Foresee Pharmaceuticals, Inc.

Transcription

1 Foresee Pharmaceuticals, Inc. Rapid Development and Commercialization of a Proprietary Sustained-release Depot Formulation of Leuprolide for the Treatment of Advanced Prostate Cancer PNWBIO Meeting 10 February 2015 John Mao, Ph.D. SVP and Head of Development 1

2 Safe-Harbor Statement This presentation contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of Examples of such forward looking statements include, but are not limited to, statements about market size, evolution of the clinical paradigm, and plans for corporate partnering and the potential markets and applications for our products, other than statements of historical fact. The forward-looking statements are based largely on our current expectations and are subject to risks and uncertainties that may cause actual results and timing of events to differ materially from those in the forward-looking statements, including our ability to access the resources necessary to achieve our milestones, attracting and retaining the expertise required to prepare regulatory filings, risks associated with the initiation, enrollment, timing, costs and results of clinical trials, unexpected delays in and unanticipated increases in costs related to our clinical trials, our ability to establish successful partnerships and collaborations with third parties, the regulatory approval process in the United States, our ability to build a commercial organization, future capital requirements and the acceptance of our products by the marketplace. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this presentation will in face be realized. We undertake no obligation to revise or update any such projections and statements after the date on which such projections and statements are made to reflect the occurrence of future events. Please contact ForeSee Pharmaceuticals, Inc. for further information about these and other risks that may affect the actual results achieved by the company. For additional information on Foresee Pharmaceuticals, Inc., go to: 2

3 Foresee Business Model -Converting Innovations to Economic Value- Experienced Team -Proven Track Record- Proprietary SIF Technology Platform & NCE Virtual Operation -Efficient Resources Allocation- Promising Pipeline -Unmet Medical Needs- -Multi-$billion Market- De-risked Reg. Strategy -505(b)(2) FDA Pathway- Commercialization -Partnership- -Build Marketing/Sales Force- Revenue Generation - Licensing fee - Upfront & milestone - Royalties - Approved products sales Enabling Continued Growth 3

4 Stabilized Injectable Formulations (SIF) Injectable biodegradable delivery carrier systems Pharmaceuticals with desired characteristics are formulated with the delivery carrier system Formulation is prefilled into syringes that are ready-to-use 4

5 SIF Delivery System Capabilities Prefilled Syringe Small Molecules Peptides Proteins Enhanced Stability Long Acting Dosage Form Product Differentiation Stabilized Injectable Formulation (SIF) Life Cycle Management 5

6 Product Pipeline & Potentials Product\Status Research Pre-clinical Phase I Phase II Phase III Market FP-001 Prostate Cancer FP-025 Asthma and COPD FP-002 Acromegaly FP-004 Opioid Dependence FP-006 Cancer FP-007 Alcohol Abuse FP-008 Diabetic Retinopathy FP-009 Chronic Wound Healing FIH trial Moving toward preclinical POC and IND 6 Registration study

7 FP Leuprolide SIF Leuprolide SIF Contains: a salt of leuprolide that minimizes or prevents the interaction/reaction between the peptide agent and the polymer in an organic solution a biodegradable polymer a pharmaceutically acceptable organic solvent Prefilled, ready-to-use syringe Stability up to 24 months Dosing frequency: 3 and 6 months (shorter durations also feasible) 7

8 LMIS 50 mg: Development Program LMIS 50 mg is a proprietary sustained-release (6- month) depot formulation of leuprolide mesylate It addresses a multi-billion market as a palliative treatment of prostate cancer Foresee develops LMIS 50 mg through an accelerated 505b(2) and/or hybrid application by leveraging existing safety and efficacy data on leuprolide acetate FP01C is a global phase 3 registration study 8

