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RESEARCH ASSOCIATE

RESEARCH ASSOCIATE MEMBERS ACADIA Pharmaceuticals Inc. San Diego, CA Aerie Pharmaceuticals, Inc. Durham, NC AMAG Pharmaceuticals, Inc. Waltham, MA Avanir Pharmaceuticals, Inc. Aliso Viejo, CA BioMarin Pharmaceutical Inc. Novato, CA CSL Behring, LLC King of Prussia, PA Esperion Therapeutics, Inc. Ann Arbor, MI Ferring Pharmaceuticals Inc. Parsippany, NJ Grifols USA, LLC Los Angeles, CA Horizon Pharma plc Deerfield, IL Ipsen Biopharmaceuticals, Inc. Basking Ridge, NJ Marathon Pharmaceuticals, LLC Northbrook, IL Shionogi Inc. Florham Park, NJ Sucampo Pharmaceuticals, Inc. Bethesda, MD Theravance, Inc. South San Francisco, CA Vifor Pharma Basking Ridge, NJ VIVUS, Inc. Mountain View, CA 76 Appendix

REFERENCES 1 DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016;47:20-33. 2 DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016;47:20-33. 3 Pharmaceutical Research and Manufacturers of America. PhRMA annual membership survey. Washington, DC: PhRMA; 2015. 4 PhRMA analysis based on IMS Health. IMS national prescription audit TM . Danbury, CT: IMS Health; 2016. 5 Pharmaceutical Research and Manufacturers of America. PhRMA annual membership survey. Washington, DC: PhRMA; 2015. 6 Teconomy Partners. The economic impact of the U.S. biopharmaceutical industry. Published April 2016. 7 US Food and Drug Administration. Novel drugs 2015. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM485053.pdf. Published January 2016. Accessed March 2016. 8 US Food and Drug Administration. 2015 biological license application approvals. http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ BiologicalApprovalsbyYear/ucm434961.htm. Published January 14, 2016. Accessed March 2016. 9 US Food and Drug Administration. Summary of NDA approvals and receipts, 1938 to the present. http://www.fda.gov/aboutfda/whatwedo/history/ productregulation/summaryofndaapprovalsreceipts1938tothepresent/default.htm. Published January 18, 2013. Accessed March 2016. 10 US Food and Drug Administration. New drugs at FDA: CDER’s new molecular entities and new therapeutic biological products. http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/DrugInnovation/ucm20025676.htm. Updated February 8, 2016. Accessed March 2016. 11 US Food and Drug Administration. Biological approvals by year. http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ BiologicalApprovalsbyYear/default.htm. Accessed March 2016. 12 US Food and Drug Administration. Orphan drug designations and approvals database. www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm. Accessed March 2016. 13 Vernon JA, Golec JH, DiMasi JA. Drug development costs when financial risk is measured using the fama-french three-factor model. Health Econ. 2010;19(8):1002-05. 14 Adis R&D Insight Database. Accessed March 2016. 15 Analysis Group Inc. Innovation in the biopharmaceutical pipeline: A multidimensional view. http://www.analysisgroup.com/uploadedFiles/Publishing/ Articles/2012_Innovation_in_the_Biopharmaceutical_Pipeline.pdf. Published January 2013. Accessed March 2016. 16 Pharmaceutical Research and Manufacturers of America. Rare diseases: A report on orphan drugs in the pipeline. http://www.phrma.org/sites/default/files/ pdf/Rare_Diseases_2013.pdf. Published 2013. Accessed March 2016. 17 National Cancer Institute. Surveillance, epidemiology, and end results program. http://seer.cancer.gov/statfacts/html/ld/all.html. Accessed March 2016. 18 Sun E, Lakdawalla D, Reyes C, et al. The determinants of recent gains in cancer survival: An analysis of the surveillance, epidemiology, and end results (SEER) database. J Clin Oncol. 2008: May Suppl. Abstract 6616. 19 US Food and Drug Administration. Package insert PEG-Intron (Peginterferon alfa-2b). http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/ pegsche080701LB.htm. Published 2001. Accessed March 2016. 20 Pharmaceutical Research and Manufacturers of America. Decade of innovation in chronic diseases. http://phrma.org/sites/default/files/pdf/decade-ofinnovation-chronic-disease.pdf. Published February 2016. Accessed March 2016. 21 Centers for Disease Control and Prevention. Health, United States, 2014. http://www.cdc.gov/nchs/data/hus/hus14.pdf. Published in 2014. Accessed March 2016. (continued from inside front cover) 22 Truven Health Analytics. Impact of pharmaceutical innovation in HIV/AIDS treatment during the highly active antiretroviral therapy (HAART) era in the US, 1987-2010: An epidemiologic and cost-impact modeling case study. http://truvenhealth.com/wp/haart-era-pharma-innovation-hiv-aids-treatment. Published December 2014. Accessed March 2016.

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