BBU Pharmaceuticals

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BBU Pharmaceuticals

  1. 1. 2013 BBU PHARMACEUTICALS, LLC A NEW DRUG FOR PARKINSON’S DISEASE TREATMENT 1
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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