Pfizer Position on Antimicrobial Resistance Management

Kirill Tverskoy, Medical Director Pfizer Russia February 21, 2017

Objectives and Trends of Nowadays Healthcare Environment

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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)

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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

WHO Global Action Plan on Antimicrobial Resistance (2015)

http://apps.who.int/iris/bitstream/10665/193736/1/9789241509763_eng.pdf

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International Initiatives in Management of Infectious Diseases

INNOVATIVE MEDICINES INITIATIVE (IMI) - Uniting European researchers in the fight against antibiotic resistance1:

• 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)” ACT2

• 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 20203

• 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

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21st 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

International initiatives expediting the approval of new AIA

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

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Stagnation in development and registration on new anti-infective agents (AIA)

FDA approvals of new ABx

in1983–2012

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/

Registration of new ABx in Russia

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Factors affecting interest of Big Pharma in development of anti-infective agents (AIA)

“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

• 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

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Combining science, tools and technologies Pfizer has a unique expertise in Anti-infectives area

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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

Pfizer: support of educational and scientific projects in Russia

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Pfizer: Support of the Governmental Strategy via transfer of technologies to Russia

Partner Products

PETROVAX PREVENAR

POLYSAN ZYVOX (PO)

NOVAMEDICA More than 30 SI including antimicrobial agents

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Summary:

All these objectives are non achievable without the joint efforts of Professional Societies, Government and Industry

• 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.