Genovate BIOTECHNOLOGY CO., LTD. Jen Chen, PhD, General Manager Industry Biotechnology Computer Semiconductor Software Maturity Maturing Middle aged Middle aged Technology intense/ Technology intense/ Technology intense/ Technology intense/ R&D critical R&D critical R&D critical R&D critical Regulation Heavily regulated Unregulated Unregulated Unregulated Intensive Moderate Intensive Not intensive Requirements Opportunity Product Development Very short Timeline Source: DRI/McGraw-Hill, Semiconductor Industry Association, American Electronics Association New Drug Development
z New Drug New Chemical Entity (NCE), New Indication, New Formulation, New Route of Administration, New Dosage Form.
z Drug Development Preclinical Clinical Studies: Sales & Product Approval Phase 1, 2, 3 Marketing Discovery Pilot-Scale Phase 4 (Post- Manufacturing Development Production Marketing Studies): * New Indications * Performance Evolution of Pharmaceutical Industry
¾ Cost Containment Pressure
¾ Need for Fast Drug Development
¾ Global Clinical Development
¾ Global Marketing Strategy
¾ Maturation of Biotech Industry
¾ Stringent Regulation
¾ Strategic Alliance
TOP 15 PRESCRIPTION DRUGS BY WORLDWIDE SALES
Worldwide Sales Rank Rank Brand Name Chemical Indication Atorvastatin calcium Cholesterol Atorvastatin calcium Astellas Pharma Cholesterol Simvastatin Merck & Co. Cholesterol Advair/Seretide Fluticasone propionate + GlaxoSmithKline Salmeterol Amlodipine besylate Hypertension Olanzapine Eli Lilly Schizophrenia Esomeprazole magnesium AstraZeneca GI disorders Procrit/Eprex Epoetin alfa Johnson & Johnson Sertraline hydrochloride Depression Venlafaxine hydrochloride Depression Clopidogrel bisulfate Bristol-Myers Squibb Thrombotic events Plavix/Iscover Clopidogrel bisulfate Sanofi-Synthelabo Thrombotic events Celebrex Celecoxib Alendronate sodium Merck & Co. Osteoporosis Diovan and Valsartan, Valsartan + Novartis Hypertension Co-Diavan Hydrochlorothiazide Risperdal Risperidone Johnson & Johnson Schizophrenia Cozaar and Losartan potassium, Merck & Co. Hypertension Losartan potassium + Hydrochlorothiazide Source: Med Ad News, May 2005 Diagram of Bio-Pharma Industry Alliance BIG PHARMA FORMULATION REGIONAL LEADER New Molecular Entities Approved In 2005
No. Product Indication Boehringer Ingelheim HIV infection GlaxoSmithKline Leukemia/Lymphoma Baraclude Bristol-Myers Squibb HBV infection Amlyn/Lilly Type 2 diabetes Novartis Chronic iron overload due to blood transfusions PrimaPharm Hypodermoclysis Hylozyme (marketed by Baxter) Hypodermoclysis Increlex Growth failure in children Growth failure in children
10 Levemir Novo Nordisk Type 1 and Type 2 diabetes
11 Mycamine Astellas Candida infections
12 Nevanac Pain/inflammation associated with cataract surgery
13 Nexavar Bayer/Onyx Advanced renal cell carcinoma
14 Revlimid Transfusion dependent anemia
15 Rozerem Insomnia
16 Symlin Type 1 and Type 2 diabetes
17 Tygacil Intra-abdominal infections and complicated skin and skin structure infections
18 Vaprisol Astellas Euvolemic hyponatremia Source: The Pink Sheet. January 9, 2006 Biologics Approved in 2005
No. Product Indication Sanofi-Aventis Booster immunization against tetanus, diphtheria and pertussis Boostrix GlaxoSmithKline Booster immunization against tetanus, diphtheria and pertussis GlaxoSmithKline Vaccine against influenza virus type A and B Gammagard Liquid IV immune globulin for primary immune deficiency Menactra Sanofi-Aventis Vaccine for prevention of invasive meningococcal disease Naglazyme BioMarin IV enzyme replacement therapy for mucopolysaccharidosis VI Bristol-Myers Squibb Rheumatoid arthritis Vaccine against measles, mumps, rubella and varicella Vaccinia immune IV immune globulin for abberrant infections globulin intravenous (human)
10 Vaccinia immune IV immune globulin for abberrant infections globulin intravenous (human) Source: The Pink Sheet. January 9, 2006 Top 10 Pharmaceutical Companies Rank 2006 Market Cap (in billions) from 2005 Johnson & Johnson GlaxoSmithKline Sanofi Aventis Novartis Merck & Co. AstraZeneca Abbott Labs Eli Lilly & Co. Top 5 Biotech Firms Rank 2006 Market Cap (in billions) from 2005 Genentech Gilead Sciences Biogen Idec Source: S&P Comstock via the Telescan Prosearch Program. Market Cap on March 1, 2006 and May 9, 2005. Recent Success of New Drugs 1) Aloxi by Helsinn/MGI
