2. BLOOD-BRAIN BARRIER (BBB) UNLOCKED
BDG-DOPAMINE® – a new Parkinson’s disease drug
featuring the direct delivery of dopamine to the brain across the blood-brain barrier based on
the proprietary delivery technology
Game-changing disruption on the market for central nervous system drugs
!
2-3 min
BBB
Substance enabling
delivery (“Provider”)
Dopamine
Dopamineagonist
(optional)
BDG-DOPAMINE®:
nasal spray
(or drops)
Brain
capillaries
Brain
2
3. EXECUTIVE SUMMARY: WHY INVEST IN BBU?
Limited efficacy of drug treatment of Parkinson’s disease (PD)
PROBLEM
BDG-DOPAMINE® offers improvement over major existing drug
substance (levodopa)
SOLUTION
Benefits patients: increased efficacy & fewer side effects
WHY OUR SOLUTION?
A
B
C
Superior product (“proof-of-concept” completed, PCT patents filed)
WHY INVEST?
+
+
+
+
BBU PHARMACEUTICALS
Benefits doctors: wider choice & treatment flexibility
Benefits pharma manufacturers: patent protection & new brand
Strong team
Underpenetrated market and massive unmet needs
Clear exit path through a trade sale
3
4. PROBLEM: LIMITED EFFICACY OF PD TREATMENT
A
PD is the 2nd most common adult-onset neurodegenerative disease.
B
No cure, few drugs, limited therapeutical efficacy
1 SUBSTANCE
WITH LIMITATIONS
NO ALTERNATIVE
Levodopa
Is the only
substance for
PD therapy at
advanced stage
BBU PHARMACEUTICALS
Slow, side
effects,
diminishing
efficacy
No
alternative
& dearth of
new drugs
4
5. OUR SOLUTION: BDG-DOPAMINE®
A new drug overcoming shortcomings of Levodopa
2-3 min
BBB
Provider
Value for
Patients vs.
Levodopa
Completed
Milestones
Dopamine
Dopamineagonist
(optional)
BDG-DOPAMINE®
nasal spray
Brain
capillaries
Brain
1
Fewer side effects
3
Lower dosage (& lower costs)
2
Fast Activaton
4
Solution to “On-Off” syndrome problem
“Proof of concept” via physiological and radioisotopic studies on animals
PCT patent application filed in Germany
BBU PHARMACEUTICALS
5
6. MARKET SIZE
GLOBAL PARKINSON’S
DISEASE DRUG MARKET
SCALE OF PROBLEM
A
PD affects 4+ million people worldwide, mostly in
the developed countries with aging population
B
Global market for PD drugs: US $2.8 – 3.9 billion
- Levodopa drugs: $0.3-0.5 billion
- Dopamine agonists (DA): $0.8-1.1 billion
C
Total market CAGR’2011-15: 8.3%
BDG-DOPAMINE® PLANNED MARKET SHARE
D
BBU PHARMACEUTICALS
10-40% of global levodopa & DA market segments
6
7. WHY BBU PHARMACEUTICALS?
TOP-NOTCH TEAM
Highly-acclaimed scientists
in the biology, neurology &
medicine
Dr. Naum Goldstein
PhD; Professor
Science Director of BBU;
Participated in Parkon®
project
BBU PHARMACEUTICALS
CLEAR BUSINESS MODEL
A
Proprietary R&D
B
“Proof of concept” completed
C
Global patent landscape
(patent applications filed in
Germany)
SUCCESSFUL TRACKRECORD
D
Clear project & exit strategy
Alexander Terterov
CEO of BBU
Built up a successful
business around PD drug
Parkon® in CIS/CEE;
7
8. THE TEAM MAKING IT HAPPEN
NAUM GOLDSTEIN
YURI VLADIMIROV
GEORGY KOVALEV
Science Director
at BBU
Professor; Doctor
of Biological
Sciences;
Professor of
Biophysics;
Academician
with the Russian
Academy of
Medical Sciences
Professor; Doctor
of Medical
Sciences
ANDREY KAMENSKY
GAGIK AVAKYAN
Professor; Doctor
of Biological
Sciences
Professor; Doctor
of Medical
Sciences;
ALEXANDER
TERTEROV
CEO of BBU
Pharmaceuticals
BBU PHARMACEUTICALS
8
9. KEY PROJECT RISKS
DESCRIPTION
MITIGATION
TECHNOLOGY RISKS
Novel technology for drug
delivery across the blood brain
barrier
The technology heavily borrows
from Parkon®, a drug admitted to
clinical practice in Russia
REGULATORY RISKS
Complex regulatory bureaucracy
related to preclinical and clinical
trials
Trials will be carried out in line
with GLP standards by service
providers cognizant of regulatory
approval process in EU and USA
BBU PHARMACEUTICALS
9
10. FUNDING ROADMAP
Current Round
Skolkovo grant may
cover up to 50% of this
amount
US $
2.5 million
PRE-CLINICAL TRIALS
2013-2014
Pre-clinical trials according to GLP standards
Round A can be broken down into smaller tranches
for each step of the trials*
This structure will minimize the risk of misuse and
overpayment and ensure maximum transparency to
investors
Next Round
Skolkovo grant may
cover up to 50% of this
amount
BBU PHARMACEUTICALS
US $
7.5 million
CLINICAL TRIALS
2015-2017
Up to Phase 2a
Clinical trials according to GCP standards
* - Subject to the agreement with service provider
10
11. EXIT STRATEGY & VALUE
COMPANY VALUE & EXIT
60
40
Players for acquisition
60
Exit
US $ million
8-10
15
20
20
0
INVESTMENTS
MILESTONES
IRR
BBU PHARMACEUTICALS
2.5
4.5
Pre-clinical Phase 0 clinical $1.1 m
$ 2.5 m
Phase 1 clinical $3.4 m
3.0
US $
million
Phase 2a
clinical
IRR of investor (assuming Skolkovo grant): 70-75%
IRR of investor (assuming no grant): 40-45%
11
12. CONTACT INFORMATION
C
Alexander Terterov
CEO, Founder
C
Nikolay Nazarov
Shareholder
T
+7.926.811.86.61
T
+7. 916. 999.90.78
E
bdirect2011@gmail.com
E
bdirect2011@gmail.com
BBU PHARMACEUTICALS
12
