Competitive Landscapes

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Competitive Landscapes Using Clinical
Intelligence To Get The Full Picture Jeff
Huntsman

Senior Vice President, Global
Saleswww.rogersmis.com
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Who We Are

• Rogers Medical Intelligence Solutions
• A subsidiary of Rogers Communications Inc (NYSE)
• The largest aggregator of medical meeting data in
  the world
• A provider of competitive intelligence and
  medical communications to the pharmaceutical and
  biotech industries

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Who is in the audience?

• How many of you are from
• A pharmaceutical company?
• A biotech company?
• An agency or other?

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Who is in the audience?

• How long have you been in this industry?
• More than 15 years
• 5 15 years
• Less than 5 years

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Who is in the audience?

• What is your area of responsibility?
• Marketing
• Market research
• Business/clinical intelligence
• Research development
• Other

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Agenda

• Discuss different types and sources of
  competitive intelligence
• Static vs dynamic information
• Importance of current- and future-focused
  information for successful launches and marketing
  
• Clinical Intelligence how the complete picture
  can change your direction
• Case studies
• Real-life scenarios that led to a change in
  competitive outlook and positioning after viewing
  clinical landscape
• Conclusion

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Competitive Intelligence more important than
ever

• Industry pipeline refill rates are not adequate
  to offset loss to generics and still maintain
  double-digit growth
• Research productivity is declining due to more
  challenging science
• The future portfolio must be supplemented with
  external opportunities
• Current brands must be optimized to maintain
  market capitalization within the industry

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The need for the full picture

• Decisions are often based on limited facts only
  about 50 of the available information is used
  for decisions
• The result?
• Inaccurate competitive intelligence, improper
  product positioning?Poor forecasting of revenue
  potential across a portfolio?Possible improper
  resource allocation and lower return on sales

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Dollar value of timetomarket for average drug

• 11-16 lost/second not on market
• 40,000-58,000 lost/hour not on market
• 960,000-1,390,000 lost/day not on market

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Society of Competitive Intelligence Professionals
(SCIP)

• Competitive intelligence (CI) is the process of
  monitoring the competitive environmenteffective
  CI is a continuous process involving the legal
  and ethical collection of information, analysis
  that doesnt avoid unwelcome conclusions.

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Sources of competitive intelligence

• Specialized Groups
• Public Associations
• Patient Advocacy Groups
• Medical Consultants
• Academic Medical Community
• Government Sources
• FDA Filings
• Trademarks
• Patents
• Regulatory Agencies
• Business Information Sources
• FDA Filings
• IMS, Dendrite
• Credit Reports

• Clinical Information Sources
• Rogers MIS
• Adis Clinical Insights
• RD Pipeline
• Medical Meetings
• Published Journals
• Internal
• Sales Force
• Senior Management
• Library
• Market Research
• Medical Community
• Opinion Leaders
• Advisory Board
• Nursing Community

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Competitive intelligence is needed across the
business chain
Life cycle management
Research
Licensing
Development
Marketing
Investors

• Clinical endpoints
• Potential claims
• Clinical issues

• New formulations
• Exclusivity extensions
• Regulatory challenges

• Disease analysis
• Platform technologies

• Potential products
• Company reviews
• Competitive bidders

• Reactions to news ?rumors
  influence opinion

• Competitor pipelines
• Market dynamics
• Launches

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Competitive Intelligence an insurance policy
for a brandthat allows you to be

• Proactive
• Prepared
• Confident
• Plan strategies with facts and focus, not
  guesses, assumptions, and hopes

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Industry Challenges

• Todays global market mandates that every effort
  be made to bring drugs to market with a robust
  clinical foundation to support aggressive
  marketing effort
• The ongoing marketing challenge is to build fast
  penetration and market share - to maximize ROI
• Monitor the competition today to plan tomorrows
  strategies!

There is no lack of data the trick is finding
the KEY information that can affect market share
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Static vs Dynamic

• Various types of data sources of competitive
  intelligence include
• financial data
• product lifecycle information
• promotional spend
• indications
• journal information
• However all these types of data are, arguably,
  STATIC. How do we change the paradigm to being
  current and DYNAMIC?

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How many can you answer?

• How many times did your competitors present
  clinical data in the last month, year, 2 years?
• Name every meeting where your key opinion leaders
  presented or published data in the last month,
  year, 2 years?
• Which phase II or phase III drug(s) could be your
  next competitor?
• What are the most current trends in the treatment
  of your therapy area?

If you can answer all of them
congratulations!If not, then this discussion
should provide some answers
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The gold standard redefined

• Published literature has long been held as the
  gold standard for competitive intelligence
• Is it comprehensive and timely enough to support
  strategic decisions?

