Neopharm Co., Ltd. · KRX:092730
Neopharm — UBS Global Life Sciences Conference 2004
23 slides from Neopharm's conference presentation, Sep 27, 2004
Slide 1: UBS Global Life Sciences Conference
UBS Global Life Sciences Conference September 27, 2004
Slide 2: Safe Harbor Statement
Safe Harbor Statement e 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. Actual results may differ materially f
Slide 3: Corporate Data
Corporate Data . Q/ e Shares Outstanding: 23.3 M e Average Volume: 260K e Recent Price (9/23/04): $8.03 e Market Capitalization: $187M ¢ Float: 5.4M ° 52-Week High/Low $22.70 - $4.66
Slide 4: Stock Performance
STOCK PERFORMANCE
Slide 5: Current Strategy
Current Strategy ° Reduce Burn Rate = 2005 targeted $43-$47 million e Continue enrolling patients in Precise Trial e Value the portfolio with a a goal of out licensing, partnering or terminating specific programs
Slide 6: NeoPharm Product Pipeline
Pr Research Clinical NeoPharm Product Pipeline Phase It FDA. Approval TLLS-PESEQQR - Glioblastoma Multiforme x LEP-ETU ~ Liposome Entrapped Paclitaxel Various Solid Tumors LE-SN3S - Liposome Entrapped SN-38 Various Solid Tumors LEVaIAON-ETU= Liposome Entrapped Antisense Oligonucleotide Various Solid
Slide 7: IL13-PE38QQR
IL13-PEQQR New treatment for glioblastoma multiforme (GBM) Brain Cancer Tumor targeted cytotoxin developed via convection enhanced delivery CED Currently enrolling patients in pivotal Phase III FDA Recognition = Orphan drug designation (U.S. & Europe) Fast track development designation Special proto
Slide 8: IL-13 Phase III Trial
IL-13 Phase III Trial PREGISE Pivotal study vs. Gliadel® wafer in first recurrent International multi-center study in North America, Europe and Israel 300 patients randomized 2:1 (1L13-PE38 :Gliadel®) Endpoint is 50% improvement in survival (42 weeks vs. 28 weeks) Study includes 2 futility analyses
Slide 9: IL13-PE38QQR Market Assumptions
IL13-PE38QQR e Market Assumptions = Average Sales Price $25,000 > $40,000/Patient = Estimated Yearly Cases: eUS 8,000-10,000 e Europe 8,000-10,000 = Overall Market Opportunity: Up to $800 million
Slide 10: NeoLipid System
NeoLipid ™ System Modified in 2003 = Consistent size/distribution - <200 nanometers = Lyophilized, easy to use Patent Protected Delivery Platform Potential Safety/ Efficacy Advantages Flexible Delivery System for Broad Range of Compounds
Slide 11: Difficult to formulate liposomes
ult to formulate Difficult to manufacture “ Leaky liposome Limited number of liposome base drugs: = Amphotericin B = Doxorubicin = * Daunorubicin Sonicator Rotavapor
Slide 12: Shake vial: ready to use liposomes
Shake vial (1 minute) = Ready to Use ‘Liposomes e Easy to manufacture e Enhanced stability e Wider range of drugs
Slide 13: Maximize $ Value
Maximize $ Value e Liposome Technology = Pharmaceutical Life Cycle Management (LCM) e Maximize the $ value of current and future products with: = Patents & exclusivities = Alternate dosage form development = Specifications for product standards & criteria
Slide 14: LEP-ETU Advantages Over Taxol
LEP-ETU Advantages Over Taxol® No Cremophor needed for formulation/ limited pre-medication e Easier to reconstitute and use in oncologist’s office e Reduced side-effect profile e 505 (b)(2) registration pathway being pursued Poster presentation at upcoming ESMO Meeting
Slide 15: Therapeutic Efficacy of Taxol or LEP-ETU on B16/F10 Tumor
Therapeutic Efficacy of Taxol® or LEP-ETU on B16/F10 Tumor Metastasis in C57BL/6 Mice Treatment I.V. x 5 on Day 10,12,14,16 and 18 Control Taxol® 12.5 mg/kg LEP-ETU 12.5 mg/kg LEP-ETU 25.0 mg/kg
Slide 16: Link to searchable text of slide
Link to searchable text of slide shown abov e
Slide 17: Liposomal SN-38 (LE-SN38)
Liposomal SN-38 (LE-SN38) (Camptosar®) Irinotecan is currently used to treat colorectal cancer and has activity in lung cancer LE-SN38 Phase I MTD of 35 mg/m? Dose limiting toxicity of neutroepenia No dose limiting diarrhea observed Abstract accepted for presentation on October 1 at the upcoming EOR
Slide 18: Summary
Summary e LEP-ETU = No Cremophor Minimal pre-medication required Similar PK profile versus Taxol® Well tolerated at doses up to 375 mg/m? 505 (b)(2) regulatory submission is planned ¢ LE-SN38 = Maximum tolerated dose of 35 mg/m? in Phase I clinical trial = No severe diarrhea = Projected Phase II cli
Slide 19: NeoPhectin
NeoPhectin e Patent protected cationic cardiolipin trasfection agent for in-vitro and in-vivo use e Delivers plasmid, antisense and siRNA to a variety of cells e 12 Companies have used our reagent
Slide 20: NeoPhectin-AT customized AON formulation effect
y Ffect of Antisense Oligonucleotide (AON) customized Y formulation of NeoPhectin-AT™ Versus DDAB- in combination with Taxotere® against Human Prostate (PC-3) Tumor Growth in SCID Mice NeoPhectin-AT™ Customized AON Formulation + Taxotere DDAB Liposome-based AON + Taxotere’ Treatment DDAB or NeoPhect
Slide 21: Milestones
Milestones ° Q4/04 = Reduce cash burn rate 100-125 patients enrolled in Precise Trial by quarter end Begin LEP(ETU) Bioequivalence study for 505(b)2 filing Prioritize pipeline Continue out licensing discussions
Slide 22: Milestones
Milestones = Cash burn rate approximately $43-$47 million = Complete Precise Trial enrollment = Out-license or partner appropriate candidates
Slide 23: Searchable text section of graphics
Searchable text section of graphics shown above UBS Global Life Sciences Conference September 27, 2004 Saf e 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 provis