BBU Pharmaceuticals is developing a new Parkinson's disease drug called BDG-Dopamine that directly delivers dopamine to the brain using a proprietary delivery technology. This new drug has the potential to improve upon existing drugs by reducing side effects, providing faster activation, and lowering dosage requirements. BBU Pharmaceuticals has completed proof-of-concept studies in animals and filed patent applications. They are seeking $2.5 million to fund pre-clinical trials with the goal of entering clinical trials and eventually being acquired by a larger pharmaceutical company.
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
