Post on 04-Feb-2018
GLG Pharma, LLCGLG Pharma, LLC
A Specialty Pharmaceutical CompanyA Specialty Pharmaceutical Company
…… …… developing the developing the next generationnext generation of of targeted drugstargeted drugs
Company SummaryCompany Summary•• Privately HeldPrivately Held
•• Experienced Management TeamExperienced Management Team
•• Development stage Development stage –– full spectrumfull spectrum
–– Marketed Products: from JV with a Public German Marketed Products: from JV with a Public German Company (PGC)Company (PGC)
–– Development PipelineDevelopment Pipeline
•• Clinical: Repositioning Marketed Products (pClinical: Repositioning Marketed Products (p--STAT3 STAT3 INHIBITORS) INHIBITORS) : CLL, AML, psoriasis: CLL, AML, psoriasis
•• Preclinical: pPreclinical: p--STAT3 INHIBITORS New Chemical STAT3 INHIBITORS New Chemical Entities (NCEs)Entities (NCEs)
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ManagementManagement•• Hector J. Gomez, MD, PhDHector J. Gomez, MD, PhDPresident & CEO President & CEO (pre/clinical trials expertise(pre/clinical trials expertise))
•• Richard Gabriel, BS, MBARichard Gabriel, BS, MBACOO COO (medicinal chemistry expertise)(medicinal chemistry expertise)
•• Michael Lovell, PhDMichael Lovell, PhDExecutive VP Executive VP (preclinical dev. expertise)(preclinical dev. expertise)
•• John J Whalen, MDJohn J Whalen, MDCMO CMO (clinical trials expertise)(clinical trials expertise)
•• Sunanda Singh, MD, PhDSunanda Singh, MD, PhDDir. Cancer Immunology Dir. Cancer Immunology (skin cancer exp)(skin cancer exp)
•• Robert A. Ballas, PhDRobert A. Ballas, PhDDirector Diagnostics Unit Director Diagnostics Unit
•• Ray JohnsonRay JohnsonChief Financial Officer (Acting)Chief Financial Officer (Acting)
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CollectivelyCollectively
> 150 years > 150 years Experience in Experience in
Drug Drug DevelopmentDevelopment
> 15 Drugs > 15 Drugs on on MarketMarket
GLG Pharma pGLG Pharma p--STAT3 Inhibitor PlatformSTAT3 Inhibitor PlatformTargeted therapies to treat diseases mediated by activated STAT3Targeted therapies to treat diseases mediated by activated STAT3
••51 patented compounds/4 in preclinical development51 patented compounds/4 in preclinical development••4 repurposed marketed products 4 repurposed marketed products –– 2 in clinical trials2 in clinical trials
CancerCancer PsoriasisPsoriasisIBDIBD
(Inflammatory (Inflammatory Bowel Disease)Bowel Disease)
RA RA (Rheumatoid (Rheumatoid
Arthritis)Arthritis)
ADPKD ADPKD (Autosomal (Autosomal
Polycystic Kidney Polycystic Kidney DiseaseDisease))
•• BreastBreast•• SkinSkin•• ProstateProstate•• 27 others27 others
•• Actinic Actinic keratosiskeratosis
•• Actinic Actinic cheilitischeilitis
OutOut--License prior to Phase III Clinical StudiesLicense prior to Phase III Clinical Studies
Dermatology Joint VentureDermatology Joint Venture••2 marketed products 2 marketed products –– revenuesrevenues••Licensing of pLicensing of p--STAT3 Inhibitors STAT3 Inhibitors –– dermatology indicationsdermatology indications
Genetic/Diagnostic/Rx Joint VentureGenetic/Diagnostic/Rx Joint Venture••Identify patients who might benefit from pIdentify patients who might benefit from p--STAT3 inhibitor treatment STAT3 inhibitor treatment ––shortens clinical trials; reduces cost of clinical trialsshortens clinical trials; reduces cost of clinical trials
RRiisskk
ModMod..
LowLow
RReewwaarrdd
ModMod..
