 16, 2014, Flamel Technologies SA (Flamel Technologies) announced that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 6, 2014 to the Company for its second New Drug Application (NDA) for an Unapproved Marketed Drug (UMD). According to the Company, it had received a Complete Response Letter (CRL) to its NDA as of April 28, 2014, and resubmitted the NDA on June 6, 2014. Additionally, the Company stated that its CRL resubmission has been classified as a Class 1 response by the FDA. The full analyst notes on Flamel Technologies are available to download free of charge at:

http://www.analystsreview.com/Jun-25-2014/FLML/report.pdf

Chimerix, Inc. Analyst Notes
On June 20, 2014, Chimerix, Inc.'s (Chimerix) stock increased 5.54%, closing at $23.26. Over the past three day trading period, Chimerix's stock increased by 5.06%, compared to the Nasdaq Composite which increased by 0.71% during the same trading period. The full analyst notes on Chimerix are available to download free of charge at:

http://www.analystsreview.com/Jun-25-2014/CMRX/report.pdf

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