CDMO Partnering Strategies for Managing a Broad Portfolio of Molecules: A Novel Biopharma s Approach. AAPS Workshop November 12 th 2017

Transcription

1 CDMO Partnering Strategies for Managing a Broad Portfolio of Molecules: A Novel Biopharma s Approach AAPS Workshop November 12 th 2017

2 Transforming the right molecules into the best medicines TM We are passionate in our mission to improve the health of patients by providing novel strategic alternatives to companies wishing to further de-risk and unlock the value of life improving medicines. 2

3 Boston Pharmaceuticals: at a glance Diversified pipeline of 5 molecules acquired in 18 months since incorporation Experienced team covering all key functions of clinical development Top-tier service providers in place to augment clinical and non-clinical drug development $600M committed capital from single investor: each development program is fully funded through clinical PoC Seeking CDMO partners to accelerate our drug development 3

4 Our business model is simple and addresses a key market need BUY WELL DEVELOP WELL SELL WELL We acquire differentiated pre-clinical or clinical candidates across a broad range of mechanisms and therapeutic areas We develop the candidates through clinical PoC using our translational medicine expertise and capital We create value for you by monetizing assets post PoC 4

5 Boston Pharmaceuticals builds a diversified pipeline with worldwide rights BOS BOS BOS BOS BOS Status ü Completed ü Completed ü Completed ü Completed ü Completed Originator Large Pharma Biotech Biotech Academia/Fund Daiichi Sankyo MOA Novel Novel Novel Novel Novel Differentiation Best-in-class First-in-class Second-in-class Best-in-class Fast follow-up Modality mab Small molecule Small molecule Small molecule Small molecule Therapeutic Area Deal Structure Autoimmune Anti-Infective Autoimmune Oncology Oncology Asset Acquisition License License License License Next Milestone Ph2a MAD 12/2017 IND Q2/2018 Ph1 Q1/2018 CTA July/2017 IND Q2/2018 5

6 Daiichi Sankyo press release 6

7 Boston Pharmaceuticals offers flexible partnering structures Structure # of Assets Originator s Participation License/ Asset Acquisition One at a time Upfront, milestones and royalties Profit Share One at a time Fixed or tiered % share of operating profits from the asset NewCo Formation Strategic R&D partnership One or more per Equity share in Newco NewCo Multiple (5-10) Callback rights on subset of assets, residual share (milestones and royalties) on non-called assets 7

8 Our business model is simple BUY WELL and addresses a key market need We acquire differentiated pre-clinical or clinical candidates across a broad range of mechanisms and therapeutic areas 8

9 Buy-Well Process and KPI LEAD # Days: 70% QUALIFIED LEAD Diligence and Contract Negotiation heavily influenced by speed and efficiency of Partner # Days: 50% DILIGENCE # Days: 10 % DECLINED # Days: 80% CONTRACT NEGOTIATION # Days: 25% PARTNERED (Asset Purchase Agreement) 9

10 Deal-Flow KPI (since Inception) 9

11 Deal-Flow Activity (since Inception) 9

12 Our business model is simple and addresses a key market need DEVELOP WELL We develop the candidates through clinical PoC using our translational medicine expertise and capital 10

13 Boston Pharma core team supported by a multidisciplinary asset team drives drug development strategy & execution External Network CROs CDMOs KOLs Clinical Operations Biomarker development Regulatory Operations Medical Writing Preclinical toxicology Tech Transfer Process Development Formulation Development Bioanalytical Testing GMP Manufacture Advisory Boards Clinical Strategy BP Internal Team & Consultants Dedicated Triad Internal Regulatory CMC Clinical Pharmacology Quality External Preclinical Toxicology Preclinical Pharmacology Modelling & Simulation New Product Planning Program Lead Clinical Operation Lead Clinical Lead Next-generation and scalable business model 13

14 Boston Pharmaceuticals organization as of November 2017 Chris Viehbacher Chairman of the Board (25+ years) Rob Armstrong Chief Executive Officer (20 years) Ed Zhang VP, Corporate Development (14 years) Constantine Chinoporos Chief Business Officer (26 years) Kristina Harter AD, Business Development (5 years) Joel Scherer Interim Chief Medical Officer Ian Sanderson Chief Financial Officer (27 years) Bill Gaskins Group VP, Operations (36 years) Xavier Valencia VP, Clinical Development (11 years) Philip Yin VP, Clinical Development (10 years) Mitchell Keegan VP, Clinical Development (20 years) Ashley Milton VP, Clinical Pharmacology (25 years) Richard Mountfield VP, Regulatory (23 years) Jennifer Goodfellow Exec Dir Procurement (25+ years) Lee Sayers Exec Dir, Program Management (18 years) Dina Berdieva Exec Dir, Clinical Operations (15 years) Rajeev Chillakuru VP, CMC (24 years) Karen Andreas Clinical Operations Lead (12 years) Kathleen Murphy Clinical Operations Lead (19 years)

