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SciDose LLC An Overview

SciDose LLC An Overview. Joseph Bohan, CEO and Co-Founder Amherst Entrepreneurship/Innovation Day March 4 th , 2011. SciDose LLC Background .

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SciDose LLC An Overview

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  1. SciDose LLCAn Overview Joseph Bohan, CEO and Co-Founder Amherst Entrepreneurship/Innovation Day March 4th, 2011 NON-CONFIDENTIAL

  2. SciDose LLC Background • Nagesh Palepu and Joseph Bohan are co-founders and controlling shareholders of SciDose. Martin Zeiger and Hoyoung Huh are advisors and minority shareholders • Company is self-funded to date by signing co-development deals with partners who pay milestones in return for profit split of products • The R&D facility, TherDose, an Indian Pvt EOU, SciDose subsidiary established in Hyderabad, India in December 2004. Campus will expand to oncology injectibles production in 2011 • All Intellectual Property, resulting from formulation work done in India, is owned and patents have been filed by SciDose for worldwide application NON-CONFIDENTIAL

  3. India operations ANDA, SNDA or 505(b)(2) registration Worldwide Development partners Multiple Technology options Low cost Rapid development Differentiated products (new IP) Commercial partnerships Build value inexpensively then partner API analogues Formulations with clear advantages High value &/or multiproduct partnerships Business Cornerstones for SciDose NON-CONFIDENTIAL

  4. Built Through Strategic Alliances • Actelion “Veletri” (Epoprostenol) • Handok Pharmaceuticals Co. Ltd. (Docetaxel) • Eagle Pharmaceuticals Inc. (15 products) • University Massachusetts (novel nanotechnology platform for oncology drugs) • Sarah Cannon Research Institute/Dr. Pravda (novel ulcerative colitis and Crohn’s Disease products) NON-CONFIDENTIAL

  5. SciDose At-A-Glance in 2011 • 1 product launched in 2010 by our partner Actelion(novel epoprostenol named “Veletri”) • 3 products filed with FDA • 11 products under internal development • Phase II study to be initiated in Q2 for novel docetaxel • Pilot study underway for ulcerative colitis product • 3 commercial collaborations covering 17 products • 4 technology platforms (including UMass nanotechnology for oncology drugs) • 2 QTEP grants received • IRBs approved at Baystate and SCRI for Crohn’s study NON-CONFIDENTIAL

  6. Current Product Portfolio • Drug Delivery Product • Epoprostenol • Launched in 2010 with Actelion: “Veletri” • Eagle/SciDose Collaboration • Oncology: 9 products • Patents filed on 6 products • Hospital Ready-To-Administer: 6 products • Patents approved on 6 products • SciDose Oncology Portfolio • 12 products • Patents filed on 3 products, 1 issued • GI and Anti-Infective Portfolio • 3 products • Patents filed on 2 products NON-CONFIDENTIAL

  7. Why Focus on Oncology & Hospital-Based Products • Improved cytotoxic drugs with fewer side effects and better efficacy will have rapid acceptance by doctors and patients (fast sales ramp) • Worldwide sales opportunities (US/EU, China and India/Brazil) • Small sales forces required for promotion of these products • Well defined end-points for clinical trials • Fast development timelines and limited patient trials using 505(b)(2) strategy (high probability of success using established agents) • Cytotoxic drugs will remain as core therapies with broader indications & reimbursement than novel biotherapies NON-CONFIDENTIAL

  8. Improving Taxotere® (docetaxel): The SciDose® Advantage • Marketed by Aventis with sales over $2.9 in 2010 • Taxotere is dissolved in Tween-80 and diluted in IV infusion bags prior to administration to patients • Patients are heavily pre-medicated with steroids and antihistamines to prevent anaphylactic reaction • The recommended dosing is 6 cycles • Taxotere Composition of Matter / Use Patent expired November 2010, and two formulation patents invalidated • Signed development deal with Handok for 505(b)2 Paragraph IV filing with limited clinical studies or sNDA with Sanofi Aventis NON-CONFIDENTIAL

