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

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A New Nasal Spray for Parkinson's

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