The Opportunity

A pharma company’s lead product was approaching patent expiration in just two years, after which three generics would enter the market. A plan was needed quickly to help extend the profitability of the product.

The Solution

Instigator’s lifecycle management expert put together a team that explored and analyzed every available option, including AG, own generic, and a new dosage form. After extensive research, it was decided that the latter was the most viable given the limited timeline available.

A P&L model was developed and a launch plan created. A key element of the plan was launching the new dosage form at least one year before patent expiration, to enable patients to the new dosage form strength.

Our team communicated with the FDA to determine what, if any, studies would be needed to launch at a lower strength. Once it was indicated that no studies would be needed, our lifecyce management expert began work by identifying and partnering with a CDMO.

Many challenges and setbacks occurred during the development, including tablet compression and dissolution issues due to reduced size and need for bilayer tablet. However, Instigator’s solid project management and technical expertise resulted in a successful product development.

The Results

Unfortunately, due to both the development issues and the abbreviated timeline, launch could not occur as early as needed to ensure an adequate number of patients could be switched to achieve an optimal ROI.

We came away from this project with a lesson learned: lifecycle management planning must be an integral part of a product from the very beginning. Everyone worked very hard to make this project happen, but our efforts simply weren’t able to overcome a product without a lifecycle management plan in place at that point in its lifespan.

Today, when we work with clients at any point in the development process, we urge them to begin thinking about lifecycle management planning as early as possible, ideally as part of the product development plan.