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Trance To Tansition2 Presentation Transcript

  • 1. Trance to… Transition
  • 2.
    • Project started in 1966
    • Leading towards 13 years of life time
  • 3.
    • The first step was the development of chemical program based on carbamates and suitable in vivo screening assay in rats
  • 4.
    • Compound with weak activity were identified quickly and initial hepatotoxicity problems were overcome with testing on humans
    • Its all happened in 1968
  • 5.
    • No result!
    • Project narrowly escaped termination
  • 6.
    • On the contrary, good progress shown by the development of H 2 antagonist thereby adding the anxiety within the project people
  • 7.
    • In 1973, Project was again started with new pace. Highly active chemical compound was proposed for further development
  • 8.
    • The compound revealed problems with thyroid toxicity which was associated with thiouracil structure. Further chemical changes were planned to eliminate this.
  • 9.
    • In 1976 a forerunner compound (Picoprazole) came into being showing
    • another toxicity alarm when tested in
    • dogs
    • An analogue of this compound was then synthesized
  • 10.
    • After 13 years effort and development of 300 compounds One breakthrough miracle which became the company’s best selling drug
  • 11.
    • Astra’s Omeprazole
    • Losec
  • 12. F rom T est T ube to P atients
  • 13. Drug Development Process
    • Drug discovery – from therapeutic concept to
    • Molecule
    • Drug development – from molecule to registered product
    • Commercialization – from product to therapeutic application to sales.
  • 14. Drug Development Chart A Long Road Towards Innovation
  • 15. Drug Discovery Hit or Miss
    • Rational approach
    • Irrational approach
    • Genomics and proteomic approach
    • Important factors to consider are:
    • Market potential
    • Patent portfolio
    • Competitive forces
    • Core competencies
  • 16. Discovering Small Molecule
    • Irrational Approach
    • Natural product collection
    • Provides diversity in composition result in variation of chemical composition and structures
    • Extraction of potential drugs
    • Extraction with organic solvent.
    • In some cases animals are the source. ACE inhibitor, analopril , captopril are examples
    • Rational Approach
    • Protein based
    • Virtual stimulation- Viagra
  • 17. Discovering Large Molecule
    • Biopharmaceuticals
    • Protein based
    • Manufacturing in biological systems
    • Vaccines
    • Hormones etc
    • 150 Biopharmaceuticals approved in USA and EU. About 500 under clinical trials. The market worth more than US $ 30 billion.
  • 18.  
  • 19. Development stage- Exploring depths to Innovate
    • Preclinical Drug development checks the toxicity on animal testing
    • Finding the promising lead by testing 1000 of compounds daily
    • Drug dosage form decision
    • Phase I, II and III
    • Pharmacogenetics
  • 20. Regulations- Watch Dog Role
    • Less concern with drug discovery process
    • Attack mainly within development phase. Strict procedures.
    • FDA has the most transparent system for IND
    • Bumps in the road- Only 5 from 5000 enter in human testing which result approx. 1 to enter for final approval
  • 21. Drugs Approved by FDA Eradication of Helicobacter pylori 28-Sep-06 biskalcitrate potassium, metronidazole and tetracycline Exposure to Organophosphorous Nerve Agents 28-Sep-06 atropine and pralidoxime chloride Prevention of Pregnancy 17-Mar-06 drospirenone and ethinyl estradiol Prevention of Influenza 05-Oct-06 Influenza Virus Vaccine Irritability Associated with Autistic Disorder 06-Oct-06 risperidone Cutaneous T-cell Lymphoma 06-Oct-06 vorinostat Chronic Obstructive Pulmonary Disease 06-Oct-06 arformoterol tartrate Non-Small Cell Lung Cancer 11-Oct-06 bevacizumab Zollinger-Ellison Syndrome 11-Oct-06 esomeprazole magnesium Head and Neck Cancer 17-Oct-06 docetaxel) Type 2 Diabetes 17-Oct-06 sitagliptin phosphate Bipolar Depression 20-Oct-06 Allergic Rhinitis Allergic Rhinitis 20-Oct-06 ciclesonide Atopic Dermatitis 20-Oct-06 desonide Chronic Hepatitis B 25-Oct-06 telbivudine Genital and Perianal Warts 31-Oct-06 Veregen Angina Pectoris 02-Nov-06 nitroglycerin Acne 07-Nov-06 clindamycin phosphate and tretinoin Indication Approval date Molecule
