Achieve Life Sciences, Inc. · NASDAQ:ACHV
Achieve Life Sciences — Oncogenex Pharmaceuticals — Merger or Acquisition (January 2017)
26 slides from Achieve Life Sciences's merger presentation, Jan 6, 2017
Slide 1: Achieve Life Science, Inc.
Exhibit 99.1 Achieve Life Science, Inc. January 2017
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements regarding the terms, timing, conditions to and anticipated completion of the proposed merger; the expected ownership of the combined company and the composition of the combined
Slide 3: Important Additional Information About the Merger
Important Additional Information About the Merger This communication is being made in respect of the proposed merger involving OncoGenex Pharmaceuticals, Inc. and Achieve Life Science, Inc. OncoGenex will file with the Securities and Exchange Commission, or SEC, a current report on Form 8-K, which w
Slide 4: Important Additional Information About the Merger
Important Additional Information About the Merger This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or
Slide 5: About the Merger
About the Merger Achieve Life Science, Inc. and OncoGenex Pharmaceuticals, Inc. signed definitive merger agreement January 5, 2017 Upon completion of the merger, Achieve shareholders are expected to own 75% and OGXI shareholders are expected to own 25% of the combined company OGXI shareholders are e
Slide 6: Post-Merger Management Team
Post-Merger Management Team Rick Stewart Chairman & CEO of Ricanto Chairman & CEO CEO of Brabant Pharma (acquired by Zogenix) Chairman & CEO of Huxley Pharma (acquired by BioMarin) CEO of Amarin Corp Founder & CBO of SkyePharma (acquired by Vectura) John Bencich, MBA, CPA CFO of OncoGenex CFO CFO of
Slide 7: Overview: Achieve Life Science, Inc.
Overview: Achieve Life Science, Inc. Achieve is a privately-held, specialty pharma company focused on the development of cytisine for smoking cessation In-licensed WW rights to cytisine from Sopharma (excluding Central and Eastern Europe) Cytisine is approved in Central and Eastern Europe for smokin
Slide 8: Expected Near-Term Milestones
Expected Near-Term Milestones Complete FDA-required IND enabling non-clinical studies in 1H 2017 File IND in 2H 2017 Initiate FDA-required Phase 1 Fed/Fasted and Repeat Dose PK studies in 2H 2017 to support future NDA filing Initiate Phase 3 trial in 1H 2018 File MAA in Europe potentially in 1H 2018
Slide 9: Market Opportunity
Market Opportunity Smoking cessation is one of the most important public health issues Nicotine globally addiction/smoking cessation = single most important public health issue globally Smoking is the #1 cause of preventable deaths worldwide • Tobacco consumption is responsible for cancers, cardiova
Slide 10: Cytisine: Product Overview
Cytisine: Product Overview Well Strong Ex-U.S. Market Experience Defined U.S. Characterized Clinical and Safety and Product Regulatory Pathway MOA Profile Opportunity • Cytisine is a plant-based • Two Phase III trials; • IND enabling studies • Oral product approved for alkyloid found in 2,050 patien
Slide 11: Clinical Overview
| Clinical Overview 11
Slide 12: Phase 3 Trial – TASC (Cytisine vs. Placebo)
Phase 3 Trial – TASC (Cytisine vs. Placebo) N=740 Cytisine vs Placebo Primary Endpoint Heavy smokers 25-day cytisine dosing 6 & 12-month quit rates Aged 18 or over; regimen or matched confirmed by exhaled Randomized 1:1 placebo carbon monoxide levels Double-blind, randomized, placebo-controlled; min
Slide 13: TASC Phase 3 Trial Results
TASC Phase 3 Trial Results 12.0% Cytisine Placebo 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% 6 months 12 months N Engl J Med; 365:13 Sept 29, 2011 13
Slide 14: Phase 3 Trial – CASCAID (Cytisine vs. NRT)
