Medical/scientific intelligence - Six-target competitive R&D assessment in diabetes

Background and objectives

Our client engaged us to support their efforts in a 6-target R&D assessment of the current and planned R&D diabetes treatment discovery landscape. KITs included:

• Current scientific development including status, approach and theories
• Clinical trial intelligence (phase 1 - phase 3)
• Product development road map
• Product lifecycle management strategy

Approach

A team of six research analysts was assembled to support the primary research efforts of the project.

Primary research efforts focused on KOLs, clinical trial partners and research scientists, as well as attendance at major medical conferences and symposiums. Project duration was three months.

Results delivered

• We were able to provide detailed intelligence concerning the development strategy for all six targets.
• We were able to provide detailed clinical trial data on five clinical trials.
• We were able to gain detailed insight from KOLs concerning the various development strategies of the targeted competitors.
• We provided a SWOT analysis of the client's development strategy in comparison to the targeted competitors.
• We provided a detailed development timeline for each competitor which provided the client with an effective and efficient benchmarking tool.

Merger and acquisition intelligence - Intelligence on target company as part of due diligence

Background and objectives

Our client, in association with a leading investment banker, was targeting a company that had a Low Molecular Weight Heparins (LMWH) in a late stage of development, with a view to a potential take-over, without alerting the target.

• Primary requirement was the assessment of the molecule for valuation
• Strength of their clinical trial and likelihood of successful registration and pricing potential
• Additional query to determine the realistic timeline for competing drugs' registration

Approach

Our approach focused on the clinical trial centres, lead investigators and CRAs:

• Multiple US and EU clinical and principal investigators were targeted
• Targets included limited number of personnel from the target company itself
• KOLs were approached to establish the status of competing compounds' development status

Results delivered

The output included all the priority 1 and 2 KITs

• Status of the clinical trial and early indication of end points
• Timelines for development
• Likely pricing scenarios
• Potential uptake scenario for valuation modelling

Commercial intelligence - Assessing generic threat and post patent loss planning

Background and objectives

Our client engaged us to provide generic defence and patent loss optimisation strategy support. As part of this engagement one module included competitive intelligence to understand:

• Which companies intended to launch in key markets
• Timing of generic launches
• Intelligence on super generics and reformulations under development by competitors
• Assessment of any issue proving bioequivalence of generics to regulators

Approach

Competitive intelligence was collected from more than 20 companies in markets which included Russia, Ukraine, China among many others.

• This involved first populating the list of potential competitors, which we accomplished by querying various primary sources as well as speciality databases which generic companies use for research
• The first wave of research was to determine who had the intent and the capabilities to launch in our client's major markets
• The second wave of research targeted only likely competitors and focused on their commercialisation strategy, likely markets they would try to enter, how aggressively they would promote (if at all) their product and whether they planned to develop a 'super generic'

Results delivered

• Thorough and comprehensive assessment of likely intensity of generic competition, including first to market and total number of likely players
• Our resulting insight provided evidence which contradicted one of the client's primary assumptions, resulting in a major shift in their strategic plan.

Conference intelligence - CI on the bio-similar companies

Background and objectives

Our client wanted to understand the culture, operations, tactics and strategies of key bio-similar companies (Sandoz, Teva, Stada, Hexal and Ratiopharm) via the 7th EGA Annual Symposium on Biosimilar Medicines.

Approach

Lifescience Dynamic's team undertook secondary intelligence before the conference and sent two consultants with expertise in bio-similars. Our approach also took account of any counter-intelligence activities that might have been taking place at the conference such as mis-information or any 'decoy' activities; our consultants were primed beforehand to recognise them. This enabled us not only to develop key hypotheses but also to test them at the congress. These were rejected or validated once the information was corroborated by a trusted source.

