commercializing health technologies- israel’s start-up success sydney.pdf · 2011. 11. 29. ·...
TRANSCRIPT
Commercializing Health Technologies-
Israel’s Start-up Success
Yaron Ilan, M.D.
Gastroenterology and Liver Units
Department of Medicine
Hebrew University-Hadassah Medical Center
Jerusalem, Israel
11/20110 0.5 hr 1 hr 3 hr
iv 3hr
O r a l
IV
Forward Looking Statements
Please be advised that the information and projections provided in this
presentation may include forward-looking statements with respect to plans,
projections or future performance of the companies presented, the occurrence
of which involves certain risks and uncertainties and is not under the control of
these companies, including, but not limited to, changes in regulatory
environment, success in implementing its research, development, sales,environment, success in implementing its research, development, sales,
marketing and manufacturing plans, protection and validity of patents and other
intellectual property rights, the impact of currency exchange rates and the effect
of competition by other companies.
Disclosure
I have financial relationships with the companies below and the
content of my presentation does include a discussion of the
investigative use of Im122, IMM124, anti-CD3, and glucosylceramide.
Director: Exalenz Biosciences, Plantylight, WAYS
Medical Director: Accelmed; Immuron; Exalenz Biosciences.
Consultant: Teva Pharmaceuticals, ENZO Biochem, Consultant: Teva Pharmaceuticals, ENZO Biochem,
Chiasma Pharma, Plantylight, and Nasvax.
From bench to bedside to commercialization
Seven new developmentsSeven new developments
at the liver unit at Hadassah
5 The Chain of Scientific Discovery:
The Critical Role of the Physician-Scientist
Faxon, MD; Circulation 2002 Apr 16;105(15):1857-60
Bridging the gap
Biomedical Research
Disease
Mechanism
Clinical
trials
New
TherapiesBasic
Research
Patient oriented research
Mechanism trialsTherapiesResearch
Translational Research
From Bench to Bedside
bench bedside
physician- scientist
20 years ago, former NIH director,
James Wyngaarden, articulated this in a paper entitled: “The clinical investigator as an endangered species.”
8
“Fighting extinction of a rare creature, the physician-scientist”.
Disease
Mechanism
Clinical
trials
New
TherapiesBasic
Research
Patient oriented research
Biomedical Research at Hadassah
Mechanism trialsTherapiesResearch
Protected
research
time
Hadasit
Start up
companies
CRC:
Clinical research
center
Hadassah
2 hospitals (locations)
31 operating theaters
9 specialty ICUs
1,130 beds 2011
Hadassah Medical Organization in numbers
1,130 beds
5,000 employees
670 physicians
>1M outpatients/year
of the Israel Academy of Sciences & Humanities
Awards for basic medical research - to Hadassah
researchers>50%
of Bio-Medical Research in Hospitals in Israel is 40%
Research in Hadassah
Conducted at Hadassah40%
Scientific Publications in the Past 4 Years2000
Winners of “Israel Prize” Awards12
� Provides Innovative technologies, Medical Research &
Development Services
� Established 1986
� Promotes and Commercializes IP (>200 active patent families)
� Promotes Collaboration with Industry (services, consulting)
Technology Transfer Company of Hadassah Medical HospitalsTechnology Transfer Company of Hadassah Medical Hospitals
Hadasit
� Established and/or holds equity in dozens of companies
including public companies
�Products: Therapeutics, Diagnostics & Medical Devices
�Over 15 new license and option agreements in 2009-2011
Start-upsLicensing to
established co.Collaborations
and JV
Hadasit - Business Models
MediFreezePlantylight
WAYS[OneDay]Hiterpia
J&JNasVax
[BiolineRx]Biokine
Immuron
GamidaCellProtab
OraMedTheravir
RegeneCure
Target characterization1 � Hadasit
Lead identification2 � Hadasit
Lead optimization3 � Hadasit
Efficacy in animal model4 ���� Hadasit
Pre-clinical5 ���� Hadasit
Manuf. of clinical grade material6 ���� Hadasit
���� Hadasit
���� Hadasit
Hadasit – One-stop shop for biotech companies
Manuf. of clinical grade material6 ���� Hadasit
Phase I7 ���� Hadasit