HighHigh
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Drug Development ProcessDrug Development Process(All Milestones Accomplished Except GLP Toxicology) (All Milestones Accomplished Except GLP Toxicology)
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SynthesisSynthesis••GLGGLG--302 302 –– 2.5kg2.5kg••GLGGLG--202 202 –– 200 g200 g••GLGGLG--401 401 –– 25 g25 g
GLGGLG--302 In Vitro302 In Vitro••BreastBreast••LungLung••BrainBrain••Multiple MyelomaMultiple Myeloma••PancreaticPancreatic••LiverLiver••Polycystic Kidney Polycystic Kidney
GLGGLG--302 Non302 Non--GLP GLP ToxicologyToxicology
No serious toxic effectsNo serious toxic effects••100 mg/kg x 24 doses100 mg/kg x 24 doses••1000 mg/kg x 7 days1000 mg/kg x 7 days••4000 mg/kg x 1 day4000 mg/kg x 1 day
GLGGLG--302 Non302 Non--GLP GLP ToxicologyToxicology
No serious toxic effectsNo serious toxic effects••1000 mg/kg x 7 days1000 mg/kg x 7 days••2000 mg/kg x 1 day2000 mg/kg x 1 day
GLGGLG--302 GLP 302 GLP Toxicology TBDToxicology TBD
••Rat x 28 daysRat x 28 days••Dog x 28 daysDog x 28 days
GLGGLG--302 Mouse Xenograft302 Mouse Xenograft••Breast (iv & oral)Breast (iv & oral)••LungLung••LiverLiver••BrainBrain••PancreaticPancreatic••Polycystic Kidney DiseasePolycystic Kidney Disease
2013 Status
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Product Indication Target Validation Preclinical Phase I Phase II Marketed
Marketed Product 1
EU Approved Rx; GLG French
Marketing RightsActinic Keratosis
Marketed Product 2
EU non-Rx; GLG French Marketing
RightsRosacea
GLG-801Re-purposed approved product
Funded By Dana Farber
Cancer InstituteChronic
Lymphocytic Leukemia
Published Proof of Concept Data
Psoriasis
Current FocusADPKD
GLG-302(NCE)
FranceCancer
Current FocusADPKD
GLG-202 (NCE)Dormant
DormantCancer
GLG-401 (NCE) Cancer
GLG-101 (NCE) DormantCancer
Published Proof of Concept Data
Current Focus
Current Focus
France
Dormant
Dormant
Dormant
Funded By Dana Farber Cancer Institute
EU Approved Rx; GLG French Marketing Rights
EU non-Rx; GLG French Marketing Rights
GLG Pharma, LLC
Funding MilestonesFunding Milestones
–– Town of Jupiter $250K (7/10). 8/10 Office/lab in JupiterTown of Jupiter $250K (7/10). 8/10 Office/lab in Jupiter-- Paragon Foundation $250K (12/10)Paragon Foundation $250K (12/10)–– Qualified Therapeutic Discovery grants: $740,000 2/11Qualified Therapeutic Discovery grants: $740,000 2/11–– SURCAG SURCAG (St. Univ. Res. Comm. Assist. Grant) $200K ((St. Univ. Res. Comm. Assist. Grant) $200K (2/11)2/11)–– FICR FICR (Fl Inst. Commercialization of Research) $200K ((Fl Inst. Commercialization of Research) $200K (8/12)8/12)–– Private Equity Investors: $100,000 6/11Private Equity Investors: $100,000 6/11–– JV Partner convertible: $200,000 9/12JV Partner convertible: $200,000 9/12–– Preclinical collaboration Preclinical collaboration valued at $750K (2 CROs) valued at $750K (2 CROs) 9/109/10–– Draft term sheet Global Pharma Draft term sheet Global Pharma –– awaiting human dataawaiting human data
•• Net $210 Million over 8 years + Royalties (7.5% Net $210 Million over 8 years + Royalties (7.5% -- 10% gross, Net 10% gross, Net 2.5% to 5%) 2.5% to 5%)
–– Strong interest from Japanese Pharma Strong interest from Japanese Pharma –– cancer cancer 77
Financial Needs- Summary
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STAGE DETAILS STATUS Financials Needs
Market(Revenues)
Dermatology JV: Product 1, Product 2
Negotiations Completed
$4.5MM: license & sales (F, J, LA, C)*
French SAS Co Focus on GLG-302 for EU from France
Process Ongoing
$2.5MM
Pre & Clinical Programs
Development: NCEs, repurposing
Collaboration: Trials ongoing CLL & AML
$9.5 MM(Complete 1st Phase 1/II)
Co-Development Draft term sheet
Anti-cancer $208MM milestones, 8% royalties
Awaiting human POC data (Ph I)
$0.5MM
Co-DevelopmentJapanese Co.
