Forward Looking Statements
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2 Forward Looking Statements This material contains forward-looking statements as defined by the Private Securities Litigation Reform Act of These include statements concerning plans, objectives, goals, strategies, future events or performance and all other statements which are other than statements of historical fact, including without limitation, statements containing words such as "believes," "anticipates," "expects," "estimates," "projects," "will," "may," "might" and words of a similar nature. Such statements involve risks and uncertainties that could cause actual results to differ materially from those projected. Some important factors that could cause actual results to differ include dependence on the efforts of third parties; dependence on new and uncertain technology and its uncertain application to new business ventures; regulatory actions or delays, or uncertainties related to product development, testing or manufacturing; ability to form and maintain strategic alliances; ability to complete certain transactions and realize anticipated benefits from acquisitions; dependence on certain intellectual property rights of both Hana and third parties; the competitive nature of Hana's industry; risks of obsolescence of certain technology; and ability to develop viable products for the health care market including the achievement of successful pre-clinical and clinical results. The forward-looking statements contained herein represent the judgment of Hana as of the date this material was drafted. Hana disclaims, however, any intent or obligation to update any forward-looking statements. 2
3 Hana Biosciences acquires, develops, and commercializes innovative products to advance cancer care. We are committed to P 3 C: People: Building a world-class team and leading core competencies in cancer drug development and commercialization. Products: Acquiring and accelerating the development and commercialization of innovative oncology product candidates. Pipeline: Expanding our pipeline by being the partner of choice for suppliers, researchers, and alliance partners. Culture: Nurturing a unique company culture focused on patients, developing extraordinary team members, creating high performing teams, and seeking goodness and grace in others with the highest standards of integrity. 3
4 Oncology Pipeline Preclinical Phase I Phase II Phase III NDA Market THERAPEUTICS Marqibo (vincristine sulfate injection, OPTISOME ) Acute Lymphoblastic Leukemia (ALL) First-Line Acute Lymphoblastic Leukemia (ALL) Relapsed Alocrest (vinorelbine tartrate injection, OPTISOME ) Solid Tumors (Breast, Non-Small Cell Lung Cancer) Topotecan hydrochloride Injection, OPTISOME Solid Tumors (Ovarian, Small Cell Lung Cancer) Talvesta (talotrexin) for Injection SUPPORTIVE CARE Menadione Solid Tumors EGFR Inhibitor-Associated Skin Rash Zensana (ondansetron HCl) Oral Spray Chemo, Radiation, and Post-Operative Induced Nausea & Vomiting Complete Ongoing Planned 4
5 OPTISOME Nanoparticle Technology Optimized for Cell Cycle Specific Chemotherapy Sphingomyelin Active cell cycle-specific drug Cholesterol The sphingomyelin-cholesterol lipid bi-layer is more tightly packed, and therefore less leaky, than first generation PC-cholesterol bi-layers: Sustained retention in the aqueous interior is key to improving activity Cell cycle-specific agents can be encapsulated in an Optisome Controls release of active drug from particle 5
6 Optisomes Preferentially Accumulate at Tumor Sites Optisomal accumulation Drug releases over time The vasculature at tumor sites is leakier than normal vasculature Pores and openings of up to 800 nm across (Normal endothelium <10 nm) Optisomal particles (~100 nm) can distribute into tumor tissue Long-circulating Optisomes accumulate in tumor tissue Preferential extravasation through vascular pores Entrapment in the interstitial space of tumors 6
