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A propitiatory Database on Japan Pharmaceutical Industry

A propitiatory Database on Japan Pharmaceutical Industry

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  • 1. 日本の製薬企業のデータベースの紹介 MP Advisors Introduces Japan Pharma Database [MP-JPD®] To Address Unanswered FAQ About Japan Pharma Formulating a competitive landscape of various therapeutic classes in Japan is challenging viz a viz the US and EU markets due to: 1. 2. 3. 4. 5. 6. Operations of various MNCs who generate significant amount of revenue but do not disclose their sales – Market Research Agencies has their limitations; no projections Disclosure of Clinical trial data – is limited/not detailed and is shared after a long gap. Lack of equivalent sites such as clinicaltrials.gov, FDA’s Orange book, etc. – company reports, various categories of CT data available at scattered sources. Mostly in Japanese. Very Difficult to get patent expiry info. from JP cos - Multiple patent extension, NO reliable Source in public domain Large contribution of ‘Japan Only’ products - difficult to make competitive landscapes for overseas companies. Language 1000+ Products 100+ Companies 450+ Key Pipeline Candidates 1 Competitive Landscape- For Companies, Products, Pipeline Candidates & Thx Classes Landscape-
  • 2. Making Of MP-JPD® A number of reliable secondary sources scrutinized Brands/ Company/ Sales • Crecon consulting Inc. • Japan Pharmaceutical reference (JPR) • Company reports • Drugs in Japan-2011 [本医薬品集フォーラム/監修 ] Patents & R&D/Pipeline • IPDL (Industrial Property Digital Library) • Japan Pharmaceuticals Information Center (JAPIC CTI) • UMIN Clinical Trials Registry (UMIN-CTR) – in case physician belongs to university hospitals • JMA CCT – in case physician belongs to private hospitals Regulatory Related • Korosho / Kosei-roudou-sho (MHLW) • Kiko (PMDA) • Kokuho Chuoukai (NHI) • Chuikyo (Central Social Insurance Medical Council) Primary data enriched thru ~25yrs of experience base HISTORIC DATA POINTS • MP proprietary financial models (15+ companies; all majors) • In-house library of clinical data points from global companies PROJECTING FUTURE • Analyst’s projections of sales thru 2016 (~350 key products, ~60% of total market) • Analyst views on NCE/NBE pipeline (viz. based on clinical data analysis, competitive landscape) • Data acquired thru interviewing management, supply chain etc - patent expiries (~250), issues related to ongoing trails etc. • Interviews with ‘key opinion leaders’, regulators (views on price cuts, expected regulatory changes) 2
  • 3. Japan Specific Challenges ‘Japan Only’ Products ‘Japan Only’ Products Drug O riginator Lice nse e JP LaunchFY 03/10 Radicut Mitsubishi Tanabe Not licensed 2001 28.0 C oniel Kyowa Hakko Not licensed 1991 Dependence on ‘Japan Only’ Products 21.00 Gasmotin Dainippon Sumitomo Takeda Anplag 1998 20.70 Mitsubishi Tanabe Not licensed 1993 16.9 C eredist Mitsubishi Tanabe Not licensed 2000 16.3 Prorenal Ono Dainippon Su 1988 15.4 Depas Mitsubishi Tanabe Not licensed 1984 11.6 Ebastel Dainippon Sumitomo Meiji Seiku 2005 Source: MP Advisors, Company reports Company Mitsubishi Tanabe Dainippon Sumitomo Kyow a Hakko Kyorin Key products sales (¥b) products sales (sold in JP only) Weight of JP focused products (%) 201.10 190.80 106.60 83.25 91.3 72.5 22.8 45.4% 38.0% 21.4% Source: MP Advisors, Company reports 9.20 Multiple Patent Expiries Multiple Patent Extension: JP vs. US/EU Japan US EU Introducti on 1988 1984 1993 Maximum period 5 years 5 years 5 years No.of extension Multiple possible Only once Only once Multiple Only one No.of possible patent eligible for extension Source: MP Advisors, Company reports Only one • Basic patent term can be extended multiple times e.g. by adding new indications • Related patents (method of use, mfg. etc.) can also be extended multiple times • JGPMA request to JPO to Limit the extension to only one patent and only once CASE STUDY: Multiple patent extension of levofloxacin (~¥44b FY 03/10 A): Launched in Nov-93; JPO gives two entries for Cravit, showing application in 1990 (reg # 2523210) & 1993 (Reg. # 3244983 )! 1st 2nd 3rd 4th stapylococcus and other 30 bacterium June 2006 Anthrax,Pest,etc. October 2006 Typhoid Fever , Paratyphoid Fever November 2007 Legionella June 2011 Most recently Levofloxacin received mfg. approval for 500mg/100ml IV bags & 500mg/20ml injections in Oct, 2010 3
  • 4. MP-JPD® : FAQ Screenshot from MP-JPD’s Company Analysis Section ~200 products going off patent in next 4yrs (worth ~¥2tr today) will come under generic pressure & their manufacturer will look for cost optimization to remain competitive – foreign alliance for API/intermediates will be one such measure… Replace name of any product/ pipeline candidate/ thx. class/ company/ company/ time line etc. (from 1000+ products, 100+ companies & 450+ pipeline pipeline candidates) – Illustrative Examples Only • • • • • • • • • What % of sales of Toyama chemical is exposed to generics and what additional % will add-in in next 4 years? There are rumors that MSD is taking over Santen – what could be the rational and synergies between the two for products & pipeline? How many products of Abbott are actually owned by Japanese mfg. & which are these companies? Which companies lead the Chinese medicine market and how it is evolving? How the anti-diabetic market in Japan is evolving? How DPP IV & SGLT-2 inhibitors classes are shaping up & how they going to impact GLP-1 analog class? Does anti-inflammatory segment offer opportunities of API/intermediate supply? What are the opportunities for generic companies in anti-Parkinson's market? What are opportunities for the generics manufacturers in next 5 years – within this what are the opportunities for generic drugs from metabolic & cardiac thx classes? Which companies will hold their patent protected revenues in 2020? Make 1000’s of such questions and MP-JPD® will answer them! 1000’ MP- JPD® For Queries & Subscription, Contact: Vrunda Shah | vrunda@mpadvisor.com |+ | www.mpadvisor.com MP Advisors, B2-3, Alkapuri Arcade, R C Dutt Road, Vadodara-390007 INDIA B2Vadodara- 4