Market entry strategy

Background and objectives

Our client wished to build an oncology franchise based on their lead product, a novel minor-groove DNA binding agent. The first indication targeted was 'malignant soft tissue sarcoma'. This indication was to be followed up with these indications:

• Renal cell carcinoma
• Metastatic malignant melanoma
• Non-small lung cancer (NSCLC)
• Metastatic breast cancer
• Metastatic ovarian cancer

The primary objective was to evaluate in strategic and financial terms different market entry options, from total licensing-out of the asset to marketing the product themselves, with intermediate options of co-promotion partnerships with companies with established oncology franchises.

For the stand-alone approach a detailed European business plan was prepared which included forecasting and the valuation of different options, the most important of which was whether to employ a contract sales force.

Approach

We designed a three phase project:

• Business analysis
  • Secondary research - external data
  • Internal financial data
  • Internal interviews
  • Forecast modelling
• Financial modelling
  • Building free cash flow model and NPV models
  • Risk analysis
  • External interviews
• Solutions and recommendations
  • Evaluation of financial outputs
  • Recommendations and presentation

Results delivered

A complete going-to-market strategy based on a robust forecast and financial numbers. We evaluated seven strategic options and prioritised them based on ROI and the strategic implications and long term goals of the company.

• Greenfield - 100% organic effort
• Contract sales force
• Co-promo win-win
• Co-promo favourable-profit share
• Co-promo favourable-high milestones
• Licence-out
• Co-promotion with big pharma company

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.