7 Preferential Accumulation of Optisomes in Tumor vs. Normal Tissue Intravital microscopy following administration of Marqibo Normal Tumor Optisome accumulation in tumor 1 Minute 60 Minutes 7
8 Oncology Pipeline Preclinical Phase I Phase II Phase III NDA Market THERAPEUTICS Marqibo (vincristine sulfate injection, OPTISOME ) Acute Lymphoblastic Leukemia (ALL) First-Line Acute Lymphoblastic Leukemia (ALL) Relapsed Alocrest (vinorelbine tartrate injection, OPTISOME ) Solid Tumors (Breast, Non-Small Cell Lung Cancer) Topotecan hydrochloride Injection, OPTISOME Solid Tumors (Ovarian, Small Cell Lung Cancer) Talvesta (talotrexin) for Injection SUPPORTIVE CARE Menadione Solid Tumors EGFR Inhibitor-Associated Skin Rash Zensana (ondansetron HCl) Oral Spray Chemo, Radiation, and Post-Operative Induced Nausea & Vomiting Complete Ongoing Planned 8
9 Marqibo (vincristine sulfate injection, OPTISOME ) N CH 3 OOC N CH 3 O OH N OHC Vincristine N H H HO OCOCH 3 COOCH 3 Marqibo Acute lymphoblastic leukemia Optisomal formulation utilizing vincristine Vincristine is approved as a single agent and in combination regimens for treatment of hematologic malignancies Allows for a significant increase in dose vs. conventional vincristine. US Orphan Drug Designation in adult ALL Status: Phase 2 relapsed ALL & Phase 3 First-Line ALL Planned 9
10 Marqibo : Cell-Cycle Specific Vincristine Activity Enhanced by Targeted OPTISOME Delivery Effects of Exposure Time on Cytotoxicity: Vincristine (VCR) In vitro against L1210 cell line Exposure Time (hrs) Free VCR (IC50*) (nm) 4 3 OPTISOME Targeting Drug Accumulation Within the Tumor Marqibo (Optisomal vincristine) 1 12, , µg Vincristine / g tumor 2 1 Free drug Conventional liposome Time (hours) * IC50 = Drug concentration required to achieve 50% cytotoxicity Source: Webb et al. Br J Cancer (1995) 10
11 VCR eq Distribution (µg/g tissue) in Tumor-Bearing Mice following Administration of either 1.5 mg/kg Marqibo or Vincristine TUMOR BONE MARROW Marqibo Marqibo Vincristine Vincristine hours 16 hours 48 hours hours 16 hours 48 hours Source: Study Report PCD-018R in NDA , and tumor xenograft is MX- (breast) 11
12 Marqibo (vincristine sulfate injection, OPTISOME ) Key Clinical Studies Clinical Study Indication Regimen # of patients Results Phase 2a, single center Aggressive NHL, relapsed/refractory Single agent Marqibo 92 36% ORR 1 (8% CR, 24% PR) Phase 2b, multi-center Aggressive NHL, relapsed/refractory, Single agent Marqibo % ORR 2 (7% CR, 18% PR) Phase 2, single center Aggressive NHL, frontline R-CHMP (M= Marqibo ) 68 93% CR, 88% 17 months 3 Phase 1 multi-center Adult ALL, relapsed/refractory Marqibo + dexamethasone 36 24% CR 4 13 trials completed with >600 patients treated with Marqibo in NHL, ALL, melanoma MTD of Marqibo = 2.25 mg/m2 or ~ 4mg per patient v. MTD of Vincristine 2 mg capped per patient 1 Hana Biosciences, Inc., VSLI-05HD; 2 Rodriquez et al. Blood 2004 (104), 11, abstract Rodriquez et al. JCO 2004 (22), 14S, abstract 8080; 4 Thomas et al. 12ASH 2006, abstract 4539
13 Marqibo (vincristine sulfate injection, OPTISOME ) Acute Lymphoblastic Leukemia Development Program Phase Indication Type Population n Treatment Primary Endpoint Phase 2 ALL Multicenter, single arm study Philadelphia Negative Adult Patients in 2nd Relapse or those who failed two lines of Anti- Leukemia Chemotherapy 56 Marqibo single agent CR/CRp Phase 3 ALL Randomized, multicenter, intergroup First-Line, Philadelphia Negative, Elderly Patients TBD Marqibo versus Vincristine in induction, consolidation, and maintenance in combination regimens EFS 13
14 Alocrest (vinorelbine tartrate injection, OPTISOME ) Plasma Concentration (µg/ml) Vinorelbine VRL, 20 mg/kg Alocrest OPTISOMAL VINORELBINE 20 mg/kg Optisomal formulation utilizing vinorelbine Vinorelbine is approved as a single agent and in combination for the first-line treatment of unresectable, advanced non-small cell lung cancer Status: Phase 1 Solid Tumors Time (h) Source: Webb. Br J Ca 72:896,