Phase II8 ���� Hadasit
Phase III9 ���� Hadasit
Regulatory approval10 � Hadasit
Launch11 � Hadasit
Phase IV12 ���� Hadasit
Many ways to reach the target
Breathing
A public companyA public company
ResultsStart10-30 Minutes from Start to Results
The BreathID® Testing Method
Exhaled 13CO2 from 150+
breath samples is
trapped, processed &
analyzed
Patient Drinks 13C -labelled
substrate
Baseline
Measurement
Patient breathes normally
through cannula
• Commercial• Validated in thousands of patients
Validated
• Parts-per-Million accuracy
BreathID® Breath Test System
• Parts-per-Million accuracy• Insensitive to human errors• Automatic online calibration
Reliable
• Automatic and continuous testing• Minimal patient cooperation needed• One-button operation• Immediate results
Easy
18
NAFLD/NASH
Vitamin B12 Insufficiency
Drug Metabolism (personalized medicine)
Carbohydrates and lipids digestion and absorption
Peptic Ulcers (H. pylori)
Gastric Emptying Rate
Gastric Accommodation
Liver reserve, Fibrosis
Lactose Intolerance
Pancreatic Function
Diabetes Insulin Resistance
Oral-Ceacal Transit
Gastric Accommodation
Bacterial Overgrowth
Published: August 17, 2009
Healthy One Day, Dying the Next: A Medical Race
A RARE DISEASE Jessa Perrin, 16, at an exam last week just weeks after undergoing a liver transplant at New York-Presbyterian.
Follow-up of Patients with Severe Acute Liver Disease Using an On-Line Breath Test
A patient with liver failure recovered without
the need for liver transplantation after
showing improvement in his breath test.
Two patients patients who died: Breath
test score remained low despite fluctuating
laboratory values.
A non-invasive alternative to liver biopsy for 75% patients
Prediction of long-term prognosis in patientswith chronic liver disease
575 patients with chronic liver disease
Su
rviv
al
Pro
bab
ilit
y
Low Risk
Medium Risk
American Liver Association 2009 Presidential Plenary
Su
rviv
al
Pro
bab
ilit
y
Time to Death (Days)
High Risk
The U.S. H. pylori Opportunity
H. pylori Incidence
• Bacteria which may reside in the stomach
• ~25% U.S.
• Bacteria which may reside in the stomach
• ~25% U.S.
Potential Market
• ~5M tests per year*
• Average reimbursement is $100
• ~5M tests per year*
• Average reimbursement is $100
Current Market Share
The U.S. H. pylori Opportunity
Potential Market
• ~25% U.S. prevalence
• May lead to• Stomach ulcers• Stomach cancer
• WHO recognized carcinogen
• ~25% U.S. prevalence
• May lead to• Stomach ulcers• Stomach cancer
• WHO recognized carcinogen
reimbursement is $100reimbursement is $100
* Validated in 6 independent surveys, interviews and focus groups which included over 500 U.S. and European PCPs, GIs and Hepatologists
Expeditious Growth
Over 100 Medical Centers in the first year in the USA
25
30
35
34
0
5
10
15
20
Q3/10 Q4/10 Q1/11 Q2/11 Q3 Up to date
79
17
23
Executive Summary
� Proven, commercially solid technology, supported by clinical data from thousands of patients, operating in 150 medical centers worldwide
� Launched 1st U.S. application in H2 2010 for testing H. pylori, a test with established reimbursement and supported by ACG & AGA
� Extensive pipeline targeting multi-million $ markets
26
� Collaboration with large pharma companies
� Publicly traded since 2007 (TASE:EXEN)
� Regulatory approvals for the BreathID® System in major territories (FDA, CE)
� Strong scientific team and advisory board
� 55 patents covering applications and products
Eating
Licensing the IP to a public companyLicensing the IP to a public company
Turning on the “secret button” in our gut
Oral Immunotherapy: Eat your disease
An attractive approach to treat diseases
Hundreds of years ago, Jewish sages wrote in the Talmud:
“If one is bitten by a mad dog, he may eat his liver and be cured.”
• Forty nine subjects with moderate-severe Crohn’s disease
• Oral administration of study drug or placebo for 15 weeks
Remission Response
AlequelTM 39% 50%
Alleviation of Crohn’s colitis by oral tolerance
Placebo 22% 30%
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