Taigen Biopharmaceuticals Holdings Limited · TPEX:4157
Taigen Biopharmaceuticals — Morgan Stanley Asia Pacific Summit (November 2015)
32 slides from Taigen Biopharmaceuticals's conference presentation, November 2015
Slide 1: TaiGen Biopharmaceuticals Holdings Ltd.
TaiGen Biopharmaceuticals Holdings Ltd. F*太景 (4157.TWO) November, 2015
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation is prepared by TaiGen Biopharmaceuticals Holdings Ltd. (“TaiGen”) and includes forward-looking statements about TaiGen and its business, including but not limited to statements regarding drug discovery, research and clinical development, regulatory approval pr
Slide 3: A Research-Driven and Product Focus Company
A Research-Driven and Product Focus Company A productive An approved R&D product platform A high value pipeline Restricted & Confidential 3
Slide 4: Company Highlights
Company Highlights Founded in 2001 in Taipei and backed by blue-chip investors including MPM Capital and Taiwan National Development Fund Led by experienced US-trained management team with pharma experience and proven track record NCE pioneer in Greater China with three Class 1.1 drugs in the
Slide 5: Seasoned Management Team Each With 20+ Years in Related Fields
Seasoned Management Team Each With 20+ Years in Related Fields Name / Title Experiences Ming-Chu Hsu, Ph.D. Founder, Chairman, and Director, Oncology and Virology Research, Roche CEO Richard King, Ph.D. Director, Discovery, AMRI SVP Research Head, Discovery Chemistry, Hoechst Marion Roussel Phillip
Slide 6: Reputable Gov't and Private Institutions Form a Strong Shareholders and BOD Bases
Reputable Gov’t and Private Institutions Form a Strong Shareholders and BOD Bases Taiwan National Development Others ~27% Fund, Taiwan Sugar, YaoHua etc. ~ 31% Employees ~4% YFY Group Other ~ 34% Institutions ~ 4% As of Apr. 11, 2015 11 BOD members (3 independent Directors included)and 3 Superviso
Slide 7: TaiGen's Focus is NCEs – The Highest Margins in the Value Curve
TaiGen’s Focus is NCEs – The Highest Margins in the Value Curve The Pharmaceutical Industry’s Value Curve TaiGen’s Focus: High New chemical entity drug discovery & development Over-the- counter and new drug Technological delivery Value- and Marketing systems added & Complexity Conventional branded C
Slide 8: Highly Differentiated NCEs in the Pipeline
Highly Differentiated NCEs in the Pipeline Restricted & Confidential 8
Slide 9: Over 300 Patents Granted for Global IP Protection
Over 300 Patents Granted for Global IP Protection Providing market exclusivity and out-licensing opportunities As of Oct. 31, 2015 Patents Product Type of Patent Granted Composition of Matter 45 Salt Form 53 Nemonoxacin Process 34 (Antibiotic) Use 22 Formulation 31 Burixafor Composition of Matter
Slide 10: Taigexyn – NCE Antibiotic for Drug-resistant Infections
Taigexyn® – NCE Antibiotic for Drug-resistant Infections ¾ Novel, non-fluorinated quinolone, broad-spectrum antibiotic with global IP protection until 2030 ¾ Expect to launch oral formulation in Taiwan and China in Q4 ‘15 ¾ Completed clinical development of intravenous formulation and expect to file
Slide 11: Taigexyn – Key Message to Prescribers
Taigexyn® – Key Message to Prescribers Potent • Superior activity against MRSA,VRSA, MDRSP, and PRSP Broad-spectrum Low resistance • Excellent activity for • Require mutations in Gram +ve, Gram -ve, three different and atypical pathogens bacterial genes Convenient Effective Safe • Once-daily use • E
Slide 12: Chinese Pharmaceutical and Quinolone Market
Chinese Pharmaceutical and Quinolone Market The Chinese pharmaceutical market is ~RMB 614 B (~US$96 B) in 2014, the second largest in the world behind the US Sales of antibiotics in 2014 is ~RMB 78 B and account for almost 25% of the global spending on antibiotics Quinolone is one of the top a
Slide 13: Top 5 Quinolone Sales in China 2014
Top 5 Quinolone Sales in China 2014 Zhejiang Xinchang Medicine, TaiGen’s partner in China, is marketing one of the top selling quinolone, Lai Li Xin, in the Chinese market. Sales Company Product (RMB Million) Bayer Avelox 1,589 Zuo Ke Yangzijiang 1,313 (Branded Levo) Lai Li Xin Zhejiang Medicine 9
Slide 14: Burixafor – Next Generation Stem Cell Mobilizer and Chemsensitizer
Burixafor – Next Generation Stem Cell Mobilizer and Chemsensitizer ¾ Potent and selective CXCR4 antagonist that mobilize stem cells and cancer cells from the bone marrow into peripheral circulation. ¾ Target indications: Hematopoietic Stem Cell Transplantation (HSCT) Chemosensitization ¾ Phase 1
Slide 15: Burixafor – Simplify Collection/Banking of Hematopoietic Stem Cells for HSCT
Burixafor – Simplify Collection/Banking of Hematopoietic Stem Cells for HSCT Current Standard of Care requires 5-8 days of G-CSF + 1-4 leukapheresis sessions Burixafor monotherapy • Can be use alone in multiple myeloma patients to mobilize sufficient stem cells for hematopoietic stem transplanta
Slide 16: Burixafor Mobilized Sufficient CD34+ Cells for Stem Cell Transplants
