Fondaparinux Sodium Injection

Fondaparinux Sodium Injection

EXECUTIVE SUMMARY

Fondaparinux is the anticoagulant which has a mechanism 300 times more potent compare to enoxoparin and parnaparin. Fondaparinux is used for stroke and vascular disease with 80 million people (Indonesia has 200 million people) and cause 1st major death in Indonesia. This form as prefilled syringe can use easily, lower injection cost and reduce risk and medication error. One of the benefit business feasibilty is making the facility to produce the prefilled syringe.Fondaparinux SodiumIndication : Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopedic surgery of the lower limbs patients undergoing abdominal surgeryTreatment of unstable anginaDossage :2.5 mg once daily in 6 hr post operation up to 8 daysPackaging :1 box @ 2 prefilled syringe 2,5 mg/0,5 mlPrevalenceNoMoleculeCompetitorValue (Q2 2012)1Fondaparinux Sodium1 (Arixtra) 28,4 M2Enoxoparin Sodium1 (Lovenox)22,4 M3Heparin5 (Inviclot, Heparin)10 M4Warfarin2 (Simarc, Warfarin)5,8 M5Parnaparin1 (Fluxum)4,7 M6Streptokinase2 (streptase, Fimakanase)4,3 MTOTAL75,6 MCompetitor antitromboliticNama obatWarfarinHeparinEnoxaparin sodiumParnaparin sodiumFondaparinox sodiumClasificationantikoagulan,Vit K InhibitorAntikoagulanLow Molecular Weight HeparinLow Molecular Weight Heparinsynthetic pentasaccharide anticoagulantSourcesintetis dari Courmarin,from Plant : Woodrufbovine and porcinebovine and porcinebovine and porcinechemical sinteticMechanisminhibits reactions that lead to the clotting of blood and the formation of fibrin clots bothin vitroandin vivovitamin K reductase resulting in depletion of the reduced form of vitamin K (vitamin KH2). As vitamin K is a cofactor for dependent coagulation factors II, VII, IX, and X and anticoagulant proteins C and S is inhibited. increase antithrombin III which finally inhibits factor Coagulant Xa dan IIa increase Prothrombin,Antithrombin III dan Faktor X which finally inhibits factor Coagulant Xa dan IIaFondaparinux potentiates (about 300 times) the neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus developmentFarmacokinetikhalf life (t1/2) 37-89 hours; Excreted : Very little in urine and to a lesser extent into the bile. 99% bound primarily to albuminHalf life 1.5 hours.Excreted :A small fraction of unchanged heparin also appears in urine. Heparin cannot be eliminated by hemodialysisHalf life=4,5 hours, Metabolized in the liverExcreted in : renal as active and non-active fragments 40% of the dose.Half life=6 hours, Metabolized in the liverExcreted in : renal Half life : 17 hours (in young people) and 21 hours (in adult) metabolized : no metabolism in bodyExcreted : in urineside EffectNausea, loss of appetite, orstomach/abdominal pain,coughing up blood, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools, chest pain, shortness of breath, difficulty swallowing.Hemorrage, Local irritation, Hypersensitivity, Osteoporosis, Elevation of serum aminotransferaseHemorrage,Local reaction,Elevation serum aminotransferase, Adverse reactionHemorrage,Severe Allergy, Increase in blood potassium Hemorrhage, Thrombocytopenia, Local Reactions, Elevations of Serum Aminotransferases Antitrombolitic ComparationFrom comparation above (mechanism, farmacokinetic, less side effect, and source of the raw material), Fondaparinux is SUPERIOR to another anticoagulantDIRECT COMPETITORMOLE DESCLaunchMAT ~ 06/2012MAT ~ 06/2011MAT ~ 06/2010MAT ~06/2012MAT ~06/2011MAT ~ 06/2012MAT ~ 06/2011MAT ~ 06/2010PricePACK DESCRUPIAHRUPIAHRUPIAHRp + ~06/2011Rp + ~06/2010UNITUNITUNIT FONDAPARINUX SODIUM28,480,819,50023,339,077,50020,110,084,50022.0316.0643,44935,60530,679655,500 ARIXTRA SYRINGE SC 2.5MG/0.5 0.5ML 2200428,480,819,50023,339,077,50020,110,084,50022.0316.0643,44935,60530,679655,500PRICE COMPARISON TO COMPETITOR NOBRAND NAMECOMPANYACTIVE INGREDIENTSPACKHNA PRICEDOSAGE (mg)Daily TherapyIDR/BoxIDR/1'sper DayCost (IDR)1 ARIXTRA SYRINGE SC 2.5MG/0.5 0.5ML 2GSKFondaparinux SodiumPFS6555003277503277503277502XXX OOTFondaparinux SodiumPFS520000260000260000260000price80% from competitor7IPA + IHPA+ IDA Market Fondaparinux Sodium (Q2 12) Unit (Box)Value (MIDR)43,44928000fondaparinux SodiumBox containing2PFSProposed HNA/ Box520000Share40%from all marketY-1Y-2Y-3Unit PFS360004320054000Unit Box180002160027000Growth202525Total Value (MIDR) 9,360 11,232 14,040 ForecastBreakdown Forecast Year 1 Q1 Q2 Q3 Q4 Unit (box) >> per month1000150016671834Unit (box) >> per quartal 3000450050005500