15 Optisomal Topotecan (topotecan hydrochloride injection, OPTISOME ) HO + N H N O O ph > 7 O N OH O N Lactone O OH N Carboxylate O OH OPTISOME Topotecan Topotecan is approved for use in relapsed small-cell lung cancer and relapsed ovarian cancer Plasma Concentration (µg/ml) Free Topotecan Optisomal Topotecan Optisomal encapsulation significantly protects the active form of drug from degradation Status: Pre-clinical Time (hrs) Source: Webb. Br J Ca 72:896,
16 Oncology Pipeline Preclinical Phase I Phase II Phase III NDA Market THERAPEUTICS Marqibo (vincristine sulfate injection, OPTISOME ) Acute Lymphoblastic Leukemia (ALL) First-Line Acute Lymphoblastic Leukemia (ALL) Relapsed Alocrest (vinorelbine tartrate injection, OPTISOME ) Solid Tumors (Breast, Non-Small Cell Lung Cancer) Topotecan hydrochloride Injection, OPTISOME Solid Tumors (Ovarian, Small Cell Lung Cancer) Talvesta (talotrexin) for Injection SUPPORTIVE CARE Menadione Solid Tumors EGFR Inhibitor-Associated Skin Rash Zensana (ondansetron HCl) Oral Spray Chemo, Radiation, and Post-Operative Induced Nausea & Vomiting Complete Ongoing Planned 16
17 Menadione pegfr Menadione No Erlotinib No Yes Erlotinib No Yes Topical treatment for the prevention of Epidermal Growth Factor Receptor (EGFR) inhibitor-associated skin rash EGFR inhibitor drugs (Tarceva, Erbitux, Vectibix ) are used to treat NSCLC, pancreatic, and head & neck cancer A major side effect of EGFR inhibitors drugs is skin rash, caused by inactivation of EGFR in normal skin > 75% of ~100,000 patients experience rash (>10% grade 3-4) Topically administered menadione inhibits phosphatases and may restore normal EGFR signaling in skin cells Status: Preclinical Source: Topical Vitamin K3 (Menadione) Prevents Erlotinib and Cetuximab-Induced EGFR Inhibition in the Skin, Roman Perez-Soler, et al (ASCO 2006); 17
18 Hana Biosciences: Management Team Mark J. Ahn, PhD President and Chief Executive Officer Genentech, Bristol-Myers Squibb, Amgen Gavin Choy, PharmD VP, Clinical Operations Gilead, Stanford University Medical Center Steven R. Deitcher, MD Executive VP and Chief Medical Officer Nuvelo, The Cleveland Clinic Foundation, The University of Tennessee John Iparraguirre VP and Chief Financial Officer Discovery Toys, BDO Seidman, LLP Hana B. Moran, PhD VP, Regulatory Affairs & Quality Assurance, SangStat Medical Corp and BioMedicines (now Intarcia), Scios (a J&J subsidiary) and Athena Neurosciences (now Elan). Alex Tkachenko, PhD VP, Corporate Development & Strategic Planning Genentech, Alnylam Pharmaceuticals, University of Medicine and Dentistry of New Jersey Fred Vitale VP and Chief Business Officer Genentech, Bristol-Myers Squibb, Amgen, Miles 18
19 2007 Milestones Therapeutics Marqibo (vincristine sulfate injection, OPTISOME ) 2H: Initiate Phase 2 second relapsed acute lymphoblastic leukemia (ALL) 2H: Initiate Phase 3 Frontline Trial in acute lymphoblastic leukemia (ALL) with U.S. cooperative groups Alocrest (vinorelbine tartrate injection, OPTISOME ) 2H: Complete Phase 1 trial in solid tumors Topotecan hydrochloride injection, OPTISOME 3Q: Submit IND 2H: Initiate Phase 1 clinical trial Talvesta (talotrexin) for Injection 2H: Complete safety analysis and determine next steps Supportive Care Menadione 2H: Complete preclinical program and submit IND Zensana (ondansetron HCl) Oral Spray 2H: Complete reformulation and determine next steps 19
20 Hana Biosciences: Summary Focused strategy in oncology captures efficiencies and enhances sustainability Diversified and stratified development stage pipeline reduces risk 4 Anti-cancer therapeutics and 2 supportive care products Acquire clinical development stage products and technology platforms which build on known mechanisms of action Experienced management team in hematology-oncology research, development and commercialization 20
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