Burixafor Mobilized Sufficient CD34+ Cells for Stem Cell Transplants In TG-0054-04 in the US, burixafor + G-CSF was able to mobilize ≥ 5 x106 CD34+ cells/kg which is sufficient for two transplants in 1 or 2 leukapheresis sessions in all patients. These encouraging results warrant the further tes
Slide 17: High Failure Rate for Harvesting Sufficient CD34+ Cells in Patients
High Failure Rate for Harvesting Sufficient CD34+ Cells in Patients G-CSF is the mainstay in hematopoietic stem cell mobilization. The failure rate reported in the literature ranges from 5-10% in healthy donors to 30- 60% in leukemia and lymphoma patients. Failure rate is highly dependent on num
Slide 18: Combination of TG-0054 and Vincristine Prolonged Disease-free Survival in ALL Model
Combination of TG-0054 and Vincristine Significantly Prolonged the Disease-free Survival Time of ALL Model • Combination of burixafor (20 mg/kg) with vincristine significantly prolonged survival time of mice with ALL. Similar prolongation of survival were seen with burixafor + chemotherapy in models
Slide 19: Metastatic Prostate Cancer Cells in the Bone Marrow
Metastatic Prostate Cancer Cells in the Bone Marrow 18F-Fluoride PET Courtesy of Prof. K. Pienta J Nucl Med 47: 287 (2006) From J Clin Investigation 121:1298 Restricted & Confidential 19
Slide 20: Chemosensitization Study of Solid Tumors at Johns Hopkins
Chemosensitization Study of Solid Tumors at Johns Hopkins Restricted & Confidential 20
Slide 21: Burixafor – One Drug, Multiple Indications, Expanded Potential
Burixafor – One Drug, Multiple Indications, Expanded Potential Autologous stem cell transplantation Allogeneic stem cell transplantation Already completed one POC trial in multiple myeloma, NHL, HD in Signed agreement with Cellex in the US. Second trial ongoing. Germany to initiate trials in allogen
Slide 22: Burixafor – Other Potential Indications
Burixafor – Other Potential Indications Studies were performed in myocardial infraction model using mini-pigs Results showed that endothelial progenitors cell are being mobilized after administration of burixafor Significant improvement in LVEF (left ventricular ejection fraction) compared to
Slide 23: Burixafor – Milestones in the Next 12-24 Months
Burixafor – Milestones in the Next 12-24 Months ¾ TG-0054-04 trials (n=12) expect to be completed by Q4 ‘15. Results will be presented at the upcoming ASH meeting (12/5-8 Orlando, FL) ¾ Chemosensitization in refractory and relapsed AML– Phase 1/2 study started in China in May 2015 .. ¾ TaiGen have i
Slide 24: Furaprevir – Highly Effective and Affordable HCV Treatment
Furaprevir – Highly Effective and Affordable HCV Treatment ¾ Furaprevir is active against all six genotypes of HCV and has the potential to reduce total treatment duration to 12 weeks or less ¾ Phase 1/2a study was completed under IND with US FDA and results were presented at AASLD. ¾ A Phase 2 12-w
Slide 25: TaiGen's Near-Term Goals and Long-Term Vision
TaiGen’s Near-Term Goals and Long-Term Vision ¾ Launch and expand indications of Taigeyxn® in China and Taiwan ¾ Establish Taigeyxn® partnerships in other territories ¾ Advance Burixafor into Phase 3 clinical development and expedite the path to commercialization ¾ Develop affordable, highly effecti
Slide 26: Backup
Backup Restricted & Confidential 26
Slide 27: HSCT Market is Growing Steadily
HSCT Market is Growing Steadily An estimate of 70,000+ hematopoietic stem cell transplants (HSCT) were performed worldwide in 2013 with a CAGR (2009-2013) of 3.8 and 4.6% for US and Europe respectively Twice as many HSCTs are performed in Europe (39,209) than the US (19,216) in 2013 Annual Numbe
Slide 28: Major Indications of HSCT
Major Indications of HSCT The top three indications for HSCTs are multiple myeloma, NHL and AML. Together these account for 59 % (Europe) and 68% (US) of all HSCTs performed in 2013. In US, an estimate of 6-8% of MM and AML patients received HSCT as treatment in 2013 HSCT in multiple myeloma i
Slide 29: CXCR4 Antagonist Sensitizes Prostate Cancer in Chemotherapy
CXCR4 Antagonist Sensitizes Prostate Cancer in Chemotherapy Domanska et al. Neoplasia (2012) 14:709-718 Restricted & Confidential 29
Slide 30: Role of CXCR4 and Prostate Cancer
Role of CXCR4 and Prostate Cancer Restricted & Confidential 30
Slide 31: Burixafor to Address Unmet Medical Needs in Chemosensitization Market
Burixafor to Address Unmet Medical Needs in Chemosensitization Market % of Patients New Cases Per Cancer Type 5‐yr Survival Rate Receiving Year* Transplants Acute myeloid 28,000 25.9% 6.2 leukemia Multiple myeloma 45,080 46.6% 7.7 Non‐Hodgkin 131,645 70.0% 0.3 lymphoma Hodgkin lymphoma 17,611 85.9%
Slide 32: Unmet Medical Needs in Metastatic Solid Tumors
Unmet Medical Needs in Metastatic Solid Tumors Cancer Type New Cases Per Year Metastatic 5‐yr Survival Rate 7 Major Non‐ US Metastatic Markets * metastatic Prostate 610,000 220,800 4% >90% 30‐37% Breast 600,000 231,840 6% 80‐90% 24‐28% • Although the five-year survival rate for patients diagnosed wi
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