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Legacy Healthcare and Alopecia Areata Program Overview

Bruce Patsner is an Oncologist and has served as Director of North American Operations for Legacy Healthcare since 2017; he is based in Boston, Massachusetts.

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Legacy Healthcare and Alopecia Areata Program Overview

  1. 1. Company and AA program overview NAAF AA Research Summit - Dec 4, 2018 Bruce Patsner, M.D., J.D. Director, North American Operations Copyright Legacy Healthcare 2007-2018Confidential
  2. 2. Legacy is Focused on Botanical drugs & Alopecia For recipient use only 2 Type Auto-immune alopecia Cancer related alopecia “Normal” alopecia Condition Pediatric AA Adult AA CIA Permanent CIA Endocrine Alopecia FPHL AGA Illustration Legacy drug candidate Ph II/III ongoing Dose trial after Ped AA 2 Ph II ongoing PoC RCT completed Planning Ph II DR PoC RCT completed Current pathway • Botanical drugs = full plant extracts. FDA & EMA 2004 regulation (updated 2016) • Requires same data-set as synthetic drug (“C”MC, preclinical, clinical efficacy) • Key benefit = lower risk of long term toxicity  better suited for chronic diseases • Commercialized as an « anti-hair loss » cosmetic since 2014. 2m+ units sold to date
  3. 3. For recipient use only 3 Pediatric AA – RAAINBOW Ph II/III trial Trial name RAAINBOW Type RCT versus Placebo….. Protocol developed in conjunction w/NAAF Location Germany, France, Bulgaria, Romania Principal Investigator Dr Ulrike Blume-Peytavi, Charité Hospital, Berlin, Germany Regulatory Phase III (pre-approval) - EMA registration process N 100 (Recruitment ongoing) Treatment duration 6 months + 6 months follow-up Primary Endpoint Relative change in SALT score from baseline (from pictures) Secondary Improvement of QoL (CDLQI, Q-5DY, PRO), prevention of new AA Reference ClinicalTrials.gov NCT03240627 Prior data 11 clinical trials in AGA and CIA adult subjects RWE safety - Cosmetovigilence from 2m+ units sold
  4. 4. Pediatric AA Patient Benefit Index - PAAPBI© • No validated pediatric AA PRO exists • PAABI developed in collaborarion with Pr Nanette Silverberg (Director of Paediatric and Adolescent Dermatology Dept., Mount Sinai, NYC) as a Patient-centered index for clinical trials • 4 other languages in process • Completed by parents and/or subject (>12 years old) • 5 domains covered • Quality of life • Goals/Expectations of therapy • Perception of efficacy (hair, nail) • Use of therapy • General opinion on product • 5 levels ranking 4For recipient use only
  5. 5. Examples of questions 5For recipient use only
  6. 6. FDA Sept-2017 PFDD meeting outcome considered For recipient use only 6 Source: US FDA Public Meeting on Patient-Focused Drug Development for Alopecia Areata. September 11, 2017. page 78 https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM576286.pdf Topic Legacy Healthcare answer A Topical solution spray B Affordable pricing planned C Trial outcome will tell … D Design: 6 months treatment and 6 months follow-up to show that benefits persist E Cosmetovigilence from 2m units sold (to AGA and CIA subjects) since 2014 shows excellent safety/tolerance and no long-term toxicity (> 1/100,000 ADR, and minor) F G H

Bruce Patsner is an Oncologist and has served as Director of North American Operations for Legacy Healthcare since 2017; he is based in Boston, Massachusetts.

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