Risk-sharing in the Pharmaceutical Industry

The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.

Klappentext

The costs of developing a new drug have reached record levels in the pharmaceutical industry. As any failure of a new drug candidate can lead to significant losses, many pharmaceutical companies are looking for new approaches to reduce their exposure to R&D risks. In this context, the book deals with the topic of out-licensing as a novel form of risk-sharing collaborations. The phenomenon of out-licensing is illustrated by three major case studies of Novartis, Schering and Roche as well as several smaller case studies. In addition, the Noble Prize awarded economic theory of Adverse Selection is applied to analyze the topic theoretically. The gained insights allow identifying the critical parameters of out-licensing collaborations and thereby provide R&D managers with recommendations on how to conclude and manage this type of deals more effectively.

Zusammenfassung
The productivity in pharmaceutical research and development faces intense pres­ sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re­ cord level of close to US$ 1 billion today. As a result, any failure of a new sub­ stance in the R&D process can lead to considerable losses, and the risks of introduc­ ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.

Inhalt
Key Issues in Managing Pharmaceutical Innovation.- Risk-sharing as New Paradigm in Pharma R&D Collaborations.- Case Studies on Risk-sharing in Pharma R&D Collaborations.- Characteristics of Risk-sharing in Pharma R&D Collaborations.- Theoretical Basis for Risk-sharing in Pharma R&D Collaborations.- Managerial Recommendations for Risk-sharing in Pharma R&D Collaborations.- Conclusion.