04/10/23

IMS LifeCycle

R&D FocusNew Product Focus

Patent Focus

Content, Sources & Updates

SLA Pharmaceutical & Health Technology DivisionSpring Meeting

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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 FocusStatistics

• 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):− 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 FocusData 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 FocusAn evolving service

1678518782

20956

2308825013

26145

0

5000

10000

15000

20000

25000

30000

2002 2003 2004 2005 2006 2007

Drug records in R&D Focus

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Sources of informationStrength 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 InformationPrimary & 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 FocusIntroduction

• 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 FocusData Content

New Product Focus records the very first launch of a product ina particular country and identifies the indication and price atthe time of this initial launch; featuring:

• 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 FocusUses 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 FocusIntroduction

• 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 FocusData 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

04/10/23

Thank you for your attention

Ben Manning

Product Manager, Global Publications

610-834-4909

bmanning@us.imshealth.com