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2011 Buzz of BIO Winner Role of PPPs in Addressing NCDs in Low- and 2011 Buzz of BIO Winner Role of PPPs in Addressing NCDs in Low- and Middle-Income Countries Cost-Effective Innovation in India Susan K. Finston, CEO Amrita Therapeutics Ltd. April 24, 2013

Take Aways • Visualizing Success for Delivery & Drug Development Systems in India • Take Aways • Visualizing Success for Delivery & Drug Development Systems in India • Introducing Amrita Therapeutics – A Case Study in Oncology Bio-Discovery • PPPs & Capacity Building – Key to Long Term Success • Continuing the Journey – Getting from Here to There 2

Visualizing Success: PPPs and Capacity Building • Balance market incentives for drug distribution, research Visualizing Success: PPPs and Capacity Building • Balance market incentives for drug distribution, research and development: – Healthcare Safety Net – Rule of Law Protections – Intellectual Property (patents, trademarks, linkage, trade secrecy) – Relationship of policy direction and mobilization of capital • The Whole vs. the Parts – Supply vs. Demand: Who are Winners and Losers? – Strategy vs. Tactics: What can we learn from past experience? Where is the data? 3

Where is India now? Growth in Biotech from $250 M (2001) to $3. 5 Where is India now? Growth in Biotech from $250 M (2001) to $3. 5 B (2010) *Projected Exponential growth forecast by 2015 4

Paradox of Indian Biotech Without Bio-Discovery Startups • Funds flow into contract research, related Paradox of Indian Biotech Without Bio-Discovery Startups • Funds flow into contract research, related bio-services, not R&D: – Little appetite for classic “high risk / high reward” investment in start-ups for R&D discovery, product development – Absence of VCs, few Angel investors for market disturbing technologies • Indian Department of Biotechnology (DBT) PPPs intend to bridge the divide; encourage innovative partnerships

Case Study on Bio-Discovery PPP: Amrita Therapeutics From the Sanskrit: “The elixir of immortality; Case Study on Bio-Discovery PPP: Amrita Therapeutics From the Sanskrit: “The elixir of immortality; the drink of the Hindu gods, which strengthens & grants immortality. ”

Amrita Management Team Ananda M. Chakrabarty, Ph. D. Co-Founder & Senior Science Advisor – Amrita Management Team Ananda M. Chakrabarty, Ph. D. Co-Founder & Senior Science Advisor – Received 1 st patented genetically engineered (GE) organism through Diamond vs. Chakrabarty (1980) – Global domain expert on bacterial proteins/peptides therapies – Advisor to U. S. , foreign governments & UN Agencies Susan K. Finston, J. D. /M. P. P. Co-Founder & Chief Executive Officer: – Veteran Bio. Pharma consultant advising Fortune 100 & start-ups – Demonstrated track record in fundraising, BD, IP and strategic development – Special expertise in India, IP and Emerging Markets

Amrita’s ATP-01 Multivalent Protein Amrita’s ATP-01 Multivalent Protein

Amrita Milestones • $. 5 M Seed Funding from GVFL & Company for soft Amrita Milestones • $. 5 M Seed Funding from GVFL & Company for soft Launch at Vibrant Gujarat (2009) • Award of DBT Biotechnology Industry Partnership Program (BIPP) Grant build-out of Protein Purification Lab (2010) • Development of novel protein/peptide drugs and filing of several provisional patents (2010 – 2011) • Initiation of research collaborations (2010)

Amrita Milestones (2) • “Buzz of BIO” (Healing) Winner at 2011 BIO International Convention Amrita Milestones (2) • “Buzz of BIO” (Healing) Winner at 2011 BIO International Convention • NEW early R&D program with the National Cancer Institute (NCI) (initiated late 2011) • Design of additional novel peptides showing good anti-cancer activity • Amrita research highlighted in Journal of Commercial Biotechnology (January 2012) and ISRN Neurology (2012). • Filing of 2 full Utility & PCT patents (Sept. 2011 & March 2012) • Relocation of Amrita Lab to UDSC TBI (late 2012) 10

Amrita’s AT-01 In Vitro Effectiveness 11 Amrita’s AT-01 In Vitro Effectiveness 11

HIV-1: ATP-01 Comparable Effectiveness to Enfurviritide (T 20) % Inhibition of Cell to Cell HIV-1: ATP-01 Comparable Effectiveness to Enfurviritide (T 20) % Inhibition of Cell to Cell Fusion % Inhibition in Lymphatic system 12

First-Ever Oncology Combination Device to Deliver Therapy to the Tumor Site Amrita’s innovative combination First-Ever Oncology Combination Device to Deliver Therapy to the Tumor Site Amrita’s innovative combination medical device utilizing biofilms for targeted cancer therapy, including for tumors that are inoperable or otherwise difficult to treat with existing therapies Two nude mice were injected with 1 m cancer cells (MCF-7); both developed visible tumors. This shows growth of the tumor in the control mouse at 5 weeks. We treated one of the mice with a drug eluting stent in situ at the site of the tumor. The bio-film coated stent caused the tumor to become necrotic, after which it dissolved and was removed. 13

Future Work Program* • Efficacy studies of AT-01 peptide in xenografted mouse model • Future Work Program* • Efficacy studies of AT-01 peptide in xenografted mouse model • Mechanism of action of AT-01 peptide • Preclinical toxicity studies of AT-01 peptide *based on available funding

Public-Private Partnerships: Benefits of Indo-US Collaboration • Shared Rule of Law / Common Law Public-Private Partnerships: Benefits of Indo-US Collaboration • Shared Rule of Law / Common Law Legacy • English as official language at governmental level & language of science in apex research institutes, companies, clinical research centers • Similar cultural values as much as differences • Large reservoir of Indian science and management talent with U. S. education/experience as ‘Brain Drain’ becomes ‘Brain Gain’ • High-level Government of India commitment to continue to build delivery systems and R&D ecosystem

Getting from Here to There • Building the track while we are riding in Getting from Here to There • Building the track while we are riding in the train • For Amrita Therapeutics, existing grant opportunities are necessary but insufficient • With a freeze in early access to capital for bio-discovery, the answers may lie in the Crowd – Crowdfunding @2 Q 2013

Thank you! Susan K Finston, J. D. , M. P. P. CEO/Managing Director +1 Thank you! Susan K Finston, J. D. , M. P. P. CEO/Managing Director +1 -202 -621 -8944 +1 -202 -330 -5550 (fax) [email protected] com biotechblog. com