crystalgenomics nc overview · 2016-02-01 · 1 histone deacetylases: transcriptional regulation...
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1CrystalGenomics, Inc.
OVERVIEWCRYSTALGENOMICS, INC.
January 2016
2CrystalGenomics, Inc.
To become a fully integrated biopharmaceutical company in Korea and expand internationally through collaborations and partnerships Vision
2000.07 Founded2003.09 Publication in Nature (article and cover based on platform technology)2006.01 IPO on KOSDAQ 2006.10 Established US subsidiary, CG Pharmaceuticals, Inc. for clinical development2012.06 Designated by the Korean government as one of the ‘KIPC’ certified companies2014.07 Designated by the Korean government as one of the ‘K-BrainPower’ companies2015.02 Obtained the NDA approval from MFDS for Acelex® in Korea (osteoarthritis)2015.09 Launch of Acelex® in Korea
History
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)
Key Pipeline
CrystalGenomics is a commercial stage biopharmaceutical companywith innovative platform technologies dedicated in the discovery anddevelopment of novel pharmaceuticals in unmet medical need areas.
Corporate Overview
3CrystalGenomics, Inc.
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 )
SCPTM NMR
Virtual Screening In vitro Assay
SCPTM LibrarySCPTM Screening
Synchrotron, NMR
Structure Determination ( SPSTM )
AGTCTCAG
TargetSelection
Lead Optimization and Candidate Selection ( SDFTM )
In vivo Evaluation
DMPKToxicologyPharmacologyDDS
BiologicalEvaluations
Target Assays Cellular AssaysIn vitro DMPK
Drug Design &MediChem
SDFTM X-raySDFTM InformaticsParallel Synthesis
Pre-clinicalCandidate
Lead / TargetComplex
OR2
R3
ON
R1
IND-enabling Tox(CRO in EU,USA)
4CrystalGenomics, Inc.
CG Has Global Standard Drug Discovery Capabilities
Viagra ®
(sildenafil)
Cialis ®
(tadalafil)
Levitra ®(vardenafil)
CrystalGenomics was the first group to solve complex crystal structure of PDE5 using SPS™ approach: nature 425, 98-102 (2003).
5CrystalGenomics, Inc.
Disease Target Candidate Indication Phase I Ph II Ph III
1Pain & Inflammation Osteoarthritis (NSAID)
1Infectious Disease MRSA (super bug)
2Cancer MDS (liquid tumor)
2Cancer Pancreatic cancer
1Cancer AML (liquid tumor)
1CNS Alzheimer’s Disease, Parkinson’s Disease
2Metabolic Anemia
1. First-in-class , 2. Best-in-class
Novel R&D Pipeline
Therapeutic Area Indication Discovery Preclinical Ph I Ph II Ph III NDA
6CrystalGenomics, Inc.
Global Pain Therapeutics Market
Global Pain Market
$ 50 B
2012 2013 2014
GLOBAL 2,719 2,918 *2,699
KOREA 52 59 70
(Unit: in millions USD)
Celebrex® Sales
Global market size of pain therapeutics was valued at $ 50B (2011) Size of the NSAID market (including COX-2 inhibitors) ≈ $ 17.5B Rapid increase in the aging and obese population will lead to further growth
of the NSAID market
Patent expiry in US
7CrystalGenomics, Inc.
Huge Unmet Medical Needs in Pain Therapeutics Market
Classification Characteristics Efficacy GI Risk CV Risk
Traditional NSAID
- Inhibits both COX-1 and COX-2- Dosage: 2-4 times a day- PPI combination regimen
Moderate ~ High High Moderate ~
High
COX-2 Inhibitors
- COX-2 selective inhibition (less COX-1 inhibition)
- Etoricoxib (Merck) – once a day (30-120mg/day)High Low Moderate ~
High
- Celecoxib - once or twice a day (200 ~ 400mg/day)
Moderate~High
Low Moderate
Tissue-Specific COX-2 Inhibitor
(Acelex®)
- COX-2 selective inhibition (less COX-1 inhibition)
- “Tissue-selective” COX-2 inhibitor - Once a day 2mg dose
High LowNone
observed to date
8CrystalGenomics, Inc.
Acelex®, Tissue Selective NSAID for Osteoarthritis
Category Projected Advantages of Acelex
Efficacy • Quicker onset of relief from the signs and symptoms of OA over celecoxib.• Achieved superior PGA (Physicians Global Assessment) scores compared to celecoxib.
Dose • Only 2 mg/day dose, the lowest daily dose among all known NSAIDs.
Administration Frequency • Convenient once-a-day dosing regimen unlike most other NSAIDs.
Gastrointestinal Side Effects • Significantly improved GI safety in comparison with traditional NSAIDs on the market.
Cardiovascular Side Effects
• Acelex’s tissue-selective-COX2-inhibition mechanism is projected to provide a meaningful enhancement of cardiovascular safety over currently available NSAIDs.
< Acelex® 2mg Capsule >Tissue-Selective NSAID 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)
9CrystalGenomics, Inc.
Acelex®, Phase III Study Results
71.9% of subjects taking Acelex experienced improvement in signs and symptoms of osteoarthritis
*PGA (Physician’s Global Assessment ): Evaluation of the test subjects by the investigators (physicians)
Acelex showed SUPERIOR EFFICACY over celecoxib with statistical significance (p = 0.005)
Overall improvement of signs and symptoms of osteoarthritis in terms of PGA* scores at week 3
10CrystalGenomics, Inc.
Acelex®, Phase III Study Results
Acelex showed QUICKER ONSET OF 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
11CrystalGenomics, Inc.
