PM360 MAY 2011

PM360 THINK TANK: Best Practices in Launching New Indications

Three questions for five experts at launching new indications:
How does launching a new indication differ from launching a new product?
Can you cite a particularly successful new-indication launch?
What are the critical pre- and post-launch decisions?

Mary Manna Anderson
President, Ogilvy CommonHealth
Medical Education and Ogilvy
CommonHealth and Scientific
Communications
mary.anderson@ogilvy.com

New-product launches allow you to exploit inherent marketplace opportunities—you’re the new player and can help redefine it. They also enjoy the “clean slate” of scientific development, permitting you to define the scientific story and build future equity. New-indication launches, however, leverage existing brand equity—for better or worse. New indications are commonly launched in the context of the initial indication and existing scientific platform. These “evolved” launches are best served by initial scientific platforms that are visionary and benefit from an initial educational platform that supports the new indication…or, at very least, doesn’t contradict it.

New indications are opportunities to ladder-up on effectiveness or clinical protection. This scenario builds the greatest emotional resonance and loyalty while leveraging the equity in the initial brand. Examples of this dynamic exist in cardiovascular medicine with beta-blockers and statins, which received initial indications in managing a disease, then gained greater secondary prevention indications. Controlling a disease is one thing, but laddering up to disease modification or establishing a mortality claim is a classic example of indications that build upon each other.

One of the most important pre-launch considerations is the product clinical-lifecycle plan. Scientific platforms should be built with a vision on the entire life of the product, recognizing that a launch indication may only be a small part of the brand’s potential. For example, a product initially indicated for adjunctive therapy, but with a potential for monotherapy, demands that the initial messaging and clinical dissemination be positioned to bring both short- and long-term success. The most important post-launch decision is to hold one’s ground on the well-conceived and -designed data communication plan. Opting for “pragmatic” switches in approaches will dilute both the communication plan and data development strategy. Simply put, make smart and sound decisions and stay the course!

Steve Hamburg
Chief Creative Partner
RosettaWishbone
steve.hamburg@rosettawishbone.com

Launching a new product typically involves the creation of a new brand. And creating a new brand is a comprehensive process that involves strategy, positioning, messaging, and creative execution—all on a fundamental level. An entirely new entity is built from the ground up, with its own visual presence, personality, and lexicon. And this new brand is inherently designed to be distinct from everything else in the competitive landscape. Launching a new indication is a different kind of undertaking, more akin to adding a wing to an existing house than to building the house itself. You’re still constructing something new, yet what you’re building should be contextual with the existing structure, conforming to the design and purpose that already exist. In fact, if the addition isn’t properly integrated into the existing structure, the entire house can be destabilized.

In similar fashion, the most effective launches of new indications are the ones that are most unified with the core brand. Even as new data, claims, and messages are communicated, the underlying brand value should be reinforced. As additional indications are added—which typically occurs in the life cycles of major pharma products—those indications should be marketed in a manner that’s continuous with the core strategic and creative imperatives of the brand.

A good example of this kind of coherent “indication expansion” (and one I was fortunate to work on) involved the brand Remicade (infliximab). Remicade is a monoclonal antibody/ TNF-alpha agent used in the treatment of autoimmune diseases. First launched in 1998 for the treatment of Crohn’s Disease, Remicade has since gained a number of important new indications: rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and ulcerative colitis. As each new indication was added, new claims, data, and messaging were added to the brand lexicon. Yet the overall brand “voice” was maintained, as was the overall brand “look.” Multiple indications did not result in fragmentation; rather, the brand was strengthened as a result of having expanded medical relevance and of communicating that relevance in a consistent, unified, branded way.

Ane Jones
SVP, Managing Director
BioLumina
ajones@biolumina.com

First impressions are everything. So a key difference in launching a new indication versus a new product is the level of brand awareness, attitudes, and familiarity associated with the first indication. A careful evaluation of any pre-existing perceptions is absolutely critical to launching subsequent indications. Is there a need to maintain, improve, or completely change this perception? The sooner we know what our target audience believes about our brand, the better our launch strategy will be.