9 LMIS 50 mg Differentiation Reference Drug: Eligard 45 mg LMIS 50 mg 9

10 Regulatory and Development Strategy Global registration as a new drug via the 505b(2) and/or hybrid medicinal product pathway INDs and CTAs active Containing all relevant CMC information on the clinical trial material Containing bridging PK/PD and toxicity studies Containing a Phase 3 registration study protocol and development rationale Supported by extensive literature data on leuprolide products Registration study is an open-label, multicenter study with a PK/PD leading phase Consistent with regulatory requirements for similar leuprolide products 10

11 Shortest Path to Global Registration Bridging studies LMIS 50 mg Data Lupron, Eligard, Leuprolide Injection Data LMIS 50 mg NDA/MAA 505b(2) and/or Hybrid Medicinal Product Pathway 11

12 LMIS 50 mg: Preclinical Evidence of Equivalence to Leuprolide Acetate LMIS 50 mg showed similar PK/PD profiles to Eligard 45 mg in male rats LMIS 50 mg Ref Drug: Eligard Testosterone castrate level Leuprolide (ng/ml) Testosterone (ng/dl) 1000 Leuprolide (ng/ml) Testosterone (ng/dl) Serum Concentration Serum Concentration Day Day 12

13 Study FP01C ClinicalTrials.gov Identifier: NCT

14 FP01C Protocol (Phase 3) Primary Objectives Determine the safety and tolerability of LMIS 50 mg for up to 1 year of exposure (2 subcutaneous doses 6 months apart) in subjects with advanced prostate carcinoma; Establish the efficacy of LMIS 50 mg in this population, as determined by magnitude and duration of suppression of serum testosterone levels for up to 1 year(2 subcutaneous doses 6 months apart); and Evaluate the pharmacokinetic behavior of serum leuprolide following 2 subcutaneous injections of LMIS 50 mg 6 months apart, under the conditions of the trial Secondary Objective To characterize the effects of LMIS 50 mg on the ancillary laboratory markers of serum prostate specific antigen (PSA) and luteinizing hormone (LH) 14

15 FP01C Protocol (Phase 3) Study Outline Open-Label Multi-national, multi-center 30 sites in the US, EU, and Taiwan 2 injections, 6 months apart Approx. 1 year patient treatment period Primary Efficacy Endpoints The percentage of subjects with a serum testosterone concentration suppressed to castrate levels ( 50 ng/dl) by Day 28 ± 1(day) following the first injection of LMIS 50 mg and the percentage of subjects with serum testosterone suppression ( 50 ng/dl) from Day 28 through Day 336 (remaining duration of the study) 15

16 Key functions for study FP01C Clinical operation Medical monitoring Safety reporting Data management, statistical programing, and statistical analysis Central labs Bioanalytical and PK/PD Technical operations and supply chain management CTM packaging/labeling and distribution 16

17 An example of enrollment projection Best Expectation Current Enrollment Worst Expectation Fully enrolled C V C V Enrollment Interim Analysis Actual

18 Photos of finished kits 2/9/

19 Clinical Development History of Eligard FDA s view: 19

20 Clinical Experience with Eligard Foreseeacer Pharmaceuticals, Inc. 20

21 Lupron 45 mg registration study 21

22 Lupron 45 mg registration study 22

23 Lupron 45 mg registration study 23

24 Roadmap to LMIS 50mg NDA/MAA Approval and Launch Drug substance and drug product Bridging clinical batch to NDA validation batches Preclinical safety and PK/PD Bridging studies to establish scientific rationale to reference RLD Clinical study PK/PD leading phase Definitive phase Regulatory Challenges to harmonize regional requirements for global registration Commercial Marketing partner(s) for rapid commercial launch 24

25 ectd Preparation ectd structure 25

26 Summary LMIS 50mg (6-mon) followed by LMIS 25mg (3- mon) Target US and EU initially followed by ROW Rapid clinical development with a clear-path to regulatory approval Significantly shortened development timeline via 505(b)(2) IND/CTA approved by US FDA, EU regulatory authorities, and Taiwan FDA Large market potential with competitive advantages Relatively low clinical and commercial risk Partnership/licensing discussions 26