Acelex®, Rapid Increase in Domestic Sales
0
2,000
4,000
6,000
8,000
10,000
Qty. Ordered by Dong-A ST
Capsule Quantity
750,000 450,0001,500,000
10,500,000
Aug. 2015 Sep. 2015 Jan. 2016 Apr. 2016
No. of caps (thousands)
12CrystalGenomics, Inc.
Launch of 2 mgCapsule 2015
Generic Entry Block2026~2034
• Launch in Korea• Export or Out-Licensing
• 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.
Acelex®, Lifecycle Management Strategy
Strengthening of the Acelex brand name through launch of multiple products
13CrystalGenomics, Inc.
First-in-class, novel antibiotic that has demonstrated excellent efficacy againstMRSA, “Superbug” strains and, demonstrated superior in vitro efficacy overexisting blockbuster drugs including Pfizer’s $1.2 billion drug, Zyvox®
▪ MRSA killed 19,000 people in US, more than HIV (2009)
▪ ‘Europe 'losing' superbugs battle” - Over 25,000 people die in the EU every year of bacterial infections that are able to outsmart even the newest antibiotics (BBC News: April 2011)
▪ Zyvox® (Pfizer) – Global sales of USD 1.2B (2010) & USD 4M in Korea w/ 20%+ CAGR (2009)
▪ Global MRSA market will grow at a CAGR of 3.4% to reach USD 3.47B by 2019 (GlobalData: June 2012)
▪ CG400549 is potentially first-in-class antibiotic to treat MRSA and other multidrug resistant bacterial strains.
▪ Phase IIa skin infection study for POC completed (USA) – 100% of evaluable subjects had clinical cures by end of the study
▪ Both oral and intravenous formulations will be developed for oral/IV switchability
CG400549, Novel Antibiotic for MRSA in Ph II Development
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• Clinical studies conducted in the EU and US thus far• During the Ph 2a study conducted in the US, 100% clinically cure rate was achieved
Case 1
Case 2
Case 3
Screening ECE EOT TOC
*ECE : 48-72 hours after Day 1 *EOT : 10-14 days after Day 1 *TOC : 21-28 days after Day 1
CG400549, Novel Antibiotic for MRSA in Ph II Development
15CrystalGenomics, Inc.
Being developed as a potentially best-in-class drug with superior efficacy andsafety profiles than other HDAC inhibitors on the market or in development
CG200745, Best-in-Class Anti-Cancer Therapeutic
▪ CG200745 is a Histone deacetylase (HDAC) inhibitor being developed to combat various tumor types
▪ “There is growing evidence that HDACs are important agents for cancer therapy, and HDAC inhibitors bear great potential as anticancer drugs.”1
▪ POTENTIALLY BEST-IN-CLASSBased on preclinical and interim Ph 1 clinical data thus far, CG200745 is projected to have superior PK profile over other HDAC inhibitors (both approved & in development) as it has high level of exposure even at low doses
▪ SUPERB EFFICACY56% of all patients had stable disease from phase I studies which included variety of solid tumor patients
▪ Ph I Multiple Dose Study Completed (Korea); Ph Ib / II Ready for MDS and pancreatic cancer1 Histone Deacetylases: Transcriptional Regulation and Other Cellular Functions (Cancer Drug Discovery and Development), 2006
16CrystalGenomics, Inc.
Korea Innovative Pharmaceutical Company Designation
CrystalGenomics was selected by the Korean Governmentas one of the ‘Korea Innovative Pharmaceutical Company’ (KIPC) on June 18, 2012.
KIPC is part of a recent initiative rolled out by the Korean Government where it pledged to nurture and support selected pharma and biotech companies to help them grow into global pharmaceutical companies by 2020.
CrystalGenomics ranked within the top 10 among all 43 KIPC designated companies.
Some of the key benefits includes: ▪ Favorable pricing & reimbursement benefits for novel
drugs▪ R&D and Financial support in research grants,
government subsidies, tax breaks, loans, etc.
17CrystalGenomics, Inc.
Fund Raisings
KSLSFKRW 100B
June 2014
January 2012
KRW 3 Billion Equity Financing
Global Pharmaceutical Industry Development Fund is KRW 100 billion fund established by the Ministry of Health and Welfare (MOHW) of Korea to promote globalization of the Korean pharmaceutical industry
Korea Seoul Life Science Fund is a KRW 100 billion, Government backed life science fund with private LPs and Hanwha VC & Oxford Bioscience as the two GPs
CG Raised KRW 26 Billion from Government backed Life Science Funds
Replenishment of cash reserves to fully support development of therapeutic programs
GPIDPKRW 100B
KRW 13 Billion Equity & Debt
FinancingInterVest
18CrystalGenomics, Inc.
Integrated Healthcare Company
API DP, Sales &Marketing
Analytical/Diagnostics
R&D
HWAIL PHARMANumber one in Korea in APIs
BTO BIOPHARMNew GMP facilities
with room for growth
SPL is one of the top bioanalyitcal service CROs in Korea
CG is a leading biopharmaceutical company in Korea
19CrystalGenomics, Inc. •19
•SBI BIOTECH CO., LTD.
Former & Current Alliance Partners
20CrystalGenomics, Inc.
CrystalGenomics, Inc.5th F. Bldg.A, Korea Bio Park700 Daewangpangyoro, Bundanggu,Seongnamsi, Gyeonggido 463-400Korea
CG Pharmaceuticals, Inc.5980 Horton Street, Suite 610Emeryville, CA 94608U.S.A.