Unmatched experience and expertise

 

We have a deep understanding of the European pharmaceutical market, which we have gathered in senior executive positions over many years.

We have mastered the complexities of operating in different jurisdictions, languages and cultures and we use our knowledge to maximize the potential for commercial success of our partners’ products regionally and locally.

 

Complex European markets

Europe is a highly attractive pharmaceutical market with a total population of over 500 million and annual expenditures of $145 billion (branded and generic drugs). This market is second only to North America.

 

At the same time the European pharmaceutical arena is complex. Although the European Union is often called a single market, it remains highly diverse. Successfully launching a new product across Europe requires local infrastructure, expertise and a deep understanding of the complexities of European markets.

 

EUROPE

United States

  • Largest market in the world
  • Centralized approval from the FDA
  • P&R is handled by major insurers, the top 10 of which cover 50% of the insured population
  • Highly concentrated around three wholesalers
  • Strict practices on transfer of value relationships
  • Homogenous language, culture and laws
  • Second largest market in the world
  • Approval is granted through the centralized process by EMA for certain types of products. For others, the mutual recognition or decentralized process may be used
  • P&R is handled in each country by multiple government agencies, each imposing varying requirements
  • Pricing is often determined by referencing other countries, making geographical launch sequence critical to maximizing profitability
  • Multiple wholesalers in each country sell to mostly independent pharmacies, complicating efforts at managing supply chains
  • Includes compliance with transfer of value statutes, incorporation of risk management plans (pharmacovigilance and REMS), and strict observance of FCPA and UK Bribery Act for U.S.-based companies
  • Heterogeneous assortment of languages, cultures and labor laws, requiring a tailored, country-focused approach
  • Requirement for detailed integration of strategies and systems

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Novel entry strategies

The prospect of commercializing a product across Europe's multiple markets can be daunting. The idea of establishing a commercial organization and product from scratch in this environment is often overwhelming, and is sometimes simply written off. Other companies do decide to launch in Europe, but opt to out-license the drug to a big pharmaceutical company, which is well established in Europe. While out-licensing cuts down on the risk it can also reduce a company's profits, and they typically lose strategic control over their asset. At the same time, there is no guarantee that the licensing company will treat the product as its No 1 priority.

 

Our value proposition bridges the gap between traditional go-it-alone and out-licensing strategies by providing a low risk shared-value approach. It could also be called a “go-it-alone – with us” strategy. We commercialize our partners’ products on their behalf. Our partnering models are tailored to fit our partners’ strategic goals, and allow them the option to recapture the asset and, if desired, the dedicated commercial organization we have built for them, at any time of the partnership.

 

European launch excellence

We co-develop European commercial strategy with our partners and execute it on our partners’ behalf but at our financial risk. We build and manage right-sized European commercial organizations, engage with multiple different stakeholders, and identify market-specific solutions for our partners’ products.

 

We leverage our unmatched launch expertise and lead our partners’ products through all the steps towards a successful European commercialization, including regulatory filing, IP protection, market access, P&R negotiations, product launch, and stakeholder management, through to the maintenance of its long-term value.

 

Building a European business

Building commercial operations from scratch requires local resources and expertise.

Attracting senior executives with the required know-how and experience can be a challenge and takes time.

 

Our Executive Team has a proven track record in establishing start-ups, building right-sized commercial organizations and launching new products. Thanks to our extensive network, we are able to rapidly recruit and train the required talent.