Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Kitov Pharmaceuticals Holdings — Investor Presentation (September 2016)
22 slides from Purple Biotech's investor presentation, Sep 7, 2016
Slide 1: Kitov Pharmaceuticals: Streamlined Late-Stage Drug Development
Company Presentation September 2016 © 2016 Kitov Pharmaceuticals Holdings Ltd. Kitov Pharmaceuticals Streamlined Late - Stage Drug Development
Slide 2: Forward Looking Statements and Kitov's Safe Harbor Statement
Forward Looking Statements and Kitov’s Safe Harbor Statement This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction . Certain statements in this presentation are forward - looking statements within the meaning of the safe harbor provisions of th
Slide 3: Company Profile
KITOV Company Profile Late stage drug addressing large market Operations F inancial Summary ▪ Lead drug candidate, KIT - 302 , developed for simultaneous treatment of osteoarthritic pain and hypertension ▪ KIT - 302 met its primary efficacy endpoint in a pivotal Phase III study ▪ NDA submission pl
Slide 4: Company Highlights
KITOV Company Highlights ▪ Proven management team with deep FDA experience and fast - track regulatory expertise ▪ Lead drug candidate KIT - 302 achieved its primary efficacy endpoint in a pivotal Phase III trial ▪ Attractive alternative, with clear marketing advantages, to currently available dru
Slide 5: Experienced Senior Management
KITOV Experienced Senior Management Paul Waymack, M.D., Sc.D. - Chairman of the Board and Chief Medical Officer: Fo rmerly FDA medical officer Isaac Israel - CEO: Formerly CEO of BeeContact Ltd . ( TASE:BCNT ), NextGen Biomed (TASE: NXGN) Simcha Rock, CPA, MBA - CFO: Formerly Senior VP Edmond de R
Slide 6: About KIT-302
▪ Fixed Dose Combination of celecoxib, a COX - 2 selective NSAID (the active ingredient in Pfizer's Celebrex ®) , and amlodipine (the active ingredient in Pfizer's Norvasc ®), a blood pressure lowering agent (calcium channel blocker) ▪ Will be indicated for the simultaneous treatment of osteoarthr
Slide 7: Medical Rationale
KIT - 302 Medical Rationale Amlodipine (active ingredient in Pfizer's Norvasc ®) ▪ Calcium channel blocker ; Anti - hypertensive ▪ Unlike other blood pressure lowering drug groups such as diuretics, ACE inhibitors, and angiotensin II receptor antagonists - calcium channel blockers do not cause det
Slide 8: Phase III Trial Design
KIT - 302 Phase III Trial Design (under Special Protocol Assessment from FDA) Demonstrate that the reduction in blood pressure in the KIT - 302 arm is at least 50 % of the reduction in the amlodipine arm Measurement of pain reduction was not required by FDA Primary End - point Newly Diagnosed hype
Slide 9: Phase III Trial Results
KIT - 302 Phase III Trial Results ▪ Results announced December 15 , 2015 ▪ Primary efficacy end - point was successfully achieved (P= 0 . 001 ) ▪ Demonstrated 2 . 5 x better b lood pressure (BP) reduction than FDA requirement ( 50 % of Amlodipine alone arm) ▪ Demonstrated consistent reduction in a
Slide 10: Beneficial Kidney Outcomes
KIT - 302 Beneficial Kidney Outcomes Measure KIT - 302 Amlodipine Creatinine plasma levels reduction - 3.22 μ mol/L - 2.55 μ mol/L Peripheral edema (% patients) 8.2% 15.6% ▪ Adverse renal events occur in approximately 1 % - 5 % of all patients using NSAIDs* ▪ Creatinine is a measure of renal func
Slide 11: Recent Achievements and Milestones
KIT - 302 Recent Achievements and Milestones Date Announced May 2016 x Received FDA minutes that support NDA submission o Advisory Committee Review is not required o FDA will accept 6 months of stability data at date of submission x Pharmacokinetic trial meets FDA bioequivalence standards with re
