Project

Post-patent Brand Defense Strategy, Injectable Oncology Market

Client

Leading specialty pharmaceutical company

Description

For the first time in the company’s history, our client was facing a loss of US patent protection on one of their key brands. VOI was brought in to help assess options and develop a strategy that would maximize profits on the franchise in the pre- and post-patent environment. Among the multitude of strategies considered were: launch of an authorized generic,  various pricing scenarios and potential lifecycle management options.

Strategy development required in-depth analysis of likely generic entrants and their capabilities, Medicare Part B and private payer reimbursement issues, influence of major customers including group purchasing organizations (GPOs) and the incentive structure of various parties in the decision-making chain. Using this research and analogous case histories, VOI developed a five year financial model incorporating top-line forecasts, the cost of executing each option and a timeline of important milestones.

In addition to evaluating external factors within the customer and competitive set, we  worked with the client to determine whether, based on the client company’s overall direction and capabilities, the recommended strategies were best handled in-house or by an outside partner.

Results

Our client is moving forward with one of the recommended strategies and expects to realize several hundred million dollars in revenue over the forecast period that would not have been realized in a typical post-patent environment.

Project

Global Biosimilar Strategic Opportunity Assessment

Client
Top 10 Generic Drug Manufacturer

Description
Our client needed to evaluate a number of strategic options regarding possible entry into the biosimilar category. VOI performed a thorough analysis of clinical, manufacturing, intellectual property and marketing issues in both advanced (e.g. US, EU, Canada) and emerging (e.g. India, China, Latin America) markets. The developing legislative and regulatory frameworks in these markets were explored in-depth. In countries such as the U.S., where governing regulations are not yet in place, the implications of various scenarios (e.g. different lengths of data exclusivity, clinical trial requirements) were explored.

Based on current market activity and probability-based (Monte Carlo) forecasts of future activity, we evaluated the commercial opportunity for the category as a whole and for selected biosimilar products. Factors considered in this phase included pricing / reimbursement, demand and penetration rates. Analyses of competitive actions, capital requirements, timing and potential partnership opportunities were also conducted. The final product included a net present value forecast of the biosimilar opportunity.

Results

The results of our analysis were used as the basis for recommendations on both market entry and a make or buy path forward. Our client is currently evaluating our findings.

Project

Structural Analysis of International Pharmaceutical Markets

Client
Top 5 Multinational Pharmaceutical Manufacturer

Description
Our client needed to understand the chain of influence in 11 international markets and how this affected the commercial prospects of their products. VOI examined the elements of the decision-making chain in these markets and determined the relative influence of each component (e.g. payers, prescribers, distributors, patients) on the product selection process.

Based on the results of our analysis, VOI recommended initiatives aimed at the most important decision-making segments in each country.

Results
Our client was able to realign their marketing efforts to focus on the most important elements of the decision-making chain, while cutting or minimizing programs aimed at less vital elements.

Project

Major Market Entry Assessment for Generic Drug Portfolio

Client
Top 20 U.S. Generic Manufacturer

Description
VOI was hired by a generic drug company to explore options for their product portfolio in Western Europe and Japan. Our client had not yet ventured into ex-U.S. regions and needed to understand these markets at both a structural and product-specific level.

For the structural component of our analysis, we assessed regulatory frameworks, approval procedures, generic pricing and reimbursement policies, penetration rates for branded and unbranded generics and customer characteristics. For the product-specific component, we looked at sales, volume and pricing trends at both the category (ATC-3 / 4) and compound levels, competitive presence, intellectual property status of original drugs and brand versus generic share figures.

Based on this analysis, VOI recommended a mix of products to launch in each country so as to maximize the commercial potential of our clients portfolio.

Results
Our client is in the process of filing approval applications based on our recommended mix of products and countries.

Project

Therapeutic Opportunity Analysis / Licensing Review

Client
R&D-based Biopharmaceutical Firm

Description
VOI reviewed the Congestive Heart Failure (CHF) market for a biotech firm that was deciding whether to follow its normal practice of licensing to a major company or to keep the new product in-house as a means of establishing itself as a full-service company with marketing and other capabilities.

We thoroughly evaluated the potential for this product based on its probability of approval and likelihood of commercial success.

Note: Although this project was specific to the CHF market, we have conducted numerous similar studies for virtually all major and minor therapeutic categories.

Results
Based on our work, our client decided that this product faced too many regulatory and commercial risks to justify a major change in company direction and decided to license the product. Our work served as the basis for product valuation in the licensing negotiations.