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Published Literature only a small piece of the
puzzle
Gain competitive intelligence earlier
All Therapy Areas
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Facts vs Guesses

• A complete look at real-time clinical data gives
  your company a competitive advantage and
  eliminates guesswork
• Strategic support
• Provide data to teams throughout the company to
  improve decisions
• Tactical decisions
• Opinion leaders, competitive intelligence, trend
  analysis

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The value of an early warning radar signal

• Before its a press release
• Before its published in a journal
• Before its a promotional claim
• Before its in an ad
• IT APPEARS AT A MEDICAL MEETING
• This data is DYNAMIC - REAL TIME!

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Discussion

• How the complete picture may change directions

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Published Clinical Resultswhy cant you find
them all?
Factors Associated with Failure to Publish Large
Randomized Trials Presented at an Oncology
Meeting. M Krzyzanowska, M Pintilie, I Tannock.
JAMA. 2003 July 23/30290(4)4905.

• GOAL Determine the rate of subsequent full
  publication of randomized controlled trials
  presented at ASCO meetings between 1989 and 1998

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510 randomized trials reviewed over 10 years

• What percentage of these oncology trial results
  never made it to a journal within 5 years of
  being presented at ASCO?
• A. 3
• B. 26
• C. 52

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B. 26 of trials were not published 5 years
after presentation at a meeting
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The 26 average broken down by therapeutic area
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Statin Citations

• The next series of questions will be based on the
  following analysis
• An analysis of information from PubMed and Rogers
  MIS on atorvastatin, cerivastatin, fluvastatin,
  pravastatin, rosuvastatin, and simvastatin from
  1998 to June 2004

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Therapy Areas

• In what therapy areas other than cardiology have
  statin drugs also been presented?
• Bone
• Endocrinology
• General medicine
• Genetics
• Gastroenterology
• Hematology
• Immunology
• Nephrology
• Oncology
• Outcomes
• Pharmacology
• Rheumatology
• Transplantation
• Neurology

• Less than 5
• 5 10
• ALL

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Statin-related material has been presented at
meetings within ALL of these therapeutic areas

• Bone
• Endocrinology
• General medicine
• Genetics
• Gastroenterology
• Hematology
• Immunology
• Nephrology
• Oncology
• Outcomes
• Pharmacology
• Rheumatology
• Transplantation
• Neurology

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Therapy areas at conferences

• For statins, what percentage of citations might
  you be missing if you looked only in cardiology
  meetings (all drugs combined)?
• 10
• 20
• 40

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Answer

• 40 of all statin data was presented at
  noncardiology-based meetings

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Therapy areas in journals

• For statins, what percentage of citations might
  you be missing if you looked only in cardiology
  journals (all drugs combined)?
• 30
• 40
• 50

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Answer

• You would be missing 40 of statin citations if
  you looked only in cardiology meetings
• You would be missing 50 of statin citations if
  you looked only in cardiology journals

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Antipsychotic Citations

• Consider the antipsychotic agent aripiprazole
  (all data released over the last 5 years). What
  are the percentages of material from conferences
  and literature?
• Conferences 30, Literature 70
• Conferences 40, Literature 60
• Conferences 70, Literature 30

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Answer
C. 70 Conferences, 30 Literature
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Geography/regionality of data

• For aripiprazole, how much information is
  delivered via non-US-related venues (meetings and
  journals)?
• 21
• 31
• 51

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Volume of data by region
51.3 of data is delivered through non-US venues
(journals or conferences)
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Clinical Landscapecase studies
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Scenario

• Client had a phase II vasopeptidase inhibitor
  (ACE/NEP)
• Not particularly strong in CV, so needed
  background of clinical landscape
• Had identified 8 competitors that possibly could
  also be coming to market in this drug class
• Vanlev (BMS) was noisy, but angioedema had been
  demonstrated in its side effect profile

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Strategy And Results

• Reviewed medical meeting presentations and
  benchmarked them against published literature
• Identified 32 potential competitors conducting
  clinical trials
• Data presented at 15 different medical meetings
  worldwide and in 12 different journals
• Conducted analysis of all data and determined
  that the amount of inhibition on ACE or neutral
  endopeptidase did not change side effect profile
• Provided complete look at the clinical landscape
  allowing client to determine an informed course
  of action

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Client Decided

• After reviewing the analysis of the clinical
  landscape and incorporating company-internal
  data, the client stopped further trials,
  potentially saving millions of dollars in trial
  work for a drug unlikely to get approval from the
  FDA

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Scenario

• Director of Competitive Intelligence had to
  present clinical needs of companys key product
  to her senior management
• Key product was a drug compound similar to a
  competitor client needed to justify presence in
  the marketplace vs the competition
• Had 3-day turn-around time to make important
  recommendations for the drugs future

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Strategy And Results

• Reviewed worldwide medical meeting presentations
  and benchmarked them against published literature
• Analysis showed that the competitor was twice as
  active in medical meeting presentations and
  published literature
• Further analyzed the data, revealing that the
  clients drug had significantly less noise, but
  the clinical quality of the studies was superior
  to those of the competition

