Neopharm Co., Ltd. · KRX:092730
Neopharm — Barrington Research Healthcare Conference (May 2008)
38 slides from Neopharm's conference presentation, May 29, 2008
Slide 1: Barrington Research Healthcare Conference
1 Barrington Research Healthcare Conference NASDAQ: NEOL Laurence P. Birch President and Chief Executive Officer
Slide 2: Safe Harbor Statement
2 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 nec
Slide 3: Dedicated to Discovery & Development
3 Dedicated to Discovery & Development Engaged in the research, development and commercialization of new and innovative drugs for various cancers and other therapeutic applications Drug development program includes two proprietary platforms: Tumor-targeting toxin platform, which includes development
Slide 4: Investment Highlights
4 Investment Highlights Multiple drug candidates in various points of clinical development Cintredekin Besudotox, Indication GBM: Confirmatory Phase III LEP-ETU: Phase II LE-DT: Phase I Robust Pipeline Additional indications for Cintredekin Besudotox, IL-13 Product initiatives funded and progressing
Slide 5: Completed Restructuring Initiative
5 Completed Restructuring Initiative Reorganization strategy, originally announced in April 2007 Key Initiatives Completed Reduced annualized cash consumption levels to approximately $5 million Realigned cost structure to optimize resources to progress several drug candidates to next strategic event
Slide 6: Near-Term Strategy
6 Near-Term Strategy Focus on optimizing NeoPharm’s drug development activities As of March 31, 2008, cash on hand of $18.2 million is sufficient to fund currently anticipated development activities well into 2009 Ensure regulatory compliance with all drug candidates Progress several liposomal drug
Slide 7: NeoPharm Product Portfolio
7 NeoPharm Product Portfolio Cintredekin Besudotox (Two Indications) Recurrent Glioblastoma Multiforme (GBM) Confirmatory Phase III trial expected to begin late 2008 Idiopatic Pulmonary Fibrosis Anticipated IND filing end of 2008 NeoLipid® Platform LEP-ETU (liposomal paclitaxel) An anti-cancer agent
Slide 8: Strong IP Portfolio - Patents
8 Strong IP Portfolio - Patents
Slide 9: NeoPharm Product Portfolio
9 NeoPharm Product Portfolio LE-DT LEP-ETU IPF Cintredekin Besudotox, IL-13 GBM Cintredekin Besudotox, IL-13 LE-rafAON Metastatic solid cancer Metastatic Breast Cancer Phase III Phase II Phase I Indication Product Preclinical Pancreatic cancer
Slide 10: Market Opportunity for Drug Candidates
10 Market Opportunity for Drug Candidates Cintredekin Besudotox Recurrent Glioblastoma Multiforme (GBM) Potential Annual Revenues: $100 million,* if approved Competition: MGI Pharma Pulmonary Fibrosis Market size, greater than $250 million no treatment currently available Competition: Standard of ca
Slide 11: Benchmarks for Success
11 Benchmarks for Success Second Quarter 2008 Executed Letter of Intent with SIRO for Confirmatory Phase III – Cintredekin Besudotox, IL-13 Commencement of Phase I – LE-DT IND Submission – LE-rafAON Third Quarter 2008 Commencement of Phase III Confirmatory Trial – Cintredekin Besudotox, IL-13 Commen
Slide 12: Product Portfolio Technologies
12 Product Portfolio Technologies
Slide 13: Cintredekin Besudotox For the Treatment of Recurrent Glioblastoma
13 Cintredekin Besudotox For the Treatment of Recurrent Glioblastoma
Slide 14: Cintredekin Besudotox - Tumor Targeting Platform
14 Cintredekin Besudotox - Tumor Targeting Platform Cintredekin Besudotox (IL13-PE38QQR) is a novel recombinant tumor targeting protein, consisting of IL-13 and truncated Pseudomonas exotoxin A Malignant Glioma cells express IL-13 receptors at high density which permit binding of IL13-PE38QQR, cytot
Slide 15: Cintredekin Besudotox Development
15 Cintredekin Besudotox Development
Slide 16: Cintredekin Besudotox Tumor-Specific Action
16 Cintredekin Besudotox Tumor-Specific Action
Slide 17: Convection Enhanced Delivery (CED)
17 Convection Enhanced Delivery (CED) Cintredekin Besudotox (IL13-PE38QQR) is delivered to patients by a convection enhanced delivery (CED) system CED utilizes a pressure gradient to distribute macro-molecules to clinically significant volumes of tissue by bulk flow CED delivery avoids plasma diluti
Slide 18: Cintredekin Besudotox - Convection-Enhanced Delivery
