mark j. alles...first new lupus drug in 50 years the first drug for huntington’s disease first...
TRANSCRIPT
New York Bio Conference 2016
Mark J. AllesChief Executive Officer
Great Progress
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69
69.5
70
70.5
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71.5
72
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
World Life Expectancy2005 - 2014*
New class of
medicines to treat
high blood
pressure
First treatment
for PTCL
Two new MS
drugs
First new lupus
drug in 50 years
The first drug for
Huntington’s
disease
First therapeutic
cancer vaccine
In 2014, 1 in 5
FDA
approvals are
personalized
medicines
17 new drugs
for rare
diseases
Oral
treatments
for Hep C
with upwards
of 90% cure
rates
2015: 4 new
drugs for
multiple
myeloma
First drug to
target root cause
of cystic fibrosis
2 new
personalized
medicines to
treat skin cancer
AGE
First vaccine for
the prevention of
cervical cancer
* The World Bank Data, accessed May 4, 2016, Life Expectancy at birth, total years http://data.worldbank.org/indicator/SP.DYN.LE00.IN/countries/1W?display=graph
Great Opportunities
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Great Challenges
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Great Challenges & Great Opportunities
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“The Politics of Pricing” vs. The Value of Medical Innovation
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We Have Been Asking the Same Question for Decades
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LIFE Magazine, May 1992 TIME Magazine, April 2013
Jimmy Carter’s Cancer Treatment Inspires New Law
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ATLANTA (AP) - Georgia's governor has signed a bill
inspired by former President Jimmy Carter's cancer
treatment.
The measure signed Tuesday by Republican Gov. Nathan
Deal prevents insurance companies from limiting coverage
of drugs for stage four cancer patients. Supporters of the bill
say patients sometimes cannot get certain drugs unless they
first try other treatment options.
Carter, now 91, announced in August that he had been
diagnosed with skin cancer that had spread to his brain and
would begin receiving doses of Keytruda. The newly
approved drug helps the immune system seek out cancer
cells appearing in a patient's body.
Carter said in March that he had stopped treatment after
several scans found no cancer in his body.
May 3, 2016
The Cost of Pharmaceuticals is a Worldwide Focus
Latin American countries are
considering joint negotiations
France is calling for the addition of drug pricing
to the agenda for the G-7 summit in May
In Japan, the government is
considering moving to annual
price reductions
Restrictive policies for NICE and
the Cancer Drugs Fund in the UK
Proposals for drug pricing
transparency in the EU
Countries in Asia are looking to
NICE Cost Effectiveness
Assessments as a model for
reimbursement decisions
The United Nations Secretary
General has convened a high-
level panel on access to
medicines
China CFDA proposal to require
lowest prices in Asia for new drug
applications
$-
$1,000
$2,000
$3,000
$4,000
$5,000
1980 2004 2009 2014 2019 2024
Na
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NATIONAL HEALTH EXPENDITURES IN BILLIONS, 1980-2024
The Growing Aging Population Drives Healthcare Spending Increase
1. Centers for Medicare & Medicaid Services. “National Health Expenditure Projections 2014-2024.” July 2015. Available at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-reports/NationalHealthExpendData/NationalHealthAccountsProjected.html
Baby Boomers
Entering Medicare
Unless We Find New Solutions, The Cost of Conditions Like Alzheimer’s, Diabetes and Obesity Will Be Crippling
$1.1 Trillion
$48B - $66B
$390B - $580B
Sources: Changing the Trajectory of Alzheimer’s Disease: How a Treatment by 2025 Saves Lives and Dollars, Alzheimer’s Association;
The State of Obesity: Better Policies for a Healthier America: 2014, Robert Wood Johnson Foundation
Proportion of Americans Age 65 and Older Living
with Alzheimer’s by Disease Stage, 2015-2050
43%
27%
30%
0
2015 Current
5.1 million
48%
23%
28%Severe
Mild
Moderate
2050 Trajectory
13.5 million
Far Too Much Cost In Healthcare Is Driven by Waste
HUNDREDS OF BILLIONS CAN BE SAVED ANNUALLY WITHOUT ADVERSELY IMPACTING PATIENT CARE
Sources: 1. http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_72.pdf 2. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3934668/ 3.http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/ 4.
http://www.ncsl.org/portals/1/documents/health/MedicalMalReform-2011.pdf 5. 0 Agency for Healthcare Research and Quality. Statistical Brief #172, April 2014 Available from: http://www.hcup-us.ahrq.gov/reports/statbriefs/sb172-Conditions-
Readmissions-Payer.pdf (Accessed December 9, 2014). 6. IMS Institute for Healthcare Informatics. Avoidable costs in US healthcare: the $200 billion opportunity from using medicines more responsibly. June 2013.
http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS%20Institute/RUOM-2013/IHII_Responsible_Use_Medicines_2013.pdf. Accessed March 2015.
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Empowering Patients & Digital Medicine:People Will Be More “Connected” Than Ever
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“Big Data” & Personalized Medicine:More Advances Expected Over the Next 5 Years
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Value-Based Insurance
Design
Disease Management
Programs
Employer Health &
Wellness Programs
Eliminated or Reduced
Copays
Fully Covers Preventive
Care
Reduced Premiums if
Participated in Disease
Management Program
Linked Pharmacists &
Employees to Fight
Chronic Conditions
Smoking Cessation
Programs
Obesity & Wellness
Education and
Programs
Who’s Done it? Who’s Done it? Who’s Done it?
