Nektar Therapeutics · NASDAQ:NKTR
Nektar Therapeutics — J.P. Morgan 2014 Healthcare Conference
23 slides from Nektar Therapeutics's conference presentation, Jan 14, 2014
Slide 1: J.P. Morgan 2014 Healthcare Conference
J.P. Morgan 2014 Healthcare Conference Howard Robin President & CEO January 14, 2014
Slide 2: Forward-looking statements
This presentation includes forward-looking statements regarding Nektar’s technology platform, drug candidates, clinical and regulatory objectives, market opportunity estimates, and royalty and milestone payment potential. Actual results could differ materially and these statements are subject to imp
Slide 3: Well-Positioned to Achieve Positive Cash Flow with High Value Phase 3/Filed Drug Candidates
Nektar Therapeutics: Well-Positioned to Achieve Positive Cash Flow with High Value Phase 3/Filed Drug Candidates In Phase 3 Phase 3 Enrollment Filed Complete US, EU, & Canada Amikacin Inhale Cipro DPI BAX 855 Phase 3/Filed Naloxegol Programs Fovista™ NKTR-102 REG1 In Phase 1 Completed Phase 2 Wholly
Slide 4: Naloxegol (NKTR-118): Potential to be First Once-Daily Oral Tablet to Treat OIC
Naloxegol (NKTR-118): Potential to be First Once-Daily Oral Tablet to Treat Opioid-Induced Constipation NDA, MAA and NDS filings accepted in US, EU and Canada US PDUFA Date: September 16, 2014 AZ will participate along with other sponsors in an FDA Advisory Panel for OIC: March 10-11, 2014 (te
Slide 5: Opioid-Induced Constipation: High Unmet Medical Need
Opioid-Induced Constipation: High Unmet Medical Need Of the $14.8 billion global opioid market, five markets account for $14.8 ~80% of total unit volume: US (49%), UK (14%), Germany (5%), Billion Canada (5%), France (5%).1 PCPs and Pain Management Specialists comprise the majority of prescribers in
Slide 6: Naloxegol: Positive Results from Phase 3 Efficacy Studies
Naloxegol (NKTR-118): Positive Results from Phase 3 Efficacy Studies Achieved Primary Endpoint with High Responder Rate in Patients with Statistical Significance Inadequate Response to Laxatives p=0.001 p=0.021 p=0.002 p=0.014 50% 50% 48.7% 45% 45% 46.8% 44.4% 40% 40% 39.7% Proportion of Responders
Slide 7: Naloxegol: Key Secondary Endpoint Met
Naloxegol: Key Secondary Endpoint Met Median Time to First Post-Dose SBM 5.9 75% Hours 12.0 70.1% Hours with SBM In First 24 Hours 60% 61.2% Percent of Patients 45% 35.8 37.2 Hours Hours 36.9% 36.6% 30% 15% Placebo Naloxegol Placebo Naloxegol n=214 25mg n=232 25mg n=214 n=232 0% KODIAC-04 KODIAC-05
Slide 8: Naloxegol: Positive Results from Long-Term 52-Week Comparative Safety Study
Naloxegol: Positive Results from Long-Term 52-Week Comparative Safety Study Large, well-controlled, 52-week, randomized (2:1), open-label safety study (KODIAC 08) compared chronic administration naloxegol to usual care (UC) • 534 patients – naloxegol 25 mg • 270 patients – usual care Most common
Slide 9: BAX 855: Longer-Acting ADVATE for Hemophilia A
BAX 855: Longer-Acting ADVATE® for Hemophilia A with Planned Filing This Year BAX 855 is designed to expand Baxter’s leadership position as a longer-acting therapy based upon ADVATE, the gold standard treatment for hemophilia A Baxter: The Clear Leader in Hemophilia Key Factor VIII Products Phas
Slide 10: Amikacin Inhale (BAY41-6551): Bayer Phase 3 Program Ongoing
Amikacin Inhale (BAY41-6551): Bayer Phase 3 Program Ongoing with Data Expected in 1H 2015 Targeted delivery of amikacin directly to lungs to treat gram- negative ventilator pneumonia • Amikacin inhale achieves greater lung exposure of antibiotic and lower systemic exposure1 65% of ICU pneumonias
Slide 11: NKTR-102 Passes Interim Efficacy Analysis in Phase 3 BEACON Study
NKTR-102 Passes Interim Efficacy Analysis in Phase 3 Pivotal BEACON Study Primary Endpoint Randomized 1:1 Patients with Arm A: Single Agent NKTR-102 Overall Survival (OS) metastatic breast cancer Secondary Endpoints Previously treated with A/T/C Arm B: Treatment of PFS CBR (n=852) Physician’s
Slide 12: NKTR-102 Exceeded Primary Endpoint in Avastin-Resistant High-Grade Glioma Study