  9. SciDose Proprietary Docetaxel (SD009)Commercial Opportunity SciDose has developed a novel, IP-protected, soluble, bioequivalent formulation of docetaxel. Product Profile: new formulation, improved safety, same presentation • Novel formulation does not contain Tween-80 or ethanol • No steroid premedication (single I.V. dose of H1 & H2 anti-histamines) • Bioequivalent to Taxotere (all 5 indication given by FDA) • Single-vial presentation equivalent to new Taxotere® presentation • Improved 8 hour stability upon first dilution • Multi-dose vial system (160mg MDV) for hospital pharmacy cost efficiencies and flexibility for different dosing regimens (q 3 weeks, weekly) • Novel J-code opportunity for 1 mg unit reimbursement • Opportunity for weekly dosing in future NON-CONFIDENTIAL

  10. SD009: Managing Risk • Intellectual Property • Expedited Patent filed March 2010, USPTO reviewed in June 2010 • Official Patent issued in August 2010 (US patent no. 7,772,274) • Clinical • Pilot BE study in India completed (n=24), final report completed • Confirmatory PK study planned in Eastern Europe for Q2 2011 • Initiate pivotal BE/safety Registration Study in 2011/2012 • CMC • Multi-dose, single vial system with chemical/physical stability completed • Registration batch manufacturing planned for H2 2011 • Clinical batches manufactured in Q3 2010 • Regulatory • FDA Type C meeting will confirm our safety program • Reimbursement • Dr. Joseph Bailes (ASCO) arranged meeting with CMS, conclusion was that coverageand new J code SD009 should not be an issue if studies are positive NON-CONFIDENTIAL

  11. Inflammatory Bowel Disease in U.S. Inflammatory Bowel Disease (IBD) Incidence: • Ulcerative colitis: 8 new cases per 100,000 people per year (1984–1993) • Crohn’s disease: 7 new cases per 100,000 people per year (1984–1993) Prevalence: • Ulcerative colitis: 246 cases per 100,000 people per year (2001) • Crohn’s disease: 162 cases per 100,000 people per year (2001) Mortality: 825 deaths (2002) Hospitalizations: 169,000—with 62 percent for Crohn's disease (2002) Ambulatory care visits: 5.9 million per year (1999–2000) Disability: 161,000 people (1990–1992) Ulcerative colitis ~750,000 patients Only colon involved Crohn’s Disease ~500,000 patients Usually end small intestine and beginning colon involved Source: http://digestive.niddk.nih.gov/statistics/statistics.htm#specific NON-CONFIDENTIAL

  12. Investigator-Sponsored Clinical Pilot Study: Results of New Therapy • Complete remission = clinical symptoms, endoscopic and histologic resolution of Ulcerative Colitis • Mucosal healing = drop in endoscopy score to 1 or less NON-CONFIDENTIAL

  13. SciDose-UMass AllianceAn Overview Todd Emrick & Hitha Palepu Amherst Entrepreneurship/Innovation Day March 4th, 2011 NON-CONFIDENTIAL

  14. Agenda • Novel polymer technology overview • History of the UMass-SciDose alliance • UMass-SciDose product development • UMass-SciDose portfolio NON-CONFIDENTIAL

  15. Synthetic Polymers as Nanotherapeutics Exploit beneficial aspects of polymers: Derived from non-biological sources, tailored properties, conjugation, architecture, multivalency, degradable, and non-degradable options Enhanced permeation and retention effect Nanomedicine for complexation and delivery Tumor vessels are disorganized and leaky Capillary width [~ 5 µm] pH ~ 7.4 pH ~ 6.0 - 6.8 Normal vessels have tight junctions. Minimize extravasation into healthy tissue Polymer-drug conjugates are large and tend to be taken up preferentially into tumor tissue (passive, selective uptake) NON-CONFIDENTIAL

  16. Advantages of polyMPC Technology Objective: Use polymers to improve the safety and efficacy of oncology drugs • Increase the size of drug: • Exploits enhanced permeation and retention effect • Lengthens in-vivo circulation time (improved PK profile) • Can improve drug stability in vivo • Improve the aqueous solubility of hydrophobic drugs (i.e. CPT) • Enable high drug-loading onto a water soluble polymer scaffold Drug Polymer backbone Drug-to-backbone linker Drug Polymer backbone Linear polymers (i.e., PEG) have drug substitution at chain-end(s). This limits drug loading on the delivery system. Grafted polymers can have high drug loadings, as long as water solubility can be maintained. NON-CONFIDENTIAL