How Employers are Reducing Healthcare Costs
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Partnering with Government to Advance Solutions
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AMP (Accelerating Medicines Partnership)Developing new diagnostics and targets in Alzheimer’s, type 2 diabetes, rheumatoid arthritis, and lupus
The Partners: biopharmaceutical companies, NIH, patient and disease organizations
BIOMARKERS CONSORTIUMCombining expertise and resources to rapidly identify, develop, and qualify biomarkers, which will then advance
new therapies and guide improvements in regulatory and clinical decision making
The Partners: biopharmaceutical companies, NIH, CMS, FDA, patient and disease organizations
LUNG-MAP (Lung Cancer Master Protocol)Using comprehensive genetic screening to identify mutations in lung cancer patients in order to direct them to a specific investigational treatment, all operating under a single clinical trial protocolThe Partners: biopharmaceutical companies, NIH, FDA, patient and disease organizations
CLINICAL TRIALS TRANSFORMATION INITIATIVE (CTTI)CTTI engages all stakeholders as equal partners to analyze existing research impediments and recommend consensus-driven, actionable solutions that will lead to a more sustainable and effective clinical trial system.The Partners: biopharmaceutical and device companies, NIH, CMS, professional societies, academic institutions, patient and disease organizations
REAGAN UDALL FOUNDATION FOR THE FDA Independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDAThe Partners: biopharmaceutical and device companies, NIH, CMS, professional societies, academic institutions, patient and disease organizations
Part D – One of the Most Successful Partnering Examples
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Gaining Part
D coverage
resulted in
an
8%decrease in
hospital
admissions
for seniors
overall
PHARMACEUTICAL INDUSTRY SUPPORT FOR THE AFFORDABLE CARE
ACT ESTIMATED TO TOTAL APPROXIMATELY
$90B BY 2020, WITH
APPROXIMATELY
$30B IN EXPENSES FROM 2011 -
2020 RELATING TO ELIMINATING PART D
COVERAGE GAP
Sources: PhRMA Medicines in development for Older Americans Reports, 2003 and 2013; Kaestner R, Long C, Alexander C. Effects of prescription drug insurance on hospitalization and mortality: evidence from Medicare Part D. The National Bureau of Economic Research. Published February 2014; http://www.businesswire.com/news/home/20120430005168/en/2020-Pharmaceutical-Industrys-Support-U.S.-Affordable-Care
Retail Spending on Prescription Medicines Is a Small Share of Total US Health Care Spending
• Prescription medicines today account for about 10% of health care spending in America, the same percentage as in 1960.
• PhRMA analysis of CMS data. National health expenditures by type of service and source of funds, CY 1960-2013. Baltimore, Md.: CMS; 2013. Accessed February 2015. Profile Figure 4 Accessed at http://chartpack.phrma.org/biophrma-chartpack/spending-and-costs/retail-spending-on-prescription-medicines-is-a-small-share-of-total-us-health-care-spending.
*Other includes dental, home health, and other professional services as well as durable medical equipment costs.
One Driver of Healthcare Spending Guaranteed to Go Down in Cost:Prices of Current Best-In-Class Therapies, Due To Limited Exclusivity Periods
Medicine Year
Brand
Price
Then
Generic
Price
Now
%
Change
DIOVAN HCT® 2010 $87 $15 -85%
LIPITOR® 2010 $85 $5 -95%
PLAVIX® 2011 $166 $8 -97%
SEROQUEL® 2010 $87 $7 -97%
ZYPREXA® 2010 $393 $12 -98%
Figures represent the average annual price for 30 pills of the most commonly dispensed
form and strength. “Then” price represents the average price in the year prior to generic
entry. “Now” price represents the average price in CY 2016.
Sources: IMS Analysis of PhRMA, May 2015; Kleinrock M. Daily cost of Medicare Part D. December 2013 Update. December 2013. IMS Institute for Healthcare Informatics.
Daily Cost of Top-10* Therapeutic Classes Most
Commonly Used by Part D Enrollees Has Declined
and is Estimated to Continue to Decline
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Co
st P
er D
ay (
$)
Actual
Estimated
* From 2006
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Solutions Will Come From Us
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Source: Sampat B, Lichtenberg F. What are the respective roles of the public and private sectors in pharmaceutical innovation? Health Affairs. 2011; 30(2):332-339.
Over 7,000 New Medicines in Development
CANCERS
1,813
CARDIOVASCULAR
DISORDERS
599
DIABETES
475HIV/AIDS
159
IMMUNOLOGICAL
DISORDERS
1,120
INFECTIOUS
DISEASES
1,256
MENTAL HEALTH
DISORDERS
511
NEUROLOGICAL
DISORDERS
1,329
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Source: Adis R&D Insight Database. Accessed May 2015.
Investment Is Coming From Our Industry
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Celgene Has Championed a Mutually Beneficial Collaborative Model
CELGENE
PLATFORMS
FibrosisCancer
Stem Cells/Resistance
Immuno-Oncology
EpigeneticsNext
GenerationBiologics
ProteinHomeostasis
Immunology
Novel IMiDs® /CRBN & Other
Ubiquitin LigaseTargets
New Targets, EpigeneticPriming &
Convergence w/ Metabolic Targets
GDF Family PKCq,
BTKi, Novel Targets
JNK1, New Targets,
Novel phenotypic
screens
Payload Delivery,Next GenEnhanced Activities
Complementary Approaches to
I/O,Breaking Tumor
Tolerance
Unique Validation / Testing
Capabilities fromTumor Tissue
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“
Future Medical Breakthroughs Will Come from Innovative & Entrepreneurial Solutions
“Patients Are Waiting…”
New York Bio Conference 2016
Mark J. AllesChief Executive Officer