1. The document outlines plans for launching a new allergy product, including developing marketing strategies, building relationships with key opinion leaders, leading pricing and market access work, and ensuring quality implementation across territories. 2. Details are provided on various launch activities and preparations, such as clinical development plans, pre-launch marketing tasks, market research studies, updated pricing and marketing strategies, and rollout strategies for different markets. 3. Strategic considerations for the launch are discussed, including segmentation of price-sensitive customer groups, managing parallel trade across EU markets, demonstrating health outcomes and pharmacoeconomics evidence, evaluating potential brand names, and establishing advisory boards and key performance indicators to monitor progress.

1. Launch Planning Remit - example
Launch
• Develop implementation plans to successfully commercialise a
product and maximize its sales throughout the product life cycle
– Develop strategy and marketing plans for current commercial products in the field
of allergy
– Develop a strong and robust relationship with key opinion leaders in the field
– Lead pricing and market access work
– Ensure quality implementation in all territories

2. Planning for optimal launch
(Examples of certain launch activities)
– Phase 3a clinical development plan
– Marketing preparation task force meetings
– Early pre-launch activities plan
– Market research study
– Phase 3b marketing profiling plan
– Updated pricing strategy
– Brand name candidates
– Updated marketing strategy
– Market launch Roll-out strategy
– Package material and commodity number
– Launch co-ordination group
Strategic Marketing Sequence, A. Yeomans

3. Pricing strategic analysis
Demand analysis
• Key decision makers
• How price (in)sensitive are they?
• Prescribing preferences across markets
Segmentation
• Which market segments are price sensitive?
• How price sensitive are they?
• What proportion of the total market is price
sensitive?
• What are the likely competitor , (if any)
responses?
Parallel trade
• Major component across the EU
Spain exporter
Germany & UK importers
• Lost revenue & profit
• Forces market forecasting
• Liability assessment
• Mitigation strategies
Health outcomes & Pharmacoeconomics
• Essential in eg. France, Spain & Australia
• Increasingly important elsewhere
• Demonstrates efficacy
• Accelerates time to market
• Powerful tool in price & reimbursement
negotiations

4. Brand name candidates
Objective
To identify a brand name which can be registered worldwide or at least in all markets
where Circassia is planning to launch the product.
Method
Normally a brand name will be established together with an external Trademark
agency, which can provide useful input and manage the identification process.
It is important that potential brand names are tested for:
• Memorability
• Pronounceability
• Scriptability
• Negative connotations
• Existing drug name associations
• Product/therapeutic class associations
• Approvability by regulatory authorities
Once a short-list of names has been developed, the next step is to find out if the
preferred candidate can be registered worldwide.

5. Brand naming approach
• Creative brainstorming
– Create Circassia brand name team
– In-house development
– Name consolidation
• Select Trademark validation specialist
– Focus need only be on trademark viability
assessment
• Decision

6. Brand elements
• Corporate branding
– Strong product and corporate
association
– Family of branded products
• Mechanistic descriptors
– Position product usage
– Emphasize science
– Gives the brandname a purpose
• Application descriptors
– Tell the user where it is used
• Manufacturing prowess
– Allow for membership of an elite
class
– Emphasize quality of the highest
order
– Reinforces competitor shortcomings
• Generic name descriptors
– Explain where the compound comes
from
– Creates a link to existing products

7. Market launch: Rollout strategy
Objective
The rollout strategy should include overview of when:
• Submission
• Approval
• Price
• Reimbursement
• Launch is expected for Regions

8. Segmentation - penetration of the
Dynamic Market
Achieving Launch Excellence ,A Question of Penetrating the Dynamic Market,
Recognizing the realities of how new product launches enter the market,
Rob Harold & Filip Odqvist, IMS Health

9. Competitor Intelligence
Pill to cure feline allergy could be the cat's whiskers
• Dr Ghaem-Maghami at Nottingham University has
identified a protein on the surface of the dendritic cells.
• Crucially, it appears to be the only protein cell involved in
the first stage of cat allergy. A drug that targets it, or the
signals it sends out, could provide widespread relief.
• The protein, known as the mannose receptor, also plays a
role in house dust mite and dog allergies
FIONA MACRAE, MAIL ONLINE 10 June 2011

10. External advisory board meetings
Objective
To establish External Advisory Boards to act as a challenger regarding
direction of clinical development and positioning.
Method
Ideally, members of External Advisory Board can be asked :
• To identify, discuss and update the target product profile, the
preliminary key selling points and positioning statements.
• To comment upon and direct the development programme.
• To act as investigators.
• To present data at congresses.
• To act as educators at later product training sessions.
• To facilitate an early acceptance and adaptation of the new product.
Strategic Marketing Sequence, A. Yeomans

11. Launch possibilities
Emerging markets

12. Launch pitfalls to avoid
• Increased regulatory uncertainty
• Decreasing access to physicians
• The sub-optimal label
• Implementation chaos
• Not allocating the budget appropriately
• Increased payer scrutiny
• Lack of adjustments due to competitive
dynamics
Reprinted with permission from MedAdNews, August 2009.
Copyright 2009 by Canon IMM, Inc. All rights reserved.

13. Close monitoring of first launch
Objective
• To assess which activities are successful/corrected when other countries launch.
• To evaluate if the launch has been successful or if adjustments are needed.
• To evaluate/update the sales forecast.
Method
The evaluation should include:
• IMS, (or related) data regarding turnover and market shares (value and volume).
• Qualitative market research to assess key selling points and product positioning.
• Competitor moves and counteractions.
• Updated sales forecasts.
Market research (6 weeks post-launch) should investigate:
• Target group(s) understand(s) and accept(s) product positioning and key messages?
• Adjustments to the launch approach are needed?
• Competitor reactions?

14. Develop & implement KPI metrics
(Monitor & adjust launch progress)
• Are the KPIs aligned to the launch strategy and critical
success factors for the brand?
• Is there a good mix of leading and lagging indicators?
• Will information against the KPI be available in a timely
manner, and at what cost?
• How will performance be tracked against the metric,
and what are the expectations?
• How quickly can a performance gap be detected and
corrective action taken?
• Who will own each action item?
IMS HEALTH IMS LAUNCH EXCELLENCE KPI STUDY

15. LAUNCH WINDOW – Maintain focus
Guiding principles during launch planning
• Launch project management
– Necessary to monitor and track progress of the launch plans
• Prepare for regulatory interactions
– The team also needs to prepare for regulatory interactions and make sure there is a compelling and
well considered label negotiation strategy in place.
• Establish a pricing and reimbursement strategy
– It is essential to have the most appropriate pricing strategy at the global level. This must ensure
adequate reimbursement and access in each of the local markets targeted for launch with the
appropriate launch sequence that minimises the risk of reference pricing, (EU).
– Health/economic models
– Local guidance on contracting and negotiation for markets is essential to implement the pricing and
market access strategy successfully.
• Establish brand development and training
– This will ensure that all functions and regions responsible for the product launch are well aware of
all of the most recent developments with respect to the market and the product brand status, as
well as the launch strategy.
– This goes hand in hand with training of all internal personnel, including the field salesforces and the
commercial and medical teams in the various local markets.
P h a r m a c e u t i c a l M a r k e t - E u r o p e J a n u a r y 2 0 1 2