IMS LifeCycle
R&D Focus
New Product Focus
Patent Focus
Content, Sources & Updates
SLA Pharmaceutical & Health Technology Division
Spring Meeting
3/22/2016
Introduction
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R&D Focus - Introduction
• This IMS service provides in-depth profiles on over 26,000
drugs in R&D, from preclinical to marketed phases, including
commercial and scientific activities.
• R&D Focus is part of IMS LifeCycle, which enables the reviews
of a drug life cycle at three critical stages: R&D stages, launch
activities and patent protection worldwide.
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R&D Focus
Statistics
• Over 26,000 records including over 9,700 drugs in active R&D
worldwide
• Searches on 36 fields including mode of administration, mechanism
of action, indication, phases of development
• Covers over 5,600 Biotechnology products
• More than 3,000 companies/organisations
• Over 3,200 licensing opportunities
• Company coverage is global (focus on the USA and Europe):
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Europe: 30%
The Americas: 51%
Middle East: 3%
Asia Pacific: 13%
Australasia: 3%
• Up to 800 updates every month, and up to 100 new drugs added
every month
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R&D Focus
Data Content
• Compound details/Chemical structures
• Latest development information (“Latest News”)
• Company activities (developers, licensors, licensees relationships)
• Latest phase including Discovery and Technology stages and phase by
country and indication
• Around 1,900 indications (i.e. Breast Cancer to Zollinger-Ellison
syndrome)
• Over 750 pharmacological actions (i.e. ACE inhibitors or 5HT4
antagonist)
• Sales profiles for the top or fastest growing therapeutic classes,
featuring previous years background financial info
• Basic patent information (initial priority details)
• Commercial/scientific summary, including regulatory progress, clinical
trials, analysts predictions
• Development history
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R&D Focus
An evolving service
30000
25013
25000
26145
23088
20956
20000
18782
16785
15000
10000
5000
0
2002
2003
2004
2005
Drug records in R&D Focus
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2006
2007
Sources of information
Strength of the Editorial team
• Team of around 15 in-house editors and free-lancers
• Improved timeliness with strict guidelines and prioritisation
process to include the information gathered in the service
within certain timeframe.
• Creation of specialist roles within the editorial team:with
editors concentrating on company information, pipeline
project and analysts predictions information.
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Sources of Information
Primary & Secondary
• Primary research via:
• Company interviews, with drug-specific questionnaires
• Company R&D days & Company investor conferences
• Scientific conferences (where specific ATCs are covered, I.e.
neuroscience or oncology)
• Business/Partnering conferences (where partnering forums are held
and cover all ATCs
• Attendance in the USA and Europe (where companies from all over the
world are represented), and also in Japan and Australia.
• Secondary research:
• Analyst briefings
• Conferences posters, conferences abstracts, review journals
• Regulatory data from the various regulatory agencies such as the US
FDA, EU EMEA and the Japanese NHI as well as Patents and other
intellectual property sources
• Online services and internet services
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Example of a drug record
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New Product Focus
Introduction
• This IMS service covers new product launches by country,
allowing for the evaluation of successful launch strategies
world-wide.
• New Product Focus is part of IMS LifeCycle, which enables the
reviews of a drug life cycle at three critical stages: R&D
stages, launch activities and patent protection worldwide.
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New Product Focus
Statistics
• Compendium of back data from 1982
• Coverage of over 70 major markets
• Over 280,000 launches with 178,000 distinct trade names,
each of which representing a first launch in a country (first
pack)
• Biotechnology, Generics and excipients
• NCEs (New Chemical Entities) - when and where a novel
compound was first launched
• Over 1,000 new pharmaceutical products reported every
month
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New Product Focus
Data Content
New Product Focus records the very first launch of a product in
a particular country and identifies the indication and price at
the time of this initial launch; featuring:
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Ingredient & Local trade name
Marketing company
Date & country of launch
Therapeutic class code & Indication (when available)
Composition (including form and dose)
Presentation (pack information)
Launch price data recorded in the local country currency but their level
differ depending on the country, as follows:
– Retail Selling Price (RSP), Retail Purchase Price (RPP), Manufacturers Selling
Price (MSP), National Health Insurance (NHI); i.e. Japan, Average wholesale
price (AWP); i.e. USA
• Historical data - records not updated - hence always showing
original companies and initial pack info at launch
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New Product Focus
Sources of information
• Data collection methods vary from market to market.
