Looking for the Pharmaceutical Product Fountain of Youth? Strategic Repositioning May Be the Answer

The crucial question when determining the fate of a mature product; where do we go from here?  From the mid-point of the product lifecycle onward the momentum gained from a very successful launch slowly begins to dampen.  New product entries, new data from competitors, generic competition, and changes in practice patterns all contribute to the product assault.   

Loss of market share is not inevitable.  Careful and critical evaluation of the potential pathways is very important.  There are multiple ways that strategic repositioning may be approached.  The exact approach will be driven by the unique circumstances surrounding the product, clinical environment and financial resources.  In one form, repositioning uses available data to further differentiate the product with upcoming generic competitors and insulate the brand from the most immediate effects of generic competition.  This ranges from specific patient subtypes to supporting data which further enhances the product’s unique benefits.  This also includes the engagement of new target audiences.

Strategic repositioning also may involve the identification of method to improve the molecule or formulation that justifies issuance of a new patent for the product.  In the 1990s several examples of this strategy are readily apparent (e.g., Prilosec to Nexium; Albuterol to Xopenex).  Finally, new formulation and delivery tactics could be used to develop an entire new product or category.  For example, salmeterol plus fluticasone equals Advair and formoterol plus budenoside equals Symbicort.

Which direction to take is guided by an analysis incorporating these four key elements:

•        Fully leverage clinical data to determine key opportunities for repositioning based upon key differentiators.

•        Determine the full potential with respect to labeling, follow-on products, and intellectual property.

•        Using data-mining techniques standardize clinical data into a consistent, accessible, and reviewable format.  Potential new indications or delivery methods can be fully explored to extend the exclusivity of a product.

•        A data-centric approach will support patent longevity, novel dosage forms within the standard exclusivity period, as well as line extensions afterward.

Effective repositioning will most certainly breathe new life into a pharmaceutical product.  It is the closest thing to the product fountain of youth.