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Client Decided

• The analysis helped justify additional
  clinical work to compete against the noise of
  the competition, and the quality of the studies
  was maintained

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Scenario

• Client had a phase II biologic for the treatment
  of multiple tumor sites in the area of oncology.
  Wanted to understand other biologics being
  developed and learn if competitors were pursuing
  the same indications

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Strategy And Results

• Reviewed medical meeting presentations and
  benchmarked them against published literature
• Attended ASCO 2002 and developed a report based
  on the coverage of competitive presentations and
  posters
• Compared retrospective data analysis against
  real-time presented data
• Able to identify and quantify potential
  competitors
• Drug indications being pursued
• Three tumor sites
• Age-related macular degeneration
• Comparative trial work of other biologics
• Identified upcoming trials
• Determined that FDA had designated one drug for
  fast-track approval
• Provided complete look at the clinical landscape,
  allowing client to determine an informed course
  of action

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Client Decided

• After reviewing the analysis of the clinical
  landscape and incorporating company- internal
  data, the client was able to benchmark existing
  marketing strategies and clinical trial work to
  determine an individualized action plan

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Scenario

• Company with an existing statin wanted to analyze
  the hyperlipidemia marketplace to gain a better
  understanding of competitive positioning and
  clinical landscape
• Knew additional competition had recently entered
  the marketplace and others were in phase III
  clinical trials

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Strategy And Results

• Reviewed worldwide medical meeting presentations
  and benchmarked them against published literature
• Identified a large increase compared to
  competitors in the number of medical meeting
  presentations for Lipitor once it was acquired by
  Pfizer
• Revealed that Warner-Lambert/Parke Davis had
  presented a large number of abstracts at medical
  meetings with little published before Lipitor was
  launched - a stealth strategy
• Analysis of Baycol found that the majority of its
  medical meeting presentations occurred at
  atherosclerosis meetings, not traditional CV
  meetings
• Focus of its presentations was on the vessel
  wall, not HDL/LDL
• Three presentations on the side effect profile
  were presented at small European meetings 3 years
  before the drug was pulled from the marketplace
• Provided complete look at the clinical landscape,
  allowing client to determine an informed course
  of action

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Client Decided

• After reviewing the analysis of the clinical
  landscape and combining company- internal data,
  the client was able to benchmark their existing
  marketing strategies and clinical trial work to
  determine an individualized action plan

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Scenario

• One of the market leaders in depression was
  losing the patent on its drug
• Client had phase III drug that was projected as
  the replacement for the drug going off patent
• Early clinical trials showed the phase III drug
  had good response rates with patients who had
  previously not responded to other depression
  medications
• Client wanted to quantify clinical presence in
  the area of treatment-resistant depression vs
  depression as a whole
• Client also wanted to see if any other drugs were
  emerging with clinical trial work in the
  treatment-resistant depression area

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Strategy And Results

• Reviewed worldwide medical meeting presentations
  and benchmarked them against published literature
• Found resistant depression accounted for 10 of
  presentation/ publication volume in overall
  depression marketplace
• Evident that the number of presentations was
  trending up during the 3-year time period
• Analysis of meeting data found that a competitive
  drug had begun trial work in the area of
  treatment-resistant depression
• Able to find the meetings where presentations had
  occurred and to pull the abstracts
• Tracked the thought leaders who were making
  presentations in this clinical area
• Provided complete look at the clinical landscape,
  allowing client to determine a better informed
  course of action

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Client Decided

• After reviewing the analysis of the clinical
  landscape and combining company-internal data,
  the client was able to benchmark existing
  marketing strategies and clinical trial work to
  determine an individualized action plan
• Client conducted more trials in the area of
  treatment-resistant depression to expand the
  market
• The maker of the competitive drug that was
  identified in the analysis continued trial work
  and it was that companys primary marketing
  strategy 3 years after the research was concluded

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Summary

• It can take up to 5 years before presented data
  appear in a journal. 26 of information released
  in oncology meetings is never published
• Conference data an early warning radar signal
• Valuable information is released at meetings in
  related therapeutic areas and can account for up
  to 40-50 of the total volume
• Valuable information is released across the globe
  
• Dont miss out on valuable insights

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CI supports strategy formation and execution
Perform environmental analysis
Monitor competitor activity at tactical/product
level to ensure no major impacts on environment
Create a future vision
Conduct internal assessment
Decide on a strategic position
Develop strategy and actions
Develop a plan
Manage the strategy process CI tracks competitor
activity to support execution of a strategic plan
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Bottom Line

• An organized competitive intelligence effort will
  enhance the decision-making process and improve
  the bottom line
• Using internal expertise and combining it with
  external efforts results in optimal performance
• The key to success is dedicated professionals
  with the proper resources to monitor the brands

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THANK YOU

• ANY QUESTIONS?

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1 [phone] info_at_rogersmis.com www.rogersmis
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