A propitiatory Database on Japan Pharmaceutical Industry

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:
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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
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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
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Crecon consulting Inc.
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Japan Pharmaceutical reference (JPR)
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Company reports
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Drugs in Japan-2011 [本医薬品集フォーラム／監修 ]
Patents & R&D/Pipeline
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IPDL (Industrial Property Digital Library)
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Japan Pharmaceuticals Information Center (JAPIC CTI)
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UMIN Clinical Trials Registry (UMIN-CTR) – in case physician belongs to university hospitals
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JMA CCT – in case physician belongs to private hospitals
Regulatory Related
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Korosho / Kosei-roudou-sho (MHLW)
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Kiko (PMDA)
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Kokuho Chuoukai (NHI)
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Chuikyo (Central Social Insurance Medical Council)
Primary data enriched thru ~25yrs of experience base
HISTORIC DATA POINTS
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MP proprietary financial models (15+ companies; all majors)
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In-house library of clinical data points from global companies
PROJECTING FUTURE
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Analyst’s projections of sales thru 2016 (~350 key products, ~60% of total market)
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Analyst views on NCE/NBE pipeline (viz. based on clinical data analysis, competitive
landscape)
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Data acquired thru interviewing management, supply chain etc - patent expiries (~250),
issues related to ongoing trails etc.
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Interviews with ‘key opinion leaders’, regulators (views on price cuts, expected regulatory
changes)
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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
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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
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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 |+91.265.232.0059 | www.mpadvisor.com
MP Advisors, B2-3, Alkapuri Arcade, R C Dutt Road, Vadodara-390007 INDIA
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