Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Kitov Pharmaceuticals Holdings — Investor Presentation (May 2016)
23 slides from Purple Biotech's investor presentation, May 4, 2016
Slide 1: Kitov Pharmaceuticals: Streamlined Late-Stage Drug Development
Company Presentation May 2016 © 2016 Kitov Pharmaceuticals Holdings Ltd. Kitov Pharmaceuticals Streamlined Late - Stage Drug Development
Slide 2: Forward-looking statements disclaimer
Streamlined Late - Stage Drug Development This presentation is not a prospectus or offer of securities for subscription or sale in any jurisdiction . All statements in this communication, other than those relating to historical facts, are "forward - looking statements" within the meaning of applicab
Slide 3: Company Profile
Streamlined Late - Stage Drug Development Company Profile Attractive, late stage asset Operations F inancial Summary ▪ Lead drug candidate, KIT - 302 addresses a multi - billion dollar market of patients with osteoarthritis and hypertension ▪ In a pivotal Phase III trial KIT - 302 met its primary
Slide 4: Investment Highlights
Streamlined Late - Stage Drug Development Investment Highlights ▪ Lead drug candidate KIT - 302 , a combination of celecoxib (Celebrex®) and amlodipine (Norvasc ®) achieved its primary efficacy endpoint in a pivotal phase III trial for treatment of pain caused by osteoarthritis, and hypertension, a
Slide 5: Key Management
Streamlined Late - Stage Drug Development Key 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 Se
Slide 6: About Kitov Pharmaceuticals
About Kitov Pharmaceuticals Our Market Our Drugs Our Development Plan
Slide 7: Fixed Dose Combination Drugs
Streamlined Late - Stage Drug Development Fixed Dose Combination Drugs ▪ Provides improved medical treatment of patients diagnosed as suffering from two or more different diseases ▪ Cost of developing a combination drug using known molecules can be materially lower than developing a new chemical ent
Slide 8: Combination Drug Pipeline
Streamlined Late - Stage Drug Development Expected NDA Submission to FDA Combination Indication Product H 2 2016 Celecoxib + Amlodipine Osteoarthritis KIT - 302 - Naproxen + Isradipine Osteoarthritis KIT - 301 * * The Company is currently focusing on KIT - 302 Kitov’s Combination Drug Pipeline
Slide 9: Osteoarthritis & Hypertension
Streamlined Late - Stage Drug Development Osteoarthritis & Hypertension ▪ Osteoarthritis, the most common type of arthritis, causes loss of cartilage, decreased mobility, and significant pain; the incidence of osteoarthritis increases with age ▪ NSAIDs are effective for treating osteoarthritis relat
Slide 10: NSAIDs and Antihypertensive Drugs
Streamlined Late - Stage Drug Development NSAIDs and Antihypertensive Drugs Since 2005 in the U.S., NSAIDs carry an FDA - mandated “Black Box” label warning of increased cardiovascular risks: In July 2015 the FDA issued a Safety Announcement stating its intention to : • Require labels for prescri
Slide 11: KIT-302 combines celecoxib with amlodipine
Streamlined Late - Stage Drug Development ▪ Many osteoarthritis sufferers do not receive NSAIDs due to physicians’ and patients’ fear of elevated blood pressure ▪ KIT - 302 combines celecoxib, the only COX - 2 selective NSAID approved in U . S . , with amlodipine, a well - known anti - hypertensive,
Slide 12: KIT-302's Advantages vs. Current Treatment