Phase 3 Trial – CASCAID (Cytisine vs. NRT) N=1,310 Cytisine vs. NRT Primary Endpoint Heavy smokers 25-day cytisine dosing 1, 2, 6-month quit rates Aged 18 or over; regimen or 8-week NRT Randomized 1:1 (patch and/or gum or lozenge) Randomized, open-label, active-controlled, non-inferiority study desi
Slide 15: CASCAID Phase 3 Trial Results
CASCAID Phase 3 Trial Results 45% Cytisine NRT 40% 35% 30% 25% 20% 15% 10% 5% 0% 1 Month 2 Months 6 Months N Engl J Med; 371:25 Dec 18, 2014 15
Slide 16: Cochrane Database Review: Cytisine Efficacy Profile
Cochrane Database Review: Cytisine Efficacy Profile Cytisine Varenicline • Pooled RR based on 2 • Pooled RR based on published studies* 27 published studies • n=937 • N=12,625 • RR (CI95%) at longest • RR (CI95%) longest follow-up 3.98 (2.01- follow-up 2.24 (2.06- 7.87) 2.43) Key findings • No appar
Slide 17: MOA Differences between Cytisine and Varenicline
MOA Differences between Cytisine and Varenicline Efficacy Cytisine and varenicline are partial agonists at the 4 2 nicotinic acetylcholine receptor Activity at this receptor in the ventral tegmental area of the brain mediates therapeutic effect The two drugs have similar efficacy Safety Varenicline
Slide 18: Clinical Development
| Clinical Development 18
Slide 19: Anticipated Path to U.S. and EU Regulatory Approval
Anticipated Path to U.S. and EU Regulatory Approval FDA directed U.S. regulatory pathway (meeting June 19, 2015) File IND utilizing non-clinical data package (compliant with current guidelines) Conduct fed/fasted and repeat dose PK studies Conduct Phase III study in the U.S. Meet with EMA to agree o
Slide 20: Planned Phase 1 Fed/Fasted Study
Planned Phase 1 Fed/Fasted Study N=36 (to be confirmed) 2 arms – fasted, high fat meal Phase 1 Treatment period = single dose End points • Primary: Non-inferiority of food versus fasted 20
Slide 21: Planned Phase 1 Repeat-dose Pharmacokinetic Study
Planned Phase 1 Repeat-dose Pharmacokinetic Study N=12 (individuals from fed/fasted study) Conducted with fed/fasted study as a Part A/Part B design Phase 1 Standard dose cytisine, high dose cytisine vs. placebo Treatment period = 25 days End points • Full PK profile on first and final dose • Peak/t
Slide 22: Planned Phase 3 Trial Design
Planned Phase 3 Trial Design N=2,100 3 arms – standard dose cytisine, high dose cytisine vs. placebo Treatment period = 25 days Phase 3 Powered at 90% End points • Primary: Biochemically verified abstinence rate at 6-months • Secondary: Abstinence rate at 1 & 3-months Patients will be provided behav
Slide 23: Manufacturing & Supply Chain
Manufacturing & Supply Chain Sopharma API & solid dosage form manufacturer • Exclusive supply agreement for 100% of the cytisine that is required by Achieve • Supply FDA enabling clinical trials • Production sufficient to meet global market EU-GMP compliant pharmaceutical manufacturing • Opened Nove
Slide 24: Multiple Layers of Product Exclusivity
Multiple Layers of Product Exclusivity Regulatory exclusivity U.S.: 5 years under Hatch-Waxman EU: 10 years under Article 8 Exclusive Worldwide Supply of Cytisine from Sopharma (Bulgaria) Derived from seeds of the tree Golden chain (Cytisus laburnum) Trees are currently only grown in orchards in Bul
Slide 25: Anticipated Path to Commercialization in U.S. and EU
Anticipated Path to Commercialization in U.S. and EU 2017 2018 2019 United States • Non-clinical studies to support IND • File IND with FDA • Initiate Phase 1 studies: Fed/Fasted and repeat dose PK studies • Initiate Phase 3 • File NDA EU • Meetings with European regulatory agencies • Potential MAA
Slide 26: Achieve – Thank you
A ACHIEVE Thank you
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