Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference

Transcription

1 Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference June 3 rd, 2015 Joe Turgeon President and Chief Operating Officer

2 Safe Harbor Statement This presentation contains forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management s current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, our strategy, the success of our drug candidates, the safety and efficacy of our drug products, product approvals, market potential, product sales, revenue, development, regulatory and approval timelines, product launches, product acquisitions, capital resources and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited experience in establishing strategic alliances, our limited marketing experience, our customer concentration, the possibility for fluctuations in customer orders, evolving market dynamics, our dependence on third parties for clinical trials, manufacturing, distribution, information and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forwardlooking statements and expressly disclaim any duty to update the information contained in this presentation except as required by law. 2

3 3 Spectrum s Focus & Overview

4 4 Key Recent Milestones

5 5 Strategically Poised for Future Growth

6 6 SPI-2012 Targets Blockbuster Market

7 A Novel Molecule for the Treatment of Neutropenia Potential to compete in a worldwide market that exceeds $6 billion FcRn Epithelial Layer Bone Marrow 7

8 SPI-2012 has Shown Strong Phase 2 Data Multicenter Phase 2 enrolled 156 patients The Phase 2 study met its primary endpoint of mean duration of severe neutropenia during cycle one 8

9 Phase 2: SPI-2012 Median Absolute Neutrophil Count (ANC) Over Time in Cycle SPI μg/kg SPI μg/kg pegfilgrastim - 6 mg SPI μg/kg ANC (10 9 /L) Days Chemo Therapy Study Drug 9 Similar ANC trends between 135 µg/kg arm and pegfilgrastim dosing arms ANC recovery was numerically greater in the 270 µg/kg arm

10 SPI-2012 Pivotal Phase 3: ADVANCE Study Schema Two 500 Patient trials, one in North America & one International Study Screening Period Treatment Period Four 21-day Cycles End of Cycle Visit Day 1 Day 2 30 Days Randomization *Chemotherapy ~500 patients SPI-2012 (3.6 mg, SC) ~250 patients Pegfilgrastim (6 mg, SC) ~250 patients 30 Days After the end of Cycle 4 10 *TC/TAC depending on North America or International Study

11 Poziotinib, a Novel pan-her Inhibitor With Clinical Activity in Several Solid Tumors Phase 1 Clinical Trials Showed Promising Clinical Activity in: Breast NSCLC Gastric Head and Neck 11

12 Poziotinib Molecule Company ORR No. of HER2+ Patients Prior HER2 directed therapy Study Poziotinib Spectrum Pharma/ Hanmi Pharma 60% 10 Trastuzumab Lapatinib Pertuzumab* Hanmi Aggregate Phase 1 Neratinib Puma Biotechnology 24% 63 Trastuzumab Phase 2: Burstein et al Lapatinib (Tykerb ) GlaxoSmithKline (Approved 2007) 6% 140 Trastuzumab Phase 2: Burstein et al *One patient treated with prior pertuzumab who had PR 12 For illustrative purposes only. Comparisons across studies with different trial designs and parameters are not indicative of superiority or inferiority of any compound.

13 13 Evomela: Strong Growth Driver Potential Under FDA Review

14 Multiple Myeloma Facts Multiple Myeloma (MM) is considered incurable Incidence of MM is increasing ~83,000 persons currently with diagnosis1 ~25,000 newly diagnosed per year Stem Cell Transplant is an important therapy for MM patients 14 Source: 1. ACS Cancer Facts and Figures (2014)

15 Evomela An Alkylating Chemotherapy Agent for use prior to Stem Cell Transplant One vial system Propylene Glycol-Free Potentially longer infusion window FDA decision expected on October 23, Evomela is currently under FDA review

16 Apaziquone: Potential to be the First Drug Approved for the Treatment of NMIBC Bladder Cancer (BC) Fifth most common cancer ~74,690 new cases per year 1 ~500,000 per year living with BC 2 High recurrence (60-70%), associated with high risk of mortality 3 TURBT is standard of care No new FDA approved drug in BC in 25 years NDA Filing planned in ACS Cancer Facts and Figures (2013), 2 SEER Cancer Statistics Review, available 3 ACS NMIBC

17 Spectrum is Positioned For Long-Term Growth SPI-2012: Poziotinib: Evomela: Apaziquone: Late-stage drug targeting blockbuster market A promising Phase 2 pan-her inhibitor Under FDA review PDUFA date: October 23, 2015 Late-stage drug could satisfy unmet need in bladder cancer 17

18 2015 Company Milestones Milestones Date FDA decision on Evomela October 23, 2015 Initiation of Phase 3 SPI-2012 Trial 2H 2015 File Apaziquone NDA 2H 2015 Start Phase 2 Study for Poziotinib By end of

19 19 Thank you