Results delivered

• Provided analysis and commentary on key BS trials
• Analysis of competitor companies' trials and communication strategies
• Summary report on key products:
  • Epoetin (anemia associated with chronic kidney failure)
  • Filgrastim (neutropenia in cancer patients)
  • Insulin
  • Interferon alfa

Conference intelligence - CI on clinical trials and emerging competitors

Background and objectives

Lifescience Dynamics was invited to undertake a competitive intelligence project in the area of hepatitis C, with a focus on clinical trials of our client's major competitors, as well as emerging competitors in their core product.

Approach

A conference for the American Association for the Study of Liver Diseases (AASLD) was the platform for gathering intelligence:

• Two analysts attended
• Our analysts utilised information from presentations and posters, as well as using both direct and indirect questioning to answer the KITs
• Follow-up telephone interviews were also used to fill holes in intelligence and corroborate findings

Results delivered

Robust findings provided the insight our client needed, including:

• Therapy was evolving; new oral small molecule classes of drugs were seen as products of the future
• New players and new products had resulted in intense industry and analyst interest; analysts believed that the client, perceived to be a laggard, could maintain its franchise in this area only through a robust programme of licensing or acquisition.
• Key competitor had an aggressive phase IV trial programme but there was no marketing threat perceived until at least 2009/2010

Product lifecycle management - Optimising the current and future ophthalmology franchise with a portfolio strategy in the face of impending generics

Background and objectives

The client, a top 10 pharmaceutical company, engaged us to undertake a strategy evaluation and formulation project taking into account pending generic threats facing ophthalmology franchises.

The key challenges facing our client were as follows:

• The optimal strategies for maximising short-term sales of the existing products may not be consistent with the long-term objectives of the portfolio.
• As market leading products in the X market, Z and Y will be important reference products for new products in development. This suggested that it is important to maintain the price of the brands as far as possible.
• However, it was also important to maintain a strong presence in the ophthalmology market as a platform for the new products. This necessitated targeted price reductions to maintain market share.
• In most markets, loss of patent is expected to occur at a similar time to the launch of the first new product. In some cases the exact timing of launch (following reimbursement negotiations where needed) relative to generic entry may be critical.
• The issue was more pressing in two European markets where generic entry could be significantly earlier than the launch of the new product.
• Price reductions in these two European markets in response to generic entry, may be optimal for those markets, but may have a knock-on effect through referencing pricing or parallel trade in other EU countries with longer patent life.
• In the US the client faced a particular challenge with the loss of patent of a competitor product in a different class but of a direct competitor. The possible implications for our client's product X and Y's volume, and to assess measures taken by ABC needed to be understood and strategies required to deal with these.

Approach

This was a large project lasting eight months with multiple phases, advance analytics, analogue modelling, competitive intelligence on generic companies, quantitative market research to measure brand equity, payer research to develop a pricing strategy for the follow-on product, and finally modelling of various strategies and tactics at country level as well as global ROI analysis.

• Intelligence about likely generics (Stages 1A, 1B 1C and 1D)
• Impact of generics on brand price and share based on country systems analysis and analogues (Stages 1C, 1D)
• Assessment of the pricing opportunity for new products (2C)
• Payer research: this tested the likely response from physicians in an environment where generic X and Y were available (2A).
• Primary intelligence: this tested the likely response from generic manufacturers; their interest and capabilities to manufacture and distribute copies or APIs of our client's product.
• Primary quantitative research: to provide the team with robust quantitative numbers for forecast modelling of revenue, and produce a market share simulations model for current products, and to measure brand equity of X and Y brands with ophthalmologists.

Results delivered

There were outputs from each activity, such as CI, which highlighted "intense" generic competition and MR "low" brand equity.

We delivered at each milestone, finally delivering global and regional strategic options of viable strategies, looking at all options, such as:

• Manufacturing
• Generics launches
• Reformulations
• Bridging
• Value enhancement

We also undertook a roadshow workshop for each of six markets and provided a template and guidance to co-ordinate strategies and tactics. All options were backed up by financial models.