  • 22. Drugs Approved by FDA Prevention of Cervical Cancer other HPV-related Diseases 08-Jun-06 Quadrivalent Human Papillomavirus Asthma 08-Jun-06 fluticasone propionate and salmeterol Parkinson’s Disease 14-Jun-06 selegiline hydrochloride Moderate-to-Severe Pain 23-Jun-06 oxymorphone Human Immunodeficiency Virus (HIV) 23-Jun-06 darunavir) Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) 28-Jun-06 dasatinib Wet Age-Related Macular Degeneration 30-Jun-06 ranibizumab Topical Local Anesthesia 06-Jul-06 lidocaine and tetracaine HIV-1 Infection 12-Jul-06 efavirenz, emtricitabine and tenofovir disoproxil fumarate Contraception 18-Jul-06 etonogestrel Hunter Syndrome 24-Jul-06 idursulfase Seborrheic Dermatitis 28-Jul-06 ketoconazole Type 2 Diabetes 31-Jul-06 pioglitazone HCl and glimepiride Epilepsy 31-Jul-06 levetiracetam Ankylosing Spondylitis 28-Aug-06 adalimumab Prevention of Invasive Fungal Infections 15-Sep-06 posaconazole Mild-to-Moderate Atopic Dermatitis 19-Sep-06 desonide Glaucoma and Ocular Hypertension 21-Sep-06 travoprost Primary Generalized Tonic-Clonic Seizures 22-Sep-06 lamotrigine Breakthrough Pain in Patients with Cancer 25-Sep-06 fentanyl Metastatic Colorectal Cancer 27-Sep-06 panitumumab Acne 07-Nov-06 clindamycin phosphate and tretinoin Indication Approval date Molecule
  • 23. Drugs Approved by FDA Heartburn/GERD, Erosive Esophagitis, Duodenal & Gastric Ulcers 27-Feb-06 omeprazole/sodium bicarbonate Major Depressive Disorder 28-Feb-06 selegiline Prevention of Pregnancy 17-Mar-06 drospirenone and ethinyl estradiol Colon Cleansing prior to Colonoscopy 17-Mar-06 sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous Heartburn/GERD, Erosive Esophagitis, Duodenal & Gastric Ulcers 27-Mar-06 omeprazole, sodium bicarbonate and magnesium hydroxide Attention Deficit Hyperactivity Disorder 06-Apr-06 methylphenidate Alcohol Dependence 13-Apr-06 naltrexone Patent Ductus Arteriosus 13-Apr-06 ibuprofen lysine Pompe Disease 28-Apr-06 alglucosidase alfa Myelodysplastic Syndromes 03-May-06 decitabine Acne Vulgaris 08-May-06 minocycline Smoking Cessation 11-May-06 varenicline Chemotherapy-induced Nausea and Vomiting 15-May-06 nabilone Parkinson’s Disease 17-May-06 rasagiline Acute Postoperative Pain 23-May-06 fentanyl Prevention of Pregnancy 25-May-06 levonorgestrel/ethinyl estradiol and ethinyl estradiol Prevention of Shingles 25-May-06 Zoster Vaccine Live Rosacea 26-May-06 doxycycline Growth Disorders 30-May-06 somatropin [rDNA origin] Asthma and other Inflammatory Conditions in Children 01-Jun-06 prednisolone sodium phosphate Facial Wrinkles and Folds 05-Jun-06 hyaluronic acid Acne 07-Nov-06 clindamycin phosphate and tretinoin Indication Approval date Molecule
  • 24. Drugs Approved by FDA Prevention of Postmenopausal Osteoporosis 04-Jan-06 estradiol/levonorgestrel Postmenopausal Osteoporosis 06-Jan-06 ibandronate sodium Primary Immunodeficiencies 09-Jan-06 (immune globulin subcutaneous Psoriasis 10-Jan-06 calcipotriene and betamethasone Gastrointestinal Stromal Tumors and Renal Carcinoma 26-Jan-06 sunitinib malate Type 1 and Type 2 Diabetes in Adults 27-Jan-06 insulin human Chronic Angina 27-Jan-06 ranolazine Exposure to Hepatitis B 30-Jan-06 (hepatitis B immune globulin Constipation 31-Jan-06 lubiprostone Seasonal Allergy Symptoms 01-Feb-06 desloratadine and pseudoephedrine Prevention of Rotavirus Gastroenteritis 03-Feb-06 rotavirus Diaper Dermatitis Complicated by Candidiasis 16-Feb-06 miconazole nitrate, zinc oxide and white petrolatum Prevention of Pregnancy 17-Feb-06 norethindrone acetate/ethinyl estradiol and ferrous fumarate Candidemia 17-Feb-06 anidulafungin Indication Approval date Molecule
  • 25. Cost Of New Drug 800 Million Pill
  • 26. Drug Development Economics
    • The cost of drug development has risen markedly in the last 30 years
    • The average cost of developing a drug now exceeds $800 million!
