Pfizer Position on Antimicrobial Resistance Management Kirill Tverskoy, Medical Director Pfizer Russia February 21, 2017
Objectives and Trends of Nowadays Healthcare Environment Effective and innovative technologies in healthcare Invasive methods of diagnostics and treatment Increasing amount of elderly patients and patients with chronic diseases Growth of hospital associated/acquired infections rate Increasing use of antimicrobial agents Spread of antibiotic and antifungal resistant strains More aggressive antimicrobial treatment (AMT) OUTCOMES: Decreased efficacy of antimicrobial agents Significant economic burden due to high AI treatment cost, treatment of complications Alliance of clinical microbiologists and chemotherapists data presented at Annual Congress of Federation of Reanimatologists and anestesiologists in Sept, 2016) 2
WHO Global Action Plan on Antimicrobial Resistance (2015) Improve awareness and understanding of antimicrobial resistance through effective communication, education and training Strengthen the knowledge and evidence base through surveillance and research Reduce the incidence of infection through effective sanitation, hygiene and infection prevention measures Optimize the use of antimicrobial medicines in human and animal health Develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions http://apps.who.int/iris/bitstream/10665/193736/1/9789241509763_eng.pdf 3
International Initiatives in Management of Infectious Diseases INNOVATIVE MEDICINES INITIATIVE (IMI) - Uniting European researchers in the fight against antibiotic resistance 1 : the world s largest public-private partnership in health care. IMI is improving the environment for pharmaceutical innovation in Europe by engaging and supporting networks of industrial and academic experts in collaborative research projects. GENERATING ANTIBIOTIC INCENTIVES NOW (GAIN) ACT 2 Special legislation conditions for Qualified Infectious Disease Product (including ABx) stimulating development of AIA (fast-track review, additional exclusivity and others) : THE 10X 20 INITIATIVE: PURSUING A GLOBAL COMMITMENT TO DEVELOP 10 NEW ANTIBACTERIAL DRUGS BY 2020 3 Initiated by IDSA (Infectious Disease Society of America) and combining of efforts of USA and EU in ABx development 1. http://www.imi.europa.eu/sites/default/files/uploads/documents/press%20releases/imipressrelease6thcallfinal.pdf. 2. http://thehill.com/images/stories/blogs/healthwatch/gainact.pdf 3. https://www.ohe.org/publications/new-drugs-tackle-antimicrobial-resistance-analysis-eu-policy-options 4
International initiatives expediting the approval of new AIA 21 st CENTURY CURES ACT (USA) expedite the process by which new high priority drugs (including AIA) are approved by easing the requirements, allows companies to provide "data summaries" and "real world evidence" such as observational studies, insurance claims data, patient input rather than full clinical trial results ADAPTIVE PATHWAYS PILOT (EU) seeks to balance timely access for patients who are likely to benefit most from the medicine with the need to provide adequate evolving information on the benefits and risks of the medicine itself. https://www.congress.gov/bill/114th-congress/house-bill/34/text https://www.gov.uk/government/publications/health-matters-antimicrobial-resistance/health-matters-antimicrobial-resistance Canas BS et al. Med Intens, Dec 2014 5
Stagnation in development and registration on new anti-infective agents (AIA) FDA approvals of new ABx in1983 2012 Registration of new ABx in Russia 16 15 14 13 12 10 10 8 6 4 4 3 3 2 1 0 1981-1985 1986-1990 1991-1995 1996-2000 2001-2005 2006-2010 2010-2014 Boucher HW, Talbot GH, Benjamin DK Jr, Bradley J, Guidos RJ, Jones RN, Murray BE, Bonomo RA, Gilbert D; Infectious Diseases Society of America. 10 x '20 Progress-development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jun;56(12):1685-94. http://grls.rosminzdrav.ru/ 6
Factors affecting interest of Big Pharma in development of anti-infective agents (AIA) Development of new AIA is expensive, long-term process with high risk of failure Amendments to intellectual property laws has resulted in earlier loss of exclusivity Anti-infective drugs are considered life-saving medications and are often the subject of aggressive price control we need a culture of cooperation between stakeholders; one that recognizes that there must be a balance between public health/clinical needs and the commercial realities of drug discovery and development Projan, S. Current Opinion in Microbiology 2003, 6, 427-430 7
Combining science, tools and technologies Pfizer has a unique expertise in Anti-infectives area 8
Pfizer: support of educational and scientific projects in Russia In collaboration with leading Russian scientific societies Pfizer supports educational and scientific projects to increase awareness and understanding of antimicrobial resistance, to implement antibiotics stewardship programs and to optimize the use of antimicrobial medicines 9
Pfizer: Support of the Governmental Strategy via transfer of technologies to Russia PETROVAX Partner PREVENAR Products POLYSAN ZYVOX (PO) NOVAMEDICA More than 30 SI including antimicrobial agents 10
Summary: Growing antibiotic resistance makes development new AIA as a crucial factor Optimization of ABx registration process is required to expedite new AIA authorization and provide earlier access to new effective medicines for patients with infectious disease Inclusion of all AIAs in EDL should be automatic upon registration to make it available for use in routine practice Implementation of antibiotics stewardship programs in all Russian hospitals is critical step to optimize use of existing and new anti-infectives and decrease budget impact. All these objectives are non achievable without the joint efforts of Professional Societies, Government and Industry 11