Pre-clinical agreement
Ongoing $0.5MM
JV - Global Diagnostic Co. Ongoing $2.5MM
F= France, J = Japan, LA = Latin America, C = Canada F= France, J = Japan, LA = Latin America, C = Canada Total $20.0MMTotal $20.0MM
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Why France?
• Oseo Matching Funds• Incubator Support Programs throughout the Regions• R&D Research Expenditures Support• Growing Biotech and Pharmaceutical Business Regions• Mentoring Programs for Start-up’s• Government Advocates to help with Regulations, Approvals
and Compliance• EU Central Location plus Access to other parts of the World
through French Assistance Export Programs• Supporting development centers (Institutions, CERN, etc.)• France is a strong part of the EU Community for Biotech• Educational (Universities and Teaching Hospitals) and for
GLG Cancer Center Networks• Boston, Support help from Yei, RETIS and Consulate
Approved Pipeline: Market potentialApproved Pipeline: Market potential
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ProductProduct IndicationIndication Market Net Present ValueMarket Net Present Value 11
1 Management Expectations, NPV, 8% discount Netherlands, France 1 Management Expectations, NPV, 8% discount Netherlands, France and Belgium only.and Belgium only.
Product 1Product 1
Product 2Product 2
Centralized Centralized European European approval forapproval forActinic KeratosisActinic Keratosis
France France –– 48.9mm 48.9mm €€
France France –– 7.0mm 7.0mm €€Itching, redness, Itching, redness, irritation, bites, irritation, bites, scaling; cosmetic scaling; cosmetic approval for approval for Germany and Germany and EMA regionEMA region
Product 1Product 1 for Actinic Keratosis for Actinic Keratosis Recent European approval (Dec. 2011)Recent European approval (Dec. 2011)
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•• Product 1Product 1 Destroys Aberrant Cells; Single Treatment, No Scar Tissue.Destroys Aberrant Cells; Single Treatment, No Scar Tissue.
•• Product 1Product 1 Greatly Improved Efficacy, Superior to CompetitorGreatly Improved Efficacy, Superior to Competitor
PDT treatment with PDT treatment with Product 1Product 1
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Actinic Keratosis and Squamous Actinic Keratosis and Squamous Cell Carcinoma TreatmentCell Carcinoma Treatment 7 Days Follow up Visit7 Days Follow up Visit
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Development of Development of Cosmeceutical Cosmeceutical Product 2Product 2 product lineproduct line
Product 2 Product 2 based on the combination of active plant based on the combination of active plant extracts and innovative herbal biocolloids is extracts and innovative herbal biocolloids is anticipated as a line of medical cosmetic products anticipated as a line of medical cosmetic products for various skin problemsfor various skin problems
The first product, The first product, Product 2 Product 2 cream, aims at the cream, aims at the regenerative care of inflamed, itching and dry skinregenerative care of inflamed, itching and dry skin
Product 2 Product 2 cream is already available in Germany cream is already available in Germany and, through distributor from Trading Services, in and, through distributor from Trading Services, in several Arabic countriesseveral Arabic countries
GLG GLG will sell in Netherlands, France and Belgiumwill sell in Netherlands, France and Belgium
Efficacy of Efficacy of Product 2 Product 2 cream cream in cosmetic testsin cosmetic tests
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Product 2Product 2
Product 2Product 2
Product 2Product 2
Product Product 22
Product 2 Product 2 treatedtreated
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Development ProductsDevelopment Products
New Chemical EntitiesNew Chemical Entities
