For more information on ongoing clinical trials of rLP2086, visit www.clinicaltrials.gov.Pfizer Inc: Working together for a healthier world™ At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com. DISCLOSURE NOTICE: The information contained in this release is as of March 20, 2014. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a product candidate, rLP2086, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results; whether and when any biologics license applications may be filed in any jurisdictions for rLP2086; whether and when any such applications may be approved by regulatory authorities as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and in its subsequent reports on Form 10-Q and Form 8-K.1 Kieny MP, Excier J, Girard M. Research and Development of New Vaccines Against Infectious Diseases. American Journal of Public Health. 2004;94(11):1931-1935. 2 Centers for Disease Control and Prevention, Meningococcal disease: help prevent it. 2011. http://www.cdc.gov/Features/Meningococcal/. Accessed February 14, 2014. 3 U.S. Food and Drug Administration. Food and Drug Administration Safety and Innovation Act. http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf. Accessed March 11, 2014. 4 U.S. Food and Drug Administration. Frequently Asked Questions: Breakthrough Therapies. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm. Accessed March 11, 2014. 5 ClinicalTrials.gov. A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years. http://clinicaltrials.gov/ct2/show/NCT01830855?term=B1971009&rank=1. Accessed March 11, 2014. 6 ClinicalTrials.gov. A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years. http://clinicaltrials.gov/ct2/show/NCT01352793?term=B1971014&rank=1. Accessed March 11, 2014. 7 ClinicalTrials.gov. A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age. http://clinicaltrials.gov/ct2/show/NCT01461980?term=B1971015&rank=1. Accessed March 11, 2014. 8 ClinicalTrials.gov. A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years. http://clinicaltrials.gov/ct2/show/NCT01299480?term=B1971012&rank=1. Accessed March 11, 2014. 9 ClinicalTrials.gov. A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years. http://clinicaltrials.gov/ct2/show/NCT01323270?term=B1971010&rank=1. Accessed March 11, 2014. 10 ClincalTrials.gov. A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents. http://clinicaltrials.gov/ct2/show/NCT00808028?term=B1971005&rank=1. Accessed March 11, 2014. 11 ClinicalTrials.gov. A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17. http://clinicaltrials.gov/ct2/show/NCT01461993?term=B1971011&rank=1. Accessed March 11, 2014. 12 ClinicalTrials.gov. A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years. (B1971016). http://clinicaltrials.gov/ct2/show/NCT01352845?term=B1971016&rank=1. Accessed March 11, 2014. 13 Pinto VB, Burden R, Wagner A, Moran EE, Lee C. The Development of an Experimental Multiple Serogroups Vaccine for Neisseria meningitidis. PLoS ONE. 2013; 8(11): 1-10. 14 Granoff D. Review of Meningococcal Group B Vaccines. Clin Infect Dis. 2010; 50(2); 554-565. 15 Murphy E, et al. Sequence diversity of the Factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009;200:379-89. 16 Richmond PC, Marshall HS, Nissen MD, et al. Safety, immunogenicity, and tolerability of meningococcal serogroup B (MnB) bivalent rLP2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012;12(8):597-607. Published online ahead of print May 2012. 17 Vesikari T, Diez-Domingo J, Ostergaard L, et al. Safety, Tolerability, and Immunogenicity of an Investigational Meningococcal Serogroup B Bivalent rLP2086 Vaccine When Administered in Regimens of 2 or 3 Doses in Healthy Adolescent Subjects aged 11 to 18 Years. Poster presented at: 9th Conference of the Meningitis Research Foundation; 2013 November 5-6. London, United Kingdom. http://www.meningitis.org/assets/x/55599. Accessed March 13, 2014.