Slide 12: Intellectual Property
KIT - 302 Intellectual Property • U.S. Patent 9 , 408 , 837 was issued August 9 , 2016 • Expected patent protection in U.S. until February 28 , 2030 • Method of use patent; Additional patent applications pending • Expected EU market exclusivity of 7 - 10 years KIT - 302
Slide 13: U.S. Market Assessment
KIT - 302 U.S. Market Assessment Kitov commissioned a third - party U . S . Market Assessment for KIT - 302 , which included data from the following : ▪ IMS Health - Analysis of patient - level data of more than 85 % of all dispensed Rx’s in the U . S . ▪ Physician Survey of 110 Key Opinion Leade
Slide 14: US Target Markets
KIT - 302 US Target Markets Osteoarthritis 50 Million patients* Hypertension KIT - 302 will be indicated for the simultaneous treatment of osteoarthritic pain and hypertension, targeting osteoarthritic patients currently prescribed with NSAIDs (either celecoxib or non - celecoxib) and also suffer
Slide 15: Physician NSAIDs Prescribing Behavior
Physician NSAIDs Prescribing Behavior Analysis - NSAIDs and celecoxib usage for osteoarthritis : NSAID’s - 60 % Celecoxib - 27 % KIT - 302 - 40 % of celecoxib Rx’s OA Rx’s Physicians provided their predicted prescribing behavior of KIT - 302 based on a description of the Target Product Profile, w
Slide 16: Physician NSAIDs Prescribing Behavior
Physician NSAIDs Prescribing Behavior NSAID’s - 60 % Non - celecoxib - 73 % KIT - 302 - 25 % of non - celecoxib Rx’s OA Rx’s Physicians provided their predicted prescribing behavior of KIT - 302 based on a description of the Target Product Profile, which was constructed based on Phase 3 clinical
Slide 17: Physician NSAIDs Prescribing Behavior
Physician NSAIDs Prescribing Behavior Analysis - Average duration of celecoxib therapy : Celecoxib Rx’s 60 % - chronic use (all indications) According to IMS data ( April 2015 - March 2016 ), ~ 60 % of celecoxib users take it for more than 90 days . FDA issued a Safety Announcement (July 2015
Slide 18: Benefits All Healthcare System Participants
KIT - 302 Benefits All Healthcare System Participants KIT - 302 expected to be the only NSAID whose labeling will indicate reduction of blood pressure and consequent lowering of the risk of heart attack, stroke and death
Slide 19: Non-Compliance Pharmacoeconomics
Non - Compliance Pharmacoeconomics ▪ Poor adherence has been identified as a significant cause of failure to control hypertension. o Poor adherence to therapy is estimated to contribute to lack of good blood pressure control in > 2 / 3 of people living with hypertension ▪ Indications suggesting t
Slide 20: Third Party Payors
KIT - 302 Third Party Payors Pharmacy Benefit Managers (PBMs) were interviewed as part of Market Assessment in order to obtain insight on Third P arty P ayers’ view of KIT - 302 : ▪ Interviewed organizations which insure ~ 150 million covered lives ▪ Most PBMs were intrigued with the potential fo
Slide 21: Summary
KITOV Summary ▪ Proven management team with deep FDA experience and fast - track regulatory expertise ▪ Lead drug candidate KIT - 302 achieved its primary efficacy endpoint in a pivotal Phase III trial ▪ Attractive alternative, with clear marketing advantages, to currently available drugs in a la
Slide 22: Thank you
US Medical Research Office : 1615 Suter's Lane NW Washington DC 20007 Thank you Kitov Pharmaceuticals Ltd . Company Headquarters : One Azrieli Center Round Tower 132 Menahem Begin Road Tel Aviv 6701101 Israel Tel : + 972 - 3 - 9333121 Email : Info@kitovpharma . com Web : www . kitovpharma . com
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