    • Spiraling costs threaten to make new drugs increasingly unaffordable to both consumers and drug development companies.
  • 27. Drug Development Economics
    • Big Pharma
      • The average revenue per company is some $10 billion
    • To maintain revenue growth at 10% per year :
      • The Big Pharma will need 3 to 4 new drugs
        • Per company
        • Per year
      • The Big Pharma will need to generate some $300 to $400 million per drug
      • At present, half the new drugs introduced each year have a market value below $ 100 Mn
  • 28. To Make It More Complex Exclusivity Time is Eroding
  • 29. .. And Productivity Does Not Seem to Be Improving
  • 30. So.. What’s the Next BIG Thing in Healthcare??? Some Adventurous Prophecies...
  • 31. Upcoming promise
    • Today:
    • Most drugs on the market today are
    • discovered inefficiently through random
    • trial and error
      • 10,000 agents tested
      • 1000 typically active
      • 100 worth investigating
      • 10 go to trials...
      • ...and ONLY 1 typically reaches patients on the market
      • Price tag is $500 to 800 M over 10-12 year period
    • Soon:
    • Structure based genomics and proteomics where scientists utilize powerful computers to design thousands of potential drugs every day
  • 32. Future Potential
    • 1.4Mn Americans will be newly diagnosed with cancer this year
      • Surgery, radiation and chemo can only cure 50 percent of these diagnosed
    • Cancer vaccines in clinical trials
      • Could prevent 850,000 cases of cancer each year
    • HIV
      • vaccine may be here by 2006, hopefully sooner
  • 33. Understanding The Value Chain First Where Does The R&D Money Go? 12% 15% 5% 9% 29% 5% 10% 4.5 % 8% 2.5% Synthesis Biology/Pharmaco Toxico/Safety Others Bioavailability Regulatory Formulation Phase I-III Phase IV Process Dvpt
  • 34. Potential Value for India’s R&D Based Industry 12% 15% 5% 9% 29% 5% 10% 4.5% 8% 2.5% Synthesis Biology/Pharmaco Toxico/Safety Others Bioavailability Regulatory Formulation Phase I-III Phase IV Process Dvpt
  • 35. T he C loning of P arent D rugs
  • 36. Ruling Generics in Pakistan
    • Source: IMS 3Q / 2006
    7.7 1 20.7 288281 Flouroquinolones Sami Novidat 18.8 1 44.6 298772 Acid pump inhibitor Getz Risek 6.6 2 10.8 302649 Antirhuematic Non- Steroid Sami Dicloran 45.2 1 17.1 391105 VitB12 Hilton Methycobal 42.6 1 65.3 558717 Interferon Getz Uniferon Share in Classes Rank Growth Value Therapeutic Classes Company Brands
  • 37. Copy Cats Taking an Edge! Source: IMS 3Q / 2006 2 1991 5% 8% 79606 Losec 1 1996 18% 45% 298772 Risek Rank Yr of Launch Mkt. Share Growth Value+000 Brands 3 2002 12.70% 18% 165989 Roferon 1 2000 42.60% 65.30% 558717 Uniferon Rank Yr of Launch Mkt. Share Growth Value+000 Brands
  • 38. Status of New Generic Launches in Pakistan Source: IMS 3Q / 2006 40 31 8 Macter 10 30 7 Searle 5 37 14 Highnoon 2 31 10 Hilton 4 38 7 Sami 1 27 16 Getz Rank Total Products New Launch in 8 Qtr Company
  • 39.  
  • 40. Hot Buttons in Generic Development
    • Whether the generic version is bioequivalent to the original drug ?
