Janssen Italy Medical Education Meeting Michael Schlag | Janssen EMEA | April 16, 2014 An Overview of Janssen Infectious Diseases and Vaccines Melinda, Goddess of Healing Melinda’s artwork reflects her journey living with HIV.
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Janssen Italy Medical Education Meeting
Michael Schlag | Janssen EMEA | April 16, 2014
An Overview of Janssen Infectious Diseases and Vaccines
Melinda, Goddess of Healing Melinda’s artwork reflects her journey living with HIV.
Infectious Diseases an ever growing public health concern
2
Population Growth
Travel Megacities Climate Change
The future looks very bright for microbes, not so
good for humanity.” Dr. Margaret Chan World Health Organization (WHO) “
Infectious Diseases and Vaccines/Who we are/Our heritage
The spread of some diseases has been halted
3
Infectious Diseases and Vaccines/Who we are/Our heritage
Water sanitation
Immunization
Antibiotics and antivirals
Our holistic approach to infectious diseases
4
Infectious Diseases and Vaccines/Who we are/Our heritage
Diagnosis Prevention Treatment Cure
Patients are at the heart of everything we do
5
Lesley UK, former HCV patient At five months post treatment the virus came back. I was devastated that I'd relapsed. I found out about a drug trial that was running in London. It was another 48 weeks of interferon and ribavirin with a 24 week period at the beginning of the trial drug.
“ In July 2010 I achieved a sustained
virological response (SVR) having been on the telaprevir [INCIVO®] trial.”
Tiko Canada, HIV patient I've been HIV positive for about 30 years. I discovered I was completely immune to all the known helpful therapies. So I enrolled in the darunavir [PREZISTA®] trial. “ Within the first five days my virus dropped 90% and has kept dropping steadily. So, I feel terrific! I haven't felt this well in years! “ To the researchers, I give my most profound thanks. I'm really impressed that they came up with such an effective agent against this virus. Thank you! ”
“ “
Infectious Diseases and Vaccines/Who we are/Our values
Our approach to R&D
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Our R&D arm is vital to building a successful company that can improve healthcare worldwide
15 new products launched in the last ten years
Most productive drug company of the last ten years (Forbes)
Infectious Diseases and Vaccines/The partner of choice/Our approach/R&D
No single company or institution can tackle the challenge of infectious diseases alone
Committed to collaboration for the advancement of global healthcare
Partners including research institutions, companies and not-for-profit organizations are key and valued contributors to our business
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Partnerships the key to our success
*Linked to case studies in appendix, partner list is not exhaustive
Infectious Diseases and Vaccines/The partner of choice/Our approach/Partnerships
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Today, we have a portfolio addressing major healthcare needs
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Hepatitis Respiratory Infections
Sexually Transmitted Infections
(STIs)
Global Public Health
Vaccines Bacterial
Infections
Infectious Diseases and Vaccines/The partner of choice/Innovative products
& Janssen Hepatitis
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1 World Health Organization. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index1.html 2 Lozano, R Global and regional mortality from 235
causes of death for 20 age groups in 1990 and 2010. Lancet 380 (9859): 2095–128. PMID 23245604 3 McHutchison J, Lawitz EJ, Shiffman ML et al.
Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection. New England Journal of Medicine 2009;361:580–93.
Infectious Diseases and Vaccines/The partner of choice/Innovative products/Hepatitis
An
tivir
als
Vaccin
es
We know that: Worldwide, chronic viral
hepatitis causes 80% of all primary
liver cancer1 with more than 750,000 people dying each year from
this lethal cancer,2 making it the third leading cause of cancer death globally.2
already marketed
in our pipeline
Hepatitis C
JNJ- 56914845
Hepatitis A Hepatitis B
HEPAVAX- GENE®
We aim to partner with the hepatitis community and healthcare systems to positively impact patients’ lives and address the global pandemic.
our hepatitis portfolio
Simeprevir TMC- 055
Ongoing IFN-free studies including simeprevir
Compound Class Partner
Simeprevir / Sofosbuvir
PI NI
Janssen Gilead
Simeprevir / Daclatasvir
PI NS5a
Janssen BMS
Simeprevir / GSK805 / TMC055
PI NS5a NNI
Janssen Janssen Janssen
Simeprevir / IDX719
PI NS5a
Janssen Idenix
Simeprevir / IDX719 / TMC055
PI NS5a NNI
Janssen Idenix
Janssen
Simeprevir / VX135
PI NI
Janssen Vertex
Beumont, M., Rome-3 HCV ad_Dec13; Jacobson I, et al. AASLD 2013. Poster 1122.