18 Cintredekin Besudotox - Convection-Enhanced Delivery
Slide 19: Cintredekin Besudotox For the Treatment of Idiopathic Pulmonary Fibrosis
19 Cintredekin Besudotox For the Treatment of Idiopathic Pulmonary Fibrosis
Slide 20: Cintredekin Besudotox - Idiopathic Pulmonary Fibrosis
20 Cintredekin Besudotox - Idiopathic Pulmonary Fibrosis New Indication Idiopathic Pulmonary Fibrosis (IPF) may result from a malfunctioning immune response Repeated immune-related damage and scarring of lungs destroys the elasticity, which affects the patients’ ability to breath Cell initiating the
Slide 21: Reduced Mouse Pulmonary Fibrosis with CB Treatment
21 Reduced Mouse Pulmonary Fibrosis with CB Treatment
Slide 22: NeoLipid Drug Delivery Platform
22 NeoLipid® Drug Delivery Platform
Slide 23: NeoLipid Drug Delivery Platform
23 NeoLipid® Drug Delivery Platform A liposome is a spherical vesicle with a bilayer membrane, composed of phospholipid and cholesterol Liposomes has central hydrophilic and peripheral hydrophobic regions Liposomes are used to deliver a wide range of drugs The hydrophilic region contains the hydroph
Slide 24: Mechanism of Action
24 Mechanism of Action Liposomes are made of lipids (fats) Cancer cells need to consume large amount of fats to sustain their extremely rapid growth They recognize the liposomal drugs as a potential source of nutrition Cancer cells absorb the liposomes loaded with anti-cancer drugs as a source of fa
Slide 25: Schematic Liposome - Drug System
25 Schematic Liposome - Drug System
Slide 26: Liposome Schematic Diagram
26 Liposome Schematic Diagram
Slide 27: Mechanism of Action - Schematic
27 Mechanism of Action - Schematic
Slide 28: Advantages of NeoLipid Drug Delivery Technology
28 Advantages of NeoLipid® Drug Delivery Technology NeoPharm’s NeoLipid® Technology offers the following potential advantages: Reduced drug toxicity and multi drug resistance by using unique lipid, cardiolipin Improved pharmacokinetics and drug release profile Enhanced intracellular penetration High
Slide 29: Development Activities
© NeoPharm Development Activities
Slide 30: Cintredekin Besudotox - GBM
30 Cintredekin Besudotox - GBM For the treatment of Recurrent Glioblastoma Multiforme (GBM) Based on the outcome of the PRECISE Trial, on March 28, 2007 the FDA concluded that an additional Phase III trial would be required The PRECISE Trial did not meet the primary endpoint of a statistically signi
Slide 31: Cintredekin Besudotox - IPF
31 Cintredekin Besudotox –IPF For the treatment of Idiopathic Pulmonary Fibrosis 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-clinical data available,
Slide 32: LEP-ETU Phase I Summary
32 LEP-ETU Phase I 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 partia
Slide 33: LEP-ETU Phase II Trial
33 LEP-ETU Phase II Trial First Patients enrolled March 31, 2008 Anticipate enrollment completion by end of third quarter 2008 Target enrollment of 35 patients in five centers Trial Design: Evaluate the anti-tumor effect and safety/tolerability of LEP-ETU in metastatic breast cancer The primary obje
Slide 34: LE-DT Phase I Trial
34 LE-DT Phase I Trial First Patients enrolled May 21, 2008 Anticipate enrollment completion by end of fourth quarter 2008 Target enrollment of 25-35 patients in three centers, including: TGen in Scottsdale, AZ The Lombardi Comprehensive Cancer Center at Georgetown University Trial Design: Determine
Slide 35: LE-rafAON Pre-Clinical
35 LE-rafAON Pre-Clinical Designed and developed to inhibit activated c-raf-1 gene, which has been associated with radiation and chemotherapy resistance. c-raf gene-specific antisense
Slide 36: Product Portfolio Timeline
36 Product Portfolio Timeline 2008 2010 2009 1 Assuming positive results from Stage I
Slide 37: Product Portfolio Timeline
37 Product Portfolio Timeline 2008 2010 2009 1 Assuming positive results from the Phase II Trial 2 Assuming positive results from the Phase I Trial
Slide 38: Conclusion
38 Conclusion Multiple drug candidates in various points of clinical development Cintredekin Besudotox, Indication GBM: Confirmatory Phase III LEP-ETU: Phase II LE-DT: Phase I Robust Pipeline Additional indications for Cintredekin Besudotox, IL-13 Product initiatives funded and progressing Trials to
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