BBU Pharmaceuticals - Intro Deck

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1 BBU PHARMACEUTICALS, LLC A NEW DRUG FOR PARKINSON’S DISEASE TREATMENT 2013

Transcript of BBU Pharmaceuticals - Intro Deck

Page 1: BBU Pharmaceuticals - Intro Deck

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BBU PHARMACEUTICALS, LLC A NEW DRUG FOR PARKINSON’S DISEASE TREATMENT

2013

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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

Brain Dopamine-agonist

(optional)

BBB

!

BLOOD-BRAIN BARRIER (BBB) UNLOCKED

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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

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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

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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

Brain Dopamine-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

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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

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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

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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

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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

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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

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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

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T

E

+7. 916. 999.90.78

[email protected]

CONTACT INFORMATION

BBU PHARMACEUTICALS

C Nikolay Nazarov Shareholder

T

E

+7.926.811.86.61

[email protected]

C Alexander Terterov

CEO, Founder