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I phar presentation-skolkovo_15.04.2013

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  • 1. IPHARDRUG DEVELOPMENTFOR FOREIGNAND DOMESTICMARKETS2013 Copyright © iPharPresidentVeniamin KhazanovProfessor, MD, Ph.D., D.Sc.
  • 2. IPHAR IS A HOLDING COMPANYMain activities: Development of innovative drugs for Russian and Globalmarket Contract services - preclinical and clinical studies of drugs(over 60 studies for Russian and foreign customers in thelast 3 years)2013 Copyright © iPhar
  • 3. APIs screeningProject “packaging”Attraction of investmentsIP protectionDrug formulationTechnology scalingPreclinical researchClinical trialsRegistrationPilot manufacturingCommercializationManufacturingand SalesCustomersDevelopment andCommercialization2013 Copyright © iPhar Russian and foreign drugmanufacturers Startup companiesIPHAR – DRUG DEVELOPMENT SERVICES
  • 4. Commercializationdepartment(preparingprojects, attraction ofinvestments, IPprotection)Management(planning, management and control of allactivities – from ideato implementation)Clinical department(clinical trials of newdrugs in Russianclinical centers)Technologicaldepartment(development andscaling drug synthesistechnology)R&D centerspecializing inpreclinical trials of drugsafety and efficacyTeam(over60 employees,6 D.Sc.,12 PhD)STRUCTURE OF IPHAR2013 Copyright © iPhar
  • 5. INTERACTION WITH OTHER ORGANIZATIONSSubstance synthesis:TSU, OOO “Novohim”(Tomsk), NIOC SB RAS(Novosibirsk), OAO“Organica”(Novokuznetsk), etc.Laboratory analysis:TSU, TPU(Tomsk), institutes of SBRAS(Novosibirsk), institutes ofRAMS and RAS (Moscow)Clinical trials:clinical centers ofTomsk, Novosibirsk, Kemerovo and other RussiancitiesRussian andforeignpharmaceuticalcompaniesIPHAR2013 Copyright © iPhaR
  • 6. ADVISORY BOARDProfessor Khazanov V. (iPhar) – pharmacologist, biochemist.Developer of over 100 drugs. Creator of a group of companiesspecializing in drug development and manufacture.– a prominent Russian chemist, inventor of 8original drugs, author of 10 monographs on drug synthesis anddevelopment.Prof. Salakhutdinov N. (Scientific Institute of Organic Chemistry,Novosibirsk) – major Russian specialist in medical chemistry anddrug synthesis.Prof. Gogvadze V. (Karolinska University, Sweden), D. Sci. –a major scientist in the field of molecular biology and toxicology.Dr. Schwarz J. (Nano Essentials Inc., Canada) – formerly one ofthe heads of formulation department of TEVA (Israel).Dr. Cleverley S. (ISIS Innovation, UK) – expert of OxfordUniversity technology transfer center.Prof. Granik V.2013 Copyright © iPhar
  • 7. 2013 2014 2015 20161. Antiulcer drug – peptic ulcer and GERD2. Anti-inflammatory - rheumatism, arthritis3. Anti-Parkinson drug - Parkinsons disease4. Antiplatelet - cardiovascular diseaseDEVELOPMENT OF INNOVATIVE DRUGSFOR GLOBAL MARKETS2013 - 2015 IPHAR plans to complete preclinical studiesof 4 innovative drugs and start clinical trials:2013 Copyright © iPhar
  • 8. Product – new molecule based on pyridopyrazindione with a newmechanism of action on H+/K+ ATPase: a reversible potassium-independent proton pump inhibitor.IP: Patent RU 2465274, priority date 05.03.2010; PCT/RU2011/000103;US application 13/602,239 dated 03.09.2012 (allowance for a patentdated 21.03.2013); EPO application 11750980.2 dated 04.10.2012;Ukraine and EAPO applications.Competitive advantages compared to the best drugs on the market(proton pump inhibitors ):• reversibly inhibits enzymes of gastric mucosa;• does not suppress normal gastric acid secretion level;• does not inhibit gastrointestinal peristalsis;• reduces the risk of night-time acid “breakthrough” and “rebound” –sudden increase in acidity after cancelling the drug.Consumer benefits – sustained normal digestion level in long-termtreatment, reduction in adverse effects incidence and disease recurrence.ANTIULCER DRUG2013 Copyright © iPhar