    • May have some inactive ingredients that are different from those of the original drug
    • FDA approval and procedures
  • 41. A Road Map for the Generic Developer
  • 42. Product Idea
    • Sustained release anti-ischemic drug for the treatment of angina
  • 43. Brief Description of the Molecule
    • Chemical Name: Ranolazine
    • Chemical Class: Piperazine Derivative
    • Therapeutic Category: Anti ischemic /pFox inhibitor
    • History of Molecule Discovery:
    • In October 2003 FDA issue a letter for the approval but still some clinical support were needed
    • In December 2003, agreement was reached after ERICA
    • In November 2004 enrollment were take place
    •   FDA/European Approval: Approval granted in late January 2006
      • Many European countries have already granted approval to pFox inhibitors
  • 44. Dosage Form Description
    • Details of Dosage Form : Solid dosage form along with film coated tablets with sustained release property. pH dependent binder is there which is soluble in aqueous media above 4.5.
    • Comments on dosage suitability: 500 mg twice a daily with half life of 2 hours is sufficient to prolong the QT interval. Dose may be increased to 1000 mg depend on severity of symptoms
  • 45. Packaging Idea
    • Packing Details :
    • Market availability:
    • Internationally - Glass bottle of 60’s,
    • Anti ischemic are available in ALU-ALU blisters in Pakistan. Suggested 20’s
    • Suggestion: Regardless of any technical reason, use of ALU-ALU blisters would be advisable to furnish premium price product.
  • 46. Target Indication - CAD
      • Therapeutic Rationale:
      • Ischemic Heart Disease (IHD) is rated as the No.1 killer of adult population worldwide
      • This is the only killer which is common among developed and developing countries
      • Asia including Pakistan is on high risk
      • The incidence is ever increasing in Pakistan
      • Major need for drugs with alternative mechanisms of action
  • 47. Target Indication
    • Disease Morbidity
    • T he prevalence of myocardial infarction in Pakistan is much higher than it is in the United States and Europe
    • According to a study carried out in 1994 by the Pakistan Cardiac Society, the incidence of myocardial infarction cases in the city is 193 patients per 100,000 population
    • According to a rough estimate, Angina figures are more than double the cases of myocardial infarction.
  • 48. Target Indication
    • Ischemic Heart Disease (IHD) was reported as 12% of the adult mortality in Pakistan
    • The overall prevalence of ischemic heart diseases in men was 2.3% in the rural and 4.7% in the urban populations and corresponding values for women over 25 years were 1.1% and 2.0%
    • Ref:
    • National Health Survey of Pakistan (NHSP)
    • Eastern Mediterranean Health Journal, Vol. 11, No. 3, 2005
    • Eastern Mediterranean Health Journal vol. 3 2005
  • 49. Now the CAD knows where is its target market - ASIA Obesity Hypertension Diabetes Smoking Genetics Lack of Physical Activity
  • 50. If the Statistics in Pakistan are applied on this room
    • Two of us have Hypertension or will develop Hypertension within three years of life
    • One of us has diabetes or will develop diabetes within five years
    • One of us will die from a CAD incident
  • 51. No body wears shoes – Threat or the Opportunity
    • More than 90% of the sales revenue , prescriptions and products for IHD is related to
      • Hemodynamic
      • Inotropic cardiac support
      • Chronotropic cardiac support
    • Very little focus on Cardiac Muscle Energization
  • 52.
