Having a productivity crisis? Join the club. While you're waiting for those new classes of drugs to come to a boil, why not cook up some new indications for the hot products in your portfolio? From Abilify in mental illness and Lyrica in pain to Avastin in oncology and Rituxan in just about everything, drugs targeted at one disease are showing their versatility in treating other conditions.
Whether you call it franchise building, brand extension, or (our favorite) platform drugs, discovering novel markets for niche-busters is a little harder than rebottling old wine.
The quagmire of the unknown in drug development means companies are increasingly opting for a new paradigm built off of a familiar phrase: If you can't work harder, work smarter.
It's a philosophy that some have termed "strategic innovation," and it represents an increasingly important strategy for mitigating development risk, protecting sales derived from existing therapies, and identifying new revenue streams. The whole approach is based on developing additional indications and claims using what you learn from drugs in your portfolio—or your competitors'—to make new products. And it requires a change of perspective: companies should view their drugs as platforms (rather than specific products) upon which to build revenue with known efficacy and safety data.
Don't confuse this approach with the life cycle management strategies of the past. After all, throughout the 1990s, many companies aimed at preserving market share against lower priced generics by reformulating existing drugs into more convenient doses. It's an approach that remains popular today: reformulations accounted for more than 50 percent of all New Drug Applications between 2002 and 2005, according to PharmSource Information Services. But that approach alone is insufficient because payors balk at reimbursing "convenience-only" reformulations. Just look at Lilly's Prozac Weekly, the 2001 follow-up to the 1990s blockbuster Prozac. It failed to gain preferred payor tiering, which consequently sent US revenues spiraling from $2.05 billion in 2000 to $30 million in 2006.
Instead, companies should look to manage risk and reward by going beyond convenience claims and looking for ways to impact perceived efficacy by carrying out clinical trials in new populations, refractory subsegments, or the like. More specifically, this means generating new efficacy data for claims where the parent compound or other drugs in the class have fallen short. In the era of evidence-based medicine, a compound with novel clinical claims cannot be considered equivalent by payors when clinical trials demonstrate a differentiated clinical profile. For companies, that means new drugs—and significant new revenues.
The literature is rife with examples of companies that have capitalized on unmet medical needs in the market through strategic innovation. However, those successes only represent the tip of the iceberg. And considering the dearth of novel targets, the number of blockbuster agents coming off-patent in the next decade, and the lower clinical development risk associated with this approach, platform drugs cannot be overlooked.
Still, strategic innovation may appear easier said than done. That's because it requires the combined efforts of internal functional areas such as R&D and new business development, with external thought leaders, consultants, and the like to understand the subtle, unmet needs within existing indications that could be served by a clinical development program. However, there are resources there that can help companies explore potential new uses. For example, according to a 2006 article in the Archives of Internal Medicine, an estimated 20 percent of outpatient prescriptions are written for clinical indications for which the drug has not been FDA approved. Companies that monitor these real world prescription patterns, keep track of small, evidence-based studies supporting novel uses, and undertake small trials to test potential sources of differentiation, can begin to amass significant data to support the further development of a compound.
In this piece, we will explore successful case studies that highlight different approaches to strategic innovation. In so doing, we hope to enhance understanding of how to create platform drugs and combine clinical data and know-how with commercial creativity to determine how to best capitalize on novel opportunities.