Purple Biotech Ltd. · TASE:PPBT
Purple Biotech — Kitov Pharmaceuticals Holdings — Investor Presentation (January 2016)
28 slides from Purple Biotech's investor presentation, Jan 11, 2016
Slide 1: Company Presentation January 2016
Company Presentation January 2016 © 2016 Kitov Pharmaceuticals Holdings Ltd. Kitov Pharmaceuticals Streamlined Late - Stage Drug Development
Slide 2: Disclaimer and forward-looking statements
Kitov Pharmaceuticals 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 t
Slide 3: About Kitov Pharmaceuticals
About Kitov Pharmaceuticals Our Market Our Drugs Our Development Plan
Slide 4: Company Financials
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Company Financials • Founded in 2010 , became a public company on the TASE in July 2013 • Successful IPO on NASDAQ in November 2015 • 3.8 M outstanding ADS • Market cap: $ 13.5 M * • $ 22 M total investment to date • >$ 10 M cash on han
Slide 5: Company Overview
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Company Overview • Kitov Pharmaceuticals is a biopharmaceutical company focused on the late - stage development of therapeutic candidates that can make a meaningful impact on people’s lives • Pivotal Phase III trial of lead drug candida
Slide 6: Company Status
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Company Status • Pipeline of two combination drugs – KIT - 301 * and KIT - 302 - intended to simultaneously treat pain caused by Osteoarthritis (OA) and hypertension, a known side effect of existing drugs intended to treat OA - induced
Slide 7: Team
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Team Paul Waymack, M.D., Sc.D.; Chairman of the Board - Former academic transplant surgeon and former FDA medical officer. Over 15 years of experience in drug development as a consultant to major pharmaceutical companies. Responsible fo
Slide 8: Our Market
About Kitov Pharmaceuticals Our Market Our Drugs Our Development Plan
Slide 9: About Combination Drugs
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development About Combination Drugs • The objective : to provide improved medical treatment of patients diagnosed as suffering from two or more different diseases • The cost of developing a combination drug could be materially lower than developing
Slide 10: Osteoarthritis & Hypertension
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Osteoarthritis & Hypertension • Osteoarthritis (OA ), the most common type of arthritis, causes the loss of cartilage, decreased mobility, and significant pain • Incidence of OA increases with age • Many drugs, including NSAID’s , are e
Slide 11: NSAIDs and Antihypertensives
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development NSAIDs and Antihypertensives Since 2005 NSAID’s carry a “Black Box” labeling Warning in the U.S. of increased cardiovascular risks: In July 2015 the FDA issued a Safety Announcement stating its intention to : • R equire labels for pr
Slide 12: Our Drugs
About Kitov Pharmaceuticals Our Market Our Drugs Our Development Plan
Slide 13: Kitov's Combination Drug Pipeline
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Expected NDA Submission to FDA Combination Indication Product H 2 2016 Celecoxib (Celebrex®) + Amlodipine besylate Osteoarthritis KIT - 302 - Naproxen (Aleve®) + Isradipine Osteoarthritis KIT - 301 * * The Company is currently focusi
Slide 14: KIT-302 combines celecoxib with amlodipine
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development • KIT - 302 combines an NSAID, celecoxib (Celebrex ®) , the only COX - 2 selective NSAID approved in the U . S . , with a well - known anti - hypertensive ( amlodipine besylate) to : • Treat OA pain, while • Treating the side effect of
Slide 15: Advantages vs. Current Treatment
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Advantages vs. Current Treatment • Patients’ compliance in taking prescribed anti - HTN medications is poor • We believe that adding a pain reliever to an anti - HTN prescription medicine will improve compliance • We provide a combinati
Slide 16: Labeling Advantage
Kitov Pharmaceuticals 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 us in writing this labeling may be used on the package insert of KIT - 302 • Following FDA
Slide 17: Intellectual Property and Exclusivity
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Intellectual Property and Exclusivity • Two Patent Families Pending: • Pharmaceutical Formulations And Methods Of Use Which Combine NSAID Compounds With Anti - Hypertensive Compounds • Methods For Ameliorating Drug Induced Elevations In
Slide 18: Marketing Considerations
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development • The global market for NSAID’s is billions of dollars annually • World - wide sales of Celebrex ® alone were $ 2.7 billion in 2014 , ~$ 1 B in 2015 (due to generic competition) • The Vimovo ® (naproxen/esomeprazole magnesium) Case Stud
Slide 19: Our Development Plan
About Kitov Pharmaceuticals Our Market Our Drugs Our Development Plan
Slide 20: FDA Approved Development Plan
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development • FDA approved the following development plan : • One Phase III clinical trial : • Initial 150 patients • 2 weeks of treatment per patient • Based on amlodipine besylate 10 mg (marketing approval is planned for 3 dosages, 2.5 mg, 5 mg,
Slide 21: FDA Approved Phase III Trial Design and Status
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development A double - blind, placebo controlled, multi - center Phase III clinical trial : • Initially, four arms of approximately 30 - 45 patients each over 2 weeks (placebo, celecoxib, amlodipine, KIT - 302 ) • Based on the FDA approved Adaptive
Slide 22: FDA Approved Phase III Trial Results
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development FDA Approved 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 [ +
Slide 23: NDA Approval Anticipated Q3 2017
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development KIT - 302 - NDA Approval Anticipated Q 3 2017 2017 2016 2015 Q 3 Q 2 Q 1 Q 4 Q 3 Q 2 Q 1 Q 4 Phase III Trial Final PK Study CMC NDA Submission until approval
Slide 24: Planned Milestones
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Status Due Date Milestone x Done November 2013 Submit pivotal protocol to FDA x Done January Complete manufacture of drug supply for pivotal study x Done March Submit a Clinical Trial application in EU x Done Q 2 2014
Slide 25: CMC - The Dexcel Agreement
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development • Dexcel Ltd. is a global pharmaceutical company (*): • Active in 20 countries, 55 drug products • Produces 5 billion tablets/capsules annually • Meets cGMP and FDA standards • Strategic agreement with Dexcel for KIT - 302 : • Dexcel to
Slide 26: Why KIT-302?
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Why KIT - 302 ? • Innovative solution for the simultaneous treatment of two common severe medical conditions • Delivers the positive benefits of combination drugs: o reduced development risk and cost o potential marketing advantage (in
Slide 27: Why Kitov?
Kitov Pharmaceuticals Streamlined Late - Stage Drug Development Why Kitov? • Strategic focus on late - stage drug development • Deep FDA experience and fast - track regulatory expertise • Proven world - caliber team • KIT - 302 window of opportunity - Phase III final clinical results announced on De
Slide 28: Thank you
US Address : 1615 Suter's Lane NW Washington DC 20007 Tel : + 1 - 202 - 965 - 2215 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
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