& Janssen Sexually Transmitted Infections including HIV
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* Part of the Janssen Global Public Health Portfolio 1 UN, World Populations Policies 2009 2 WHO, HIV/AIDS Online Q&A
Infectious Diseases and Vaccines/The partner of choice/Innovative products/STIs
An
tivir
als
Vaccin
es
We know that: HIV is the single most significant population concern causing
excessive deaths and impacting families, healthcare services and economies.1
Globally, there are around 34 million people living with HIV.2
already marketed
in our pipeline
HIV HIV
HEPAVAX- GENE®
We aim to help all patients achieve an undetectable viral load and a better quality of life.
our portfolio
HIV
Fixed dose combination darunavir w/
cobicistat
& Janssen Vaccines
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1 World Health Organization http://www.who.int/mediacentre/factsheets/fs378/en/index.html 2 World Health Organization http://www.who.int/immunization/newsroom/highlights/2012/en/index.html
Infectious Diseases and Vaccines/The partner of choice/Innovative products/Vaccines
We know that: 2-3 million deaths are averted
annually by vaccination.1 But an estimated 22 million infants worldwide are still
missing out on basic vaccines.1 WHO
Member States recently endorsed a landmark Global Vaccine Action Plan, a roadmap to
prevent millions of deaths by 20202
We are committed to
supporting individuals, organizations and states realize the Global Vaccine Action Plan for 2020 by developing new and improved vaccines for vaccine-preventable infections
Cholera Typhoid Influenza Hepatitis B
HEPAVAX- GENE®
Hepatitis A
Markete
d
vaccin
es
our portfolio
HEPAVAX- GENE®
HIV
diphtheria, tetanus, pertussis Hep B, Hib
Pip
elin
e
vaccin
es Bacteremia
Men B ExPEC
Influenza
Universal influenza vaccine
Lower RTI
RSV* vaccine Rabies Polio Dengue
fever HIV FluCell®
Meningococcal disease
& Janssen Global Public Health
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* SIRTURO® has been approved by the US FDA and by the EMA 1 Harvard Global Health Institute http://globalhealth.harvard.edu/infectious-diseases
Infectious Diseases and Vaccines/The partner of choice/Innovative products/Global public health
Vaccines MDR-TB HIV
Long acting rilpivirine (TMC278-
LA)
our portfolio
We know that:
Infectious diseases spread, irrespective of national borders and class divides.1
We align groundbreaking science and innovative access models to drive better outcomes, improve quality of life for patients and sustainably advance healthcare worldwide.
Markete
d
pro
du
cts
Pip
elin
e
prod
ucts
Rabies Polio Dengue fever
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Our Approach to Access for HIV: Global Access and Partnership Program (GAPP)
Committed to sustainable access in 112 resource-limited countries
Ensuring appropriate and safe use of our HIV medicines
http://www.janssenhivproductinfoafrica.com/
Address unique challenges of HIV drug access
Infectious Diseases and Vaccines/The partner of choice/Our approach/Access
2007 2008 2009 2010 2011 2012
GAPP established
License & commercialization
agreement for generic darunavir
covering India
Five generic licensing agreements for
rilpivirine covering 112 resource-limited
countries signed before first
regulatory approval
Policy not to enforce darunavir patents in SSA and
LDCs established
Licensing agreement for
darunavir expanded to
enable generic production in
India
First commercialization
& distribution agreement for PREZISTA®
covering SSA and LDCs
Reaching Patients in Need
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As of June 2013
Requirements Core Elements
Appropriate external
partnerships and collaborations
Medical engagement to
ensure appropriate use
Value Drug must provide value (efficacy, cost
savings)
Organization Dedicated resources to
coordinate, communicate, and execute activities
Impact Drug must get into the
hands of people who need it
Consistent communication to the right people (external and
internal)
5 Key Elements to Access and Affordability Model
1) Pricing: that balances between value/innovation, affordability and appropriate use
2) Registration: Prioritized registration efforts by high disease burden
3) Partnerships: Innovative partnerships to improve access including transfer of technology (India) and local manufacturing and commercialization (Russia/CIS countries)
4) Appropriate Use: Support of appropriate use through responsible distribution in collaboration with international and national TB programs
5) R&D commitments: Regulatory commitments in R&D, including
Phase 3 program
Pediatric formulation (EU)
Patient registry
The people who use our products are at the heart of everything we do:
– Our ethical framework is driven by our Credo
Our holistic approach includes diagnosis, prevention, treatment and cure
We value collaboration:
– Our business is based on our innovation and partnerships which we translate into commercial success
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Infectious Diseases and Vaccines summary
Infectious Diseases and Vaccines/Summary
Thank you
Melinda, Goddess of Healing Melinda’s artwork reflects her journey living with HIV.
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