Early Thinking Pays Off In Powerful Launch Labels

The first thing everyone wants to know about a new drug is, “how is it better?” The way the answer is worded in TV commercials, online promotion, and physician sales materials can be worth billions of dollars to a pharma manufacturer. And it all depends on what the FDA or the EMA allows in the label.

For an early example, Eli Lilly’s TV commercials for Cialis said outright that the product is “ready when you are” for men with erectile dysfunction. (Competitor Viagra’s window of efficacy is just 4 hours). Observers familiar with development of Cialis say that as soon as Phase II studies showed a 17-hour half-life, the team began strategizing how to get competitive language about it into the label. “Improves erectile function compared to placebo up to 36 hours post-dose” became a key part of the Dosage and Administration section, helping propel Cialis to blockbuster sales. And even as the company was launching the product for PRN use, it was conducting studies to get a lower-dose, daily-use version approved, anticipating a whole new market.

A set of best practices has emerged starting at Phase II, or even earlier for orphan diseases and oncology drugs. Some call this process label optimization; our proprietary process for it is called Winning Label. Name it what you like, these steps bring strategic discipline and collaboration to the task of optimizing clinical trial design for competition, beyond simply getting to market faster.

Step 2: Define the launch environment

Intelligence-gathering should be future-oriented. In our process, for example, we define the upcoming launch environment: how stakeholder expectations will evolve, new market entrants, genericization and changes in clinical, access and reimbursement guidelines. We look at how the FDA and the EMA accept new biomarkers and other efficacy/safety metrics. The goal: to identify label claims that will win this drug a compelling value proposition in the years following its launch half a decade from now.

We also review clinical trial designs for pipeline competitors. What outcomes are they measuring? What assumptions are they challenging?

A deep understanding of audiences and their unmet needs drives this quest for unexpected, uncontested, or superlative label language that can prevail in current and future markets. As an example, for years marketers of hormonal birth control assumed a period-like monthly discharge was mandatory... until they listened to patients who clamored for freedom from the need for tampons, pads and PMS. An entire new category of "pills" and label claims emerged in Seasonale, Lybrel, and others.

Some factors we consider are:

• What primary endpoint addresses the desired claim in a clinically meaningful way? Is it a well-established endpoint? Are secondary endpoints such as patient-reported outcomes (PROs) needed to differentiate the product commercially? What is needed to prove controversial claims such as less abuse potential, efficacy in obesity, or improved compliance? Consider factors such as patient preferences for dosing regimen, or tablet size, or particularly unwelcome adverse events that PROs could document.
• What are our pivotal trial design options, especially regarding comparators? Out-performing a weak comparator will not be impressive if the market has already moved away from using it.
• Will use of novel emerging clinical trials designs (such as adaptive and basket trials) cause confusion to physicians and their patients?
• How would we quantify opportunities like the clinical impact of un-addressed administration, storage, and other management hurdles we can solve through form factors, packaging, or kinetics?
• What must be shown to claim an earlier place in a treatment sequence? In combination with other drugs, or as monotherapy?
• In our current environment, where patient convenience or tolerability do not always factor into reimbursement decisions, is there a safety signal that we could turn to potential advantage? Should our trials be designed a priori to compare a specific unwanted event and potentially claim superiority over a competitor, rather than rely on a posteriori comparisons that provide less compelling proof?
• How will the clinical trial patient population affect commercial use? Will inclusion or exclusion criteria expand or limit broader utilization in the elderly and/or children? Conversely, can we “own” an unmet need characterized by an underserved subpopulation of patients – for example, treatment-naive (or on concomitant therapy), or genetically distinct patient groups.

We look as well at practicalities. The more outcomes studied, the longer and more costly the clinical development program. Add in regulatory negotiation time if you use new biomarkers, endpoints, or non-standard metrics, and budgets and timelines maybe upended.

Clinical colleagues can offer valuable counsel early on, while the team evaluates options and before it issues bid requests. They can suggest less costly approaches, advise on recruitment, and show how to capture data points that might be overlooked. For example, if shorter time to onset of effect is a potential claim, these experts can advise on how costly capturing data more frequently and/or increasing statistical power through large sample sizes would be.

Benefits Of Using This Process
A label optimization process such as Winning Label can deliver a strong return on investment for any drug, but it is particularly valuable for products entering rapidly-changing fields like oncology, in areas where real-world evidence is gaining acceptance, and for small/midsize companies with limited experience commercializing new drugs. Does your process include these best practices? The answer could have profound consequences for your product’s bottom line.

Check out the article on Pharma intelligence.