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

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 client’s portfolio.

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

Project

Mature Brands Revitalization Model

Client
Mid-size Specialty Pharmaceutical Company

Description
Our client’s business model relied on the acquisition of mature brands owned by major pharmaceutical companies. For a variety of reasons, these products were no longer being actively promoted by the major companies, and our client purchased them at a low cost with the intention of revitalizing them through renewed marketing efforts. Although our client had been successful in employing this model for the first several products acquired, they had experienced several disappointments with more recent additions to the portfolio. The goal was to develop a systematic approach to marketing that would maximize each product’s potential.

To achieve this objective, VOI conducted an in-depth examination of mature (5+ years after launch) pharmaceutical brands that had successfully reversed sales / share declines. This included extensive quantitative and qualitative analysis of all significant factors affecting product performance, including changes in amounts and allocations of marketing funds, competitive actions, marketing strategy, labeling, pricing and managed-care relationships.

Common factors in successful revitalization were identified and translated into a systematic approach for application with other mature brands.

Results
In addition to incorporating these principles into their marketing efforts, our client uses these guidelines in their acquisition process as they narrow down potential candidates to those that will be amenable to this approach.

Project

Over-the-Counter Launch Intentions, ANDA Approval

Client
Top 10 Generic Manufacturer, OTC Division

Description
Our client needed to know a competitor’s intentions towards launching a generic version of a popular allergy drug, which was about to make an Rx-to-OTC switch. Due to peculiarities in the FDA approval process, the status of the competitor’s ANDA was unknown and was holding up our client’s ability to launch — a potentially expensive proposition given that our client had already begun to manufacturer the product. Relying on a variety of sources, VOI was able to determine the status of the competitor’s application.

Results
VOI provided information that was used by the client’s legal team to move their tentatively approved ANDA to full approval status. As a result, our client was able to launch on time and to ship their accumulated inventory without loss.