The whole can be greater than the sum of its parts when it comes to brands with multiple indications. Therefore, another big difference in launching a new indication is the need to evaluate the level of synergy with the existing indication(s). Ideally, a new product with potential for multiple indications should have a brand vision and positioning at launch that will span its lifecycle. So, mining for insights that may identify common themes in physician behaviors and beliefs across indications is critical. Evaluating the scientific and clinical profiles, indication by indication, is equally important. Working with clients from early-stage development through launch, we are able to develop launch strategies and creative based on these insights. In certain situations, however, it may not be feasible to create a unified platform: different indications may present significantly different marketing environments, such as 1) the unmet needs of each indication-specific audience, 2) the clinical performance of the product by indication, and 3) the treatment drivers within each disease state. A careful analysis of these differences and/or similarities will help determine the best approach to launching the new indication.

Bob Lojewski
AVP, Commercial Development SNS
Pfizer
bob.lojewski@pfizer.com

Launching a new indication may differ from launching a new product in that, in some instances, you are looking to build upon the current customer experience with your product, assuming it will be used by the same prescriber base. The difference is subtle, but with new indications the emphasis is on the indication and secondarily on the product. The new indication is fulfilling a market expansion opportunity; the data for the new indication often helps the medical community better understand the benefits and risks of the product. Marketing teams need to ensure that the new information is highlighted for prescribers, as well as communicate how these data relate to the initial indication.

When launching a new product, the emphasis is on the product. The launch of a product requires the company to educate potential prescribers on the product’s method of action (if novel), followed by a review of data for a primary indication that appropriately captures the risk benefit profile of the product. Prescribers need to understand the safety and tolerability profile, as well as how to dose the product so they can use the product for those patients who are most likely to benefit.

Pre-launch, it is critical to consider whether the new indication requires a different dose, or if the new indication is treated by a new prescriber base. If dosage and prescriber are different, then the marketing team is effectively re-launching the product. Post-launch, you want to monitor the utilization of the product relative to the indications, to determine whether the product is performing up to expectations.

Stuart Davis
Head of Aesthetics Marketing
Dermik, a division of sanofi-aventis
stuart.davis@sanofi-aventis.com

A big difference between launching a new indication and a new product is the need to understand how to leverage or evolve the existing brand’s equity. To develop a campaign for a new indication, you need to consider the current perception of the brand. Conversely, a new-product launch offers a clean slate, where brand equity can be created without any constraints. New indications should also (on average) require less investment (assuming the current brand's equity is strong) and (typically) less physician training, education and sampling.

There are a number of critical pre- and post launch-decisions. One of the most important pre-launch steps is to understand the relative importance of physician and consumer audiences. Knowing this helps you figure out how to position the brand, develop a consistent brand image for all customer groups, and allocate spend at launch. Second, understand the perceptions of competing products in the category and the key unmet needs your brand can uniquely satisfy. And then develop a communication plan to maximize your brand's uptake. Some of the most important post-launch decisions are financially driven. Assess short term vs. long term profitability, to allow for optimum ROI via increased awareness spending upfront. And figure out how to optimally allocate the marketing mix between medical, physician promotion or consumer spending buckets as a function of where you are in the launch process. Finally, understand both how you are tracking towards your pre-launch goals and how to continue to drive sales well beyond the first year of launch.

One of the most successful launches in the dermatology aesthetic category has been Botox Cosmetic, a great example of a brand that is still in launch mode. Launched in 2003, the brand maintains strong consumer awareness, is a $1.5B global brand with double-digit growth, and new indications are still being added (like migraine, in 2011). The brand has become part of popular culture and is now a word in the dictionary.

The opinions expressed by the authors in the Think Tank section are their own and do not necessarily reflect those of their affiliated companies or organizations.