• In most industrialized countries, wholesaler to pharmacy
transaction data is collected directly from wholesalers.
• In other countries and for all hospital data, a representative
sample is obtained and then projected to produce national
estimates.
• Regular validation studies are undertaken by IMS in
conjunction with the pharmaceutical industry (EPHMRA).
• New Product Focus identifies new chemical entities or new
active substances by referring to R&D Focus, patents and
regulatory data
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New Product Focus
Uses of a product launch information database
• Comprehensive world-wide analysis of product launches
− Monitor global product activity to track launches in all markets
and sectors
• Valuable pricing information
− Benchmark product pricing strategy against market leaders,
including pricing of generics
− Unique on the market
• Launch strategies
− Search for key comparator drug launches to identify successful
launch strategies of a product extension, looking at indication, or
specific dose forms
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Patent Focus
Introduction
• This IMS service provides evaluated patent information for
marketed drugs and those in phase III and above active R&D,
allowing the user to plan effectively for patent expiry far into
the future.
• Patent Focus is part of IMS LifeCycle, which enables the
reviews of a drug life cycle at three critical stages: R&D
stages, launch activities and patent protection worldwide
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Different patent types per compound
“Covering all angles”
Aim of originators is to cover the invention from all angles
• Product patent
• Claims the novel compound - generally most important
• Process patent
• Claims the process for preparing the compound e.g. gene expression
technology to enhance the production of recombinant proteins
• Method of use patent
• Claims the method of treating/preventing a condition e.g. method for
treating TNF-mediated inflammatory diseases, specifically arthritis
• Composition patent
• Claims the therapeutic compositions e.g. sustained release capsules
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Patent Focus
Statistics
• Over 3,000 patent families with CAS (Chemical Abstracts
Service) numbers
• Over 139,000 patent records worldwide - with numbers,
filing and estimated expiry dates
• Covers 120 countries, including European Patent and
applications
• Covers biotech products: 17,800 patents records where
mode of action is biotechnology
• Covers patent extensions including Supplementary Protection
Certificates (SPCs), Japanese and USA extensions (i.e.
Paediatric exclusivities)
• 8,500 additions per year
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Patent Focus
Data content
Over 32 fields to search from including:
• Product Synonyms (trade names)
• Chemical Abstract Service (CAS) registry numbers
• Patent originator
• Therapy Class / Indication
• Patent numbers and filing dates by country
• Patent types (I.e. product, method of use, process, composition
etc…)
• Estimated patent expiry dates and SPCs by country
• Commercial comments by country
• Final product chemical structures
• Please note: Patent Focus does not include Data Exclusivity data,
featured in the Market Segmentation data.
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Patent Focus
Sources of information
• Patent information emanates from official patent
documentation relating to projects in development, either a
patent application or a granted patent document
• Close relationship with CAS, the Chemical Abstract Services
(American Chemical Society) to maintain up-to-date records
within the service
• Close contact with patent attorneys at local country levels and
work with official patent journals to reflect the latest
amendments to the patent laws
• Secondary resources, such as the Orange Book, official
country patent journals, online and internet services are also
monitored to update information on patent legal status,
lapsing, granting, extensions, SPCs, paediatric exclusivities,
marketing exclusivities, orphan drug status
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Thank you for your attention
Ben Manning
Product Manager, Global Publications
610-834-4909
bmanning@us.imshealth.com
3/22/2016