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Abstract ▼ AI-Helper

Most pharmaceutical licensing deals are made in the early stage of drug development. While this development process is not unique for complicated technology, a special feature of drug development is that it is highly regulated and a well-defined process. Its statistics in terms of costs and chances ...

Most pharmaceutical licensing deals are made in the early stage of drug development. While this development process is not unique for complicated technology, a special feature of drug development is that it is highly regulated and a well-defined process. Its statistics in terms of costs and chances of technical success have been researched extensively. This enables relatively detailed calculations as benchmarks for actual deals to be made. Based on such calculations and on the analysis of licensing terms in published agreements, various companies offer quite expensive information, databases, software programs and consultation services to help establish what might be reasonable economic terms in a licensing deal. Over the years, pharmaceutical royalties have been the subject of various articles in journals. Most specific on this subject was the article on determining pharmaceutical royalties. Many other articles are about a more general nature deal with determining reasonable royalty rates, evaluating and underpinning the empirical value and usefulness of the 25% rule. The object of this article is to provide a relatively simple analytical approach based on the major economic terms underlying pharmaceutical licensing deals. The aim is to enhance the understanding of the relations between the major factors involved. Details are disregarded, as generally, where the terms of licensing deals depend on predictions over a considerable length of time, the value of detail is limited. Some specific issues addressed by the approach are the impact on profits of large investments, high risks and long development times characteristic of drug development, the consequent strong impact that the ultimate sales levels and operating margins may have on what might be considered a reasonable royalty rate, and the relationship between upfront payments and milestone payments to be paid during pharmaceutical development and the royalties due once the drug enters the market.

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