NKTR-102 Exceeded Primary Endpoint in Avastin-Resistant High-Grade Glioma Study Glioma is one of the most deadly cancers Limited data and limited survival in patients third-line or greater (after failing Avastin) NKTR-102 exceeded primary endpoint with 6-week PFS of 55% • 6-Week PFS of 25% was
Slide 13: Anti-Tumor Synergy of NKTR-102 in Combination with PARP Inhibitor
Anti-Tumor Synergy of NKTR-102 in Combination with PARP Inhibitor MX-1 Breast Cancer Model BRCA1 Deficient All animals tumor-free by 14 days following treatment with NKTR-102 in combination with PARP inhibitor Combination treatment very well tolerated with no body weight loss MX-1 Breast Cancer
Slide 14: NKTR-181: New Opioid Molecule for Chronic Pain
NKTR-181: New Opioid Molecule for Chronic Pain NKTR-181 designed to target Global Chronic Pain chronic pain market Therapy Market with a novel opioid: Slow rate of entry into CNS Antidepressants Antiepileptics designed to: $1.5B $3.6B • Reduce abuse liability Opioids • Reduce drowsiness $12.6B NSA
Slide 15: NKTR-181 Enters the Brain Slowly to Reduce Euphoria
NKTR-181 Enters the Brain Slowly to Reduce Euphoria Oxycodone NKTR-181 Plasma to CNS Equilibration1 Plasma to CNS Equilibration2 Plasma Concentration Plasma Concentration Pupil Constriction Pupil Constriction 2.9 Hours 11 Minutes Plasma Drug Concentration Reduced Euphoria andPupil Low Abuse Liabilit
Slide 16: NKTR-181 Significantly Reduced Pain Scores During Titration Period in Phase 2 Study in OA
NKTR-181 Significantly Reduced Pain Scores During Titration Period in Phase 2 Study in OA Enriched Enrollment Withdrawal Design (EERW) 7 6.8 6 Only 3% of patients 40% could not titrate Average Decrease to effective pain relief All Patients 5 n=213 Randomization 4 Baseline 3.9 NKTR-181 3.7 (46% reduc
Slide 17: Placebo Arm Did Not Rebound
Placebo Arm Did Not Rebound Enriched Enrollment Withdrawal Design (EERW) 7 6.8 6 5 4.1 Placebo 4 4.0 3.9 NKTR-181 3.7 (46% reduction 3 from screening) Screening Titration 21-day Double-blind Period Period Placebo-controlled Period 17
Slide 18: Reasons for Lack of Placebo Rebound
Reasons for Lack of Placebo Rebound EERW design not optimal for a unique drug like NKTR-181 with low CNS side effects • EERW design adopted to study opioids with tolerability issues and high CNS side effects: typical drop-out rates >50% • NKTR-181 drop-out rate for AEs was only 18% because of low
Slide 19: Next Step for NKTR-181: Guidance from FDA and Key Pain Experts
Next Step for NKTR-181: Guidance from FDA and Key Pain Experts Highly productive initial meeting with FDA under Fast Track Status • First Phase 3 study can be started this year in patients with OA • Parallel design suitable for pivotal registration studies • No requirement to use EERW for registra
Slide 20: Proposed Parallel Design Pivotal Study in Patients with Osteoarthritis
Proposed Parallel Design Pivotal Study in Patients with Osteoarthritis Blinded Titration 12 Week to Analgesic Dose Treatment Period Primary Randomized 1:1 Patients with NKTR-181 Endpoint: osteoarthritis (OA) of the knee WOMAC Pain Subscale (n~600) Placebo Change from Baseline Eliminate continued u
Slide 21: Acute Pain Programs
Acute Pain Programs Phase 1 Multiple-Ascending Dose Study for NKTR-192 • NKTR-192 demonstrated significant and rapid analgesic effect • At the highest 200 mg dose, analgesic activity was superior to 20 mg of IR oxycodone • NKTR-192 also exhibited low CNS side effects with low levels of sedation an
Slide 22: NKTR-171: First Subjects Dosed in Phase 1 for New Neuropathic Pain Candidate
NKTR-171: First Subjects Dosed In Phase 1 for New Neuropathic Pain Candidate Gabapentinoids widely Global Sales used for neuropathic pain of Neuropathic Pain despite limited efficacy Treatments $4.6 Billion Sodium channel blockers Off-label are highly efficacious but antidepressants $100M Opioid
Slide 23: Nektar Catalysts for 2014 and Beyond
Nektar Catalysts for 2014 and Beyond Ended 2013 with $262 Million NOTE: Partnered programs are based on Nektar’s estimates, and are not based upon specific partner guidance 23
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