  • 9. The drug is based on a new small molecule (terpenoidderivative), differing in its properties from the known antiparkinsoncompounds.IP rights - OOO«Rionis»: patent RU 2418577, priority date 24.12. 2009;PCT/RU2010/000778; US application No. 13/518,814 dated 22.06.2012;EPO application 10844832.5 dated 20.07.2012; EAPO application.Competitive advantages :•does not cause dyskynesia and other motor and non-motor adverseeffects, present in levodopa;•effectiveness – as good as levodopa, unlike most competitors(dopamine agonists or MAO and COMT inhibitors);•can potentially have neuroprotective action and eliminate some non-motor disorders of Parkinson disease;•can be used to treat drug-induced parkinsonism.Consumer benefits :1) Makes safe and long-term PD monotherapy possible;2) Slows down the disease progression;3) Eliminates non-motor disorders.ANTI-PARKINSON DRUG2013 Copyright © iPhar
  • 10. Product - the new patented compound - N-[3-(4-nitrophenylamino)-indole-2-ilmethylene]aminoguanidine hydrochloride with a new mechanism ofaction - selective inhibition of inducible NO-synthase.IP: Patent RU 2478618, priority date 15.03.2010; PCT/RU 2011/000142;US application 13/634,840 dated 13.09.2012; EPO application 11756610.9dated 12.10.2012; Ukraine and EAPO applications.The main advantage of the drug over the worldwide used analogs(NSAIDs) is the absence of dangerous ulcerogenic effects, because itspharmacological target is NO-synthase and not cyclooxygenase.Efficiency - the new compound exhibits anti-inflammatory action as potentas voltaren and indomethacin in peritonitis and arthritis models (ED50 –50 mg/kg, mice, rats)Safety - the compound has low toxicity (LD50>5000 mg/kg, mice).Market. There are no direct market analogs of the new drug. World marketof NSAIDs amounts to $10 billion.ANTI-INFLAMMATORY DRUG2013 Copyright © iPhar
  • 11. Product – a new molecule - indolinone-3 derivative with a new mechanismof action - a nitric oxide donor and a stimulator of soluble guanylate cyclaseand cGMP synthesis.IP: Patent RU (application № 2011144895 dated 08.11.2011);PCT/RU2012/000884.Competitive advantages: Unlike aspirin, the new molecule does not haveulcerogenic side effect. Unlike the known antiplatelet drugs, it has anti-hypertensive and cardioprotective properties, reducing xenobiotic load, theincidence of adverse effects and costs of cardiovascular disease treatment.Efficacy is proven in in vitro (GC activity) and in vivo models (plateletaggregation, parenchymal hemorrhage, hypertension). Effective doses:10 -7 mol in vitro, 4-12 mg/kg (per os), 0,01-1,0 mg/kg (intravenously).Low toxicity - LD50 = 8900 mg/kg in oral administration in mice.Market. The world antiplatelet drug market amounts to $15 billion.The novel drug aims to be a possible alternative to clopidogrel and newantiplatelet drugs (prasugrel, ticagrelor) used in CVD treatment.ANTIAGGREGANT (ANTIPLATELET DRUG)2013 Copyright © iPhar
  • 12. Product – a new molecule – glycyrrhetic acid derivative, a structuralanalogue of the known compound - Bardoxolone methyl (ReataPharmaceuticals/ Abbott Laboratories), which underwent Phase III clinicaltrials as antioxidant inflammation modulator for the treatment of chronickidney disease in type 2 diabetes.Mechanism of action – modulator of activity of transcription factorsNrf2k,NFkB and PPAR.Promising areas of application:1) Oncology;2) Neurodegenerative diseases (Alzheimers disease, Parkinsonsdisease, multiple sclerosis).IP: Patent RU 2401273 dated 30.03.2009; Russian patent application №2012129738 dated 13.07.2012Efficiency: proven anti-tumor activity in vitro at doses of 0,5 – 5x10-6 molLow toxicity - LD50 > 5000 mg/kg in oral administration in mice.ANTICANCER DRUG2013 Copyright © iPhar
  • 13. IPHARPresident: Veniamin Khazanov,Professor, MD, Ph.D., D.Sc.Address: Elizarovykh str. 79/4, Tomsk, RussiaTel./fax: +7(3822)248721Mob.: +79138295599e-mail: gen_dir@iphar.ruwww.iphar.ru2013 Copyright © iPhar