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Imagine you are VP of Product Development at a smaller-sized private Generics Pharmaceutical company, with approximately 200 million dollars in annual sales from two generic drugs that focus on the diabetic market. Things have been pretty sweet up to now, but newer innovator drugs are coming to market that are far superior to your 15 year old generic products both in efficacy and safety.
Today, your company’s CEO asked you to prepare a strategy on whether to pursue one of the several options that may enhance product development and your company’s position in the marketplace. Two anti- obesity drugs are coming off patent and may be viable candidates to expand your product line and enter the weight loss market. Estimates indicate that it could raise annual sales 100% to 400 million dollars. However, your company has also become aware of a smaller European research company with one product in early Phase 2 studies that is showing promise for use as an anti-dementia drug. This option is projected to be a blockbuster, with projected annual sales of approximately $750 million, and could put your company on the map with the potential to go public. In this case, your company must make a substantial investment to continue the European firm’s clinical research, but in exchange your company will obtain an exclusive licensing and distribution agreement.
Compare and contrast the issues with either strategy and provide a recommendation to your CEO. Please assure that you cover the regulatory requirements, including data and information needs, to accomplish your chosen path.
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