15 A track record of meaningful drug development; Over 300 years of experience 6

16 We are supported by a strategic network of best-in-class development partners Technical Writing CMC Biomarkers Clinical Pharmacology Clinical and Data Management Preclinical Statistics Pharmacovigilance Storage and Distribution KOLs Bioanalytics Toxicology Regulatory 7

17 We establish a clear development strategy BOS RET inhibitor in RET+ cancer 7

18 Our Go-No Go (GNG) investment decisions are based on objective success criteria 7

19 Example of our Develop-Well KPI Dashboard 7

20 Boston Pharmaceuticals has developed a rapid and efficient Asset on-boarding and execution process DILIGENCE CONTRACT NEGOTIATION PARTNERED (Asset Purchase Agreement) ASSET TRANSFER (Materials & Information) BP EXECUTION 9

21 Boston Pharmaceuticals has developed a rapid and efficient Asset on-boarding and execution process Integrated Development Plan (idp 1.0) Develop order-ofmagnitude estimates for timelines and budgets idp 2.0 Finalized timelines and budgets for all line functions Planning and Execution is facilitated by tight integration of key line functions: Clinical, Regulatory, CMC and Quality 9

22 How the CMC Line Function prepares for rapid execution Draft RFP and OOM Estimates from CDMO Partners LOI to lock-in Development & Manufacturing Slots (if needed) Initial Tech Transfer CDMO Agreement(s) Signed & Project KOM Complete Tech Transfer CDMO Execution 9

23 Example of rapid project initiation from APA signing to first dose in 7 months June July Aug Sep Oct Nov Dec Jan Feb Asset Purchase Agreement (APA) Signed 20 June Clinical Dev Strategy Transfer to BP vendor, labelling, packaging & shipment to site Clin Trial Supplies Tech transfer of GMP manufacturing process to BP s selected CDMO Tech Transfer Concept Sheet Protocol Development Regulatory Strategy Pre-IND Meeting Request FDA feedback 14 Nov IND Finalization First Patient Screened (9 Jan) Start of Process Dev IND submission 7 Dec IND First Patient Dosed (17 Jan) Phase 1 SAD CMC activities Regulatory activities Clinical activities 23

24 Example of rapid pharmaceutical development Accelerated development with Translational Pharmaceutics approach June July Aug Sep Oct Nov Dec Jan Feb Mar APA Signed CDMO Negotiation CDMO MSA Signed KOM TODAY Finalize 2 to 3 DP Prototype Formulations LOI Signed Tech Transfer Formulation Development DP Scale-up Regulatory Strategy JIT GMP Manufacturing of 3 DP forms IMPD Development Clinical Dev Strategy CTA Finalization CTA submission Protocol Development Protocol finalized based on DP formulations chosen First Patient To Be Dosed Phase 1 SAD CMC activities Regulatory activities Clinical activities 24

25 Boston Pharmaceuticals: A PARTNER OF CHOICE Next-generation and scalable business model Flexible and creative deal structures A proven drug development team Mutually-beneficial value creation with a diverse set of capabilities across a wide variety of disease areas that are tailored to the specific needs and circumstances of Boston Pharma s partners dedicated to efficiently designed and rigorous PoC clinical programs with end goal of out-licensing or partnering Ph3-ready programs Transforming the right molecules into the best medicines TM 25