  17. polyMPC-CPT Conjugates Objective: prepare a CPT delivery system with excellent water solubility and controllable release. MPC ATRP initiator Camptothecin TMS-PgMA CuBr/bpy DMSO/MeOH One-pot ATRP polymerization/click reaction > 15 wt% loading of CPT Mol.Wt. 32 kDa methanol (flow marker) PolyMPC-CPT Multiple copies of drug on backbone NON-CONFIDENTIAL

  18. polyMPC-Camptothecin Conjugates 6.8 nm • Drug loading up to 18 wt%; compare to 1.7 wt% in Prothecan, 3.7 wt% in EZN-2208 • CPT equivalent solubility 36.7 mg/mL, compare to 6.7 mg/mL SN-38 in EZN-2208 Mn 7,900 g/mol PDI 1.27 Linkers Z NON-CONFIDENTIAL

  19. CPT Release Profiles in Different Media P10 Z = P11 Z = T1/2 determined by HPLC, monitoring drug release NON-CONFIDENTIAL

  20. Cell Culture Analysis of polyMPC-CPT Toxicity MCF7 cells OVCAR-3 cells COLO 205 cells polyMPC-graft-CPT P11 polyMPC-graft-CPT P11 polyMPC-graft-CPT P11 polyMPC-graft-CPT P10 polyMPC-graft-CPT P10 polyMPC-graft-CPT P10 IC50 values (µM) The higher IC50 values for CPT-polyMPC conjugates are due to the expected gradual release of the drug from the polymer backbone Comparable IC50 values for conjugates P10 and P11 originate from their similar hydrolysis rates. The very high drug solubility and slow drug release stand to potentially benefit future in vivo therapeutics. Cell viability: CellTiter Glo luminescence assay NON-CONFIDENTIAL

  21. 1. The License • Who: SciDose, CVIP • When: June, 2009 • What: SciDose and CVIP signed the license, giving SciDose the worldwide development and marketing rights to Dr. Emrick’s polymer technology in exchange for two milestones per product (completion of Phase I, first commercial sale in US/EU/Japan) and a royalty percentage NON-CONFIDENTIAL

  22. 2. The UMass-SciDose Sponsored Research • Who: SciDose, Dr. Emrick & team • When: May 2010 – present • What: The SciDose team and Dr. Emrick + team work together on developing novel drug-polymer conjugates. SciDose sponsors the four UMass students who work exclusively on the alliance’s program. NON-CONFIDENTIAL

  23. 3. The Toxicology/PK Studies • Who: PVLSI, SciDose, Dr. Emrick + team • When: October 2010 – present • What: Animal studies for a polyMPC-oncology conjugate began in fall 2010 at Pioneer Valley Life Sciences Institute. To date, two studies have been completed and a third has started at PVLSI • Study 1: Maximum-tolerated dose • Study 2: Pilot toxicology • Study 3: Efficacy NON-CONFIDENTIAL

  24. Product Development • Formulation • Formulation work to be conducted at TherDose, upon 5 g lab scale-up and MTD is confirmed • Preclinical • Perform pilot studies to confirm MTD and lead conjugate • Perform IND-enabling GLP studies on lead formulation • Xenograft studies to measure efficacy • Single dose toxicology in 2 species • Repeat dose toxicology in 2 species • ADME studies NON-CONFIDENTIAL

  25. Product Development (continued) • CMC • Transfer to scale-up site upon 5 g lab manufacture • Scale-up site to perform small-scale – commercial manufacturing • Formulation manufacturing at TherDose (clinical), TBD (registration/commercial) • Clinical/Regulatory • File US IND, initiate pilot and pivotal studies • Submit NDA upon pivotal study completion and 12-month stability data on registration batches NON-CONFIDENTIAL

  26. UMass/SciDose Portfolio • Current marketed products: • Oncology product • Camptothecin • Topotecan (Hycamtin®) • New chemical entities: • Conjugate intended for: • Mucositis • Diabetic neuropathy and retinopathy • Chemotherapeutic-induced neuropathy • Potential indications: retinopathy, nephropathy • Conjugate intended for: • Pancreatic cancer • Liver cancer • Potential indications: other GI cancers NON-CONFIDENTIAL

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