8Simulation of Import Finished FondaparinuxBEP in the 1st yearCalculationFondaparinux sodium(%) IDR HNA price100% 520,000 Distribution Margin10% 52,000 Ex-factory price (HJP)90% 468,000 COGS35% 163,800 P & LFondaparinux Sodium Injection PFS Year-1Year-2Year-3Year-4Year-5HNA/Unit (Ex dist. price) (IDR)520,000572,000629,200692,120761,332 Distribution Margin52,00057,20062,92069,21276,133HJP/Unit (Ex. Factory Price) (IDR)468,000514,800566,280622,908685,199Sales Target in Unit (box)18,00021,60027,00033,75042,188Growth (%)120%125%125%120%Sales in Value (MIDR) HNA Sales (million)9,36012,35516,98823,35932,119 HJP Sales (Net) (million)8,42411,12015,29021,02328,907COGS35%35%35%35%35% Direct and Indirect costs2,9483,8925,3517,35810,117 R&D cost00000 Registration BPOM150000Total COGS (MIDR)2,9633,8925,3517,35810,117Gross Profit/Gross Margin (MIDR)5,4617,2289,93813,66518,789Marketing Expenses (MIDR)35% Promotion activity2,9483,8925,3517,35810,117 Incentive (3%)281371510701964Total Selling & Marketing Cost (MIDR)3,2294,2635,8618,05911,081General & Administration Costs (MIDR)5056679171,2611,734Operating Income (MIDR)1,7262,2983,1604,3455,9749DEVELOPMENT, REGISTRATION AND PATENT ANALYSISRnD development : 6-9 monthsPatent analysis (molecule Fondaparinux Sodium) Tanggal Permohonan Patent ke HAKI 30 Maret 2004, could be expired on 2024. GSK claim :A use of a dose of 2.5 mg of the pentasaccharide methyl 0-(2-deoxy-2-sulfoarnino-6-0-sulfo- a-D-glucopyranosyl)-(l4)-0-(P-D-glucopyranosyl uronic acid)-(l 4)-0-(2-deoxy-2- sulfoaiio-3,6-di-0-sulfo-a-D-glucopyranosyl)-(l4)-0-(2-0-sulfo-ct-L-idopyranosyl uronic acid)-(l >4)-2-deoxy-2-sulfoamino-6-0-sulpho-a-D-glucopyranoside or apharmaceutically acceptable salt thereof for the preparation of a medicament for the treatment of Acute Coronary Syndromes (ACS).