Streamlined Late - Stage Drug Development KIT - 302 ’s Advantages vs. Current Treatment Patient Advantages • Simultaneous treatment of two severe medical conditions • Convenience of taking one pill instead of two • Should lower patient co - pay for one drug as opposed to two drugs Physician Advan
Slide 13: KIT-302 Should Enjoy Labeling Advantage
Streamlined Late - Stage Drug Development ▪ FDA policy (March 2011 ) states that a drug that lowers blood pressure will be permitted to carry the following in its labeling: ▪ FDA informed Kitov in writing this labeling may be used on the package insert of KIT - 302 ▪ Following FDA approval of KIT -
Slide 14: Intellectual Property and Market Exclusivity
Streamlined Late - Stage Drug Development Intellectual Property and Market Exclusivity ▪ Two Patent Families Pending: • Pharmaceutical Formulation a nd Methods - Of - Use patents which c ombine NSAID compounds w ith Anti - Hypertensive compounds • Methods for a meliorating Drug - Induced Elevations
Slide 15: About Kitov Pharmaceuticals
About Kitov Pharmaceuticals Our Market Our Drugs Our Development Plan
Slide 16: Phase III Trial Design
Streamlined Late - Stage Drug Development ▪ Double - blind, placebo controlled, multi - center Phase III clinical trial in 152 patients ▪ Four arms, each of 30 - 45 patients, treated for 2 weeks with once daily oral dosage of placebo , celecoxib ( 200 mg) , amlodipine ( 10 mg), and KIT - 302 ( 200 m
Slide 17: Phase III Trial Results
Streamlined Late - Stage Drug Development Phase III Trial Results Daytime Systolic Daytime Diastolic Nighttime Systolic Nighttime Diastolic KIT - 302 - 10.6 [1.3 ] - 7.5 [0.9 ] - 10.5 [1.5 ] - 7.0 [1.2 ] Amlodipine - 8.8 [1.2 ] - 5.5 [0.8 ] - 6.4 [1.7 ] - 3.2 [1.2 ] Celecoxib - 0.5 [1.6 ] - 1.5 [
Slide 18: NDA approval expected H2 2017
Streamlined Late - Stage Drug Development KIT - 302 - NDA Approval Expected H 2 2017 2017 2016 Q 4 Q 3 Q 2 Q 1 Q 4 Q 3 Q 2 Q 1 COMPLETED Q 4 2015 Phase III Trial Final PK Study CMC NDA Submission until approval
Slide 19: Planned Milestones
Streamlined Late - Stage Drug Development Status Due Date Milestone x Complete Q4 2015 Complete patient enrollment in Phase III Trial x Complete Phase III clinical trial top - line results x Complete Phase III clinical trial final results x Complete Q 1 2016 Pre - NDA meeting Q 2 2016 Pre - NDA meet
Slide 20: Market Considerations
Streamlined Late - Stage Drug Development ▪ World - wide sales of Celebrex ® were $2.7 billion in 2014, ~$ 1B in 2015 (due to generic erosion) ▪ Following the successful completion of the Phase III clinical trial, Kitov intends to: • Partner KIT - 302 with pharmaceutical marketing partners • Negotia
Slide 21: CMC Outsourced to Dexcel Pharma
Streamlined Late - Stage Drug Development ▪ KIT - 302 CMC is partnered with Dexcel Pharma - Israel’s largest private pharmaceutical company • 47 years in operation; 1,000 + employees; 5 billion tablets produced per year; 3 state of - the art FDA - inspected manufacturing plants; 300 marketing author
Slide 22: Summary: Why Kitov?
Streamlined Late - Stage Drug Development Summary: Why Kitov? ▪ Proven management team with d eep FDA experience and fast - track regulatory expertise ▪ KIT - 302 is innovative solution for the simultaneous treatment of both osteoarthritis and hypertension ▪ Attractive alternative, with clear market
Slide 23: Thank you
US Address : 1615 Suter's Lane NW Washington DC 20007 Thank you Kitov Pharmaceuticals Ltd. Israel Address : One Azrieli Center Round Tower 132 Menahem Begin Rd . Tel Aviv 6701101 Tel : + 972 - 2 - 625 - 4124 www.kitovpharma.com
Kitov Pharmaceuticals Holdings — Investor Presentation (May 2016) on 6ix