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Acelex capsule 2mg - tissue selective cox-2 inhibitor crystal genomics acelex nc jan2016

ACELEX capsule 2mg - Tissue Selective COX-2 inhibitor CrystalGenomics Acelex NC Jan2016. Acelex® (polmacoxib) is a non-steroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, for the treatment of symptoms associated with arthritis. Suffering from joints pain which might have been due to age or other reason. Acelex capsule 2 mg is one of new drug in the market for joints pain relief.

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Acelex capsule 2mg - tissue selective cox-2 inhibitor crystal genomics acelex nc jan2016

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  1. Overview of Acelex® (Polmacoxib), a Novel NSAID for Osteoarthritis January 2016

  2. Corporate Overview CrystalGenomics is a commercial stage biopharmaceutical company with innovative platform technologies dedicated in the discovery and development of novel pharmaceuticals in unmet medical need areas. Vision To become a fully integrated biopharmaceutical company in Korea and expand internationally through collaborations and partnerships History 2000.07 Founded 2003.09 Publication in Nature (article and coverbased on platform technology) 2006.01 IPO on KOSDAQ 2006.10 Established US subsidiary, CG Pharmaceuticals, Inc. for clinical development 2012.06 Designated by the Korean government as one of the ‘KIPC’ certified companies 2014.07 Designated by the Korean government as one of the ‘K-BrainPower’ companies 2015.02 Obtained the NDA approval from MFDS for Acelex® in Korea (osteoarthritis) 2015.09 Launch of Acelex® in Korea Key Programs Next generation NSAID, Acelex® for osteoarthritis (first-in-class) Novel antibiotic candidate for MRSA infection, CG400549 (first-in-class) Molecular-targeted cancer therapeutic, CG200745 (best-in-class)

  3. AGTC TCAG O R2 R3 O N R1 Platform Technology : Overview Integration of in vitro experiments and in silico technology enables the company to streamline the drug discovery process from gene to drug. Lead Discovery ( SCPTM ) Structure Determination ( SPSTM ) SCPTMLibrary SCPTM Screening SCPTM NMR Virtual Screening In vitro Assay Target Selection Synchrotron, NMR Lead Optimization and Candidate Selection ( SDFTM ) Drug Design & MediChem SDFTM X-ray SDFTM Informatics Parallel Synthesis In vivo Evaluation DMPK Toxicology Pharmacology Biological Evaluations Target Assays Cellular Assays In vitro DMPK IND-enabling Tox (CRO in EU,USA) Lead / Target Complex Pre-clinical Candidate

  4. CG Has Global Standard Drug Discovery Capabilities CrystalGenomics was the first group to solve the complex crystal structure of PDE5 using SPS™ technology: Nature 425, 98-102 (2003). Viagra ® (sildenafil) Cialis ® (tadalafil) Levitra ® (vardenafil)

  5. Former & Current Alliance Partners • SBI BIOTECH CO., LTD. • 5

  6. Novel Therapeutics Pipeline R&D Pipeline 1. First-in-class , 2. Best-in-class

  7. Next Generation NSAID, Acelex® (polmacoxib) (Novel NSAID with Tissue-Selective Activity)

  8. Acelex®, A Novel NSAID for Osteoarthritis Acelex® 2mg Capsule Novel NSAID for the relief of signs and symptoms of osteoarthritis ▪ Global market for arthritis drugs was USD 50B, of which $17.5B consisted of COX-2 drugs & NSAIDs but existing therapies have CV and GI safety issues and there is a great unmet medical need for a safer drug1 ▪ 16,344 deaths and 545,452 hospital admissions from GI bleeding in 2006 and heavy NSAID usage partially to blame2 ▪ Celebrex® (Pfizer) - 2012 global sales was USD 2.7B and USD 51M+ sales in Korea with double digit CAGR (2012) ▪ Approved by the MFDS of Korea (Feb. 5, 2015) ▪ Launched in September 2015 (marketed and sold by Dong-A ST) ▪ Partnered with TR-Pharm for commercialization of Acelex in Turkey & MENA region, covering 19 countries (Jan. 2016) Acelex Target Market 1IMS Top Line Industry Data (2009) 2Statistical Brief #65 Healthcare Cost and Utilization Project Jan. 2009 Agency for Healthcare Research & Quality, Rockville, MD

  9. Acelex®, Tissue Selective NSAID for Osteoarthritis < Acelex® 2mg Capsule > Tissue-SelectiveNSAID for the Relief of Signs Symptoms of Osteoarthritis (OA) • Approved by the MFDS (Feb. 2015), • Launched in Korea by Dong-A ST (Sep. 2015) • Partnered with TR-Pharm for Turkey & MENA (Jan. 2016)

  10. OA Market Characteristics • Osteoarthritis (OA) is characterized by deterioration of cartilage tissue within joint and involves entire joint1 • Nearby muscles • Underlying bone • Ligaments • Joint lining (synovium) • Joint cover (capsule) • The cause is still not completely known and there is no cure • Aging of population is driving growth of OA market • Cartilage degradation is positively correlated with increasing age and is most common in people over 55 years of age • Obesity epidemic resulting in more wear and tear on joints is also contributing to growth of OA market 1 Business Insights © 2009; The Autoimmune Outlook to 2013

  11. Positioning of A Novel NSAID,Acelex® for Osteoarthritis • Acelexwould be the first, tissue-selective and once-a-day osteoarthritis drug with a novel mode of action that specifically targets affected joints to relieve pain and restores mobility • Acelex 2 mg once-a-day could provide more rapid onset of relief from the signs and symptoms of osteoarthritis in comparison with Celebrex 200 mg once-a-day without added safety risk.