Pra Reg : 6-12 monthsRegistration 12-15 monthsNIE10DISPUTE THE PATENT ????Invent by Sanofi synthelabo and Organon as Fondaparinux Sodium for DVT hip knee replacement and hip fracture and get the first approval in european Union Both Sanofi and Glaxo Smithkline bought the invention and patent in the world. They claim that this fondapoarinux with complex molecule is use for acute coronary syndromeGlaxo Smithkline registered the patent to HAKI in March 24th 2004 and this patent will be expired in 2024How to avoid the patent :Search another functional compound of Fondaparinux Sodium (another cristal) Another indication beside acute coronary syndrome example : Another form as an ordinary vial with extreme lower price.Please Check HAKI for SURE!!!!11

Why Prefilled syringe ??Improve patients outcomesReduce the risk of medication errorReduce the risk of catheter damageReduce storages and disposable costRemoval of preservativesLower injection costsless preparationThe worldwide prefilled market is estimated to be one billion units 1 Prefilled syringes in the US market have been growing at a rate of 20% per year for at least five yearSome products in Indonesia used Prefilled SyringePrevalance Prefilled SyringeNoProductMoleculeCompany1Osflex SyringeHialuronate (radang sendi)Novell2FraziparineCa NadroparinGSKNoProductMoleculeCompany1Hemapo syringe 3000 IURH Erythropoetin Kalbe Farma2LovenoxEnoxoparin NaSanofi Aventis3NeupogenFilgastrimRocheSyntetic APIBiological API13

Machine for Prefilled Syringe and component

Price of Prefilled Syringe

Filling Machine :USD 300000-500000 / set (depends on)2.Packaging machine = USD 75000-150000 /set (depends on)3. Standart syringe : USD 0.11-0.194/syringe, source Schott

Production facility :Type A sterile room production (dedicated)HVAC system include humadity

Apakah ada update harga yang baru untuk mesin??? Mesin yang dipilih kelasnya apa? Investasi basicnya seperti water, power, building, land????14Develop another product beside Fondaparinux Toll in (manufacturing)Patent the process, facility with using Prefilled syringe machine >> Monopoly the market

BUSINESS FEASIBILITY of Prefilled Syringe

For next 10 or 20 years, feasibility of pharmaceutical business would move forward to peptide, vaccine, and biological product. Prefilled Syringe could be the primary one15Another Product developed in PFSNoMoleculeValue in 1st year (assumption 30-40% from market value)Remark1Fondaparinux Sodium9 Billionantitrombolitic2Hyaluronic acid1.5 BillionIrritation, burning sensation, wound healingTOTAL10,5 billionPrice depends on the market situation. At least, similar with competitorDiscuss with BPOM if the form of product changed >> general ampul/syringe to prefilled syringe example for Ketamin, Ketorolac etcantithrombotics, vaccines, antiinfectives, and other biotech drugs indicated for chronic conditions such as rheumatoid arthritis,multiple sclerosis, psoriasis and Crohns disease, blood stimulant drugsSWOT ANALYSIS Strength1. Fondaparinux sodium has a good value in the market 28 M with one competitor only2. Fondaparinux is the first in a new class of agents, an indirect factor Xa Inhibitor, which selectively inhibits factor Xa via antithrombin-dependent actions* 3. Fonadaparinux is the most superior in anticoagulant class with the material source is sintetic, not from animal especially pork. HALAL4. Use only once in a day, compare to other heparin 2-3 times a day5. It will usually be used when the patient has a history of heparin allergy, but not acute Weakness1. Expensive compare to another anticoagulant, but for daily cost similar to cheaper.2. Fondaparinux lacks a specific antidote in the event of excessive anticoagulation3. Must have dedicated facility to produce Prefilled syringe with air and humadity conditionSWOT ANALYSISSWOT ANALYSIS Opportunity1. Anticoagulant is the most needed in the stroke and vascular disease. Stroke and vascular disease is the 1st reason cause a death in indonesia2. Over all, the market value of anticoagulant is 75,6 M. Another anticoagulant can be substituted or replaced by Fondaparinux sodium.3. No company yet in Indonesia has prefilled syringe facility4. Fondaparinux is the leader in anticoagulant, innovator. No other me too product yet ThreatPatent molecule covered until March 2024If there are no PFS facility, must import with higher price Import product must take longer time and restricted by PP 1010SWOT ANALYSISKEY SUCCES FACTOR

Anticoagulant is the promising product in Indonesia with ethical marketing strategy . Having a good relationship, seminar, and exhibition are neededAvoid the patent, find the other cristal (functional compound) or the other indications Prefilled syringe become one of the primary needs of injection form for next couple years due to vaksin, peptide product. Prepare the facility is properly needs >> looking for machine, room facility, etc