    • Treat the Disease but Support the Deceased
    Concept selling required Sharp Product Management Well Trained Sales Force
  • 53. Competitive Advantages
    • Technological advantage –
    • More clinically established in terms of studies than the predecessor
    • Sustained release form
    • Use of pH dependent binder in the formulation
    • Release of product in lower GI Tract with pH greater than 4.5
    • Clinical Advantage –
    • Metabolic modulator in treatment of angina
    • New mechanism of treatment which is different than the conventional one and can be used as adjunct also
    • No hemodynamic effect
  • 54. IMS Status 14 Growth 5,596,848,000 Value 51422400 Units Total Cardio 3 Growth 354,366,000 Value 3,736,800 Units Total Nitrates 14 Growth 1,008,467,000 Value 13,859,700 Units Total Beta Blockers 12 Growth 817,938,000 Value 8,302,700 Units Total Calcium Antagonist (Plain)
  • 55. IMS Status- Nitrates 57 10900 720 Bioglan Isotrate 15 13779 315 Barret Imdur 13 14112 1546 Biogenics AngiocardSR 27 14385 11065 GSK Angised 0 21795 644 Schwarz Isoket -22 22575 1042 Schwarz Elanton 10 36813 5642 Roche Ismo 9 52501 3322 Efroze Monis Range 22 53675 2969 EGIS Nitromint -14 47653 3368 Pharmax Sustac SR         Nitrates GROWTH VALUE +000 UNITS+00 COMPANY PRODUCT
  • 56. IMS Status- Beta Blockers 58 23,794 130,7 Roche Dimitone 56 25,356 176,4 Ferozsons Carveda 9 30,300 907,6 Nabiqasim Normitab 17 31,954 939,8 Zafa Zafnol -1 33,036 597,9 Zafa Atenolol 6 67,400 421,5 Novartis Mepresor 22 92,979 814,1 Almiral Blokium 18 106,890 1,164,0 Merck Concor 9 115,614 2,141,6 Zeneca Inderal 15 304,738 4,097,3 Zeneca Tenormin GROWTH VALUE +000 UNITS+00 COMPANY PRODUCT
  • 57. IMS Status- Calcium Antagonist 20 12565 2068 sami Onato 28 14742 1032 MASS Amodip 21 21285 2540 Merck Lodopin 18 21366 10929 Zafa Zodip -22 22947 1309 Hilton Cardiosil 10 53663 3385 Bayer Adalat 14 70444 4073 Tanabe Herbessor 46 94616 15364 Searle Calan 11 108895 16372 Wilson Sofvasc 15 246379 10688 Pfizer Norvasc GROWTH VALUE +000 UNITS+00 COMPANY PRODUCT
  • 58. Available Cardiac Energizer 20 36006 2300 Vastrel MR. 21 36417 2324 Vastrel 32 9077 683 Dinemic Growth Value Units Q4-2002   >999 39099 2312 60 58387 3544 11.1 8645 650 Growth Value Units Q4-2003 40 54674 3233 15 67219 4035 -17 7150 501 Growth Value Units Q4-2004 19 64894 3838 11 74656 4461 -3 6938 453 Growth Value Units Q4-2005 11 78222 4670 -8 6578 425 Growth Value Units Q1-2006
  • 59. 65%
  • 60. Aspirations
    • Market Aspirations
    • Increasing demography of Angina and MI
    • IHD among leading cause of death
    • Modern life style pushes people towards Heart Disease
    • Increasing urbanization also adding ice to cake
    • Growing health awareness bringing more and more patients to health care facilities-Thus increasing prescriptions
    • available therapies are towards altering
    • hemodynamics
    • The only molecule working for myocardial energization is weak in background support ..
  • 61. Aspirations
      • Technical Aspirations
      • Sustained release property
      • Specialized dissolution mode of product
      • pfox Inhibitors
      • Brand Aspirations
      • Functional:
      • Expressive:Treat the disease Support the deceased
      • Central: Cardiac Energizer
  • 62. USPs
    • Sustained release anti-ischemic
    • No Hemodynamics Effect only Cardiac energization
  • 63. Possibility of Customer Acceptance
    • FDA approval back ground
    • Technology: Control dissolution profile of product
    • Patient often receive incomplete relief from anginal symptons with conventional antianginal drugs.
    • No hemodynamic effects may result in patient compliance
  • 64. Pricing Ideas MRP: Rs. 240 per pack of 20’s TP: Rs. 204 per pack of 20’s Exfactory: Rs. 183.6 per pack of 20’s Exfactory per tab: 9.18 Rs.
  • 65. Forecast
    • We aspire for…
      • 1% co-prescriptions with 10 leading nitrates, beta blockers
      • 0.5% co-prescriptions with Ca Channel Blockers
      • 5% of total pFox market
    Value Forecast for First Year 15,000,000 Rs (Ex-Fact) Unit Forecast for First Year 82,000 Packs (20’s)
  • 66. Caution Check Patent Status
  • 67. Raw Material Cost According to a rough Estimate, to maintain the profitability same as Dinemic, the RM of Ronalizine should be around 30$/Kg Caution
  • 68. “ The single largest challenge facing drug developers — both pharmaceutical and biotechnology companies — is to contain R&D costs and reduce development times without compromising clinical test design. It’s a tall order.” Tufts Center Director, Dr. Kenneth I Kaitin