  12. Product Profiles of Marketed NSAIDs and COX-2 Inhibitors

  13. Polmacoxib COX-2 CA Mechanism of Polmacoxib Polmacoxib, a dual inhibitor of COX-2 and human CA (carbonic anhydrase), does not inhibit COX-2 in CA-rich tissues (e.g. CV system), but it fully inhibits COX-2 in CA-deficient tissues (inflamed joints). Whole Blood, Blood Vessels, CV Tissues Inflamed Joints (OA, RA) CA << COX-2  Preferred binding to COX-2 CA >> COX-2  Preferred binding to CA Limited side effects Good efficacy

  14. Summary of Clinical Studies for Acelex

  15. Compiled Summary of Completed Studies

  16. Compiled Summary of Completed Studies

  17. Phase III Clinical Study Summary

  18. Phase III Study: Study Title & The Objectives Study Title and the Objectives of the Study • Study Title: • A Double-blind, Randomized, Multicenter, Active- and Placebo-Controlled Phase III • Study to Evaluate the Efficacy and Safety of CG100649 in Osteoarthritis Patients • Objectives: • The objective of the 6-week Efficacy Study was to evaluate the safety and • non-inferiority of the analgesic efficacy of polmacoxib (formerly CG100649) 2 mg • vs. celecoxib 200 mg, and the analgesic superiority of polmacoxib 2 mg vs. • placebo, when administered once daily in subjects with osteoarthritis of • the hip or knee over the 6 week treatment period. • The objective of the Extension Study was to collect a total of 24 weeks of • safety data for those subjects who agreed to continue into the extension.

  19. Acelex®, Phase III Study Results Acelex showed SUPERIOR EFFICACY over celecoxib with statistical significance (p = 0.005) 71.9% of subjects taking Acelex experienced improvement in signs and symptoms of osteoarthritis Overall improvement of signs and symptoms of osteoarthritis in terms of PGA* scores at week 3 *PGA (Physician’s Global Assessment ): Evaluation of the test subjects by the investigators (physicians)

  20. Acelex®, Phase III Study Results Acelex showed QUICKER ONSETOF RELIEF from osteoarthritis symptoms over celecoxib Acelex showed statistically significant superiority over placebo at Week 3 (p=0.003), but celecoxib did NOT show statistically significant differentiation from placebo at Week 3 (p=0.069) WOMAC Physical Function scores at Week 3 Acelex demonstrated non-inferior or better efficacy against celecoxib in all other efficacy endpoints including WOMAC-pain and –stiffness subscales at week-3 and week-6

  21. Phase III Study: Safety (6-week Treatment Period) Safety Results from the 6-week Efficacy Study • There were no drug-related serious adverse events in either of the polmacoxib or celecoxib treatment groups. • Most of the adverse events were mild to moderate and were expected to happen in this type of trial. • There were no statistically significant differences in all three groups.

  22. Phase III Study: Conclusions (6-week Treatment Period) Conclusions Polmacoxib has successfully met the clinical study endpoints as the 2 mg dose of polmacoxib was tolerated well and based on the results of the 6‑week treatment period, polmacoxib 2 mg demonstrated analgesic efficacy and safety similar to that of celecoxib 200 mg, and analgesic superiority over that of placebo. However, based on the secondary endpoints of WOMAC-Physical function at Week 3 and PGA at Week 3, the efficacy profile of polmacoxib was superior in comparison with celecoxib. This suggests that polmacoxib 2 mg achieves a quicker onset of relief from the signs and symptoms of osteoarthritis compared to celecoxib 200 mg. The Treatment Emergent Adverse Events (TEAEs) were reported in this study were generally mild and of the type expected for COX-2 inhibitor drugs. There were no clinically meaningful or statistically significant differences in the number of TEAEs among the groups treated with polmacoxib 2 mg, celecoxib 200 mg or placebo.

  23. Phase III Study: Extended Safety Study Safety Conclusions from Safety Extension Study (24 weeks) • Only polmacoxib 2mg administered (open-label, single arm) •  There were no drug-related serious adverse events. •  During the safety extension study, the 2mg dose of polmacoxib was tolerated well • and TEAEs were generally mild. •  There were no notable increases in the incidence of any TEAEs during the 18-week • safety extension period, or the combined 24-week extended safety period. •   There were no clinically relevant findings in the analysis of clinical laboratory tests, • vital signs, ECGs, or physical examination results.

  24. Product Profile of Acelex

  25. Acelex®, Lifecycle Management Strategy • Expansion of Acelex portfolio through development of combination products, incrementally modified products, new dosage forms, and additional indications. • Goal is to maintain exclusive position up to 2026~2034 and maximize revenues. Launch of 2 mg Capsule 2015 Generic Entry Block 2026~2034 • Launch in Korea • Export or Out-Licensing Strengthening of the Acelex brand name through launch of multiple products

  26. CrystalGenomics, Inc. 5th F. Bldg.A, Korea Bio Park 700 Daewangpangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 463-400 Korea CG Pharmaceuticals, Inc. 5980 Horton Street, Suite 610 Emeryville, CA 94608 U.S.A.

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