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GLG Pharma Intellectual PropertyGLG Pharma Intellectual Property(New Chemical Entities)(New Chemical Entities)
Application/Patent Application/Patent NumberNumber
Application Application DateDate STATUSSTATUS TitleTitle
US 2006/0030536 AlUS 2006/0030536 Al Feb. 2006/Feb. 2006/20122012 Pending/refiledPending/refiled
COMBINATION THERAPIES COMBINATION THERAPIES FOR CANCER AND FOR CANCER AND PROLIFERATIVE PROLIFERATIVE ANGIOPATHIES ANGIOPATHIES –– GLGGLG--401401
US 2007/0191490 AlUS 2007/0191490 Al Aug. 2007Aug. 2007 PendingPendingWITHACNISTIN COMPOUNDS WITHACNISTIN COMPOUNDS FOR TREATMENT OF FOR TREATMENT OF CANCER CANCER –– GLGGLG--101101
WO 2008/070697 A2WO 2008/070697 A2 Jun. 2008Jun. 2008 PendingPending
STAT3 INHIBITOR HAVING STAT3 INHIBITOR HAVING ANTIANTI--CANCER ACTIVITY AND CANCER ACTIVITY AND ASSOCIATED METHODS ASSOCIATED METHODS ––GLGGLG--202202
Patent No.Patent No. 7,960,4347,960,434 Jun.2011Jun.2011 IssuedIssued
SMALL MOLECULE SMALL MOLECULE INHIBITORS OF STAT3 WITH INHIBITORS OF STAT3 WITH ANTIANTI--TUMOR ACTIVITY TUMOR ACTIVITY ––GLGGLG--302 and analogs302 and analogs
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GLG Pharma Intellectual PropertiesGLG Pharma Intellectual Properties
Application/Patent Application/Patent NumberNumber
Application Application DateDate STATUSSTATUS TitleTitle
US 2006/0030536 AlUS 2006/0030536 Al Feb. 2006/Feb. 2006/20122012 ReRe--filed 2012filed 2012 GLGGLG--801 801 –– Repurpose DrugRepurpose Drug
US 2007/0191490 AlUS 2007/0191490 Al Aug. 2007Aug. 2007 PendingPending DiagnosticDiagnostic
WO 2008/070697 A2WO 2008/070697 A2 Jun. 2008Jun. 2008 PendingPending PDT Protected FormulationPDT Protected Formulation
Patent No.Patent No. 7,960,4347,960,434 Jun.2011Jun.2011 IssuedIssued OTC Protected FormulationOTC Protected Formulation
GLG Pharma STAT3 GLG Pharma STAT3 InhibitorsInhibitors
Proof of Concept Proof of Concept in Preclinical in Preclinical
Models of CancerModels of Cancer
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Efficacy has been shown asEfficacy has been shown as•• Suppression of growthSuppression of growth•• Tumor regressionTumor regression•• SurvivalSurvival
Target Validation SummaryTarget Validation Summary
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GLG-302 (S3I-201)
GLG-202 (S3I-M2001)
GLG-401 (S3I-295)
GLG 101 (Withacnistin)
In vitro Efficacy
Cancer cell types Breast
HCC, MMPancreas
Glioblastoma
BreastPancreas
Breast MM
Breast Lung
In vivo Efficacy – MouseBreast (MDA-MB-468) √
Lung (A549) √
Breast (MDA-MB-231) √ √
Hepatocellular Carc. (Huh 7) √
Pancreatic (Colo-357) √
Pancreatic (PANC-1) √
Glioblastoma (U87 & U373) √
Autosomal Dominant PKD √
GLGGLG--302 302 Antitumor Activity: Antitumor Activity: SuppressedSuppressed Tumor GrowthTumor Growth
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Human Breast Cancer, Athymic nude mice5 mg/kg iv every 2 or 3 days
Siddiquee et al., PNAS 104(18):7391-7396, 2007
n=8 per group
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Why France?• Oseo Matching Funds• Incubator Support Programs throughout the Regions• R&D Research Expenditures Support• Growing Biotech and Pharmaceutical Business Regions• Mentoring Programs for Start-up’s• Government Advocates to help with Regulations, Approvals
and Compliance• EU Central Location plus Access to other parts of the World
through French Assistance Export Programs• Supporting development centers• EU Community for Biotech• Educational and for GLG Cancer Center Networks• Boston, Support help from Yei, RETIS and Consulate
THANK YOUTHANK YOU
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CONTACT INFORMATIONRichard Gabriel, BS, MBACOO, GLG Pharma, LLC
President, GLG Pharma, SAS781-883-6639 cell
hrlgabriel@gmail.com