26 Thank You! 14 26

27 ADDRESS BOSTON PHARMACEUTICALS 55 Cambridge Parkway, Suite 401 Cambridge, MA WEBSITE 27

28 APPENDIX SLIDES 14 28

29 CHRISTOPHER VIEHBACHER EXECUTIVE CHAIRMAN of THE BOARD and CO-FOUNDER LEADERSHIP EXPERTISE and NETWORKS Chris Viehbacher has over 25 years of experience in the biotech and pharmaceutical industries. He is the former CEO and Member of the Board of Directors of Sanofi, a Fortune 50 Biopharmaceutical company based in Paris with sales of over $35 billion and a market capitalization of over $100 billion. During Chris s six year tenure Sanofi underwent a significant business transformation, completed over $30 billion of acquisitions, most notably that of Genzyme, and developed a novel approach to building a pipeline of new medicines. Chris was also the Chairman of the Board of Genzyme in Boston. In 2015 Chris joined the Board of Directors of Pure Tech as well as the Board of Vedanta, a Pure Tech portfolio company. He also joined the Board of Trustees of Northeastern University. Prior to joining Sanofi, Chris spent 20 years with GlaxoSmithKline in Germany, Canada, France and, ultimately, the US as President of GSK s North American pharmaceutical division. Chris was a Member of the Board of Directors of GSK plc in London and Co- President of GSK s Portfolio Management Board. Chris began his career with Price Waterhouse after graduating with a degree in Commerce at Queen s University in Canada. Chris qualified as a Chartered Accountant while with Price Waterhouse in Canada and later with PW in Hamburg, Germany. HONOUR and DISTINCTION Chris has been a strong advocate for the healthcare industry. He has co-chaired with Bill Gates, the CEO Roundtable on Neglected Diseases, which led to over 1.3 billion people being treated for such diseases free of charge. He continues to chair the CEO Roundtable on Cancer, helping companies to reduce the risk of cancer to their employees in the United States and China. He was the Chairman of the Board of the Pharmaceutical Research and Manufacturers of America in Washington as well as President of the European Federation of Pharmaceutical Industries and Associations in Brussels. At the World Economic Forum at Davos, Chris was a past Chair of the Health Governors and co-chaired an initiative with industry, public health and government stakeholders to create a Global Charter for Healthy Living. He is also a past member of the International Business Council. Chris has in the past served on various advisory groups at MIT, Duke University and Queen s University at Kingston, Ontario. Chris has received the Pasteur Foundation Award for outstanding commitment to safeguarding and improving health worldwide. He has also received France s highest civilian honour, the Legion d Honneur. Various awards from the Thompson Reuters/ Extel Investor Survey, including top CEO and top European Company, have recognized his commitment to investor relations. 15

30 ROBERT ARMSTRONG, PhD CHIEF EXECUTIVE OFFICER and CO-FOUNDER LEADERSHIP EXPERTISE and NETWORKS With over twenty years of experience working in research and development in the biopharmaceutical industry, Rob has been involved in the discovery and clinical development of programs across multiple disease areas. Rob created and led the small molecule R&D organization at Amgen in Thousand Oaks, CA. He subsequently co-led research at Lilly as Vice President of Global Medicinal Chemistry, was head of the translational medicine group Chorus, and was Vice President of Global External R&D. He served on the finance and scientific advisory boards of Lilly BioVentures. Prior to working in industry, Rob was a tenured Professor of Chemistry and Biochemistry at the University of California at Los Angeles. Rob received his BS in chemistry at UCSD, his Ph.D. in chemistry at CSU, and was an NIH postdoctoral fellow at Harvard. Rob is an advisor to Gelesis and serves on the board of directors of early stage biotechnology companies Curza Therapeutics, Cloud Pharmaceuticals, Entrega Bio, and Artax Biopharma. 16

31 CONSTANTINE CHINOPOROS CHIEF BUSINESS OFFICER LEADERSHIP EXPERTISE and NETWORKS Constantine Chinoporos has 20 years of business development experience. He joins Boston Pharmaceuticals from Sanofi, where he was Vice President and Chief Licensing Officer, responsible for the global business development function since In addition, the North American and European regional Business Development teams reported to him. Some of the notable transactions he was directly responsible for included Sanofi s $2.5 billion Immuno-Oncology pact with Regeneron, acquisition of the Rx to OTC rights for Cialis from Eli Lilly, and the purchase of Priority Review Vouchers from Biomarin and Retrophin. Constantine brings extensive experience in Business Development with nearly 20 years of working in external innovation-focused roles in the biotech and pharma industries. He joined Sanofi following its acquisition of Genzyme in 2011, and assumed the role of regional head of Business Development for Sanofi s North American Pharmaceutical division. Prior to this position, he was a Vice President in Genzyme s Corporate Development group, which he joined in Before Genzyme, Constantine served in various capacities at Eli Lilly and Company over a twelve year period, including roles in Corporate Finance & Investment Banking as well as the Office of Alliance Management. Constantine received an undergraduate degree in History as well as an MBA from Cornell University. 18

32 IAN SANDERSON CHIEF FINANCIAL OFFICER LEADERSHIP EXPERTISE and NETWORKS Ian joins Boston Pharmaceuticals from Catabasis Pharmaceuticals, where he was Chief Financial Officer and oversaw operations. He led the re-positioning and successful IPO of Catabasis in Prior to joining Catabasis, Ian was a senior advisor with JSB Partners, advising life sciences companies on corporate finance, M&A and business development transactions. Before JSB Partners, Ian spent 20 years with Cowen and Company, most recently as a Managing Director and Senior Pharmaceuticals Analyst, leading Cowen's emerging and specialty pharmaceuticals research team. During his career at Cowen, Ian was named to several Institutional Investor Analyst All Star teams for his coverage of the specialty pharmaceuticals sector, and helped build one of the top-ranked healthcare research teams on Wall Street. Prior to his pharmaceuticals research analyst career, Ian was a health care investment banker with Cowen and Houlihan Lokey. He began his healthcare career in the finance group of U.S. Surgical Corporation (now Medtronic). Ian earned a BA in political economy from Williams College and an MBA in finance from the Wharton School. 19