Neopharm Co., Ltd. · KRX:092730
Neopharm — Investor Presentation (August 2007)
19 slides from Neopharm's investor presentation, Aug 16, 2007
Slide 1: NeoPharm Investor Presentation
Nasdaq: NEOL Laurence P. Birch President and CEO Dr. Aquil Rahman Chief Scientific Officer Emeritus
Slide 2: Safe Harbor Statement
Safe Harbor Statement Various remarks that we may make about future expectations, plans and prospects for the Company constitute forward-looking statements for purposes of the Safe-Harbor provisions under The Private Securities Litigation Reform Act of 1995. Such forward-looking statements are neces
Slide 3: Dedicated to Discovery & Development
Dedicated to Discovery & Development Engaged in the research, development and commercialization of new and innovative cancer drugs for therapeutic applications Drug development program includes two proprietary platforms: NeoLipid drug delivery system Tumor-targeting toxin platform, which includes de
Slide 4: Restructuring Initiative
Restructuring Initiative Reorganization strategy announced in April 2007 aimed at: Reducing annualized cash consumption levels to approximately $5 million plus $2-to-$3 million for external clinical costs Realigning cost structure to progress several drug candidates to next strategic event Reorganiz
Slide 5: Near-term Strategy Avenues for Opportunity
Near-term Strategy Avenues for Opportunity Identify appropriate partner and/or out-license candidates Ensure regulatory compliance with all drug candidates Manage cost structure to maximize resources allocated to drug development activities, which includes offshore trials Progress several drug produ
Slide 6: NeoPharm's Drug Platforms and Candidates
NeoPharm’s Drug Platforms and Candidates NeoLipid Platform LEP-ETU (liposomal paclitaxel) An anti-cancer agent that is designed to prevent cell division by promoting the assembly and stabilization of microtubules Possible indications for breast, ovarian, prostate, and non-small cell lung cancers LE-
Slide 7: Market Opportunity for Drug Candidates
NeoLipid Platform LEP-ETU Potential Annual Revenues: $75 to $100 million,* if approved Competition: US Biosciences (Previously, American Pharmaceutical Partners, APP), Bristol Myers: Generic Taxol LE-SN38 Potential Annual Revenues: $250 million,* if approved Competition: Pfizer, CPT-11 LE-DT Potenti
Slide 8: Milestones for NeoLipid Platform
Milestones for NeoLipid Platform Upcoming Trials LEP-ETU – indication breast cancer – Phase II currently projected to start in early 2008 Approximately 35 patients LE-SN38 – indication triple negative breast cancer; possible indication on proof of concept Possible Phase II currently projected to sta
Slide 9: Milestones for Cintredekin Besudotox
Milestones for Cintredekin Besudotox Two Indications For the treatment of pulmonary fibrosis and asthma Licensing agreement initiated with NIH in June 2007 Approximately 40,000 Americans die each year from pulmonary fibrosis Few treatments exist for this disease and no known cure Compiling all pre-c
Slide 10: Benchmarks for Success
Benchmarks for Success NeoLipid Platform LEP-ETU – Phase II patient enrollment – early 2008* LE-SN38 – Phase II patient enrollment – mid-to-late 2008* LE-DT – Phase I patient enrollment – early 2008* LE-rafAON – IND submission – late 2007* Phase I Trial to start following submission IL-13 for indica
Slide 11: NeoLipid Drug Delivery Platform
NeoLipid Drug Delivery Platform
Slide 12: NeoLipid Proprietary Liposomal Platform
NeoLipid Proprietary Liposomal Platform Small Size ~150 – 200 nanometers Uniform Manufacturing 95% at ≤200 nanometers Entrapment Efficiency>80% Easy to Use Lyophilized Reconstitutes in two-to-five minutes Provides increased solubility Deliver More Active Drug
Slide 13: Paclitaxel Product Profiles
IV every three weeks IV every three weeks IV every three weeks Administration 275 mg/m2 260 mg/m2 175 mg/m2 Expected/Usual Dose Safety 325 mg/m2 260 mg/m2 175 mg/m2 MTD 13%-42% (expected) 71% 70% Neuropathy 4% (expected) No No 25% (Target) Moving into Phase II LEP LEP-ETU ETU2 Launched Launched Stat
Slide 14: LEP-ETU Summary
LEP-ETU Summary Phase I clinical trial results for LEP-ETU LEP-ETU appeared to be well tolerated in terms of typical paclitaxel side effects by the majority of patients, including those receiving the higher doses of drug Antitumor activity was observed: 16% of patients experiencing partial responses
Slide 15: LE-SN38 Summary
LE-SN38 Summary Phase I clinical trial results for LE-SN38 Demonstrated the safety and tolerability of LE-SN38 Established a maximum tolerated dose (MTD) for all but a small subset of patients that metabolize SN-38 slowly Pharmacokinetic analysis of blood samples from patients treated with LE-SN38 s
Slide 16: LEP-DT Summary
LEP-DT Summary LEP-DT is NEOPHARM’s early stage liposomal formulation of the anti-cancer agent docetaxel, which is the active ingredient in Sanofi Aventis’ Taxotere Has been approved for use in breast cancer, non-small cell lung cancer, adenocarcinoma and head and neck cancer indications Next Steps
Slide 17: Currently Projected Phase I and II Completions
Currently Projected Phase I and II Completions LE-rafAON LE-DT LE-SN38 LEP-ETU Phase II Trial2 – projected start early 2009 Phase II Trial2 – projected completion mid-2009 Phase III Trial1 – projected start late 2009 Phase I Trial – projected start early 2008 Phase I Trial – projected completion mid
Slide 18: Projected Phase I and II Completions
Projected Phase I and II Completions As of June 30, 2007: Cash on hand of $25 million Sufficient resources available to fund operations into 2009 and progress several drug candidates to next strategic event IL-13 (Pulmonary Fibrosis) IL-13 (GBM) Phase I Trial – projected completion early 2009 Phase
Slide 19: Conclusion
Conclusion Successful completion of Restructuring initiative Significantly reduced cash consumption rate Key technical positions retained to support development activities Continue to identify new out-license and partnership opportunities Further protect and enhance the value of NEOPHARM’s intellect