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Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference
June 3rd, 2015
Joe Turgeon President and Chief Operating Officer
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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 forward-looking statements and expressly disclaim any duty to update the information contained in this presentation except as required by law.
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Spectrum’s Focus & Overview
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Key Recent Milestones
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Strategically Poised for Future Growth
SPI-2012 Targets Blockbuster Market
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FcRn
Bone Marrow
Epithelial Layer
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A Novel Molecule for the Treatment of Neutropenia
Potential to compete in a worldwide market that exceeds $6 billion
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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
• Similar ANC trends between 135 µg/kg arm and pegfilgrastim dosing arms • ANC recovery was numerically greater in the 270 µg/kg arm 9
Phase 2: SPI-2012 Median Absolute Neutrophil Count (ANC) Over Time in Cycle 1
0
5
10
15
20
25
30
35
40
0 5 10 15 20
ANC
(109
/L)
Days
SPI-2012 - 270 μg/kg
SPI-2012 - 45 μg/kg
SPI-2012 - 135 μg/kg
pegfilgrastim - 6 mg
Study Drug
Chemo Therapy
Screening Period
30 Days
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SPI-2012 Pivotal Phase 3: ADVANCE Study Schema
Ran
dom
izat
ion
Treatment Period Four 21-day Cycles End of Cycle Visit
Day 1 Day 2
Pegfilgrastim (6 mg, SC)
~250 patients
SPI-2012 (3.6 mg, SC) ~250 patients *Chemotherapy
~500 patients ≥30 Days
After the end of Cycle 4
*TC/TAC depending on North America or International Study
Two 500 Patient trials, one in North America & one International Study
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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
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. 2010
Lapatinib (Tykerb®)
GlaxoSmithKline (Approved 2007)
6% 140 Trastuzumab Phase 2: Burstein et al. 2008
Poziotinib
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*One patient treated with prior pertuzumab who had PR
For illustrative purposes only. Comparisons across studies with different trial designs and parameters are not indicative of superiority or inferiority of any compound.
Evomela: Strong Growth Driver Potential Under FDA Review
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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
Source: 1. ACS Cancer Facts and Figures (2014)
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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, 2015
Evomela is currently under FDA review
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Apaziquone: Potential to be the First Drug Approved for the Treatment of NMIBC
Fifth most common cancer ~74,690 new cases per year1
~500,000 per year living with BC2
High recurrence (60-70%), associated with high risk of mortality3
1ACS Cancer Facts and Figures (2013), 2 SEER Cancer Statistics Review, available http://seer.cancer.gov, 3 ACS 2014. NMIBC
Bladder Cancer (BC)
TURBT is standard of care
No new FDA approved drug in BC in 25 years
NDA Filing planned in 2015
Poziotinib:
A promising Phase 2 pan-HER inhibitor
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Spectrum is Positioned For Long-Term Growth
SPI-2012:
Late-stage drug targeting blockbuster
market
Evomela:
Under FDA review PDUFA date:
October 23, 2015
Apaziquone:
Late-stage drug could satisfy
unmet need in bladder cancer
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2015 Company Milestones
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 2015
Milestones Date
Thank you
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