Ö First me-too that has delayed and acute antivomiting effect 2) Cialis by Lilly
Ö First me-too that has long half-life to be claimed as “Weekend Pill” 3) Factive by LG
Ö First me-too antibiotic approved by Korean FDA 4) Caduet by Pfizer
Ö Combo of Lipitor and Norvasc 5) Niaspan by Kos
Ö Once-a-day formulation of Niacin Factive® (gemifloxacin) - Fast and ACTIVE LG Life Sciences, Ltd. Novelty of invention: Shift of Ciprofloxacin’s 6-member ring “Piperazine” to a 5-member ring “pyrrolidine” and creates a unique structure “Oxime” to increase activity against G(+) Clinical Development: 9,402 patients involved in phase 2/3 studies (5,249 received Factive®) 5 Phase 2: STDs, RTI/AECB, LRTI, uncomplicated SSTI, uncomplicated UTI 4 Phase 3: RTI/AECB, RTI/Sinusitis, RTI/Pneumonia, uncomplicated+complicated UTI LG company initiated its antibiotic project. 1995-1996 Discovered by LG, the compound completed phase 1 in Europe. 1997.05.12 Strategic alliance with SB (now GSK) for the worldwide development & commercialization of the compound outside of Korea while LG retained the option to co-promote the product with SB in certain markets in South East Asia. Phase 2 completed in the US. 1999.12.15 Phase 3 completed and the NDA filed to the US FDA by SB. 2000.12.15 Not approvable letter granted by the US FDA citing concerns about efficacy and potential liver damage and drug-related rashes. 2002.04.15 Following its merger with Glaxo, GSK returned the product rights to LG. Factive® (gemifloxacin) - Fast and ACTIVE LG Life Sciences, Ltd. 2002.10.22 Licensed to GeneSoft for North America and Europe. At the request of the US FDA, a further study was performed in 1,011 young adult female patients in order to characterize further a gemifloxacin-associated rash seen in previous trials. 2002.12.27 New drug approval in Korea. 2003.03.04 GeneSoft presented new data showing no increase in liver enzymes or heart rhythm problems but a much higher incidence of rash in Factive® patients. US FDA advisory panel voted 18-0 for approval for the CAP indication and 15-3 for approval for the AECB indication. 2003.04.04 New drug approval from the US FDA for RTI (CAP & AECB). Factive® was expected to generate $67M in annual global sales and royalty revenues for LG. 2003.07.29 US FDA approved Factive® for multi-drug resistant S. pneumoniae indication. Similar approvals pending in UK, Canada, Hungary and South Africa. 41.03.12 51.02.09 54.08.26 82.05.03 56.06.30 84.12.12 66.07.02 91.08.26 82.03.17 93.10.18 49.07.22 90.09.27 59.08.25 92.05.12 4.94 0. 89 71.06.16 92.11.05 55.06.30 93.12.13 Challenges in Taiwan Biotech/Pharma Industry
z Taiwan biotech/pharma companies are too small
Ö Need M&A to create Big 3 with individual sales >US$100M and R&D budget 10%
z Collaboration between industry and academics
Ö Need joint drug discovery and development projects that focused on competitive program with our strength
z Alliance with US marketing-driven specialty pharmas
Ö Need government’s $$ to invest/establish marketing network for our products to go abroad
AUTHORIZATION TO ADMINISTER NON-PRESCRIPTION MEDICATION TO CAMPER (TO BE COMPLETED BY PARENT/GUARDIAN) Name of camper __________________________________ Date of attendance______________________ Please check off which non-prescription medications you give permission to be administered by the Health Care Manager to the above named camper on an as nee
Acomplia® (Rimonabant) in der Schweiz zugelassen für die Behandlung adipöser und übergewichtiger Patienten mit mindestens einem zusätzlichen kardiovaskulären Risikofaktor Paris, 3. April 2007 − Sanofi-aventis gibt heute bekannt, dass die Schweizerische Zulassungsbehörde Swissmedic die Zulassung für ACOMPLIA® (Rimonabant) für die folgende Indikation erteilt hat:
Genovate BIOTECHNOLOGY CO., LTD.
Industry
New Drug Development
Evolution of Pharmaceutical Industry
TOP 15 PRESCRIPTION DRUGS BY WORLDWIDE SALES
Worldwide Sales
Diagram of Bio-Pharma Industry 
New Molecular Entities Approved In 2005
Biologics Approved in 2005
Top 10 Pharmaceutical Companies
Recent Success of New Drugs
Factive® (gemifloxacin) - Fast and ACTIVE
Factive® (gemifloxacin) - Fast and ACTIVE
41.03.12
Challenges in Taiwan Biotech/Pharma Industry